NICE Infection Control Guidelines

Partial Update of NICE Clinical Guideline 2
Infection: prevention and

control of healthcare-associated
infections in primary and
community care
Clinical Guideline
Methods, evidence and recommendations
Commissioned by the National Institute for

Health and Clinical Excellence
Infection Prevention and Control
Contents
Published by the National Clinical Guideline Centre at

The Royal College of Physicians, 11 St Andrews Place, Regents Park, London, NW1 4BT
First published 2003
© National Clinical Guideline Centre - 2012
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Contents
Explaining the changes in the partial update

This guidance partially updates and replaces NICE clinical guideline CG2, Infection control, prevention
of healthcare-associated infection in primary and community care (published June 2003).
New and updated recommendations have been included on infection prevention and control in
primary and community care.
Recommendations are marked to indicate the year of the last evidence review: [2003] if the evidence
has not been updated since the original guideline, [2003, amended 2012] if the evidence has not
been updated since the original guideline, but changes have been made that alter the meaning of the
recommendation, [2012] if the evidence has been reviewed but no change has been made to the
recommendation and [new 2012] if the evidence has been reviewed and the recommendation has
been added or updated.
New and updated evidence reviews and recommendations are shaded pink with ‘Update 2012’ in the
right hand margin.
Appendix D.10 contains recommendations from the 2003 guideline that have been consulted on for
deletion from this 2012 update. Details of any replacement recommendations are included. The
original NICE guideline and supporting documents are available from www.nice.org.uk/guidance/CG2

4
Contents
Contents
Guideline development group and project team............................................................................. 10
Guideline development group members (2012) ........................................................................ 10
Guideline development group members (2003) ........................................................................ 10
Guideline Development Group co-optees (2012) ...................................................................... 11
National Clinical Guideline Centre Project team (2012) ............................................................. 11
Acknowledgements (2012) ....................................................................................................... 12
Guideline Review Panel (2012) ................................................................................................. 12
Guidelines Advisory Committee (2003) ..................................................................................... 12
Stakeholder List (2012) ............................................................................................................. 12
1 Introduction ............................................................................................................................. 13
1.1 Introduction (2012) ........................................................................................................ 13
1.2 Introduction (2003) ........................................................................................................ 15
2 Development of the guideline ................................................................................................. 16
2.1 What is a NICE clinical guideline? .................................................................................... 16
2.2 Remit.............................................................................................................................. 16
2.3 Who developed this guideline? ....................................................................................... 17
2.4 What this guideline update covers .................................................................................. 17
2.5 What this guideline update does not cover ..................................................................... 18
2.6 Structure of the updated guideline ................................................................................. 18
2.6.1 Chapters .......................................................................................................... 18
2.6.2 Methodology ................................................................................................... 19
2.6.3 Recommendations ........................................................................................... 19
2.6.4 Appendices ...................................................................................................... 19
2.7 Relationships between the guideline and other NICE guidance ....................................... 19
2.8 Background and context to the Guidelines (2003) ........................................................... 20
2.9 Scope and Purpose of the Guidelines (2003) ................................................................... 20
3 Methods .................................................................................................................................. 21
3.1 Methods (2012) .............................................................................................................. 21
3.1.1 Amendments to 2003 text ............................................................................... 21
3.1.2 Developing the review questions and outcomes .............................................. 21
3.1.3 Searching for evidence ..................................................................................... 25
3.1.4 Evidence of cost-effectiveness ......................................................................... 31
3.1.5 Developing recommendations ......................................................................... 33
3.2 Methods (2003) .............................................................................................................. 35
4 Guideline summary .................................................................................................................. 37
4.1 Key priorities for implementation ................................................................................... 37

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Contents
4.1.1 Standard principles – general advice ................................................................ 37

4.1.2 Standard principles for hand decontamination................................................. 38
4.1.3 Long-term urinary catheters ............................................................................ 38
4.1.4 Vascular access devices .................................................................................... 39
4.2 Full list of recommendations........................................................................................... 40
4.2.1 Standard Principles .......................................................................................... 40
4.2.2 Long-term urinary catheters ............................................................................ 44
4.2.3 Enteral feeding ................................................................................................ 46
4.2.4 Vascular access devices .................................................................................... 47
4.3 Key research recommendations...................................................................................... 51
4.3.1 Standard principles of infection prevention and control ................................... 51
4.3.2 Hand decontamination .................................................................................... 51
4.3.3 Intermittent urinary catheters: catheter selection............................................ 51
4.3.4 Indwelling urinary catheters: catheter selection ............................................... 51
4.3.5 Indwelling urinary catheters: antibiotic prophylaxis ......................................... 51
4.3.6 Vascular access devices: skin decontamination ................................................ 51
5 Standard Principles .................................................................................................................. 52
5.1 Introduction ................................................................................................................... 52
5.2 Education of patients, carers and their healthcare workers............................................. 52
5.2.2 Review question .............................................................................................. 55
5.3 Research recommendation ............................................................................................. 61
6 Standard principles for hand decontamination........................................................................ 62
6.1 Introduction ................................................................................................................... 62
6.2 Why is hand decontamination crucial to the prevention of healthcare-associated
infection in the community? ........................................................................................... 63
6.3 When to decontaminate hands ....................................................................................... 64
6.3.1 Review question .............................................................................................. 64
6.4 Choice of hand cleaning preparation............................................................................... 72
6.4.1 Review question .............................................................................................. 72
6.5 Decontaminating wrists and bare below the elbow policy............................................... 78
6.5.1 Review question .............................................................................................. 78
6.6 Is hand decontamination technique important? ............................................................. 82
6.7 Does hand decontamination damage skin? ..................................................................... 82
6.8 Research recommendations ........................................................................................... 83
7 Standard principles for the use of personal protective equipment .......................................... 84
7.1 Introduction ................................................................................................................... 84
7.2 Infection Control Dress Code – protect your patients and yourself! ................................ 84
7.3 Gloves: their uses and abuses ......................................................................................... 85
7.3.1 To glove or not to glove?.................................................................................. 85

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Contents
7.3.2 Do gloves leak? ................................................................................................ 85

7.4 Which types of gloves provide the best protection against healthcare-associated
infections? ...................................................................................................................... 87
7.4.1 Review question .............................................................................................. 87
7.5 When should plastic aprons or fluid repellent gowns be worn?....................................... 90
7.5.1 Review question .............................................................................................. 90
7.6 When is a facemask, eye protection or other facial protection necessary? ...................... 97
8 Standard principles for the safe use and disposal of sharps..................................................... 98
8.1 Introduction ................................................................................................................... 98
8.2 Sharps injuries – what’s the problem? ............................................................................ 98
8.3 Do safety cannulae reduce sharp injuries compared to standard cannulae? .................. 102
8.3.1 Review question ............................................................................................ 102
8.4 Do safety needle devices reduce sharps injuries compared to standard needles? ......... 105
8.4.1 Review question ............................................................................................ 105
9 Waste disposal....................................................................................................................... 112
9.1 Introduction ................................................................................................................. 112
9.1.2 Research recommendations........................................................................... 115
10 Long term urinary catheters .................................................................................................. 116
10.1 Introduction ................................................................................................................. 116
10.2 Education of patients, carers and healthcare workers ................................................... 117
10.3 Assessing the need for catheterisation.......................................................................... 117
10.4 Catheter drainage options ............................................................................................ 118
10.4.1 How to select the right system ....................................................................... 118
10.5 Types of long-term catheters ........................................................................................ 119
10.5.1 Review question – intermittent catheters ...................................................... 119
10.5.2 Review question – long-term indwelling catheters ......................................... 133
10.5.3 Is one catheter better than another? ............................................................. 136
10.6 Asepsis ......................................................................................................................... 137
10.6.1 Review question ............................................................................................ 137
10.7 Catheter Insertion ........................................................................................................ 138
10.7.1 Catheterisation is a skilled procedure............................................................. 138
10.8 Catheter Maintenance .................................................................................................. 138
10.8.1 Leave the closed system alone! ...................................................................... 138
10.8.2 Appropriate maintenance minimises infections.............................................. 139
10.9 Do bladder instillations or washouts reduce catheter associated symptomatic urinary
tract infections? ............................................................................................................ 140
10.9.1 Review question ............................................................................................ 140
10.9.2 Changing catheters ........................................................................................ 149
10.10 Use of antibiotics when changing long-term urinary catheters ...................................... 149

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Contents
10.10.1 Review question ............................................................................................ 149

10.10.2 Cost-effectiveness evidence ........................................................................... 150
10.10.3 Evidence statements ...................................................................................... 151
10.11 Areas for Further Research ........................................................................................... 153
10.12 Research Recommendations......................................................................................... 154
11 Enteral feeding....................................................................................................................... 156
11.1 Introduction ................................................................................................................. 156
11.2 Education of patients, carers and healthcare workers ................................................... 157
11.3 Preparation and storage of feeds .................................................................................. 158
11.3.1 Select the right system ................................................................................... 158
11.3.2 Hygienic preparation of feeds is essential ...................................................... 158
11.3.3 Store feeds safely........................................................................................... 158
11.4 Administration of feeds ................................................................................................ 159
11.4.1 Minimal handling reduces risk........................................................................ 159
11.4.2 Review question ............................................................................................ 160
11.5 Care of insertion site and enteral feeding tube ............................................................. 161
11.5.1 Keep the tube clear ........................................................................................ 161
11.5.2 Review question ............................................................................................ 161
11.6.1 Preparation and storage of feeds ................................................................... 163
11.6.2 Administration of feeds.................................................................................. 163
12 Vascular access devices .......................................................................................................... 164
12.1 Introduction ................................................................................................................. 164
12.1.1 Expert review of evidence .............................................................................. 165
12.2 Education of patients, carers and healthcare professionals ........................................... 165
12.3 Aseptic technique ......................................................................................................... 166
12.3.1 Review question ............................................................................................ 166
12.4 Skin decontamination prior to insertion of peripheral vascular access devices .............. 168
12.4.1 Review question ............................................................................................ 168
12.5 Types of vascular access device dressing ....................................................................... 174
12.5.1 Review question ............................................................................................ 174
12.6 Vascular access device frequency of dressing change.................................................... 182
12.6.1 Review question ............................................................................................ 182
12.7 Decontaminating skin when changing dressings............................................................ 186
12.7.1 Review question ............................................................................................ 186
12.8 General Principles for management of vascular access devices ..................................... 196
12.8.1 Decontaminating peripheral and centrally inserted catheter ports and hubs
before access ................................................................................................. 196
12.8.2 Review question ............................................................................................ 196

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Contents
12.8.3 Inline filters do not help prevent infections .................................................... 198

12.8.4 Antibiotic lock solutions have limited uses in preventing infection ................. 198
12.8.5 Systemic antibiotic prophylaxis does not reliably prevent CRBSI ..................... 198
12.8.6 A dedicated catheter lumen is needed for parenteral nutrition ...................... 199
12.8.7 Maintaining catheter patency and preventing catheter thrombosis may help
prevent infections .......................................................................................... 199
12.8.8 Systemic Anticoagulation ............................................................................... 199
12.8.9 Heparin versus normal saline intermittent flushes ......................................... 200
12.8.10 Needleless devices require vigilance .............................................................. 201
12.8.11 Change intravenous administration sets appropriately................................... 201
12.9 Administering infusions or drugs................................................................................... 202
12.9.1 Review question ............................................................................................ 202
12.9.2 Clinical evidence ............................................................................................ 202
12.9.3 Cost-effectiveness evidence ........................................................................... 202
12.9.4 Evidence statements ...................................................................................... 202
12.9.5 Recommendations and link to evidence ......................................................... 202
12.10.1 Current issues ................................................................................................ 203
12.10.2 Emerging Technologies .................................................................................. 203
12.11 Research recommendations ......................................................................................... 203
13 Glossary ................................................................................................................................. 204
14 Abbreviations ........................................................................................................................ 218
15 Reference List ........................................................................................................................ 220

9
Guideline development group and project team

Guideline development group members (2012)
Name Role
Dr Carol Pellowe (Chair) Senior Lecturer Infection Control, Florence Nightingale School of Nursing and
Midwifery, King's College, London
Elizabeth Gibbs Patient member and member of National Alliance of Childhood Cancer
Parents Organisations (NACCPO)
Ms Ellie Hayter Professional Practice Lead, Sussex Community NHS Trust, West Sussex
Mrs Zara Head Nurse Practitioner, Doncaster
Update 2012
Dr Eugenia Lee General Practitioner, Thamesmead, London
Associate in Public Health at Greenwich Teaching Primary Care Trust,
Greenwich
Mr Michael Nevill Infection Control Lead, British Pregnancy Advisory Service (bpas)
Mr Brian Pullen Infection Control Manager and Registered Paramedic, South East Coast
Ambulance Service NHS Foundation Trust
Dr Godfrey Smith Consultant Medical Microbiologist, and Infection Prevention Doctor, Royal
Liverpool and Broadgreen University Hospitals NHS Trusts (member until
GDG 7)
Dr Julian Spinks General Practitioner, Strood, Kent
Dr Sally Stucke Consultant Paediatrician (Community Child Health), Wye Valley NHS Trust
(formerly Hereford Hospital NHS Trust)
Mr Graham Tanner Patient member, Member of National Concern for Healthcare Infections
(NCHI)
Mrs Sue Wright Lead Nurse Infection Prevention and Control, Cornwall and the Isles of Scilly
Primary Care Trust, Cornwall
Guideline development group members (2003)

Name Role
Dr Anne Mulhall (Chair) Independent Consultant
Prof Robert Pratt Project Director, Thames Valley University, London
Carol Pellowe Project Manager, Thames Valley University, London
Dr Godfrey Smith Honorary Consultant Microbiologist, Royal Liverpool Hospital
Dr Sarah Chieveley Williams Consultant Anaesthetist, University College Hospital NHS Trust, Harrow
Mr Joe Peters Consultant Surgeon, Princess Alexandra Hospital, Harlow
Mr PJR Shah Senior Lecturer in Urology and Consultant Urologist, University College
London Hospital NHS Trust
Prof David Silk Consultant Physician, Central Middlesex Hospital, London
Dr Jim Newey General Practitioner, Weaver Vale Practice, Runcorn
Jo Bray Nutrition Nurse Specialist, Central Middlesex Hospital, London
Daphne Colpman Continence Adviser, University College London Hospitals NHS Trust
Anne Carroll Community Infection Control Nurse, South West Kent Primary Care Trust
Nicola Pratelli Community Infection Control Nurse, South West London Health Protection
Unit

10
Name Role
Ian McQuarrie District Nurse Team Leader, Langthorne Health Centre, London
Mrs Carolyn Wheatley Patient representative, Patients on Intravenous and Nasogastric Nutrition
Therapy (PINNT)
Gerry Richardson Research Fellow (Health Economist), Centre for Health Economics, York
Lisa Cooper Head of Dietetics, St Catherine’s Hospital, Wirral
Elizabeth McInnes Senior Research and Development Fellow, National Collaborating Centre for
Nursing and Supportive Care
Guideline Development Group co-optees (2012)

Name Role
Ms Kelly Alexander Lead Antibiotic Pharmacist, Central Manchester Foundation NHS Trust
Dr Paul Averley General Dental Practitioner
Ms Daphne Colpman Incontinence Specialist, St Helier Hospital, Epsom
Mr Andrew Jackson Consultant Nurse, Intravenous Therapy and Care, Rotherham General
Hospital
Ms Vera Todorovic Consultant Dietician in Clinical Nutrition, Dietetic and Nutrition Services,
Bassetlaw Hospital, Worksop
Professor Mark Wilcox Consultant / Clinical Director of Microbiology/ Pathology, Leeds Teaching
Hospitals NHS Trust. Professor of Medical Microbiology, University of Leeds.
Lead on Clostridium difficile infection in England, Health Protection Agency
Update 2012
National Clinical Guideline Centre Project team (2012)
Name Role
Ms Joanna Ashe Senior Information Scientist
Ms Nina Balachander Senior Research Fellow and Project Manager (until September 2010)
Ms Sarah Bermingham Health Economist
Dr Caroline Blaine Research Fellow (from January 2011)
Dr Lee-Yee Chong Senior Research Fellow
Mrs Karen Head Senior Research Fellow and Project Manager (from September to December
2010)
Dr Sarah Hodgkinson Senior Research Fellow and Project Manager
Dr Jennifer Hill Guidelines Operations Director (until March 2011)
Ms Susan Latchem Guidelines Operations Director (from March 2011)
Dr Smita Padhi Research Fellow (from January 2011)

11
Acknowledgements (2012)
The Guideline Development Group and project team would like to thank David Wonderling, Hati
Zorba, Ebenezer Tetteh, Liz Avital and Cordelia Coltart (RCP clinical advisor) for all their help and
support throughout the guideline. We would also like to thank Drs Kathy Zebracki, Lawrence Vogel,
Caroline Anderson, and Ms. Kathleen Chlan for providing access to quality of life data collected from
their research cohort of patients with spinal cord injuries. In addition, we would like to thank Simon
Update 2012
Harrison, Consultant urological surgeon, who helped with queries on care of patients with long-term
urinary catheters.
Guideline Review Panel (2012)

The Guideline Review Panel is an independent panel that oversees the development of the guideline
and takes responsibility for monitoring concordance to NICE guideline development processes. In
particular, the panel ensures that stakeholder comments have been adequately considered and
responded to.
Guidelines Advisory Committee (2003)

Name Role
Professor Martin Eccles Professor of Clinical Effectiveness, Centre for Health Services Research,
(Chairman of the University of Newcastle upon Tyne
Committee)
Miss Amanda Wilde Association of British Healthcare Industries (ABHI) representative
Mrs Joyce Cormie Lay representative
Mrs Judy Mead Head of Clinical Effectiveness, Chartered Society of Physiotherapy
Dr Marcia Kelson Director, Patient Involvement Unit for NICE, College of Health, London
Stakeholder List (2012)
Update 2012
The full list of stakeholders is listed in Appendix C.

12
Introduction
1 Introduction
1.1 Introduction (2012)
Clinical context
A wide variety of healthcare is delivered in primary and community care settings. Healthcare-
associated infections arise across a wide range of clinical conditions and can affect patients of all
ages. Healthcare workers, family members and carers are also at risk of acquiring infections when
caring for patients.
HCAI can occur in otherwise healthy individuals, especially if invasive procedures or devices are used.
For example: indwelling urinary catheters are the most common cause of urinary tract infections and
bloodstream infections are associated with vascular access devices.
HCAI are caused by a wide range of microorganisms. These are often carried by the patients
themselves, and have taken advantage of a route into the body provided by an invasive device or
procedure. HCAI can exacerbate existing or underlying conditions, delay recovery and adversely
affect quality of life.
Patient safety has become a cornerstone of care and preventing HCAI remains a priority. It is
estimated that 300,000 patients a year in England acquire a HCAI as a result of care within the
NHS180. In 2007, meticillin-resistant Staphylococcus aureus (MRSA) bloodstream infections and
Clostridium difficile infections were recorded as the underlying cause of, or a contributory factor in,
approximately 9000 deaths in hospital and primary care in England.
Update 2012
HCAI are estimated to cost the NHS approximately £1 billion a year, and; £56 million of this is
estimated to be incurred after patients are discharged from hospital180. In addition to increased
costs, each one of these infections means additional use of NHS resources, greater patient
discomfort and a decrease in patient safety. A no tolerance attitude is now prevalent in relation to
avoidable HCAI.
Rationale for the update
Since the publication of the NICE clinical guideline on the prevention of HCAI in primary and
community care in 2003, many changes have occurred within the NHS that place the patient firmly at
the centre of all activities. First, the NHS Constitution for England69 defines the rights and pledges
that every patient can expect regarding their care. To support this, the Care Quality Commission
(CQC), the independent regulator of all health and adult social care in England, ensures that health
and social care is safe, and monitors how providers comply with established standards. In addition,
the legal framework that underpins the guidance has changed since 2003.
New guidance is needed to reflect the fact that, as a result of the rapid turnover of patients in acute
care settings, complex care is increasingly being delivered in the community. New standards for the
care of patients and the management of devices to prevent related healthcare-associated infections
are needed that will also reinforce the principles of asepsis.
This clinical guideline is a partial update of ‘Infection control: prevention of healthcare-associated

infection in primary and community care’ (NICE clinical guideline 2; 2003), and addresses areas in
which clinical practice for preventing HCAI in primary and community care has changed, where the
risk of HCAI is greatest or where the evidence has changed. The Guideline Development Group (GDG)
recognise the important contribution that surveillance makes to monitoring infection, but it is not
within the scope of this guideline to make specific recommendations about this subject. Where high-
quality evidence is lacking, the GDG has highlighted areas for further research.
13
Introduction
Audience
The population covered in this guideline is all adults and children receiving healthcare where
standard infection control precautions apply in primary and community care. This guideline is
commissioned by the NHS, but people providing healthcare in other settings, such as private settings,
may also find the guidance relevant.
This guideline applies to all healthcare workers employed in primary care and community care
settings including ambulance services and will ensure safe practice if applied consistently. Much care
is also delivered by informal carers and family members and these guidelines are equally applicable
to them.
Healthcare settings covered by this guideline are:

• Primary care settings, such as general practices, dental clinics, health centres and polyclinics. This
also includes care delivered by the ambulance service.
• Community care settings (such as residential homes, nursing homes, patient's own home, schools
and prisons) where NHS healthcare is provided or commissioned.
Style
The GDG recognised that there is a legal duty to implement some of the recommendations in this
guideline in order to comply with legislation. The word ‘must’ is used in these recommendations and
Update 2012
details of the relevant legislation are given in footnotes to the recommendations.
The GDG was also aware that the consequences of not implementing some other recommendations
on patient safety would be very serious – that is, there would be a greatly increased risk of adverse
events, including death. The GDG therefore concluded that that the use of the word ‘must’ in these
recommendations is justified, in line with the guidance in chapter 9 of ‘The guidelines manual
(2009)’.For ease, the GDG have added details of the applicable legislation as footnotes to the
relevant recommendations. All other instances of ‘must’ in a recommendation should be considered
related to patient safety and the high risk of adverse events to patients if they are not implemented.
Medical Device Regulations169 implement the EC Medical Devices Directives into UK law. They place
obligations on manufacturers to ensure that their devices (including medical gloves, needles and
other devices discussed in this guideline) are safe and fit for their intended purpose before they are
CE marked and placed on the market in any EC member state. Guidance168 on the MHRA's adverse
incident reporting system is available for reporting adverse incidents involving medical devices.
This update is integrated with the original recommendations and evidence from the 2003 guideline.
Changes in methodology and processes since 2003 have resulted in a different presentation of the
evidence that has informed the Guideline Development Group discussions in 2012. The
recommendations made in this update are clearly marked as New 2012 or Amended 2012. The
original recommendations for which the evidence has not been reviewed or updated are marked
2003. The 2003 recommendations that have not been deleted or replaced as part of this update
remain current and applicable to the NHS and are enhanced by the revisions made in this update.
14
Introduction
1.2 Introduction (2003)

These guidelines were directly funded by the Department of Health (England) with additional funding
from The National Institute for Clinical Excellence (NICE).
NICE commissioned the development of these guidelines from Thames Valley University under the
auspices of the National Collaborating Centre for Nursing and Supportive Care. The full guidelines for
preventing healthcare-associated infections in community and primary care are published by Thames
Valley University and are available on its website <www.richardwellsresearch.com>, the NICE
website <www.nice.org.uk> and on the website of the National Electronic Library for Health
<www.nelh.nhs.uk>.
These guidelines were developed by a multidisciplinary Guideline Development Group (GDG) that
represented all key stakeholders and included a patient representative.
Due to the breadth of the guideline, several members were appointed for their specialist knowledge
of a particular medical device.
Conflicts of interest were formally monitored throughout the guideline development period and
none was noted.
The aim of the group was to develop recommendations for practice based on the available evidence
and knowledge of the practicalities of clinical practice.
The group met at approximately monthly intervals and followed the working procedures outlined by
NICE.
During the scoping exercise, patient groups were contacted for their advice and visits made to
specialist centres to discuss issues with patients and staff. Arrangements were made with a patients’
organization to give extra support to the patient representative to be able to comment on all devices.
15
Development of the guideline
2 Development of the guideline

2.1 What is a NICE clinical guideline?
NICE clinical guidelines are recommendations for the care of individuals in specific clinical conditions
or circumstances within the NHS – from prevention and self-care through primary and secondary
care to more specialised services. We base our clinical guidelines on the best available research
evidence, with the aim of improving the quality of health care. We use predetermined and
systematic methods to identify and evaluate the evidence relating to specific review questions.
NICE clinical guidelines can:

• provide recommendations for the treatment and care of people by healthcare workers
• be used to develop standards to assess the clinical practice of individual healthcare workers
• be used in the education and training of healthcare workers
• help patients to make informed decisions
• improve communication between patient and healthcare worker.
While guidelines assist the practice of healthcare professionals, they do not replace their knowledge
and skills.
We produce our guidelines using the following steps:

• the guideline topic is referred to NICE from the Department of Health
• stakeholders register an interest in the guideline and are consulted throughout the development
process
Update 2012
• the scope is prepared by the National Clinical Guideline Centre (NCGC)
• the NCGC establishes a guideline development group
• a draft guideline is produced after the group assesses the available evidence and makes
recommendations
• there is a consultation on the draft guideline
• the final guideline is produced.
The NCGC and NICE produce a number of versions of this guideline:

• the full guideline contains all the recommendations, plus details of the methods used and the
underpinning evidence
• the NICE guideline lists the recommendations
• the NICE pathway is an online tool brings together all related NICE guidance and associated
products in a set of interactive topic-based diagrams
• information for the public (‘understanding NICE guidance’ or UNG) is written using suitable
language for people without specialist medical knowledge.
This version is the full version. The other versions can be downloaded from NICE at www.nice.org.uk
2.2 Remit
NICE received the remit for this guideline from the Department of Health. They commissioned the
NCGC to produce the guideline.
The original guideline was referred from the Department of Health (DH) in July 2001 with the
following remit:
16
We would like NICE to produce a guideline on infection control in primary and community care. This
guideline will be expected to address a standard approach to preventing and controlling healthcare-
associated infections in primary and community care and additional guidance for selected healthcare
interventions with a potential risk for infection.
NICE has commissioned the National Clinical Guidelines Centre for Acute and Chronic Conditions to
partially update ‘Infection control: prevention of healthcare-associated infection in primary and
community care’, NICE clinical guideline 2.
2.3 Who developed this guideline?

A multidisciplinary Guideline Development Group (GDG) comprising professional group members and
consumer representatives of the main stakeholders developed this guideline (see section on
Guideline Development Group Membership and acknowledgements).
The National Institute for Health and Clinical Excellence funds the National Clinical Guideline Centre
(NCGC) and thus supported the development of this guideline. The GDG was convened by the NCGC
and chaired by Carol Pellowe in accordance with guidance from the National Institute for Health and
Clinical Excellence (NICE).
The group met every 4 to 6 weeks during the development of the guideline. At the start of the
guideline development process all GDG members declared interests including consultancies, fee-paid
work, share-holdings, fellowships and support from the healthcare industry. At all subsequent GDG
meetings, members declared arising conflicts of interest, which were also recorded. Members were
either required to withdraw completely or for part of the discussion if their declared interest made it
Update 2012
appropriate. The details of declared interests and the actions taken are shown in Appendix B.
Staff from the NCGC provided methodological support and guidance for the development process.
The team working on the guideline included a project manager, systematic reviewers, health
economists and information scientists. They undertook systematic searches of the literature,
appraised the evidence, conducted meta analysis and cost effectiveness analysis where appropriate
and drafted the guideline in collaboration with the GDG.
2.4 What this guideline update covers

This guideline covers the following populations:
All adults and children receiving healthcare where standard infection control precautions apply in
primary and community care. Healthcare workers, family members and carers who provide
healthcare in primary and community settings. Guideline developers will pay particular attention to
the needs of different age groups, different genders, people with disabilities and minority ethnic
groups.
This guideline covers the following healthcare settings:
Primary care settings, such as general practices, dental clinics, health centres and polyclinics. This
also includes care delivered by the ambulance service. Community care settings (such as care homes,
patient's own home, schools and prisons) where NHS healthcare is provided or commissioned. This
guideline is commissioned for the NHS, but people providing healthcare in other settings, such as
private settings, may find the guidance relevant.
This guideline covers the following clinical issues:
Hand decontamination including when to decontaminate hands, the choice of hand cleaning
preparation and the most effective hand decontamination technique.
17
Personal protective equipment (PPE) including the safe disposal of personal protective equipment in
line with European Union (EU) legislation, the appropriate use of plastic aprons and fluid-repellent
gowns and which gloves provide the best protection against infections.
The safe use and disposal of sharps including the choice of sharps equipment and safe disposal of
sharp instruments and needles in line with current EU legislation.
Long-term urinary catheters (more than 28 days) including the use of antibiotics when changing
indwelling urinary catheters, the use of bladder irrigation, instillations and washouts, types of
catheters to use and aseptic technique.
Percutaneous gastrostomy feeding including the use of syringes in enteral feeding systems.
Vascular access devices (VADs), including types of dressings, decontamination of ports, hubs and skin
and aseptic technique.
Information and support for healthcare workers, patients and carers:
For further details please refer to the scope in Appendix A and review protocols in Appendix E.
2.5 What this guideline update does not cover

This guideline covers does not cover:
• people receiving healthcare in secondary care settings,
• advice on the diagnosis, treatment or management of specific infections,
Update 2012
• advice on the procedures of insertion of urinary catheters, percutaneous gastrostomies or
vascular access devices,
• infection prevention measures for invasive procedures carried out by paramedic services, such as
at a major trauma, other than in the clinical areas listed section 2.4,
• decontamination or cleaning of the healthcare environment and equipment, other than the
clinical devices listed in 2.4.
2.6 Structure of the updated guideline

All updated text, including evidence reviews and recommendations are marked by a shaded pink box
with ‘Update 2012’ in the right hand margin.
2.6.1 Chapters
The structure of the updated guideline has been kept as close to the original guideline as possible:
• Standard principles general recommendations (including education of patients, carers and their
healthcare workers)
• Standard principles for hand decontamination
• Standard principles for the use of personal protective equipment
• Standard principles for the safe use and disposal of sharps
• Waste disposal (including general recommendation about disposal of healthcare waste)
• Long-term urinary catheterisation
• Enteral feeding
• Vascular access devices (VADs).
18
2.6.2 Methodology
The methodology of writing NICE guidelines has changed substantially since the previous guideline,
therefore the updated sections are in a very different style and clearly present evidence tables,
evidence statements and linking evidence to recommendation sections, detailed in the methodology
chapter, which are not present in the sections that have not been reviewed in this update. The
presentation of evidence remains the same as in the original 2003 guideline for recommendations
not updated.
2.6.3 Recommendations
Recommendations made in the original 2003 guideline that were not within the scope of the partial
update were reviewed to check for accuracy and consistency in light of the new recommendations
made. These recommendations are marked as [2003] and yellow shading in these recommendations
indicates where wording changes have been made for the purposes of clarification only.
Recommendations are marked [2003, amended 2012] if the evidence has not been updated since the
original guideline, but changes have been made that change the meaning of the recommendation,
such as incorporated guidance being updated or equality issues. Appendix D.10 contains these
changes.
Recommendations are marked as [2012] if the evidence has been reviewed but no change has been
made to the recommendation or [new 2012] if the evidence has been reviewed and the
recommendation has been added or updated. All updated text and recommendations are in a
shaded pink box with ‘Update 2012’ in the right hand margin.
Update 2012
Appendix D.10 contains recommendations from the 2003 guideline that have been deleted or
amended in the 2012 update. This is because the evidence has been reviewed and the
recommendation has been updated or because NICE has updated other relevant guidance and has
replaced the original recommendations. Where there is no replacement recommendation, an
explanation for the proposed deletion is given.
2.6.4 Appendices
The appendices of the 2003 guideline have been moved to sit at the end of the guideline rather than
at the end of each chapter to improve the flow of the guideline. This includes the AGREE scores,
systematic review process, evidence tables and reference lists.
2.7 Relationships between the guideline and other NICE guidance

Related NICE Clinical Guidelines:
• Tuberculosis. NICE clinical guideline 117 (2011). Available from www.nice.org.uk/guidance/CG117
• Lower urinary tract symptoms. NICE clinical guideline 97 (2010). Available from
www.nice.org.uk/guidance/CG97
• Needle and syringe programmes. NICE public health guidance 18 (2009). Available from
www.nice.org.uk/guidance/PH18
• Surgical site infection. NICE clinical guideline 74 (2008). Available from
• Prophylaxis against infective endocarditis. NICE clinical guideline 64 (2008). Available from
http://www.nice.org.uk/guidance/CG64
• Urinary tract infection in children. NICE clinical guideline 54 (2007). Available from
19
• Urinary incontinence. NICE clinical guideline 40 (2006). Available from

• Nutrition support in adults. NICE clinical guideline 32 (2006). Available from
NICE Related Guidance currently in development:
Update 2012
• Intravenous fluid therapy in adults in hospital. NICE clinical guideline. Publication expected June
2013.
• Urinary incontinence in neurological disease. NICE clinical guideline. Publication expected:
October 2012.
• Stroke rehabilitation. NICE clinical guideline. Publication expected: April 2012.
• Healthcare-associated infections in secondary care settings. NICE advice. Publication expected:
November 2011.
2.8 Background and context to the Guidelines (2003)

The prevalence of healthcare-associated infections in patients in primary and community care
settings in the United Kingdom is not known. Many infections in these patients may have been
acquired in hospital and only identified following early discharge into the community. The risk of
infection will also be influenced by the use of various medical devices, such as urinary and central
venous catheters and enteral feeding systems.
Incorporating evidence-based infection prevention and control advice into routine clinical care
activities is believed to be important in reducing the incidence of preventable healthcare-associated
infections111. Consequently, guidelines for preventing healthcare-associated infections in caring for
patients in primary and community care settings were commissioned.
2.9 Scope and Purpose of the Guidelines (2003)

The scope of these guidelines was established at the start of the guideline process, following a period
of consultation, including a survey and focus group discussions with community and primary care
practitioners. This consultation process has been previously described199 and the full scoping exercise
is available from the NICE website <www.nice.org.uk> (Appendix D.2).
These guidelines were developed to help prevent healthcare-associated infections (HAI) in

community and primary care. They provide guidance for standard infection control precautions that
may be applied by all healthcare workers to the care of all patients in community and primary care
settings. They also provide guidance to non-professional carers, patients and their families.
These guidelines are intended to be broad principles of best practice which need to be incorporated
into local practice guidelines. Four sets of guidelines have been developed:
• Standard Principles for preventing healthcare-associated infections in community and primary
care;
• Guidelines for preventing infections associated with the use of long-term urinary catheters;
• Guidelines for preventing infections associated with the use of enteral feeding systems;
• Guidelines for preventing infections associated with the use of long-term central venous
catheters.
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Methods
3 Methods
3.1 Methods (2012)
This guidance was developed in accordance with the methods outlined in the NICE Guidelines
Manual 2009.182
3.1.1 Amendments to 2003 text

All text and recommendations from the previous guideline that have not been updated (therefore
review questions have not been generated and evidence has not been searched for) have been left
unchanged. Amendments to recommendations are detailed in Appendix D.10.
Exceptions include:
Text in previous guideline Change made and reason for change
Must Should or ensure. Must is only used if there is a legal duty to apply
the recommendation, or the consequences of not following a
recommendation are so serious (for example, there is a high risk that
the patient could die) that using ‘must’ (or ‘must not’) is justified.
Healthcare personnel Healthcare worker. This is for consistency with other NICE guidelines
and is considered a more suitable term. The GDG considered the
term ‘healthcare workers’ to include a wider group of people than
healthcare professionals, which they considered only those staff with
professional qualifications.
Update 2012
Community and primary or Removed as all recommendations refer to primary and community
community staff settings.
Central venous catheters Vascular access devices. The updated scope includes peripheral
venous catheters and therefore some text is expanded to include all
types of vascular access devices where appropriate.
Prostatomegaly Prostatic enlargement. The GDG considered that the term
prostatomegaly is an out-of-date term and that prostatic
enlargement is plain language terminology.
Healthcare-associated infection Changed to healthcare-associated infection (HCAI). Abbreviation
(HAI) updated to avoid confusion as HAI may be read hospital acquired
infection and not the broader healthcare-associated infection.
Methicillin resistant Staphylococcus Changed to Meticillin-resistant Staphylococcus aureus to be
aureus consistent with current Department of Health terminology and the
British National Formulary.
3.1.2 Developing the review questions and outcomes

Review questions were developed in a PICO framework (patient, intervention, comparison and
outcome) for intervention reviews. For qualitative reviews the SPICE framework (setting, population,
intervention, comparison and evaluation methods) was used. This was to guide the literature
searching process and to facilitate the development of recommendations by the guideline
development group (GDG). They were drafted by the NCGC technical team and refined and validated
by the GDG. The questions were based on the key clinical areas identified in the scope (Appendix A).
Further information on the outcome measures is shown below and detailed in the review protocols
(Appendix E).
21
Methods
Chapter Review questions Outcomes

Standard What information do healthcare professionals, Information and evidence about
principles patients and carers require to prevent healthcare- what type of information should
associated infections in primary and community be provided to patients regarding
care settings? hand decontamination to prevent
healthcare-associated infections.
Hand What is the clinical and cost effectiveness of when Colony forming units, hand
decontamination to decontaminate hands, including after the decontamination compliance,
removal of gloves, on hand decontamination MRSA and C. diff reduction and
compliance, MRSA and C. diff reduction or cross cross infection and removal of
infection, colony forming units and removal of physical contamination.
physical contamination?
Hand What is the clinical and cost effectiveness of Colony forming units, hand
decontamination cleaning preparations (soap and water, alcohol decontamination compliance,
based rubs, non-alcohol products and wipes) for MRSA and C. diff reduction and
healthcare worker hand decontamination, on hand cross infection and removal of
decontamination compliance, MRSA and C. diff physical contamination.
reduction or cross infection, colony forming units
and removal of physical contamination?
decontamination healthcare workers decontaminating wrists vs. not decontamination compliance,
decontaminating wrists or usual practice on MRSA MRSA and C. diff reduction and
and C. diff reduction or cross infection, colony cross infection and removal of
Update 2012
forming units and removal of physical physical contamination and
contamination and transient organisms? transient organisms.
decontamination healthcare workers following bare below the decontamination compliance,
elbow policies (short sleeves or rolled up sleeves) MRSA and C. diff reduction and
vs. no bare below the elbow policy (long sleeves, cross infection and removal of
not rolled up or no specific restrictions) on MRSA physical contamination and
and C. diff reduction or cross infection, colony transient organisms.
forming units and removal of physical
contamination and transient organisms?
Personal What is the clinical and cost effectiveness of Ability to perform task, blood
protective healthcare workers wearing vinyl, latex or nitrile borne infections, bodily fluid
equipment gloves on user preference and reduction of contamination, glove porosity,
hypersensitivity, blood borne infections, glove holes or tears, hypersensitivity
porosity and tears? and user preference.
Personal What is the clinical and cost effectiveness of Blood borne viruses and bodily
protective healthcare workers wearing plastic aprons or fluid fluid contamination.
equipment repellent gowns vs. no aprons or gowns, gloves
only or standard uniform on the reduction of blood
and bodily fluid and pathogenic microorganism
contamination?
Sharps What is the clinical and cost effectiveness of Blood borne infection,
healthcare workers using safety needle cannulae compliance, infection related
vs. standard cannulae on compliance and user mortality and morbidity, sharps
preference, infection related mortality and injuries and user preference.
morbidity and sharps injuries?
Sharps What is the clinical and cost effectiveness of Blood borne infection,
healthcare workers using safety needle devices compliance, infection related
(needle free, retractable needles, safety mortality and morbidity, sharps
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Methods

resheathing devices) vs. standard needles on injuries and user preference.
compliance and user preference, infection related
mortality and morbidity and sharps injuries?
Waste Disposal Are there any changes in the legislations which Updated based on legislation.
affect the disposal of personal protective
equipments in relation to patient care in the
primary and community care settings?
Waste Disposal Are there any changes in the legislations which Updated based on legislation.
affect the disposal of sharp instruments and
needles in relation to patient care in the primary
and community care settings?
Long-term urinary What is the clinical and cost effectiveness of Symptomatic UTIs, bacteraemia,
catheters different types of long-term indwelling urinary frequency of catheter change,
catheters (non-coated silicone, hydrophilic coated, encrustations and blockages,
or silver or antimicrobial coated/impregnated) on mortality, patient preference and
urinary tract infections, bacteraemia, frequency of comfort.
catheter change, encrustations and blockages,
mortality, and patient preference?
catheters different types of long-term intermittent urinary mortality, patient preference and
catheters (non-coated, hydrophilic or gel reservoir) comfort.
on symptomatic urinary tract infections,
bacteraemia, mortality, and patient preference?
Long-term urinary In patients performing intermittent Symptomatic UTIs, bacteraemia,
catheters catheterisation, what is the clinical and cost mortality, patient preference and
Update 2012
effectiveness of non-coated catheters reused comfort.
multiple times compared to single-use on urinary
tract infections, bacteraemia, mortality, and
patient preference?
catheters bladder instillations or washouts on reduction of frequency of catheter change,
catheter associated symptomatic urinary tract encrustations and blockages,
infections and encrustations and blockages? mortality, patient preference and
comfort.
Long-term urinary In patients with long-term urinary catheters (more Antibiotic resistance,
catheters than 28 days), what is the clinical and cost bacteraemia, mortality, patient
effectiveness of prophylactic antibiotics (single preference, symptomatic UTIs,
dose or short course) use during catheter change upper UTIs.
on reduction of urinary tract infections?
Enteral feeding What is the clinical and cost effectiveness of single Blockages or tube occlusion,
vs. reusable syringes used to flush percutaneous diarrhoea, vomiting, fungal
endoscopic gastrostomy (PEG) tubes on reduction colonisation, gastrostomy site
of tube blockages, diarrhoea, fungal colonisation, infection and peritonitis.
gastrostomy site infection, peritonitis and
vomiting?
Vascular access What is the most clinical and cost effective product Catheter tip colonisation,
devices or solution for decontamination of the skin prior to infection related mortality,
insertion of peripherally inserted VAD on catheter septicaemia, VAD line removal,
tip colonisation, infection related mortality, VAD related bacteraemia, VAD
frequency of line removal, septicaemia, related phlebitis and VAD related
bacteraemia and phlebitis? soft tissue infection.
Vascular access What is the clinical and cost effectiveness of Catheter tip colonisation,
devices dressings (transparent semipermeable, frequency of dressing change,
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Methods

impregnated or gauze and tape) covering infection related mortality,
peripherally or centrally inserted vascular access septicaemia, VAD related
device insertion sites, including those that are bacteraemia and VAD related
bleeding or oozing, on catheter tip colonisation, phlebitis.
frequency of dressing change, infection related
mortality, septicaemia, bacteraemia and phlebitis?
Vascular access What is the clinical and cost effectiveness of Catheter tip colonisation,
devices frequency of dressing change (from daily up to 7 frequency of dressing change,
days) on catheter tip colonisation, frequency of infection related mortality,
dressing change, infection related mortality, septicaemia, VAD related
septicaemia, bacteraemia and phlebitis? bacteraemia, VAD related
phlebitis.
devices or solution for skin decontamination when infection related mortality,
changing VAD dressings on catheter tip septicaemia, VAD line removal,
colonisation, infection related mortality, frequency VAD related bacteraemia, VAD
of line removal, septicaemia, bacteraemia and related phlebitis and VAD related
phlebitis? soft tissue infection.
Vascular access What is the most clinical and cost effective Catheter tip colonisation,
devices duration of application of decontamination infection related mortality,
product/solution to the skin prior to insertion of septicaemia, VAD line removal,
peripherally inserted VAD on catheter tip VAD related bacteraemia, VAD
colonisation, infection related mortality, frequency related phlebitis and VAD related
of line removal, septicaemia, bacteraemia and soft tissue infection.
Update 2012
phlebitis?
devices or solution for decontaminating VAD ports and infection related mortality,
hubs prior to access on catheter tip colonisation, septicaemia, VAD line removal,
infection related mortality, septicaemia, VAD related bacteraemia, VAD
bacteraemia and frequency of line removal? related phlebitis and VAD related
soft tissue infection.
Vascular access What is the clinical and cost effectiveness of multi Catheter tip colonisation,
devices dose vials vs. single-use vials for administrating infection related mortality,
infusions or drugs on preventing contamination of septicaemia, VAD line removal,
the infusate and healthcare-associated infection? VAD related bacteraemia, VAD
related phlebitis and VAD related
soft tissue infection.
Asepsis (Long- What is the most clinically and cost effective UTIs, infection related mortality,
term urinary technique (such as aseptic technique, non-touch septicaemia, bacteraemia,
catheters) technique, aseptic non-touch technique or a clean phlebitis, compliance and MRSA
technique) when handling long-term urinary or C. diff reduction.
catheters to reduce colony forming units, urinary
tract infections, compliance, MRSA or C. diff
reduction and mortality?
Asepsis (Enteral What is the most clinically and cost effective Infection related bacteraemia,
feeding) technique (such as aseptic technique, non-touch infection related mortality,
technique, aseptic non-touch technique or a clean compliance and MRSA or C. diff
technique) when handling PEGs to reduce reduction.
healthcare-associated infections?
Asepsis (Vascular What is the most clinically and cost effective Catheter tip colonisation,
access devices) technique (such as aseptic technique, non-touch Infection related mortality,
technique, aseptic non-touch technique or a clean septicaemia, VAD related
technique) when handling vascular access devices bacteraemia, VAD related
to reduce infection related bacteraemia, phlebitis, phlebitis, compliance and MRSA
24
Methods

compliance, MRSA or C. diff reduction and or C. diff reduction.
mortality?
3.1.3 Searching for evidence
3.1.3.1 Clinical literature search
Systematic literature searches were undertaken to identify evidence within published literature in
order to answer the review questions as per The Guidelines Manual [2009]182. Clinical databases
were searched using relevant medical subject headings, free-text terms and study type filters where
appropriate. Studies published in languages other than English were not reviewed. Where possible,
searches were restricted to articles published in English language. All searches were conducted on
core databases, MEDLINE, Embase, CINAHL and The Cochrane Library. The additional subject specific
database PsychInfo was used for the patient information questions. All searches were updated on
18th April 2011. No papers after this date were considered.
Search strategies were checked by looking at reference lists of relevant key papers, checking search
strategies in other systematic reviews and asking the GDG for known studies. The questions, the
study types applied, the databases searched and the years covered can be found in Appendix F.
During the scoping stage, a search was conducted for guidelines and reports on the websites listed
below and on organisations relevant to the topic. Searching for grey literature or unpublished
literature was not undertaken. All references sent by stakeholders were considered.
Update 2012
• Guidelines International Network database (www.g-i-n.net)
• National Guideline Clearing House (www.guideline.gov)
• National Institute for Health and Clinical Excellence (NICE) (www.nice.org.uk)
• National Institutes of Health Consensus Development Program (consensus.nih.gov)
• National Library for Health (www.library.nhs.uk)
3.1.3.2 Health economic literature search
Systematic literature searches were also undertaken to identify health economic evidence within
published literature relevant to the review questions. The evidence was identified by conducting a
broad search relating to the five key areas in the guideline: long-term urinary catheters, vascular
access devices, hand decontamination, sharps and personal protective equipment, in the NHS
economic evaluation database (NHS EED), the Health Economic Evaluations Database (HEED) and
health technology assessment (HTA) databases with no date restrictions. Additionally, the search was
run on MEDLINE and Embase, with a specific economic filter, to ensure publications that had not yet
been indexed by these databases were identified. This was supplemented by additional searches that
looked for economic and quality of life papers specifically relating to asepsis, urinary tract infections
and catheter-related bloodstream infections the same databases as it became apparent that some
papers in this area were not being identified through the first search. Studies published in languages
other than English were not reviewed. Where possible, searches were restricted to articles published
in English language.
The search strategies for health economics are included in Appendix F. All searches were updated on
18th April 2011. No papers published after this date were considered.
3.1.3.3 Evidence synthesis
The Research Fellow:
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Methods
• Identified potentially relevant studies for each review question from the relevant search results
by reviewing titles and abstracts – full papers were then obtained.
• Reviewed full papers against pre-specified inclusion / exclusion criteria to identify studies that
addressed the review question in the appropriate population and reported on outcomes of
interest (review protocols are included in Appendix E).
• Critically appraised relevant studies using the appropriate checklist as specified in The Guidelines
Manual.182
• Extracted key information about the study’s methods and results into evidence tables (evidence
tables are included in Appendix G).
• Generated summaries of the evidence by outcome (included in the relevant chapter write-ups):
o Randomised studies: meta-analysed, where appropriate and reported in GRADE (Grading of
Recommendations Assessment, Development and Evaluation) profiles for clinical studies – see
section 3.1.3.6 for details.
o Observational studies: data presented as a range of values in GRADE profiles.
o Qualitative studies: each study summarised in a table (available in Appendix G) where possible,
and the quality of included studies assessed against the NICE quality checklists for qualitative
studies 182. Key common themes between studies which were relevant to the review question
were summarised and presented with a comment of the quality of studies contributing to the
themes in the main guideline document. GRADE does not have a system for rating the quality
of evidence for qualitative studies or surveys, and therefore there are no GRADE quality ratings
for the themes identified.
Update 2012
3.1.3.4 Inclusion/exclusion
The inclusion and exclusion criteria were considered according to the PICO used in the protocols, see
Appendix F for full details.
A major consideration in determining the inclusion and exclusion criteria in the protocol was the
applicability of the evidence to the guideline population. The GDG decided to exclude certain settings
and populations that could not be extrapolated to community settings, these are detailed per review
question in the protocols. See “Indirectness”, section 3.1.3.10.
Laboratory studies were excluded because the populations used (healthy volunteers, animals or in
vitro) and settings are artificial and not comparable to the population we are making
recommendations for. These studies would undoubtedly be of very low quality as assessed by GRADE
and therefore RCTs, cohort studies or GDG consensus opinion was considered preferable.
Abstracts, posters, reviews, letters/editorials, foreign language publications and unpublished studies
were excluded.
3.1.3.5 Methods of combining clinical studies
Data synthesis for intervention reviews
Where possible, meta-analyses were conducted to combine the results of studies for each review
question using Cochrane Review Manager (RevMan5) software. Fixed-effects (Mantel-Haenszel)
techniques were used to calculate risk ratios (relative risk) for the binary outcomes. The continuous
outcomes were analysed using an inverse variance method for pooling weighted mean differences
and where the studies had different scales, standardised mean differences were used. Statistical
heterogeneity was assessed by considering the chi-squared test for significance at p <0.1 or an I-
squared inconsistency statistic of >50% to indicate significant heterogeneity. Where there was
26
Methods
heterogeneity and a sufficient number of studies, sensitivity analyses were conducted based on risk
of bias and pre-specified subgroup analyses were carried out as defined in the protocol.
Assessments of potential differences in effect between subgroups were based on the chi-squared
tests for heterogeneity statistics between subgroups. If no sensitivity analysis was found to
completely resolve statistical heterogeneity then a random effects (DerSimonian and Laird) model
was employed to provide a more conservative estimate of the effect.
The means and standard deviations of continuous outcomes were required for meta-analysis.
However, in cases where standard deviations were not reported, the standard error was calculated if
the p-values or 95% confidence intervals were reported and meta-analysis was undertaken with the
mean difference and standard error using the generic inverse variance method in Cochrane Review
Manager (RevMan5) software. Where p values were reported as “less than”, a conservative
approach was undertaken. For example, if p value was reported as “p <0.001”, the calculations for
standard deviations were based on a p value of 0.001. If these statistical measures were not available
then the methods described in section 16.1.3 of the Cochrane Handbook 121 ‘Missing standard
deviations’ were applied as the last resort.
For binary outcomes, absolute differences in event rates were also calculated using the GRADEpro
software using total event rate in the control arm of the pooled results.
3.1.3.6 Appraising the quality of evidence by outcomes
Update 2012
After appropriate pooling of the results for each outcome across all studies, the quality of the
evidence for each outcome was evaluated and presented using the GRADE toolbox107. The software
(GRADEpro) developed by the international GRADE working group was used to record the
assessment of the evidence quality for each outcome.
In this guideline, findings were summarised using two separate tables. The “Clinical Study
Characteristics” table includes details of the quality assessment. Reporting or publication bias was
only taken into consideration in the quality assessment and included in the Clinical Study
Characteristics table if it is clear there was a risk of bias. Each outcome was examined separately for
the quality elements listed and defined in Table 1 and each graded using the quality levels listed in
Table 2. The main criteria considered in the rating of these elements are discussed below (see section
3.1.3.7 Grading of Evidence). Footnotes were used to describe reasons for grading a quality element
as having serious or very serious problems. The ratings for each component were summed to obtain
an overall quality assessment for each outcome listed in Table 3.
The “Clinical Summary of Findings” table includes meta-analysed outcome data (where appropriate),
an absolute measure of intervention effect (calculated from the summary statistics for the meta-
analysed relative measure and the mean control event rate) and the summary of quality of evidence
for that outcome. In the Clinical Summary of Findings table, the columns for intervention and control
indicate the total of the sample size for continuous outcomes. For binary outcomes such as number
of patients with an adverse event, the event rates (n/N: total number of patients with events divided
by total number of patients across studies) are shown with percentages (note: this percentage is an
output of GRADEpro software. It is not the results of the meta-analysis and is not used in decision
making).
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Methods
Table 1: Description of quality elements in GRADE for intervention studies

Quality element Description
Limitations Limitations in the study design and implementation may bias the estimates of the
treatment effect. Major limitations in studies decrease the confidence in the estimate
of the effect.
Inconsistency Inconsistency refers to an unexplained heterogeneity of results.
Indirectness Indirectness refers to differences in study population, intervention, comparator and
outcomes between the available evidence and the review question, or
recommendation made.
Imprecision Results are imprecise when studies include relatively few patients and few events and
thus have wide confidence intervals around the estimate of the effect relative to the
clinically important threshold.
Publication bias Publication bias is a systematic underestimate or an overestimate of the underlying
beneficial or harmful effect due to the selective publication of studies.
Table 2: Levels of quality elements in GRADE

Level Description
None There are no serious issues with the evidence.
Serious The issues are serious enough to downgrade the outcome evidence by one level.
Very serious The issues are serious enough to downgrade the outcome evidence by two levels.
Update 2012
Table 3: Overall quality of outcome evidence in GRADE
Level Description
High We are very confident that the true effect lies close to that of the estimate of the
effect.
Moderate We are moderately confident in the effect estimate: the true effect is likely to be close
to the estimate of the effect, but there is a possibility that it is substantially different.
Low Our confidence in the effect estimate is limited: the true effect may be substantially
different from the estimate of the effect.
Very low We have very little confidence in the effect estimate. The true effect is likely to be
substantially different from the estimate of effect.
3.1.3.7 Grading the quality of clinical evidence
After results were pooled, the overall quality of evidence for each outcome was considered. The
following procedure was adopted when using GRADE:
1. A quality rating was assigned, based on the study design. RCTs start HIGH and observational
studies as LOW, uncontrolled case series as LOW or VERY LOW.
2. The rating was then downgraded for the specified criteria: Study limitations, inconsistency,
indirectness, imprecision and publication bias. These criteria are detailed below. Observational
studies were upgraded if there was a large magnitude of effect, dose-response gradient, and if all
plausible confounding would reduce a demonstrated effect or suggest a spurious effect when
results showed no effect. Each quality element considered to have “serious” or “very serious” risk
of bias was rated down -1 or -2 points respectively.
3. The downgraded/upgraded marks were then summed and the overall quality rating was revised.
For example, all RCTs started as HIGH and the overall quality became MODERATE, LOW or VERY
LOW if 1, 2 or 3 points were deducted respectively.
4. The reasons or criteria used for downgrading were specified in the footnotes.
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Methods
The details of criteria used for each of the main quality element are discussed further in the following
sections 3.1.3.8 to 3.1.3.11.
3.1.3.8 Study limitations
The main limitations for randomised controlled trials are listed in Table 4.
Table 4: Study limitations of randomised controlled trials

Limitation Explanation
Allocation Those enrolling patients are aware of the group to which the next enrolled patient
concealment will be allocated (major problem in “pseudo” or “quasi” randomised trials with
allocation by day of week, birth date, chart number, etc).
Lack of blinding Patient, caregivers, those recording outcomes, those adjudicating outcomes, or data
analysts are aware of the arm to which patients are allocated.
Incomplete Loss to follow-up not accounted and failure to adhere to the intention to treat
accounting of principle when indicated.
patients and
outcome events
Selective outcome Reporting of some outcomes and not others on the basis of the results.
reporting
Other limitations For example:
• Stopping early for benefit observed in randomised trials, in particular in the absence
of adequate stopping rules
Update 2012
• Use of unvalidated patient-reported outcomes
• Carry-over effects in cross-over trials
• Recruitment bias in cluster randomised trials.
3.1.3.9 Inconsistency
Inconsistency refers to an unexplained heterogeneity of results. When estimates of the treatment

effect across studies differ widely (i.e. heterogeneity or variability in results), this suggests true
differences in underlying treatment effect. When heterogeneity exists (Chi - square p<0.1 or I -
square inconsistency statistic of >50%), but no plausible explanation can be found, the quality of
evidence was downgraded by one or two levels, depending on the extent of uncertainty to the
results contributed by the inconsistency in the results. In addition to the I - square and Chi - square
values, the decision for downgrading was also dependent on factors such as whether the
intervention is associated with benefit in all other outcomes or whether the uncertainty about the
magnitude of benefit (or harm) of the outcome showing heterogeneity would influence the overall
judgment about net benefit or harm (across all outcomes).
If inconsistency could be explained based on pre-specified subgroup analysis, the GDG took this into
account and considered whether to make separate recommendations based on the identified
explanatory factors, i.e. population and intervention. Where subgroup analysis gives a plausible
explanation of heterogeneity, the quality of evidence was not downgraded.
3.1.3.10 Indirectness
Directness refers to the extent to which the populations, intervention, comparisons and outcome
measures are similar to those defined in the inclusion criteria for the reviews. Indirectness is
important when these differences are expected to contribute to a difference in effect size, or may
affect the balance of harms and benefits considered for an intervention.
29
Methods
Studies that were in settings other than primary care and community settings were downgraded
using GRADE if the GDG considered that the study was indirect. For further details and any
exceptions are detailed in the review protocols, see Appendix E.
3.1.3.11 Imprecision
Results are often imprecise when studies include relatively few patients and few events and thus
have wide confidence intervals around the estimate of effect. This, in turn, may mean that we are
uncertain if there is an important difference between interventions or not. If this is the case, the
evidence may be considered to be of lower quality than it otherwise would be because of resulting
uncertainty in the results.
The thresholds of important benefits or harms, or the MID (minimal important difference) for an
outcome are important considerations for determining whether there is a “clinically important”
difference between interventions, and in assessing imprecision. For continuous outcomes, the MID is
defined as “the smallest difference in score in the outcome of interest that informed patients or
informed proxies perceive as important, either beneficial or harmful, and that would lead the patient
or clinician to consider a change in the management”.107,129,233,234 An effect estimate larger than the
Update 2012
MID is considered to be “clinically important”. For dichotomous outcomes, the MID is considered in
terms of changes in absolute risk.
The difference between two interventions, as observed in the studies, was compared against the
MID when considering whether the findings were of “clinical importance”; this is useful to guide
decisions. For example, if the effect size was small (less than the MID), this finding suggests that
there may not be enough difference to strongly recommend one intervention over the other based
on that outcome.
The confidence interval for the pooled or best estimate of effect was considered in relation to the
MID, as illustrated in Figure 1. Essentially, if the confidence interval crossed the MID threshold, there
was uncertainty in the effect estimate in supporting our recommendations (because the CI was
consistent with two decisions) and the effect estimate was rated as imprecise.
For the purposes of this guideline, an intervention is considered to have a clinically important effect
with certainty if the whole of the 95% confidence interval describes an effect of greater magnitude
than the MID. Figure 1 illustrates how the clinical importance of effect estimates were considered
along with imprecision, and the usual way of documenting this is in the evidence statements
throughout this guideline. Results are imprecise when studies include relatively few patients and few
events and thus have wide confidence intervals around the estimate of the effect relative to the
clinically important threshold.
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Methods
Figure 1: Imprecision and evidence statements
Position of Evidence statement

confidence
interval
A A Statistically significant but not clinically important
B B It is unlikely that there is any difference
C
C Statistically significant and clinically important
D D Uncertain whether there is any difference
E
E E Statistically significant difference of uncertain clinical
importance
Source: Figure adapted from GRADEPro software and modified to reflect the application of imprecision rating in the
guideline process. The effect estimates of the top three examples (A-C) were considered precise because neither
the upper or lower confidence limits crossed the MID. Conversely, the bottom three examples (D and E) were
considered imprecise because the CI crossed the MID in each case, and this reduced our certainty of the results.
For this guideline, there was no information in the literature on what was the most appropriate MID,
and the GDG adopted the default threshold suggested by GRADE. This was a relative risk reduction of
25% (relative risk of 0.75 for negative outcomes) or a relative risk increase of 25% (risk ratio 1.25 for
Update 2012
positive outcomes) for binary outcomes. The GDG interpreted the risk ratio and 95% confidence
interval relative to the threshold, also taking into account the 95% confidence intervals of the
absolute effect estimates. For continuous outcomes, a standardised mean difference (SMD) of 0.5
was considered the minimal important difference for most outcomes.
3.1.4 Evidence of cost-effectiveness

Evidence on cost-effectiveness related to the key clinical issues being addressed in the guideline was
sought. The health economist:
• Undertook a systematic review of the economic literature.
• Undertook new cost-effectiveness analysis in priority areas.
3.1.4.1 Literature review
The Health Economist:

• Identified potentially relevant studies for each review question from the economic search results
by reviewing titles and abstracts – full papers were then obtained.
• Reviewed full papers against pre-specified inclusion / exclusion criteria to identify relevant studies
(see below for details).
• Critically appraised relevant studies using the economic evaluations checklist as specified in The
Guidelines Manual182.
• Extracted key information about the study’s methods and results into evidence tables (evidence
tables are included in Appendix H).
• Generated summaries of the evidence in NICE economic evidence profiles (included in the
relevant chapter write-ups) – see below for details.
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Methods
Inclusion/exclusion
Full economic evaluations (studies comparing costs and health consequences of alternative courses
of action: cost–utility, cost-effectiveness, cost-benefit and cost-consequence analyses) and
comparative costing studies that addressed the review question in the relevant population were
considered as potentially applicable economic evidence.
In the absence of any full economic evaluations, studies that reported cost per hospital, or reported
average cost-effectiveness without disaggregated costs and effects, were considered for inclusion on
a case by case basis.
Abstracts, posters, reviews, letters/editorials, foreign language publications and unpublished studies
were excluded. Studies judged to be ‘not applicable’ were excluded (this included studies that took
the perspective of a non-OECD country).
Remaining studies were prioritised for inclusion based on their relative applicability to the
development of this guideline and the study limitations. For example, if a high quality, directly
applicable UK analysis was available then other less relevant studies may not have been included.
Where exclusions occurred on this basis, this was noted in the relevant section.
For more details about the assessment of applicability and methodological quality see the economic
evaluation checklist (The Guidelines Manual).182
When no relevant economic analysis was identified in the economic literature review, relevant UK
NHS unit costs were presented to the GDG to inform discussion of economic considerations.
NICE economic evidence profiles
Update 2012
The NICE economic evidence profile has been used to summarise cost and cost-effectiveness
estimates. The economic evidence profile shows, for each economic study, an assessment of
applicability and methodological quality, with footnotes indicating the reasons for the assessment.
These assessments were made by the health economist using the economic evaluation checklist from
The Guidelines Manual182. It also shows incremental costs, incremental outcomes (for example,
QALYs) and the incremental cost-effectiveness ratio from the primary analysis, as well as information
about the assessment of uncertainty in the analysis. See Table 5 for more details.
If a non-UK study was included in the profile, the results were converted into pounds sterling using
the appropriate purchasing power parity192 and Hospital and Community Health Services Pay and
Prices Inflation Index.53
Table 5: Content of NICE economic profile

Item Description
Study First author name, reference, date of study publication and country perspective.
Limitations An assessment of methodological quality of the study(a):
• Minor limitations – the study meets all quality criteria, or the study fails to meet
one or more quality criteria, but this is unlikely to change the conclusions about
cost effectiveness.
• Potentially serious limitations – the study fails to meet one or more quality
criteria, and this could change the conclusion about cost effectiveness
• Very serious limitations – the study fails to meet one or more quality criteria and
this is very likely to change the conclusions about cost-effectiveness. Studies with
very serious limitations would usually be excluded from the economic profile
table.
Applicability An assessment of applicability of the study to the clinical guideline, the current NHS
situation and NICE decision-making(a):
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Methods
Item Description
• Directly applicable – the applicability criteria are met, or one or more criteria are
not met but this is not likely to change the conclusions about cost effectiveness.
• Partially applicable – one or more of the applicability criteria are not met, and this
might possibly change the conclusions about cost effectiveness.
• Not applicable – one or more of the applicability criteria are not met, and this is
likely to change the conclusions about cost effectiveness.
Other comments Particular issues that should be considered when interpreting the study.
Incremental cost The mean cost associated with one strategy minus the mean cost of a comparator
strategy.
Incremental effects The mean QALYs (or other selected measure of health outcome) associated with
one strategy minus the mean QALYs of a comparator strategy.
ICER Incremental cost-effectiveness ratio: the incremental cost divided by the respective
QALYs gained.
Uncertainty A summary of the extent of uncertainty about the ICER reflecting the results of
deterministic or probabilistic sensitivity analyses, or stochastic analyses of trial data,
as appropriate.
182
(a) Limitations and applicability were assessed using the economic evaluation checklist from The Guidelines Manual.
3.1.4.2 Undertaking new health economic analysis
As well as reviewing the published economic literature for each review question as described above,
original economic analysis was undertaken by the Health Economist in priority areas. Priority areas
for new health economic analysis were agreed by the GDG after formation of the review questions
Update 2012
and consideration of the available health economic evidence.
Additional data for the analysis was identified as required through additional literature searches
undertaken by the Health Economist, and discussion with the GDG. Model structure, inputs and
assumptions were explained to and agreed by the GDG members during meetings, and they
commented on subsequent revisions.
See Appendix J for details of the health economic analysis/analyses undertaken for the guideline.
3.1.4.3 Cost-effectiveness criteria
NICE’s report ‘Social value judgements: principles for the development of NICE guidance’ sets out the
principles that GDGs should consider when judging whether an intervention offers good value for
money.182,183
In general, an intervention was considered to be cost-effective if either of the following criteria

applied (given that the estimate was considered plausible):
• The intervention dominated other relevant strategies (that is, it was both less costly in terms of
resource use and more clinically effective compared with all the other relevant alternative
strategies), or
• The intervention cost less than £20,000 per quality-adjusted life-year (QALY) gained compared
with the next best strategy.
3.1.5 Developing recommendations

Over the course of the guideline development process, the GDG was presented with:
• Evidence tables of the clinical and economic evidence reviewed from the literature. All evidence
tables are in Appendix G and H.
• Summary of clinical and economic evidence and quality (as presented in chapters 5 to 12).
33
Methods
• Forest plots (Appendix I).

• A description of the methods and results of the cost-effectiveness analysis undertaken for the
guideline (Appendix J).
Recommendations were drafted on the basis of the GDG interpretation of the available evidence,
taking into account the balance of benefits and harms, quality of evidence, and costs. When clinical
and economic evidence was of poor quality, conflicting or absent, the GDG drafted recommendations
based on consensus. Expert advisors were invited to provide advice on how to interpret the
identified evidence. The considerations for making consensus based recommendations include the
balance between potential harms and benefits, economic or implications compared to the benefits,
current practices, recommendations made in other relevant guidelines, patient preferences and
equality issues. The consensus recommendations were made through discussions in the GDG, or
methods of formal consensus were applied. Formal consensus methods used in this guideline
included voting at the GDG or anonymous voting via email. The GDG Chair ensured sufficient time for
responding and encouraged all members to express their views. The GDG also considered whether
the uncertainty is sufficient to justify delaying making a recommendation to await further research,
taking into account the potential harm of failing to make a clear recommendation (See 3.1.5.1).
The main considerations specific to each recommendation are outlined in the Evidence to
Recommendation Sections preceding the recommendation section in each chapter.
3.1.5.1 Research recommendations
When areas were identified for which good evidence was lacking, the guideline development group
Update 2012
considered making recommendations for future research. Decisions about inclusion were based on
factors such as:
• the importance to patients or the population
• national priorities
• potential impact on the NHS and future NICE guidance
• ethical and technical feasibility.
3.1.5.2 Validation process
The guidance is subject to an eight week public consultation and feedback as part of the quality
assurance process and peer review of the document. All comments received from registered
stakeholders are responded to in turn and posted on the NICE website when the pre-publication
check of the full guideline occurs.
3.1.5.3 Updating the guideline
Following publication, and in accordance with the NICE guidelines manual, NICE will ask a National
Collaborating Centre or the National Clinical Guideline Centre to advise NICE’s Guidance executive
whether the evidence base has progressed significantly to alter the guideline recommendations and
warrant an update.
3.1.5.4 Disclaimer
Health care providers need to use clinical judgement, knowledge and expertise when deciding
whether it is appropriate to apply guidelines. The recommendations cited here are a guide and may
not be appropriate for use in all situations. The decision to adopt any of the recommendations cited
here must be made by the practitioners in light of individual patient circumstances, the wishes of the
patient, clinical expertise and resources.
34
Methods
The National Clinical Guideline Centre disclaims any responsibility for damages arising out of the use
or non-use of these guidelines and the literature used in support of these guidelines.
Update 2012
3.1.5.5 Funding
The National Clinical Guideline Centre was commissioned by the National Institute for Health and
Clinical Excellence to undertake the work on this guideline.
3.2 Methods (2003)

The guidelines were developed using a systematic review process and associated protocols
(Appendix D). In each set of guidelines a more detailed description is provided.
For each set of guidelines, an electronic search was conducted for current national and international
guidelines. They were retrieved and subjected to critical appraisal using the AGREE Instrument259,
which provides “a framework for assessing the quality of clinical practice guidelines.”
Where guidelines met the AGREE criteria they were included as part of the evidence base supporting
each set of guidelines. They were also used to verify professional consensus. The emphasis given to
each guideline depended on the rigour of its development and its comprehensiveness in relation to
the review questions. In some instances they were used as the primary source of evidence.
Review questions for the systematic reviews of the literature were developed for each set of
guidelines following advice from key stakeholders and expert advisors.
Searches were constructed for each set of guidelines using relevant MeSH (medical subject headings)
and free-text terms. On completion of the main search, an economic filter was applied. The following
databases were searched:
• Medline
• Cumulated Index of Nursing and Allied Health Literature (CINAHL)
• Embase
• The Cochrane Library:
• The National Electronic Library for Health
• The NHS Centre for Reviews and Dissemination (CRD)
• CRD includes 3 databases: Database of Abstracts of Reviews of Effectiveness (DARE), NHS
Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA)Database
• Health CD Database
• Health Management Information Consortium Database
• The National Research Register
• The Web of Science
• The Institute of Health Technology
• Health CD Database
• Health Management Information Consortium Database
• HMIC includes 3 databases: The Department of Health Library and Information Service (DHData),
Health Management Information Service (HELMIS) from the Nuffield Institute and the Kings Fund
Database.
The results of each search including abstracts were printed. The first sift of citations involved a
review of the abstracts. Studies were retrieved if they were:
• relevant to a review question;
35
Methods
• primary research/systematic review/meta-analysis;

• written in English.
Where there was no abstract, the full article was retrieved.
No research designs were specifically excluded but wherever possible, in use rather than in vitro
studies were retrieved.
The second sift involved a critical review of the full text, and articles relevant to a review question
were critically appraised. The SIGN data extraction form237 was used to document the results of
critical appraisal (Available from the SIGN website http://www.sign.ac.uk). A form for descriptive
studies was designed by us based on the SIGN methodology.
The evidence tables and reports were presented to the GDG for discussion. At this stage, expert
advice derived from seminal works and appraised national and international guidelines were
considered. Following extensive discussion the guidelines were drafted.
Although economic opinion was considered for each review question, the economic scope described
above did not identify any high quality cost-effectiveness evidence, e.g., economic evaluations
alongside randomised controlled trials. As a result, simple decision analytic modelling was employed
using estimates from published literature and expert opinion from the GDG. Results were estimated
initially for a “base case,” i.e., the most likely scenario. These results were then subjected to
sensitivity analysis where key parameter values were varied. Areas were targeted where the impact
on resource use was likely to be substantial. In addition, where there was no evidence of difference
in clinical outcomes between interventions, simple cost analyses were performed to identify the
potential resource consequences.
Factors influencing the guideline recommendations included:

• the nature of the evidence;
• the applicability of the evidence;
• costs and knowledge of healthcare systems.
Consensus within the GDG was mainly achieved though discussion facilitated by the group chair.
Where necessary, agreement was arrived at by open voting.
36
Guideline summary
4 Guideline summary
4.1 Key priorities for implementation
From the full set of recommendations, the GDG selected 10 key priorities for implementation. The
criteria used for selecting these recommendations are listed in detail in The Guidelines Manual182.
For each key recommendation listed, the selection criteria and implementation support points are
indicated by the use of the letters shown in brackets below.
The GDG selected recommendations that would:

• Have a high impact on outcomes that are important to patients (A)
• Have a high impact on reducing variation in care and outcomes (B)
• Lead to a more efficient use of NHS resources (C)
• Promote patient choice (D)
• Promote equalities (E)
• Mean patients reach critical points in the care pathway more quickly (F).
In doing this the GDG also considered which recommendations were particularly likely to benefit
from implementation support. They considered whether a recommendation:
Update 2012
• Requires changes in service delivery (W)
• Requires retraining of professionals or the development of new skills and competencies (X)
• Affects and needs to be implemented across various agencies or settings (complex interactions)
(Y)
• May be viewed as potentially contentious, or difficult to implement for other reasons (Z)
4.1.1 Standard principles – general advice
1. Everyone involved in providing care should be:

• educated about the standard principles of infection prevention and control and
• trained in hand decontamination, the use of personal protective equipment, and the safe
use and disposal of sharps. [A,B,C,D,F,X,Y] [2012]
2. Wherever care is delivered, healthcare workers must a have available appropriate supplies
of:
• materials for hand decontamination
• sharps containers
• personal protective equipment. [A, B, E, W, Y] [new 2012]
a
In accordance with current health and safety legislation (at the time of publication of the guideline [March 2012]): Health
and Safety at Work Act 1974, Management of Health and Safety at Work Regulations 1999, Health and Safety
Regulations 2002, Control of Substances Hazardous to Health Regulations 2002, Personal Protective Equipment
Regulations 2002, and Health and Social Care Act 2008.
37
Guideline summary
3. Educate patients and carers about:

• the benefits of effective hand decontamination
• the correct techniques and timing of hand decontamination
• when it is appropriate to use liquid soap and water or handrub
• the availability of hand decontamination facilities
• their role in maintaining standards of healthcare workers’ hand decontamination. [A, B, C, E,
X, W, Y] [new 2012]
4.1.2 Standard principles for hand decontamination
4. Hands must be decontaminated in all of the following circumstances:

• immediately before every episode of direct patient contact or care, including aseptic
procedures
Update 2012
• immediately after every episode of direct patient contact or care
• immediately after any exposure to body fluids
• immediately after any other activity or contact with a patient’s surroundings that could
potentially result in hands becoming contaminated
• immediately after removal of gloves. [A, W, X] [new 2012]
4.1.3 Long-term urinary catheters
5. Select the type and gauge of an indwelling urinary catheter based on an assessment of the
patient’s individual characteristics, including:
• age
• any allergy or sensitivity to catheter materials
• gender
• history of symptomatic urinary tract infection
• patient preference and comfort
• previous catheter history
• reason for catheterisation. [A, B, C, D, F, W, Y, Z] [new 2012]
6. All catheterisations carried out by healthcare workers should be aseptic procedures. After
training, healthcare workers should be assessed for their competence to carry out these
types of procedures. [A, B, C, X, Y] [2003]
7. When changing catheters in patients with a long-term indwelling urinary catheter:

Update 2012
• do not offer antibiotic prophylaxis routinely

• consider antibiotic prophylaxis b for patients who:
– have a history of symptomatic urinary tract infection after catheter change or
– experience trauma c during catheterisation. [A, B, C, W, X, Y, Z] [new 2012]
b
At the time of publication of the guideline (March 2012), no antibiotics have a UK marketing authorisation for this
indication. Informed consent should be obtained and documented
c
The GDG defined trauma as frank haematuria after catheterisation or two or more attempts of catheterisation.
38
Guideline summary
4.1.4 Vascular access devices
8. Before discharge from hospital, patients and their carers should be taught any techniques
they may need to use to prevent infection and safely manage a vascular access device d. [A,
F, Y] [2003, amended 2012]
9. Healthcare workers caring for a patient with a vascular access deviced should be trained, and
assessed as competent, in using and consistently adhering to the infection prevention
practices described in this guideline. [A, B, C, F, X, Y, Z] [2003, amended 2012]
10.Decontaminate the skin at the insertion site with chlorhexidine gluconate in 70% alcohol
Update
2012
before inserting a peripheral vascular access device or a peripherally inserted central
catheter. [A, B, F, W, X] [new 2012]
d
The updated recommendation contains 'vascular access device' rather than 'central venous catheter'. This change has
been made because peripherally inserted catheters were included in the scope of the guideline update.
39
Guideline summary
4.2 Full list of recommendations

4.2.1 Standard Principles
4.2.1.1 General advice

• educated about the standard principles of infection prevention and control and
• trained in hand decontamination, the use of personal protective equipment, and the safe
use and disposal of sharps. [2012]
2. Wherever care is delivered, healthcare workers must e have available appropriate supplies
of:
• personal protective equipment. [new 2012]

Update 2012
• the availability of hand decontamination facilities
• their role in maintaining standards of healthcare workers’ hand decontamination. [new
2012]
4.2.1.2 Hand decontamination
4. Hands must be decontaminated in all of the following circumstances:

• immediately before every episode of direct patient contact or care, including aseptic
procedures
• immediately after every episode of direct patient contact or care
• immediately after any other activity or contact with a patient’s surroundings that could
potentially result in hands becoming contaminated
• immediately after removal of gloves. [new 2012]
e
40
Guideline summary
5. Decontaminate hands preferably with a handrub (conforming to current British standardsf ),

except in the following circumstances, when liquid soap and water must be used:
• when hands are visibly soiled or potentially contaminated with body fluids or
• in clinical situations where there is potential for the spread of alcohol-resistant organisms
(such as Clostridium difficile or other organisms that cause diarrhoeal illness). [new 2012]
Update 2012
6. Healthcare workers should ensure that their hands can be decontaminated throughout the
duration of clinical work by:
• being bare below the elbowg when delivering direct patient care
• removing wrist and hand jewellery
• making sure that fingernails are short, clean and free of nail polish
• covering cuts and abrasions with waterproof dressings. [new 2012]
7. An effective handwashing technique involves three stages: preparation, washing and

rinsing, and drying. Preparation requires wetting hands under tepid running water before
applying liquid soap or an antimicrobial preparation. The handwash solution must come into
contact with all of the surfaces of the hand. The hands must be rubbed together vigorously
for a minimum of 10–15 seconds, paying particular attention to the tips of the fingers, the
thumbs and the areas between the fingers. Hands should be rinsed thoroughly before drying
with good quality paper towels. [2003]
8. When decontaminating hands using an alcohol handrub, hands should be free from dirt and
organic material. The handrub solution must come into contact with all surfaces of the hand.
The hands must be rubbed together vigorously, paying particular attention to the tips of the
fingers, the thumbs and the areas between the fingers, until the solution has evaporated
and the hands are dry. [2003]
9. An emollient hand cream should be applied regularly to protect skin from the drying effects
of regular hand decontamination. If a particular soap, antimicrobial hand wash or alcohol
product causes skin irritation an occupational health team should be consulted. [2003]
4.2.1.3 Use of personal protective equipment
10. Selection of protective equipment musth be based on an assessment of the risk of

transmission of microorganisms to the patient, and the risk of contamination of the
healthcare worker’s clothing and skin by patients’ blood, body fluids, secretions or
excretions. [2003]
f
At the time of publication of the guideline (March 2012): BS EN 1500:1997.
g
For the purposes of this guideline, the GDG considered bare below the elbow to mean: not wearing false nails or nail
polish; not wearing a wrist-watch or stoned rings; wearing short-sleeved garments or being able to roll or push up
sleeves.
h
41
Guideline summary
Update 2012
11. Gloves used for direct patient care:
• must i conform to current EU legislation (CE marked as medical gloves for single-use) j and
• should be appropriate for the task. [new 2012]
12.Gloves musti be worn for invasive procedures, contact with sterile sites and non-intact skin
or mucous membranes, and all activities that have been assessed as carrying a risk of
exposure to blood, body fluids, secretions or excretions, or to sharp or contaminated
instruments. [2003]
13.Gloves mustk be worn as single-use items. They must be put on immediately before an
episode of patient contact or treatment and removed as soon as the activity is completed.
Gloves must be changed between caring for different patients, and between different care
or treatment activities for the same patient. [2003]
14. Ensure that gloves used for direct patient care that have been exposed to body fluids are
disposed of correctly, in accordance with current national legislation k or local policies (see
section 4.2.1.5). [new 2012]
15. Alternatives to natural rubber latex gloves mustiError! Bookmark not defined. be available
for patients, carers and healthcare workers who have a documented sensitivity to natural
rubber latex. [2012]
Update 2012
16. Do not use polythene gloves for clinical interventions. [new 2012]
17. When delivering direct patient care:

• wear a disposable plastic apron if there is a risk that clothing may be exposed to blood, body
fluids, secretions or excretions or
• wear a long-sleeved fluid-repellent gown if there is a risk of extensive splashing of blood,
body fluids, secretions or excretions onto skin or clothing. [2012]
18. When using disposable plastic aprons or gowns:

• use them as single-use items, for one procedure or one episode of direct patient care and
• ensure they are disposed of correctly (see section 4.2.1.5). [2012]
19. Face masks and eye protection musti be worn where there is a risk of blood, body fluids,
secretions or excretions splashing into the face and eyes. [2003]
20. Respiratory protective equipment, for example a particulate filter mask, mustiError! Bookmark not
defined.
be used when clinically indicated. [2003]
i
j
At the time of publication of the guideline (March 2012): BS EN 455 Parts 1 - 4 Medical gloves for single-use.
k
For guidance see (at the time of publication of the guideline [March 2012]): ’Safe management of healthcare waste’
(2011); available from www.dh.gov.uk/en/Publicationsandstatistics/
Publications/PublicationsPolicyAndGuidance/DH_126345
42
Guideline summary
4.2.1.4 Safe use and disposal of sharps
21. Sharps should l not be passed directly from hand to hand, and handling should be kept to a
minimum [2003, amended 2012]
22.Used needles:
• must not be bent or broken before disposal
• must not be recapped.
In dentistry, if recapping or disassembly is unavoidable, a risk assessment must be

undertaken and appropriate safety devices should be used. [new 2012]
23. Used sharps must be discarded immediately by the person generating the sharps waste into
a sharps container conforming to current standards m. [new 2012]
24. Sharps containers:

• must n be located in a safe position that avoids spillage, is at a height that allows the safe
disposal of sharps, is away from public access areas and is out of the reach of children
• must notn be used for any other purpose than the disposal of sharps
• must notn be filled above the fill line
• mustn be disposed of when the fill line is reached
• should be temporarily closed when not in use
Update 2012
• should be disposed of every 3 months even if not full, by the licensed route in accordance
with local policy. [new 2012]
25. Use sharps safety devices if a risk assessment has indicated that they will provide safer
systems of working for healthcare workers, carers and patients. [new 2012]
26. Train and assess all users in the correct use and disposal of sharps and sharps safety
devices. [new 2012]
4.2.1.5 Waste disposal
27. Healthcare waste must be segregated immediately by the person generating the waste into
appropriate colour-coded storage or waste disposal bags or containers defined as being
compliant with current national legislationn and local policies. [new 2012]
28. Healthcare waste must be labelled, stored, transported and disposed of in accordance with
current national legislationn and local policies. [new 2012]
29. Educate patients and carers about the correct handling, storage and disposal of healthcare
waste. [new 2012]
l
The updated recommendation contains 'should' rather than ‘must’ (which is in the 2003 guideline) because the GDG
considered that this is not covered by legislation (in accordance with the NICE guidelines manual, 2009).
m
At the time of publication of the guideline (March 2012): UN3291 and BS 7320
n
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Guideline summary
4.2.2 Long-term urinary catheters
4.2.2.1 Education of patients, their carers and healthcare workers
30. Patients and carers should be educated about and trained in techniques of hand
decontamination, insertion of intermittent catheters where applicable, and catheter
management before discharge from hospital. [2003]
31. Community and primary healthcare workers must be trained in catheter insertion, including
suprapubic catheter replacement and catheter maintenance. [2003]
32. Follow-up training and ongoing support of patients and carers should be available for the
duration of long-term catheterisation. [2003]
4.2.2.2 Assessing the need for catheterisation
33. Indwelling urinary catheters should be used only after alternative methods of management
have been considered. [2003]
34. The patient’s clinical need for catheterisation should be reviewed regularly and the urinary
catheter removed as soon as possible. [2003]
35. Catheter insertion, changes and care should be documented. [2003]
4.2.2.3 Catheter drainage options
36. Following assessment, the best approach to catheterisation that takes account of clinical
need, anticipated duration of catheterisation, patient preference and risk of infection should
be selected. [2003]
37. Intermittent catheterisation should be used in preference to an indwelling catheter if it is

clinically appropriate and a practical option for the patient. [2003]
38. Offer a choice of either single-use hydrophilic or gel reservoir catheters for intermittent
self-catheterisation. [new 2012]
39. Select the type and gauge of an indwelling urinary catheter based on an assessment of the
patient’s individual characteristics, including:
Update 2012
• age
• gender
• reason for catheterisation. [new 2012]
40. In general, the catheter balloon should be inflated with 10 ml of sterile water in adults and
3–5 ml in children. [2003]
44
Guideline summary
41. In patients for whom it is appropriate, a catheter valve may be used as an alternative to a
drainage bag. [2003]
4.2.2.4 Catheter insertion
42. All catheterisations carried out by healthcare workers should be aseptic procedures. After
types of procedures. [2003]
43. Intermittent self-catheterisation is a clean procedure. A lubricant for single-patient use is

required for non-lubricated catheters. [2003]
44. For urethral catheterisation, the meatus should be cleaned before insertion of the catheter,
in accordance with local guidelines/policy. [2003]
45. An appropriate lubricant from a single-use container should be used during catheter
insertion to minimise urethral trauma and infection. [2003]
4.2.2.5 Catheter maintenance
46. Indwelling catheters should be connected to a sterile closed urinary drainage system or
catheter valve. [2003]
47. Healthcare workers should ensure that the connection between the catheter and the
urinary drainage system is not broken except for good clinical reasons, (for example
changing the bag in line with the manufacturer’s recommendations). [2003]
48. Healthcare workers must decontaminate their hands and wear a new pair of clean, non-
sterile gloves before manipulating a patient’s catheter, and must decontaminate their hands
after removing gloves. [2003]
49. Patients managing their own catheters, and their carers, must be educated about the need
for hand decontamination o before and after manipulation of the catheter, in accordance
with the recommendations in the standard principles section (section 4.2.1.). [2003,
amended 2012]
50. Urine samples must be obtained from a sampling port using an aseptic technique. [2003]
51. Urinary drainage bags should be positioned below the level of the bladder, and should not
be in contact with the floor. [2003]
52. A link system should be used to facilitate overnight drainage, to keep the original system
intact. [2003]
53. The urinary drainage bag should be emptied frequently enough to maintain urine flow and
prevent reflux, and should be changed when clinically indicated. [2003]
o
The text ‘Patients managing their own catheters, and their carers, must be educated about the need for hand
decontamination…’ has replaced ‘Carers and patients managing their own catheters must wash their hands…' in the
2003 guideline.
45
Guideline summary
54. The meatus should be washed daily with soap and water. [2003]
55. To minimise the risk of blockages, encrustations and catheter-associated infections for
Update 2012
patients with a long-term indwelling urinary catheter:
• develop a patient-specific care regimen
• consider approaches such as reviewing the frequency of planned catheter changes and
increasing fluid intake
• document catheter blockages. [new 2012]
56. Bladder instillations or washouts must not be used to prevent catheter-associated

infections. [2003]
57. Catheters should be changed only when clinically necessary or according to the
manufacturer’s current recommendations. [2003]
58.When changing catheters in patients with a long-term indwelling urinary catheter:
Update 2012
• consider antibiotic prophylaxis p for patients who:
– have a history of symptomatic urinary tract infection after catheter change or
– experience trauma q during catheterisation. [new 2012]
4.2.3 Enteral feeding
59. Patients and carers should be educated about and trained in the techniques of hand
decontamination, enteral feeding and the management of the administration system before
being discharged from hospital. [2003]
60. Healthcare workers should be trained in enteral feeding and management of the
administration system. [2003]
61. Follow-up training and ongoing support of patients and carers should be available for the
duration of home enteral tube feeding. [2003]
4.2.3.2 Preparation and storage of feeds
62. Wherever possible pre-packaged, ready-to-use feeds should be used in preference to feeds
requiring decanting, reconstitution or dilution. [2003]
63. The system selected should require minimal handling to assemble, and be compatible with
the patient’s enteral feeding tube. [2003]
64. Effective hand decontamination must be carried out before starting feed preparation.
[2003]
p
indication. Informed consent should be obtained and documented.
q
46
Guideline summary
65. When decanting, reconstituting or diluting feeds, a clean working area should be prepared
and equipment dedicated for enteral feed use only should be used. [2003]
66. Feeds should be mixed using cooled boiled water or freshly opened sterile water and a no-
touch technique. [2003]
67. Feeds should be stored according to the manufacturer’s instructions and, where applicable,
food hygiene legislation. [2003]
68. Where ready-to-use feeds are not available, feeds may be prepared in advance, stored in a
refrigerator, and used within 24 hours. [2003]
4.2.3.3 Administration of feeds
Update
2012
69. Use minimal handling and an aseptic technique to connect the administration system to the
enteral feeding tube. [new 2012]
70. Ready-to-use feeds may be given for a whole administration session, up to a maximum of
24 hours. Reconstituted feeds should be administered over a maximum 4-hour period.
[2003]
71. Administration sets and feed containers are for single use and must be discarded after each
feeding session. [2003]
4.2.3.4 Care of insertion site and enteral feeding tube
72. The stoma should be washed daily with water and dried thoroughly. [2003]
73.To prevent blockages, flush the enteral feeding tube before and after feeding or
Update 2012
administering medications using single-use syringes or single-patient-use (reusable) syringes
according to the manufacturer’s instructions. Use:
• freshly drawn tap water for patients who are not immunosuppressed
• either cooled freshly boiled water or sterile water from a freshly opened container for
patients who are immunosuppressed. [new 2012]
4.2.4 Vascular access devices
74. Before discharge from hospital, patients and their carers should be taught any techniques
they may need to use to prevent infection and safely manage a vascular access device r
[2003, amended 2012]
75. Healthcare workers caring for a patient with a vascular access device s should be trained,
and assessed as competent, in using and consistently adhering to the infection prevention
practices described in this guideline [2003, amended 2012]
r
s
47
Guideline summary
76. Follow-up training and support should be available to patients with a vascular access
devices and their carers [2003, amended 2012]
4.2.4.2 General asepsis
77. Hands must be decontaminated (see section 4.2.1.2) before accessing or dressing a vascular
Update 2012
access device. [new 2012]
78. An aseptic techniquet must be used for vascular access device catheter site care and when
accessing the system. [new 2012]
4.2.4.3 Vascular access device site care
79. Decontaminate the skin at the insertion site with chlorhexidine gluconate in 70% alcohol
before inserting a peripheral vascular access device or a peripherally inserted central
catheter. [new 2012]
80. Use a sterile transparent semipermeable membrane dressing to cover the vascular access
device insertion site. [new 2012]
Update 2012
81.Consider a sterile gauze dressing covered with a sterile transparent semipermeable
membrane dressing only if the patient has profuse perspiration, or if the vascular access
device insertion site is bleeding or oozing. If a gauze dressing is used:
• change it every 24 hours, or sooner if it is soiled and
• replace it with a sterile transparent semipermeable membrane dressing as soon as possible.
[new 2012]
82. Change the transparent semipermeable membrane dressing covering a central venous
access device insertion site every 7 days, or sooner if the dressing is no longer intact or
moisture collects under it. [2012]
83. Leave the transparent semipermeable membrane dressing applied to a peripheral cannula
insertion site in situ for the life of the cannula, provided that the integrity of the dressing is
retained. [new 2012]
84.Dressings used on tunnelled or implanted central venous catheter sites should be replaced
every 7 days until the insertion site has healed, unless there is an indication to change them
sooner [2003]
85. Healthcare workers should ensure that catheter-site care is compatible with catheter
materials (tubing, hubs, injection ports, luer connectors and extensions) and carefully check
compatibility with the manufacturer’s recommendations. [2003]
Update 2012
86. Decontaminate the central venous catheter insertion site and surrounding skin during
dressing changes using chlorhexidine gluconate in 70% alcohol, and allow to air dry.
Consider using an aqueous solution of chlorhexidine gluconate if the manufacturer’s
recommendations prohibit the use of alcohol with their catheter. [2012]
t
The GDG considered that Aseptic Non Touch Technique (ANTT™) is an example of an aseptic technique for vascular access
device maintenance, which is widely used in acute and community settings and represents a possible framework for
establishing standardised aseptic guidance.
48
Guideline summary
87. Individual sachets of antiseptic solution or individual packages of antiseptic-impregnated

swabs or wipes should be used to disinfect the dressing site. [2003]
4.2.4.4 General principles for management of vascular access devices
Update 2012
88. Decontaminate the injection port or vascular access device catheter hub before and after
accessing the system using chlorhexidine gluconate in 70% alcohol. Consider using an
aqueous solution of chlorhexidine gluconate if the manufacturer’s recommendations
prohibit the use of alcohol with their catheter. [new 2012]
89. In-line filters should not be used routinely for infection prevention. [2003]
90. Antibiotic lock solutions should not be used routinely to prevent catheter-related
bloodstream infections (CRBSI). [2003]
91. Systemic antimicrobial prophylaxis should not be used routinely to prevent catheter
colonisation or CRBSI, either before insertion or during the use of a central venous catheter.
[2003]
92. Preferably, a single lumen catheter should be used to administer parenteral nutrition. If a
multilumen catheter is used, one port must be exclusively dedicated for total parenteral
nutrition, and all lumens must be handled with the same meticulous attention to aseptic
technique. [2003]
93. Preferably, a sterile 0.9 percent sodium chloride injection should be used to flush and lock
catheter lumens. [2003]
94. When recommended by the manufacturer, implanted ports or opened-ended catheter

lumens should be flushed and locked with heparin sodium flush solutions. [2003]
95. Systemic anticoagulants should not be used routinely to prevent CRBSI. [2003]
96. If needleless devices are used, the manufacturer’s recommendations for changing the
needleless components should be followed. [2003]
97. When needleless devices are used, healthcare workers should ensure that all components
of the system are compatible and secured, to minimise leaks and breaks in the system.
[2003]
98.When needleless devices are used, the risk of contamination should be minimised by
decontaminating the access port with either alcohol or an alcoholic solution of chlorhexidine
gluconate before and after using it to access the system. [2003]
99. In general, administration sets in continuous use need not be replaced more frequently
than at 72-hour intervals unless they become disconnected or a catheter-related infection is
suspected or documented. [2003]
100. Administration sets for blood and blood components should be changed every 12 hours,
or according to the manufacturer’s recommendations. [2003]
49
Guideline summary
101. Administration sets used for total parenteral nutrition infusions should generally be
changed every 24 hours. If the solution contains only glucose and amino acids,
administration sets in continuous use do not need to be replaced more frequently than
every 72 hours. [2003]
102. Avoid the use of multidose vials, in order to prevent the contamination of infusates. [new
Update
2012
2012]
50
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Infection field on theand
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Control
Guideline summary
4.3 Key research recommendations

The following research recommendations are those prioritised by the GDG. Additional
recommendations have been made and are detailed within the chapters.
4.3.1 Standard principles of infection prevention and control
1. What are the barriers to compliance with the standard principles of infection prevention and
control that patients and carers experience in their own homes?
4.3.2 Hand decontamination
2. When clean running water is not available, what is the clinical and cost effectiveness of using
wipes, gels, handrubs or other products to remove visible contamination?
4.3.3 Intermittent urinary catheters: catheter selection
3. For patients performing intermittent self-catheterisation over the long term, what is the
clinical and cost effectiveness of single-use non-coated versus single-use hydrophilic versus
Update 2012
single-use gel reservoir versus reusable non-coated catheters with regard to the following
outcomes: symptomatic urinary tract infections, urinary tract infection-associated bacteraemia,
mortality, patient comfort and preference, quality of life, and clinical symptoms of urethral
damage?
4.3.4 Indwelling urinary catheters: catheter selection
4. For patients using a long-term indwelling urinary catheter, what is the clinical and cost
effectiveness of impregnated versus hydrophilic versus silicone catheters in reducing
symptomatic urinary tract infections, encrustations and/or blockages?
4.3.5 Indwelling urinary catheters: antibiotic prophylaxis
5. When recatheterising patients who have a long-term indwelling urinary catheter, what is the
clinical and cost effectiveness of single-dose antibiotic prophylaxis in reducing symptomatic
urinary tract infections in patients with a history of urinary tract infections associated with
catheter change?
4.3.6 Vascular access devices: skin decontamination
6. What is the clinical and cost effectiveness of 2% chlorhexidine in alcohol versus 0.5%
chlorhexidine in alcohol versus 2% chlorhexidine aqueous solution versus 0.5% chlorhexidine
aqueous solution for cleansing skin (before insertion of peripheral vascular access devices
[VADs] and during dressing changes of all VADs) in reducing VAD related bacteraemia and VAD
site infections?
51
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onNICE
the first
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page
Guideline
and insert
2 footer text if required>
Standard Principles
5 Standard Principles
5.1 Introduction
The updated review question in this chapter is:
• Education of patients, carers and healthcare workers.
The new review question in this chapter is:
Update 2012
• Patient information about hand decontamination.
This chapter introduces hand decontamination, personal protective equipment (PPE) and sharps.
Several new questions and updates are included in the hand decontamination, PPE and sharps
chapters. Key health and safety legislation1,3,4,68,115 has also been considered when drafting these
recommendations.
The GDG considered the addition of the patient information hand decontamination review question
in this update as a key area paramount to patient safety. This is also an area where there is variation
in practice and important equality issues were identified.
The GDG has prioritised three recommendations in this chapter as a key priority for implementation,
see sections 5.2.1.1 and 5.2.2.4.
Standard Principles provide guidance on infection control precautions that should be applied by all
healthcare workers to the care of patients in community and primary care settings. These
recommendations are broad principles of best practice and are not detailed procedural protocols.
They need to be adapted and incorporated into local practice guidelines.
5.2 Education of patients, carers and their healthcare workers

To improve patient outcomes and reduce healthcare costs, it is essential that everyone providing
care in the community is educated about hand decontamination, the appropriate use of gloves and
protective clothing, and the safe disposal of sharps. Adequate supplies of soap, alcohol rub, towels
and sharps bins must be made available wherever care is delivered and this may include providing
healthcare workers undertaking home visits, with their personal supply. Patients and carers should
request that healthcare workers follow these principles.24
52
Standard Principles
The following recommendations have been updated based on the evidence reviewed in the standard
principles chapters for hand hygiene, personal protective equipment and the safe use and disposal of
sharps in chapters 6, 7 and 8, respectively.
5.2.1.1 Recommendations

• educated about the standard principles of infection prevention and
control and
• trained in hand decontamination, the use of personal protective
Recommendations equipment, and the safe use and disposal of sharps. [2012]
Relative values of different The GDG have added “and the safe use …” of sharps to this recommendation.
outcomes The safe use of sharps is very important as identified from the evidence of the
sharps review question (see section 8.4.1.4). Although no specific review
question was asked for this recommendation, the review questions for sharps
safety devices feed into this recommendation.
The GDG wish to emphasise the safe use of sharps, and want to increase the
awareness of safe sharps use and reduce injuries.
Trade off between clinical The clinical benefit from education about standard principles (hand
benefits and harms decontamination, personal protective equipment and sharps) would lead to
decreased healthcare-associated infections, sharps injuries and a better
understanding of why standard principles are important.
Update 2012
Potential harms could be from poor or inaccurate education and therefore it is
important to consider how this education should be delivered, see also 8.4.1.4
The use of sharps safety devices in section 8.4.1.4 concludes that sharps
injuries were still occurring despite safety devices being introduced and this
was linked to a lack of, or ineffective, training. GDG consensus was that
without adequate education sharps injuries will continue to be a problem.
Economic considerations Hand decontamination products, PPE and sharps disposal equipment are
designed to reduce the transmission of microorganisms between healthcare
workers, patients, and the environment. Healthcare workers should be
educated about the proper use of such materials in order to properly perform
their job. Any small increase in time or resource use is likely to be outweighed
by a reduced rate of infection and injury.
Quality of evidence See also the review questions in chapter 8 regarding safe use of sharps.
No RCTs were identified for safety needle devices, but several observational
studies were identified. These studies had several limitations and were all very
low quality.
Other considerations Minor changes made from the original recommendation. ‘In the community’
has been removed from the recommendation as the GDG considered that this
may be confusing and may be interpreted as not including GP surgeries and
care home. The safe use of sharps has been reviewed in the sharps chapter 8.
The GDG have prioritised this recommendation as a key priority for
implementation as they considered that it has a high impact on outcomes that
are important to patients, has a high impact on reducing variation in care and
outcomes, leads to a more efficient use of NHS resources, promotes patient
choice and means that patients reach critical points in the care pathway more
quickly. See section 4.1 for further details.
53
Standard Principles
2. Wherever care is delivered, healthcare workers must u have

available appropriate supplies of:
Recommendations • personal protective equipment. [new 2012]
Relative values of different The GDG have added “personal protective equipment” to the list of supplies
outcomes that must be provided.
The most important outcome is to protect healthcare workers from health care
associated infections and prevent cross contamination of infections from
patient to patient.
Trade off between clinical Healthcare workers are required by law to be provided with appropriate
benefits and harms supplies of hand decontamination products, PPE and sharps disposal
equipment (Health and Safety at Work Act 19741, Health and Safety
Regulations 20024, Control of Substances Hazardous to Health Regulations
115 3
2002 , Management of Health and Safety at Work Regulations 1999 , Health
68
and Social Care Act 2008 ).
This recommendation complies to current legislation and safeguards
Update 2012
individuals from the risk, or any increased risk, of being exposed to health care
associated infections or of being made susceptible, or more susceptible, to
them.68
Economic considerations Hand decontamination products, PPE and sharps disposal equipment are
designed to reduce the transmission of microorganisms between healthcare
workers, patients, and the environment. Healthcare workers must be provided
with the materials necessary to properly perform their job. Where healthcare
workers are not currently provided with appropriate supplies, this
recommendation may be associated with an implementation cost.
Noncompliance with this recommendation may be associated with costs in the
form of fines or litigation.
Quality of evidence See sharps waste disposal chapter, which refers to Safe Management of
Healthcare Waste.72
No specific clinical evidence review was applicable for this recommendation.
However, evidence was reviewed for effectiveness of different types of gloves
and gowns versus aprons in the personal protective equipment chapter.
Other considerations The updated recommendation includes supplies of gloves and PPE. The term
‘must’ is used as it is covered by legislation (Health and Safety at Work Act
1974,1 Health and Safety Regulations 2002,4 Control of Substances Hazardous
to Health Regulations 2002,115 Management of Health and Safety at Work
Regulations 1999,3 Health and Social Care Act 200868) in line with the guidance
from the NICE Guidelines Manual (2009)’.182
outcomes and promote equality. See section 4.1 for further details.
u
In accordance with current health and safety legislation (at the time of publication of the guideline [March 2012]):
Health and Safety at Work Act 1974, Management of Health and Safety at Work Regulations 1999, Health and Safety
54
Standard Principles
5.2.2 Review question

What information do healthcare professionals, patients and carers require to prevent healthcare-
associated infections in primary and community care settings?
5.2.2.1 Focus of the review:
The review aimed to inform the GDG about what information should routinely be provided to
patients and carers to prevent healthcare-associated infections. Hand decontamination was
acknowledged to be simple, yet extremely effective and necessary for the prevention of healthcare-
associated infections. Hence, the GDG decided to prioritise the information needs of patients and
carers regarding their own hand decontamination and healthcare worker hand decontamination for
the purposes of this review.
See Evidence table G.1.1, Appendix G.
5.2.2.2 Evidence reviewed
Update 2012
Qualitative studies (focus group discussions, interviews), surveys and observational studies
evaluating patients’ perceptions regarding their own hand decontamination and participation in
health care worker hand decontamination were included in the review. The findings were analysed
and themes which emerged consistently were noted and are presented. Twenty two studies were
included in this review.
The review included studies looking at different populations and settings, including developing
countries. This contributes to the strength as well as the limitations of the quality of evidence.
Including information from indirect settings and populations may limit the applicability of the
findings to patients cared for in the community in the UK. However, many themes were consistent
irrespective of these differences and therefore will also most likely be applicable to the UK. Some of
the included qualitative studies are of good quality and report in detail the sampling strategies,
methods used and the analysis. Some studies have poor sampling strategies and did not report
verification of results or triangulation of findings with participants. Details of methods and analysis
were also not provided. The qualitative studies using interviews and focus group discussions may be
in general, at risk of responder bias as people may give responses depending on the interviewer’s
status, style of questioning and the associated circumstances. Also, studies which used structured
observations may be at risk of observer bias as people may behave differently when they are aware
of being observed.
Among the surveys included, some do not report validation and piloting of questionnaires.
Details about the quality and applicability that are specific to the themes found are documented
alongside the themes in Table 6.
55
Standard Principles
Table 6: Summary of findings and study quality

No. of studies Themes and supporting evidence Comments on limitations , indirectness,
and study consistency, and other considerations
design
1. General perceptions about hand washing.
4 x Survey 1.1 Hand washing is widely believed to be effective in preventing infection (including MRSA, Limitations: Two studies had poor sampling
80,163,195,204
healthcare-associated infections, flu outbreaks and wound care): strategies (non-random sampling or
1 x Cohort • MRSA: More than 80% inpatients [UK]80, members of the public and people who had MRSA in convenience based sampling was used).33,80
study 159 163
[Ireland] understood hand washing is effective in reducing transmission.
80,163 Validation of questionnaires and verification of
analysis was not reported in any of the surveys.
1 x [Survey • Inpatients: 95% realised that hand washing was important to prevent HCAI [UK & USA]33,159, and 80,163,195,204
+Interviews]33 98.7% of patients with wounds realised that that hands should be washed before the dressing is
1 x [FGD changed [USA].204 Indirectness: All studies were not conducted in
+Interviews ]
175 the target population or settings, and not
• Flu prevention: More than 80% members of the public thought hand washing was an effective
conducted with the objectives of finding out
1 x Telephone prevention measure for flu [UK]175, and swine flu226, although only 28.1% reported washing their
what information is required by patients. 3
survey
226
hands more than usual because of swine flu [UK].226
Update 2012
studies were conducted during flu outbreaks
• More than 90% of participants perceived hand-washing as an effective measure to prevent H1N1 175,195,226
and 3 among inpatients.33,80,204
(avian flu) infection [Korea].195
Consistent themes emerged across different
settings and populations.
1x survey195 1.2 Perceived efficacy of washing hands is associated with hand washing: Indirectness: Both surveys were conducted to
1 x Telephone • Perceived effectiveness of hand-washing was positively correlated (p=0.002) with hand-washing investigate perceptions during flu
survey 226 195
frequency [Korea] , and actually washing hands more regularly (odds ratio 1.8. 95% CI 1.5 to 2.2) outbreaks.195,226
226
[UK]. Consistency: Both UK and Korean studies
showed the correlation.
3 x [Survey 1.3 Variation in preference for alcohol gels and hand rubs: Limitations: Small sample size and poor
+Interviews • Hand wipes (82% of inpatients,[UK])33, soap and water (54.3% of parents in A&E, US)252 were the sampling strategy in one study (non random
33,207,256 33
] preferred options . sampling ).
231
• Rinse free alcohol gel was well received (children and teachers, UK) , 85% of inpatients would use One study was at high risk of bias as patients
1 x Survey 252 207
it for themselves [UK]. .= were asked their preference after using all the
1 x [Structured products once at the bedside. This may not be
• After testing alcohol foam, wet cloth with antiseptic, alcohol wipes, bowl of soapy water and
observations indicative of actual preference over time. Also,
followed by a mobile sink, the mean satisfaction score for alcohol foam was slightly higher than
+Interview + two of the products compared could not be
others (unclear whether this difference is significant, statistically or clinically). Alcohol foam and the
FGD] 231 used by some patients.256
bowl of soapy water was equally preferred as the first option by ethnic minority groups (Hindus and
Muslims)[UK].256 Indirectness: Studies were indirect in terms of
56
Standard Principles
population and setting (conducted among

inpatients in hospitals).
1 x [Survey 1.4 Lack of accessibility of hand washing facilities, alcohol gels and hand rubs: Limitations: Small sample size, Non random
33
+Interviews ] • 55% reported not having been offered facilities to wash/clean hands during current hospital stay methods of sampling used; Responder bias may
[UK].
33 have occurred as interviews were conducted by
33
HCW. Indirect population (inpatients).
2. Factors motivating people to wash their hands.
2.1 Feeling of “disgust”, usually related to contamination, dirt or activities prompts hand washing:
4 x [Structured Among studies done mostly in mothers, disgust was associated with: Limitations: Poor sampling strategies
observations • bodily fluids or excrement: such as “after you’ve been to the loo” (UK),54 “women have-periods” (convenience based sampling/ non-random
54,56
+Interview + (mothers, India.
56 sampling); No details of verification of
FGD]54,56,130,231 231 130 results or triangulation reported in any of the
• visible dirt on hands: “bits on our hands” (children, UK), dirt [Botswana].
56 studies.
• unpleasant smell: “I don’t want the scent of that thing [faeces] to remain on my hands.”[Ghana] ,
Indirectness: Two studies were conducted in
“whenever I’ve had a cigarette .. I wash my hands” [ UK].54
54
developing countries.56,130 2 studies were
• unpleasant feeling on hands: “... I don’t particularly like the feel on my hands ...sticky”[UK 2003]
Update 2012
130
conducted in the UK and were also indirect in
“stickiness”,[Botswana]. terms of population (school children231,
54
mothers ).
Consistency: Disgust as a motivator of hand
washing was consistent across different
settings (countries), and populations (children,
adults).
2 x [Structured 2.2 Responsibility: not wanting to pass on to others, and a responsibility of protecting others: Limitations: Poor sampling strategies
observations • Worried about passing it to others: > 90% of members of public, patients who had MRSA and were (convenience based sampling/non random
54,56
+Interview + worried about passing it to their families .
163 sampling). No details of verification of
54,56
FGD] results or triangulation reported in any of the
• Looking after (protecting) others: This includes mothers who want to protect their babies and
1 x [FGD children against infection,54,56 and also the wider, members of the general public expressed a wider studies.
+Interviews ]175 sense of responsibility to protect the health of ‘others’ in society [UK].
175 Indirectness: 1 review included studies from
56
1 x Survey163 developing countries.
Consistency: Consistent themes emerged
across different settings and populations
1 x Survey195, 2.3 Perceived themselves (or others) to be susceptible to infections: Limitations: The frequency of hand washing
1 x [Structured • Hand-washing was associated with perceived susceptibility of flu infection(p=0.001).[university was self reported, which may be different from
195,226
observations 195
students, Korea] , (Adjusted OR 1.5, 95% CI 1.3 to 1.8)[general public, UK 2009].
226 actual practice.
+Interview + • Frightened of more germs going about … they have got no immune system really”[mothers, UK Indirectness: Studies in conducted among
57
Standard Principles
54
FGD54 ] 2003].54 mothers and child carers; in flu outbreak
226,195 195
1 x Telephone situations, and in Korea.
survey226 Consistency: Consistent themes emerge in spite
of differences.
3 x [Structured 2.4 Believed or understood that it is important in prevention of Infection: Limitations: Poor sampling strategies(use of
observations • Associated with infection getting worse with hand washing not practiced before certain activities, convenience based sampling or non-random
54,56 204
+Interview + e.g. washing hands after going to the toilet while having diarrhoea and before eating. [mothers, sampling strategies); Small sample size
54,56,231
FGD] UK 2003].
54
Indirectness: Studies were conducted among
54
• ‘So I don’t get ill’ (Year 2 child).
231 mothers and child carers; and in developing
56
2 x Survey
204,236 countries .
• Not washing hands was associated with spreading diseases (e.g. cholera and diarrhoea) to
children [mothers, Uganda, Ghana 2009].
56 Consistency: Consistent themes emerge in spite
204 of differences in population and settings.
• Hands should be washed before dressing is changed (98.7% of public) [USA 2007].
• hand washing was considered very important after touching infected skin (87%), after
coughing/sneezing (79% ).236
3. Patient perceptions and experience of participation in healthcare worker hand
Update 2012
decontamination.
3.1 Perceptions and experience of patients regarding their own participation in improving HCW
compliance with hand decontamination:
4 x Survey There were variations in studies about whether patients were comfortable or likely to ask doctors or Limitations: Validation of questionnaire and
81,151,153,273
nurses to clean their hands: verification of findings not reported in any of
81,151,153,273
1 x Cohort • 79% of inpatients reported being likely to ask, with younger patients (mean age 42) more so than the surveys.
study159 older patients (mean age 60) [UK].
81
Indirectness: All studies were conducted in
1 x [Survey • About 60% of patients, with or without MRSA, did not try to ask a medical personnel to wash acute care settings among inpatients.81,153,207,273
207
+Interviews] their hands even once since their last stay in hospital [UK].153
• less than half of members in the public felt comfortable in asking [Switzerland].151
• less than half of patients reported feeling comfortable in asking in one study [USA]273, but 68% of
patients were comfortable in another [UK]159. The % of actually asking when hospitalised are
much lower (5%), and patients who are more comfortable are more likely to ask [USA].273
• 94% of inpatient had not asked their nurse or doctor; 53% trusted that the HCWs would have
already cleaned their hands [UK].207
3.2 Factors affecting patient participation in implementation of hand decontamination among
healthcare workers:
4x Believing that it is alright to ask based on encouragement from HCW, presence of reminders, or Limitations: Validation of questionnaire and
58
Standard Principles
Survey58,81,151,153 observing similar behaviour in other patients encourages participants, for example: verification of findings not reported in any of
58,81,151,153
1 x [Survey • An explicit invitation from a HCW increased the intention to ask a physician from 29.9% to 77.8% the surveys; one study at risk of
+Interviews]207 of respondents; (p<.001) and the intention to ask a nurse from 34.0% to 82.5%; (p<.001) responder bias as interviews were conducted
151
[inpatients, Switzerland].151 by HCW.
• instructed by a doctor to do so [UK].
58 Indirectness: Indirect in terms of population
and settings (conducted in acute care settings
• staff wearing badges saying it was OK, letters from their surgeon or ward manager to be 58,81,151,153,207
among inpatients).
encouraging to be able to ask staff to wash their hands, posters on a wall – more than 50%
81
inpatients [UK].
• Observed other patients doing the same (about 65% of inpatients, UK).81
• Respondents reported that they were more likely to ask a nurse or doctor to clean their hands if
they were given a bottle of hand rub by the hospital [UK].207
• Intention to ask healthcare workers about handwashing is an important factor in actually asking
about hand washing (covariance 0.36, p<0.001).153
3 x Survey Profession or seniority of healthcare workers (HCW) Validation of questionnaire and verification of
Update 2012
58,81,151
There are variations whether one group of HCW are more likely to be asked than others: findings not reported in the surveys.58,81,151
1 x Cohort • The number of participants who reported themselves comfortable or willing to ask about hand Indirectness: All studies were indirect to the
159
study washing were similar or slightly more (a few percentage points) for nurses compared to doctors target population and settings (conducted in
1 x [Survey [UK58,207], even after explicit encouragement to do so [Switzerland].151 acute care settings among inpatients).
+Interviews]207 • Most patients (about 76%) were not comfortable in asking nurse or doctors to wash their hands
[Switzerland].151
• Student nurses, trained nurses, venepuncturists and healthcare assistants were more likely to be
asked to wash their hands; Surgeons, junior doctors, physiotherapists and porters were most
81
likely never to be asked to wash their hands [UK].
• Of the patients who did ask, 141 (90%) asked nurses and 50 (32%) asked physicians whether they
had washed their hands [USA].159
80,153
2 x Survey Knowledge about infections, previous hospital admissions, history of infections Validation of questionnaire and verification of
1 x Cohort • Patients would be more willing to ask healthcare workers whether they have washed their hands findings not reported in the surveys.80,153
study159 80
if they were less anxious about asking hospital staff and had prior hospital admissions[UK] or Indirectness: All studies were indirect to target
80
had a history of MRSA infection [UK]. population and settings (conducted in acute
• There is a possible relationship between knowledge and asking about hand washing (covariance care settings among inpatients).
0.06) [UK].153
• 57% asked after reading a patient education brochure on hand washing [USA].159
59
Standard Principles
5.2.2.3 Economic evidence:
No economic evidence was identified.
5.2.2.4 Recommendations:

• the availability of hand washing and decontamination facilities
• their role in maintaining standards of healthcare workers’ hand
Recommendations decontamination. [new 2012]
Relative values of different The reduction of healthcare-associated infections through increased
outcomes awareness and practice of hand decontamination is important. The
involvement of patients in their own and healthcare workers’ hand
decontamination in healthcare settings will be likely to contribute to better
practice of hand decontamination.
Trade off between clinical Patient education has the potential to improve awareness and encourage hand
benefits and harms decontamination compliance which may result in fewer healthcare-associated
infections. The potential clinical harms are minor (skin irritation, perceived
inconvenience) and are outweighed by the potential benefits.
Economic considerations The GDG discussed patient education in the context of routine healthcare
Update 2012
practice. It was expected that any impact on time and resource use would be
minimal and would likely be offset by a reduction in infections.
Quality of evidence Evidence was obtained from a wide range of study designs, ranging from large
scale surveys to qualitative studies using interviews, focus groups, and
structured observations.
There are limitations (such as indirectness of populations) in the evidence.
Most studies were not designed to identify the strength of association
between knowledge, attitude or perception about hand decontamination in
affecting behaviours.
However, the themes which emerged about the perception and factors which
encourage or discourage hand decontamination are consistent across settings
and populations, increasing the confidence that these findings are applicable
to patients in the community.
Other considerations The GDG considered equality issues, in particular, language and disability, for
example, lack of mobility and cognitive impairment in the implementation of
this recommendation. Language barriers should not be a reason for non-
provision of information. The GDG also considered that additional support may
be required for patients and carers with learning difficulties.
The GDG also discussed that there might be concerns about using handrubs
that contain alcohol. It is important that patients are aware of the pros and
cons of using these products. If religious beliefs are a source of concern, the
patients could be made aware of the official stand of religious bodies about
the product. For example, the official position of Muslim Councils of Britain is
that “External application of synthetic alcohol gel, however is considered
permissible within the remit of infection control because (a) it is not an
intoxicant and (b) the alcohol used in the gels is synthetic, i.e., not derived from
fermented fruit. Alcohol gel is widely used throughout Islamic countries in
health care setting”178.
When information is available, the GDG felt it would be useful to direct the
60
Standard Principles
patients to these information sources to clarify the positions. The GDG were
aware that not all patients may be comfortable in asking health care workers
to wash their hands and that they will need encouragement to do so along
with education. The review looked at factors which encouraged patients to do
so and be more involved in hand decontamination of healthcare workers. The
GDG prioritised this recommendation as a key priority for implementation as
they considered that it has a high impact on outcomes that are important to
patients, has a high impact on reducing variation in care and outcomes, leads
to a more efficient use of NHS resources and promotes equalities. See section
4.1 for further details.
5.3 Research recommendation

1. What are the barriers to compliance with standard precautions of infection prevention and
Update 2012
control that patients and carers experience in their own homes?
Why this is important
Recent changes to the delivery of healthcare mean that care is increasingly delivered within a
patient’s home environment. Infection prevention in this setting is just as important as in hospital.
There are currently approximately six million unpaid carers in the UK, a number that is likely to
increase with an aging population. The association between carer training and infection rates is
unknown. No evidence of surveillance of healthcare-associated infections in the community is
currently available in the UK.
A qualitative study is needed to investigate the themes surrounding the barriers to patient and carer
compliance with the standard principles of infection prevention in their own homes. It would be
important to assess whether lack of awareness or knowledge is a barrier. If patients and carers have
received education this should be assessed to see if this was applicable to the patient’s home setting.
Areas of low compliance in the home environment need to be identified. The findings could have far-
reaching implications for discharge planning and duty of care.
61
Infection
field on theand
first
Control
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Standard principles for hand hygiene
6 Standard principles for hand decontamination

6.1 Introduction
The updated review questions in this chapter are:
• When to decontaminate hands?
• Which hand cleaning preparation to use?
The evidence and text from the previous guideline that has been superseded by this update is
included in Appendices D.6 and D.9.
New review questions included in this chapter are:

• Should wrists be washed?
• Should sleeves be rolled up for clinical care?
These two new review questions are important and have been prioritised for inclusion in this update
as they continue to be contentious and healthcare workers need to be able to identify best practice
Update 2012
based on the evidence. Although current practice is that wrists should be washed as part of hand
decontamination, there is uncertainty as to whether there is evidence to support this. In addition,
there is a need to identify an end point to the areas of the hand to be included. It is recognised that
workwear should not impede effective hand decontamination, as detailed and reviewed in section
4.2.1.3, and should not come into contact with patients when delivering direct patient care or
environmental surfaces when cleaning.
Sections not updated in this chapter are:

• Hand washing techniques
• Skin damage due to hand decontamination.
The GDG were made aware that current guidance on hand decontamination for the dental
profession is detailed in the Department of Health’s ‘Health Technical Memorandum 01-05:
Decontamination in primary care dental practices’.67
The GDG has prioritised one recommendation in this chapter as a key priority for implementation,
see section 6.3.1.4.
The following section provides the evidence for recommendations concerning hand hygiene practice.
The difficulty of designing and conducting ethical, randomised controlled trials in the field of hand
hygiene, together with the lack of studies conducted in community and primary care means that
recommendations in some areas of hand hygiene are predominantly based on expert opinion derived
from systematically retrieved and appraised professional, national and international guidelines that
focus on nosocomial infection. In reducing the length of hospital stay, care previously delivered only
in hospitals has progressively shifted to outpatient and home settings. In addition, healthcare
practitioners are increasingly working across the boundaries of acute and community care and
invasive procedures are performed in outpatient clinics, nursing home and home settings. These
factors create the potential for patients to be at greater risk of acquiring a healthcare-associated
infection outside the hospital setting.
The areas discussed include:

• assessment of the need to decontaminate hands
• the efficacy of hand decontamination agents and preparations;
• the rationale for choice of hand decontamination practice;

<Click this field on the first page and insert footer text if required>
62
• technique for hand decontamination

• care to protect hands from the adverse effects of hand decontamination practice.
6.2 Why is hand decontamination crucial to the prevention of

healthcare-associated infection in the community?
Overviews of epidemiological evidence conclude that hand-mediated transmission is a major
contributing factor in the current infection threats to hospital in-patients. These include both
meticillin-sensitive and meticillin-resistant Staphylococcus aureus (MRSA), and multi-resistant Gram-
negative aerobes and enterococci. The transmission of microorganisms from one patient to another
via the hands, or from hands that have become contaminated from the environment, can result in
adverse outcomes. Primary exogenous infection is a direct clinical threat where microorganisms are
introduced into susceptible sites, such as surgical wounds, intravascular cannulation sites, enteral
feeding systems or catheter drainage systems. Secondary endogenous infection creates an indirect
clinical threat where potential pathogens transmitted by the hands establish themselves as
temporary or permanent colonisers of the patient and subsequently causes infection at susceptible
sites. Evidence from two previous reviews210 conclude that in outbreak situations contaminated
hands are responsible for transmitting infections and our previous systematic review indicates that
effective hand decontamination can significantly reduce infection rates in gastro-intestinal infections
and in high-risk areas, such as intensive care units.210
Our systematic review identified two clinically-based trials88,228 and two descriptive studies that
confirmed the association between hand decontamination and reductions in infection106,206. In a non-
randomised controlled trial (NRCT) a hand washing programme was introduced and in the post
intervention period respiratory illness fell by 45%228. A further NRCT, introducing the use of alcohol
hand gel to a long-term elderly care facility, demonstrated a reduction of 30% in HCAI over a period
of 34 months when compared to the control unit.88 One descriptive study demonstrated the risk of
cross infection resulting from inadequate hand decontamination in patient’s homes.106
Expert opinion is consistent in its assertion that effective hand decontamination results in significant
reductions in the carriage of potential pathogens on the hands and logically decreases the incidence
of preventable HCAI leading to a reduction in patient morbidity and mortality.24,128,143
63
6.3 When to decontaminate hands

Several hand hygiene guidelines and policies have been introduced detailing when hands should be
decontaminated. This review questions aims to determine when hands should be decontaminated by
looking at the implementation of published hand hygiene guidance and whether hand
decontamination compliance has increased and infection has reduced.
What is the clinical and cost effectiveness of when to decontaminate hands, including after the
removal of gloves, on hand decontamination compliance, MRSA and C diff. reduction or cross
infection, colony forming units and removal of physical contamination?
The GDG considered that colony forming units (CFUs) and hand decontamination compliance were
the most important outcomes for this review question.
Update 2012
6.3.1.1 Clinical evidence
Four cohort studies were identified, where the intervention was the introduction of a hand
decontamination guideline (before and after implementation studies). All studies aimed to increase
hand decontamination compliance through a multi-modal hand decontamination intervention.
Allegranzi et al., 20107 implemented the World Health Organisation (WHO) hand hygiene
improvement strategy (including the 5 moments of hand hygiene) in a hospital in Mali, Africa. The
WHO 5 moments of hand hygiene encourages health-care workers to clean their hands (1) before
touching a patient, (2) before clean/aseptic procedures, (3) after body fluid exposure/risk, (4) after
touching a patient and (5) after touching patient surroundings. Other elements of implementation
strategy include improving access to handrub, training and education, evaluation and feedback and
reminders in the workplace. Aragon et al., 200515 implemented the Centres for Disease Control (CDC)
2002 guideline in one US hospital and Larson et al., 2007145 implemented the same guideline in 40 US
hospitals. This intervention encourages healthcare workers to use handrub or wash their hands
before and after every contact. Aragon et al., 200515 also used reminders in the workplace. Rosenthal
et al., 2005222 implemented the Association for Professionals in Infection Control (APIC) hand hygiene
guideline in a hospital in Buenos Aires, Argentina. This intervention used education and reminders in
the workplace.
No studies from the previous 2003 guideline met the inclusion criteria for this review question.
See Evidence Table G.2.1, Appendix G, Forest Plots in Figure 1-5, Appendix I.
64
Table 7: After vs. before implementation of a hand hygiene guideline - Clinical study
characteristics
Number
of
Outcome studies Design Limitations Inconsistency Indirectness Imprecision
Implementation of APIC guideline
Hand 1 Observational Serious No serious Serious No serious
decontaminati studies limitations(a) inconsistency indirectness imprecision
(b)
on compliance
- overall222
Nosocomial 1 Observational Serious No serious Serious No serious
(a)
infections – studies limitations inconsistency indirectness imprecision
(b)
per 1000 bed
days222
Implementation of WHO 5 moments of hand hygiene
Hand 1 Observational No serious No serious Serious No serious
decontaminati studies limitations inconsistency indirectness imprecision
(b)
on compliance
- overall7
(b)
on compliance
– before
Update 2012
patient
contact7
(b)
on compliance
– before
aseptic task7
(b)
on compliance
– After body
fluid exposure
7
risk
(b)
on compliance
– After patient
7
contact
Hand 1 Observational No serious No serious Serious Serious
(b) (c)
on compliance
– After
contact with
patient
surrounding7
Healthcare- 1 Observational No serious No serious Serious Serious
associated studies limitations inconsistency indirectness imprecision
(b) (c)
infections –
Overall7
65
Number
of
(b) (c)
infections –
Urinary tract
7
infections
(b) (c)
infections –
Primary blood
stream
7
infections
Implementation of CDC 2002 guideline
decontaminati studies limitations(d) inconsistency indirectness imprecision
(b)
on compliance
– Before
patient care15
decontaminati studies limitations(d) inconsistency indirectness imprecision
(b)
on compliance
– After patient
care15
Update 2012
Catheter 1 Observational Serious No serious Serious No serious
associated studies limitations(e) inconsistency indirectness imprecision
(b)
urinary tract
infection145
Central line 1 Observational Serious No serious Serious Serious
associated studies limitations(e) inconsistency indirectness imprecision
(b) (c)
blood stream
infection145
Colony 0 RCT or
forming units observational
studies
MRSA 0 RCT or
reduction or observational
cross infection studies
C. diff 0 RCT or
reduction or observational
cross infection studies
Removal of 0 RCT or
physical observational
contamination studies
(a) Authors note that in addition to the implementation of a hand hygiene guideline other CVC and urinary catheter specific
infection control interventions were also being conducted simultaneously.
(b) Hospital intervention rather than community.
(c) The relatively few events and few patients give wide confidence intervals around the estimate of effect. This makes it
difficult to know the true effect size for this outcome.
(d) Unclear as to the exact population of patients and HCW involved in the study. Limited baseline data given.
(e) Baseline hand decontamination compliance not stated.
66
Table 8: After vs. before implementation of a hand hygiene guideline - Clinical summary of
findings
Outcome After Before Relative risk Absolute effect Quality
Implementation of APIC guideline
Hand decontamination 358/1639 155/1932 RR 2.72 138 more per 1000 VERY
compliance - overall (21.8%) (8%) (2.28 to 3.25) (103 more to 181 more) LOW
Nosocomial infections – N/R N/R RR 0.59 N/R VERY
per 1000 bed days (0.47 to 0.75) LOW
Implementation of WHO 5 moments of hand hygiene
compliance - overall (21.8%) (8%) (2.28 to 3.25) (103 more to 181 more) LOW
compliance – before (20.7%) (4.6%) (2.92 to 7.03) (88 more to 276 more) LOW
patient contact
compliance – before (14.8%) (2.6%) (2.95 to 11.06) (50 more to 260 more) LOW
aseptic task
compliance – After body (41%) (15.8%) (1.84 to 3.67) (133 more to 422 more) LOW
fluid exposure risk
Update 2012
compliance – After (39.8%) (16.3%) (1.97 to 3.04) (158 more to 332 more) LOW
patient contact
compliance – After (3.7%) (3.3%) (0.55 to 2.25) (15 fewer to 41 more) LOW
contact with patient
surroundings
Healthcare-associated 22/144 25/134 RR 0.82 34 fewer per 1000 VERY
infections – Overall (15.3%) (18.7%) (0.49 to 1.38) (95 fewer to 71 more) LOW
Healthcare-associated 10/144 8/134 (6%) RR 1.16 10 more per 1000 VERY
infections – Urinary tract (6.9%) (0.47 to 2.86) (32 fewer to 111 more) LOW
infections
Healthcare-associated 1/144 3/134 RR 0.31 15 fewer per 1000 VERY
infections – Primary (0.7%) (2.2%) (0.03 to 2.95) (22 fewer to 44 more) LOW
blood stream infections
Implementation of CDC 2002 guideline
compliance – Before (41%) (30%) (1.26 to 1.48) (78 more to 144 more) LOW
patient care
compliance – After (74%) (71%) (0.99 to 1.1) (7 fewer to 71 more) LOW
patient care
Catheter associated 524/17315 498/17162 RR 1.04 0 more per 1000 VERY
urinary tract infection 4 (0.3%) 5 (0.3%) (0.92 to 1.18) (0 fewer to 1 more) LOW
Central line associated 771/16195 848/15300 RR 0.86 1 fewer per 1000 VERY
blood stream infection 4 (0.5%) 3 (0.6%) (0.78 to 0.95) (0 fewer to 1 fewer) LOW
67
6.3.1.2 Cost-effectiveness evidence
Two studies were identified which evaluated the costs and consequences associated with relevant
hand hygiene guidance. Cummings et al 201052,52 developed a mathematical model to estimate the
cost of noncompliance between patient contacts and potential contamination of surfaces after
exposure; Stone et al., 2007250,251 evaluated the relationship between adherence to CDC guidelines
and the cost of hand decontamination products at 40 US hospitals.
No cost-effectiveness evidence was identified in the previous 2003 guideline. The following brief
analysis was in the section comparing different hand decontamination products in the 2003 guideline
but seems better placed here, since it was not a comparative analysis of different hand
decontamination products but an estimate of the cost-effectiveness of alcohol handrub compared to
‘not washing’:
‘Economic analysis of cost effectiveness is based on the assumption that the rate of infection in
primary and community care is 4%, i.e. half that in hospital, and that alcohol gel reduces
infection rate in 30% or 25%, i.e. to 2.8% or 3.0% compared to not washing. For every 1000
patients, between 10 and 12 infections would be avoided. If each infection resulted in a nurse
visit (estimated cost £25) then between £250 and £300 would be saved in avoided costs. This is
without the possibility of Accident and Emergency Department attendances and/or inpatient
stays. Therefore, if the cost of an alcoholic handrub is within 25 pence of the cost of conventional
handwashing, it will be cost saving. If one were to include patient outcomes (i.e. avoiding
infection with the associated morbidity and mortality) and hospital attendance, the cost
effectiveness of hand hygiene with alcohol rubs would increase.’
Update 2012
The true baseline rate of infection in the community is far more complex than this estimate
suggests118 and the assumed reduction in the rate of infections is slightly greater than that observed
for overall infections in the clinical studies included in our review.6,7 For other, more severe infections
such as vascular and urinary catheter-associated infections, baseline rates are much greater and the
relative risk reduction associated with hand washing is variable.7,15 It is important to take into
account different patterns of resistance, cost, morbidity, and mortality associated with different
infections to gain an accurate estimate of cost-effectiveness for different infection control
interventions. Given that these assumptions are overly simplistic, plus the fact that this analysis did
not take into account any measure of compliance to hand hygiene guidance or downstream cost and
quality of life consequences resulting from infection, this analysis has serious limitations and is only
partially applicable.
Table 9: Hand hygiene guidance – Economic summary of findings

Study Limitations Applicability Other comments
(a) (c)
Cummings Minor limitations Partially applicable Outcomes: MRSA colonisation and
52
2010 MRSA infection after noncompliant
patient contact episodes; cost per
noncompliant episode.
251 (d)
Stone 2007 Potentially serious Partially applicable Outcomes: Difference in hand hygiene
limitations(d) product costs between hospitals with
high and low rates of compliance to
CDC guidelines.
(a) Cost of hand decontamination product not accounted for.
(b) US Hospital perspective - rate of patient contact, exposure, and transmission may be different in a UK community
setting; health effects not expressed as QALYs.
(c) Not a comparative analysis; no measure of patient outcome (i.e. infection rates) and no account of the cost of infection.
(d) USA Hospital perspective, no measure of patient outcome.
68
Table 10: Hand hygiene guidance – Economic summary of findings

Incremental
Study Incremental cost effects ICER Uncertainty
Cummings Each time healthcare workers do N/A N/A A 1% and 5% increase in
201052 not wash their hands between compliance to guideline
patients was associated with a cost recommendations
of £1.29, £34.14 depending on resulted in hospital-wide
whether the MRSA status of the savings of £25, 772 and
first patient is known or unknown. £128, 863, respectively.
Not washing hands before direct
contact with one patient after
coming in contact with another
patient’s environment was
associated with a cost of £1.01.
Stone 2007251 Hospitals with high compliance had N/A N/A N/A
an annual hand hygiene product
cost that was £2, 995 greater than
hospitals with low compliance.
6.3.1.3 Evidence statements
Clinical There is a statistically significant and clinically important increase in hand

decontamination compliance (before patient contact, before aseptic task, after body
fluid exposure and after patient contact) with the implementation of the WHO 5
moments (VERY LOW QUALITY).
Update 2012
It is uncertain whether there is any difference in hand decontamination compliance
after contact with patient surroundings, or healthcare-associated infections with the
implementation of the WHO 5 moments (VERY LOW QUALITY).
There is a statistically significant and clinically important increase in hand

decontamination compliance before patient care with the implementation of the
CDC 2002 hand hygiene guideline (VERY LOW QUALITY).
It is unlikely that there is any difference in hand decontamination compliance after

patient care, or in catheter associated UTIs with the implementation of the CDC 2002
hand hygiene guideline (VERY LOW QUALITY).
There is a statistically significant decrease of uncertain clinical importance in central

line associated blood stream infections with the implementation of the CDC 2002
hand hygiene guideline (VERY LOW QUALITY).
There is a statistically significant and clinically important increase in hand

decontamination compliance and a statistically significant decrease in nosocomial
infections per 1000 bed days with the implementation of the APIC hand hygiene
guideline (VERY LOW QUALITY).
No studies were identified that reported colony forming units, MRSA reduction or
cross infection, C. diff reduction or cross infection or removal of physical
contamination.
Economic Noncompliance with hand hygiene guidance is associated with infection-related costs
(MINOR LIMITATIONS AND PARTIALLY APPLICABLE). Although compliance with hand
hygiene guidelines is associated with an increase in the use of hand decontamination
products (POTENTIALLY SERIOUS LIMITATIONS AND PARTIALLY APPLICABLE), it is
69
likely that this cost will be offset by a reduction in infections and infection-related
costs (MINOR LIMITATIONS AND PARTIALLY APPLICABLE).
6.3.1.4 Recommendations and link to evidence
4. Hands must be decontaminated in all of the following

circumstances:
• immediately before every episode of direct patient contact or
care, including aseptic procedures
• immediately after every episode of direct patient contact or
care
• immediately after any other activity or contact with a patient’s
surroundings that could potentially result in hands becoming
contaminated
Recommendations • immediately after removal of gloves. [new 2012]
Relative values of different The GDG felt that reducing colony forming units (CFUs), and improving hand
outcomes decontamination compliance were the most important outcomes. However,
CFUs were not reported in any of the included studies. Healthcare-associated
infections were reported in the studies and were considered to be an
important outcome by the GDG.
Reduction of MRSA and C. diff infections, prevention of MRSA and C. diff cross
infections, and the removal of physical contamination were also felt to be
Update 2012
important outcomes. However, none of these outcomes were reported in the
included studies.
Trade off between clinical When considering the evidence, the GDG wrote this recommendation
benefits and harms cognisant of the fact that the World Health Organisation (WHO) 5 moments of
hand hygiene being the current international model of when to
decontaminate hands which is widely implemented in the UK. The potential
benefits of this recommendation are:
• protection of patients
• protection of healthcare workers
• protection of healthcare environment
• prevention of cross infection of pathogenic organisms.
The evidence shows that there is an increase in hand decontamination
compliance before and after patient contact with the implementation of the
WHO 5 moments, but no difference after contact with patient surroundings.
This is the same finding as with the implementation of the CDC 2002 guideline;
increased hand decontamination compliance before patient care, but no
statistically significant difference in hand decontamination compliance after
patient care. Hence, the recommendation does not specifically separate out
hand decontamination after contact with a patient’s surroundings as a
separate bullet point. Catheter associated UTIs and nosocomial infections per
1000 bed days were shown to decrease with the implementation of the CDC
2002 and APIC guidelines, respectively.
Potential harms include the effect of continual washing on hands and skin
condition (leading to dry cracked hands being more susceptible to increased
infections and thus the spread of infection), which may depend on the product
used (see section 6.4 below) and impact on staff time.
Additional harms could include increased numbers of skin allergies from
continual handwashing/decontamination, leading to additional occupational
health visits. The GDG did not consider that a separate recommendation was
70
necessary to address these potential harms.

Economic considerations The GDG agreed that any marginal increase in costs (in terms of staff time and
product cost) associated with increased compliance to hand hygiene guidance
will likely be offset by a corresponding reduction in infection rates. It is
possible that only a small improvement in compliance to hand hygiene
guidelines is necessary in order for healthcare organisations to realise cost
savings.
Quality of evidence Four very low quality cohort studies were identified. The population is indirect
(not in community settings) and one study is based in a low income country7.
There is also a variation in the intervention used, which is the hand hygiene
guideline implemented. There are different guidelines implemented (WHO,
CDC and APIC) and the guideline implementation involves a multi-modal hand
decontamination strategy, which is not just the implementation of a new
strategy of when to decontaminate hands, but also introducing handrubs to
increase compliance and education about how to decontaminate hands
effectively. Therefore the effects on compliance and infection could be
attributed to the increased availability of handrub and improved hand
decontamination technique as well as the strategy of when to decontaminate
hands.
No evidence was identified looking at hand decontamination specifically after
Update 2012
the removal of gloves, but GDG consensus was that this should be included. It
was included in the previous guideline under the PPE section relating to glove
disposal. The part of the original recommendation in the PPE section relating
to hand decontamination after removal of gloves has now been incorporated
into this recommendation.
Other considerations The GDG considered that this recommendation relates to patient safety and
that the consequence of not implementing it mean that the risk of adverse
events are so severe, that the use of the word ‘must’ is appropriate in line with
guidance from the NICE Guidelines Manual (2009)182. The recommendation is
consistent with the WHO 5 moments of hand hygiene. Whilst the GDG felt that
‘direct patient contact or care’ should cover aseptic procedures within the first
bullet point, they felt that adding in ‘including aseptic procedures’ clarified
this.
There can be problems in accessing water and clean towels in the community
setting, and the GDG acknowledge that there is variation in level of resources
across the country and in homes. The GDG felt that it was important that all
healthcare staff have access to alcohol handrub to decontaminate hands
whatever the setting and those working in the community should have access
to hand washing kits where it is not available e.g. soap, paper towels and/or
wipes. Please see recommendation 5.2.1.1 in the standard precautions chapter
detailing the importance of access to hand decontamination supplies.
implementation as they consider that it has a high impact on outcomes that
are important to patients. For further details see section 4.1.
71
6.4 Choice of hand cleaning preparation

The following question aims to determine which is the most clinical and cost effective hand cleaning
preparation. This is an important question given that a wide variety of products exist, including
variations in concentrations of alcohol contained in products. The GDG considered the most
important outcomes to be colony forming units (CFUs), hand decontamination compliance, removal
of physical contamination and general reduction of cross infection.
What is the clinical and cost effectiveness of cleaning preparations (soap and water, alcohol based
rubs, non-alcohol products and wipes) for healthcare worker hand decontamination, on hand
decontamination compliance, MRSA and C. diff reduction or cross infection, colony forming units and
removal of physical contamination?
Five trials were identified (three RCTS and two randomised crossover trials) comparing alcohol
handrub with antiseptic handwash102,144,152 or non-antiseptic handwash.152,282,287 Alcohol handrub
containing 45% 2-propanol and 30% 1-propanol was used in Girou et al., 2002102, Lucet et al., 2002152,
Winnefeld et al., 2000282 and Zaragoza et al., 1999287 and the handrub in Larson et al., 2001144
contained 61% ethanol. All of these studies were included in the previous 2003 guideline, no
additional studies were found from the update search.
Update 2012
See Evidence Table G.2.2, Appendix G, Forest Plots in Figure 8, Appendix I.
Table 11: Alcohol handrub vs. non-antiseptic soap - Clinical study characteristics
Number
of
Log 10 CFU 1 Crossover Serious No serious Serious No serious
(Finger print limitations(a) inconsistency indirectness(b) imprecision
technique)152
Mean CFU 1 Crossover Serious No serious Serious No serious
(a) (b)
(Hand printing limitations inconsistency indirectness imprecision
on blood agar
287
plates)
CFU (Mean log 1 RCT Serious No serious Serious N/A(d)
282 (c) (b)
change) limitations inconsistency indirectness
Hand 0 RCT
decontaminatio
n compliance
MRSA reduction 0 RCT
or cross
infection
C. diff reduction 0 RCT
or cross
infection
Removal of 0 RCT
physical
contamination
(a) Crossover study, healthcare workers used both intervention and control.
72
(b) Hospitals setting rather than community.

(c) Unclear allocation concealment.
(d) No standard deviation reported so confidence intervals are unknown, therefore unknown whether effect is precise or
not.
Table 12: Alcohol handrub vs. non-antiseptic soap - Clinical summary of findings
Alcohol Non-antiseptic Relative
Outcome handrub soap risk Absolute effect Quality
Log 10 CFU (Finger print MD 0.76 lower LOW
43 43 -
technique) (0.93 to 0.59 lower)
Mean CFU (Hand MD 7 lower (32.27 LOW
printing on blood agar 43 43 - lower to 18.27
plates) higher)
CFU (Mean log change) 26 25 - Intervention: -0.342 LOW
Control: +0.122
P = 0.004(a)
(a) No standard deviation reported, p value reported as stated in the study.
Table 13: Alcohol handrub vs. antiseptic soap - Clinical study characteristics
Number
of
Log 10 CFU 1 Crossover Serious No serious Serious Serious
Update 2012
(Finger print limitations(a) inconsistency indirectness(b) imprecision(c)
technique)152
CFU (Finger 1 RCT Serious No serious Serious Serious
print limitations(d) inconsistency indirectness(b) imprecision(c)
technique)102
CFU - 2 weeks 1 RCT Serious No serious Serious No serious
(Glove juice limitations(d) inconsistency indirectness(b) imprecision
technique)144
CFU - 4 weeks 1 RCT Serious No serious Serious No serious
(Glove juice limitations(d) inconsistency indirectness(b) imprecision
144
technique)
Hand 0 RCT
decontaminati
on compliance
MRSA 0 RCT
reduction or
cross infection
C. diff 0 RCT
reduction or
cross infection
Removal of 0 RCT
physical
contamination
(d) Unclear allocation concealment.
73
Table 14: Alcohol handrub vs. antiseptic soap - Clinical summary of findings
Alcohol Antiseptic Relative
Outcome handrub soap risk Absolute effect Quality
Log 10 CFU (Finger MD 0.2 lower VERY
43 43 -
print technique) (0.35 to 0.05 lower) LOW
CFU (Finger print 12 11 - MD 34 lower VERY
technique) (104.98 lower to 36.98 higher) LOW
Log 10 CFU - 2 weeks 26 26 - MD 0.09 higher LOW
(Glove juice technique) (0.39 lower to 0.57 higher)
Log 10 CFU - 4 weeks 26 24 - MD 0.08 higher LOW
(Glove juice technique) (0.42 lower to 0.58 higher)
Table 15: Antiseptic soap vs. non-antiseptic soap - Clinical study characteristics
Number
of
Log 10 CFU 1 Crossover Serious No serious Serious No serious
(Finger print limitations(a) inconsistency indirectness imprecision
technique)152 (b)
Hand 0 RCT
decontamination
compliance
Update 2012
MRSA reduction 0 RCT
or cross infection
C. diff reduction 0 RCT
or cross infection
Removal of 0 RCT
physical
contamination
Table 16: Antiseptic soap vs. non-antiseptic soap - Clinical summary of findings
Antiseptic Non-antiseptic
(a) (a)
Outcome soap soap Relative risk Absolute effect Quality
Log 10 CFU (Finger MD 0.56 lower LOW
43 43 -
print technique) (0.77 to 0.35 lower)
(a) Number of healthcare workers in each study arm.
(b) Mean log change in CFUs given for intervention and control.
Two trial-based cost-analyses44,144 and one cost-consequence analysis251 comparing the use of alcohol
handrub to non-antiseptic soap were included. For a list of excluded studies and reasons for
exclusion, please refer to Appendix L.
The GDG were also presented with the current UK prices of hand decontamination cleaning
preparations to inform decision making.
No economic studies were identified in the previous 2003 guideline. In the previous guideline, the
informal economic evaluation presented in section 6.3.1.2 was included under the current section.
74
However, this evaluation did not consider the cost-effectiveness of alternative hand
decontamination cleaning preparations and was therefore not considered appropriate for this
question.
Table 17: Alcohol handrub vs. non-antiseptic soap – Economic summary of findings
Study Limitations Applicability Other Comments
44
Cimiotti 2004 Potentially serious Partially Outcomes: observed hand
limitations(a) applicable(b) decontamination quality; direct
product cost; application time per
product.
Larson 2001144 Potentially serious Partially Outcomes: mean microbial count;
limitations(c) applicable(d) application time per product.
Stone 2007251 Potentially serious Partially Outcomes: Difference in hand
(e) (f)
limitations applicable decontamination product costs
between hospitals with high and low
rates of compliance to CDC guidelines.
(a) Non-randomised cross-over study design; subjective outcome measure of hand hygiene quality.
(b) Neonatal ICU; US hospital perspective.
(c) No patient outcomes, no consideration of uncertainty, industry funded.
(d) Surgical ICU; US hospital perspective
(e) No comparative analysis.
(f) USA Hospital perspective, no measure of patient outcome.
Table 18: Alcohol handrub vs. non-antiseptic soap – Economic summary of findings
Study Incremental cost Incremental effects ICER Uncertainty
Update 2012
44
Cimiotti 2004 Alcohol handrub is £30 Better quality hand Alcohol-based N/R
less costly per 1000 hygiene, and less product dominant
hand hygiene episodes. time required per
hand regimen with
alcohol-based
product.
Larson 2001144 Alcohol handrub is Greater reduction in Alcohol-based N/R
£0.09 less costly per microbial cultures, product dominant
shift. fewer deviations
from protocol, and
less time required
per hand regimen
with alcohol-based
product.
251
Stone 2007 Hospitals with a high N/A N/A N/A
ratio of alcohol
handrub use had an
annual hand hygiene
product expenditure
that was £3, 174
greater than hospitals
with a low ratio of
alcohol handrub use.
Table 19: Hand decontamination product costs

Alcohol-based Non-antiseptic
handrub liquid Soap Antiseptic Soap Paper towels
Mean cost per litre (£) 3.16 4.79 7.13 1.07 (250 sheets)
187
Source: Based on average 2010 Supply Chain prices.
75
Clinical There is a statistically significant reduction of uncertain clinically importance in mean

log change in CFUs and it is unlikely that there is any difference in log 10 CFUs after
use of alcohol handrubs compared to handwashing with non-antiseptic soap and
water (LOW QUALITY).
There is a statistically significant, but not clinically important, reduction in log 10

CFUs after use of alcohol handrubs compared to antiseptic soap and water (VERY
LOW QUALITY).
It is uncertain whether there is any difference in CFUs (glove juice technique) with
alcohol handrubs compared to antiseptic soap and water (LOW QUALITY).
There is a statistically significant, but not clinically important, reduction in log 10

CFUs after use of antiseptic soap compared to non-antiseptic soap and water (LOW
QUALITY).
No studies were identified that reported hand decontamination compliance, MRSA

reduction or cross infection, C. diff reduction or cross infection or removal of physical
contamination.
Economic On a per-hand decontamination episode basis, alcohol-based handrub appears to be

less costly and lead to better hand decontamination practice than non-antiseptic
soap. (POTENTIALLY SERIOUS LIMITATIONS AND PARTIALLY APPLICABLE EVIDENCE)
Update 2012
5. Decontaminate hands preferably with a handrub (conforming

to current British Standardsv), except in the following
circumstances, when liquid soap and water must be used:
• when hands are visibly soiled or potentially contaminated with
body fluids or
• in clinical situations where there is potential for the spread of
alcohol-resistant organisms (such as Clostridium difficile or
Recommendations other organisms that cause diarrhoeal illness). [new 2012]
Relative values of different The GDG considered the most important outcomes to be colony forming units
outcomes (CFUs), hand decontamination compliance, removal of physical contamination
and general reduction of cross infection of all infections. However the only
outcome reported in the included studies were CFUs.
Trade off between clinical The benefits of implementing this recommendation are the reduced spread of
benefits and harms potential pathogens and to prevent the spread of HCAI. In addition, the GDG
considered that the visibility of alcohol handrub and hand cleaning enhances
the patient experience (as a form of reassurance that infection control
precautions are being used). The GDG felt that it also reinforces good basic
practice for self care.
The evidence shows that alcohol handrubs are as effective, if not more
effective, at reducing CFUs on hands compared to hand washing. Alcohol
handrub has also been linked to increased hand decontamination compliance,
which is also found in the multi model hand decontamination interventions
included in the ‘when to wash your hands’ review question, see section
6.3.1.4.
The exceptions in the bullet points for when to perform hand washing are
v
At the time of publication of the guideline (March 2012): BS EN 1500: 1997.
76
based on GDG informal consensus, based on discussions at the GDG meeting,

as no RCT evidence was identified, but are also consistent with WHO guidance.
The GDG considered that during outbreaks such as diarrhoeal illness (which is
outside the scope of this guideline), alcohol is ineffective at killing spores such
as C. diff. Mechanical friction from washing hands with soap and water was
considered more appropriate for physically removing spores from the surface
of contaminated hands. The GDG also sought advice from the microbiologist
co-optee.
Potential harms are the effect of continual washing on hands and skin
condition and the danger of ineffective ‘over the counter’ (not conforming to
current European and British Standards) compliant handrubs being used. The
GDG did not feel a separate recommendation was warranted to mitigate
against the potential harm of continual hand washing other than
recommendation 6.7.1.1 and have specified within the new recommendation
that handrub used should meet the specified European and British Standard.
Economic considerations The GDG agreed that alcohol handrub is likely to be cost saving in terms of
staff time and product costs except in outbreak situations. The GDG thought
that in situations where there is potential for the spread of alcohol-resistant
organisms, soap and water is the only appropriate cleaning preparation.
Quality of evidence Three very low to low quality RCTs were identified comparing alcohol rubs to
hand washing with soap and water. All of these studies were downgraded for
indirectness as they are hospital based and not in community settings. These
studies all had relatively small sample sizes and an imprecise estimate of
effect. The studies identified only reported one outcome that was prioritised
by the GDG, CFUs, which showed no statistical difference with alcohol
handrubs compared to hand washing with soap and water. However, GDG
Update 2012
consensus was used to recommend handrub based on the long established
role of alcohol in hand decontamination, acknowledging that poor RCT
evidence was attributed to manufacturers performing laboratory tests to meet
EU standards and not necessarily requiring further RCT evidence to prove
efficacy.
No RCTs or cohort studies were found for visibly soiled hands. The RCTs
identified stated that healthcare workers should wash hands with soap and
water if hands were visibly soiled and thus the intervention group (handrub)
washed their hands in this situation.
that the consequence of not implementing it means that the risk of adverse
events are so severe, that the use of the word ‘must’ is appropriate and in line
182
with guidance from the NICE Guidelines Manual (2009).
The GDG noted that although there was no evidence available for non-alcohol
handrubs they did not want to prevent such products being used if they meet
European and British Standards. Therefore, the recommendation specifies a
‘handrub conforming to current European and British Standards’, rather than
an ‘alcohol’ handrub.
BS EN 1500 is the British Standard test for determining the bactericidal efficacy
of hygienic hand disinfection (handrubs).27 The hands of 12-15 volunteers are
artificially contaminated with Escherichia coli and treated in a crossover design
with the test or reference product (60 second application of 60% 2-propanol.
The tested handrub should not be significantly less effective than the reference
alcohol).
There can be problems in accessing water and clean towels in the community
setting, and the GDG acknowledge that there is variation in levels of resources
across the country and in homes. It is important that all healthcare staff have
access to handrub to decontaminate hands whatever setting and those
working in the community should have access to hand washing kits where
running water and clean towels are not available e.g. soap, paper towels
77
and/or wipes. Please see recommendation 5.2.1.1 in the standard precaution

general recommendation detailing importance of access to hand
decontamination supplies. Also see the recommendation on hand
decontamination technique in section 6.6.1.1 as training in proper hand
decontamination methods is important.
The GDG discussed that it may be difficult in the community to determine
which patients were infected with C. diff or MRSA and recommended that
those caring for patients with any diarrhoeal illness should wash their hands
with liquid soap and water. The GDG also discussed that there might be
concerns about using handrubs that contain alcohol. It is important that
patients are aware of the pros and cons of using these products. If religious
beliefs are a source of concern, the patients could be made aware of the
official stand of religious bodies about the product. When information is
available, it would be useful to direct the patients to these information sources
to clarify the positions. For example, the official position of the Muslim
Councils of Britain is that “External application of synthetic alcohol gel........ is
considered permissible within the remit of infection control because (a) it is not
an intoxicant and (b) the alcohol used in the gels is synthetic, i.e., not derived
from fermented fruit. Alcohol gel is widely used throughout Islamic countries in
health care setting”.178
6.5 Decontaminating wrists and bare below the elbow policy

Update 2012
What is the clinical and cost effectiveness of healthcare workers decontaminating wrists vs. not
decontaminating wrists or usual practice on MRSA and C. diff reduction or cross infection, colony
forming units and removal of physical contamination and transient organisms?
What is the clinical and cost effectiveness of healthcare workers following bare below the elbow
policy (short sleeves or rolled up sleeves) vs. no bare below the elbow policy (long sleeves, not rolled
up or no specific restrictions) on MRSA and C. diff reduction or cross infection, colony forming units
and removal of physical contamination and transient organisms?
The GDG considered cross infections as the most important outcome.
No RCT or cohort studies examined whether wrists should be washed in regular hand
decontamination. One RCT compared the effectiveness of hand washing between a group with bare
below the elbow uniform policy vs. another group with usual uniform.
The GDG defined bare below the elbow (BBE) as not wearing false nails or nail polish when delivering
direct patient care. Not wearing a wrist-watch or stoned rings. Healthcare workers garments should
be short sleeved or be able to roll or push up sleeves when delivering direct patient care and
performing hand decontamination.
It is recognised that healthcare workers delivering direct patient care in the outdoor environment
(for example ambulance staff) would still be required to wear long sleeved high visibility and
inclement weather clothing in accordance with health and safety legislation. Local uniform policy
should reflect these requirements while also allowing the wearer to perform effective hand
decontamination when delivering direct patient care.
78
Table 20: Bare below the elbow (BBE) policy vs. control (usual uniform) - Clinical study
characteristics
Number
of
Compliance: 1 RCT Serious No serious No serious Serious
Percentage of the limitation(a) inconsistency indirectness(b) imprecision(c)
areas of the hands
(wrist & palm)
missed87
Percentage of the limitation(a) inconsistency indirectness(b) imprecision(c)
areas of the wrists
87
missed
(a) (b) (c)
Percentage of the limitation inconsistency indirectness imprecision
areas of the palms
missed87
Colony forming 0 RCT
units
Cross infection of 0 RCT
MRSA
Cross infection of C. 0 RCT
Update 2012
diff
Removal of physical 0 RCT
contamination and
transient organisms
(a) Randomisation allocation and concealment method not reported. Participants were aware of the observation and
evaluation of their hand washing - there is a risk of performing better (i.e. wash hands more thoroughly) than usual.
(b) Indirect population. The study only recruited medical students and doctors working in a teaching hospital. Other
healthcare professionals were not recruited and there were no further information about the population. Outcomes
were indirect – measured % of areas of missed by the alcohol gel. However, the GDG believe this is not serious
indirectness and did not lower their confidence of the results.
(c) Actual values were not reported, and number of participants in each arm not reported. Number of participants were
obtained from authors.
Table 21: Bare below elbow policy vs. control (usual uniform) group - Clinical summary of
findings
Outcome BBE policy Control Relative risk Absolute effect Quality
Compliance: Percentage 9.3 ± 9.2 11.1 ± 7.2 N/A 1.80 [-4.46, 0.86] LOW
of the areas of the
hands (wrist & palm)
missed
Compliance: Percentage 38.9±38.7 52.8 ±27.9 N/A -13.9%[-24 to 3.3](a) LOW
of the areas of the wrists
missed
Compliance: Percentage 7.2± 7.1 8.2±6.4 N/A -1.00 [-3.17, 1,17] LOW
of the areas of the palms
missed
(a) Calculated by NCGC based on the information from authors – BBE policy arm had 73 participants, control arm had 76
participants.
79
No cost-effectiveness evidence was identified in the update search and none was included in the
previous 2003 guideline.
This question was not thought relevant for economic consideration.
Clinical It is unlikely there is any difference in the percentage areas missed on the palms and
on the whole hand during hand washing with alcohol handrub in the BBE policy
group compared to the control group. There is statistically significant decrease of
uncertain clinical importance in the percentage of areas on the wrists missed during
hand washing with alcohol handrub in BBE policy group compared to the control
group (LOW QUALITY).
No studies were identified that reported colony forming units, cross infection of
MRSA, cross infection of C. diff or removal of physical contamination and transient
organisms.
Economic No economic studies were identified.
Update 2012
6. Healthcare workers should ensure that their hands can be
decontaminated throughout the duration of clinical work by:
• being bare below the elboww when delivering direct patient
care
• removing wrist and hand jewellery
• making sure that fingernails are short, clean and free of nail
polish
• covering cuts and abrasions with waterproof dressings. [new
Recommendations 2012]
Relative values of The GDG considered cross infections as the most important outcome. The GDG
different outcomes also considered compliance to hand decontamination practices, the
effectiveness of removal of physical contamination (bodily fluids and dirt) and
the reduction of microbial counts as measured by colony forming units (CFUs)
to be the most important considerations.
Trade off between clinical This recommendation could lead to better and more effective hand
benefits and harms decontamination. There is some evidence that healthcare professionals
following BBE uniform policies are less likely to miss the wrist area when
washing hands. The GDG are aware of obligations for staff to follow local
uniform policy.
There are no clinical harms from this recommendation.
Economic considerations The additional staff time taken to adhere to this recommendation is minimal.
Any potential reduction in infections associated with compliance to this
recommendation would result in cost savings.
Quality of evidence No RCT or cohort studies comparing decontaminating the wrists against not
w
For the purposes of this guideline, the GDG considered bare below the elbow to mean; not wearing false nails or nail
polish; not wearing a wrist-watch or stoned rings; wearing short-sleeved garments or being able to roll or push up
sleeves.
80
decontaminating the wrist in hand decontamination were found. There were

also no relevant laboratory studies comparing bacterial counts on the wrists.
Only one RCT was found comparing the impact of BBE vs. usual practice on the
thoroughness of hand and wrist decontamination. The quality of evidence was
low. Without any data of infections, it is difficult to interpret the clinical
importance of the areas missed during handwashing.
There is no evidence that washing the wrist helps to reduce infections.
Recommendations for nails and covering cuts and abrasions came from the
previous edition of this guideline. Clinical questions for these factors were not
included in the guideline update.
Other considerations The GDG developed this recommendation based on consensus. The GDG
developed the recommendation after considering the evidence and were
aware of current policies and guidelines in this area from the Department of
Health70, WHO285 and professional bodies such as the Royal College of
225
Nursing . The recommendation is congruent with the uniform or hand
decontamination policies of these bodies.
The GDG considered that ‘duration of clinical work’ covered any instance when
clinical work was being delivered for example, a shift.
The final two bullet points of this recommendation were not reviewed for this
update and therefore are taken directly from the 2003 guideline: making sure
that fingernails are short, clean and free of nail polish and covering cuts and
abrasions with waterproof dressings.
The GDG recognise that healthcare workers are either reluctant or cannot
remove wedding rings and are aware that some local dress code policies
consider that one plain band is acceptable. The evidence related to what
specifically constitutes BBE was not reviewed for this guideline and the GDG
Update 2012
could not make a more detailed recommendation in this area. For the
purposes of this guideline the GDG considered bare below the elbow to mean;
not wearing false nails or nail polish, not wearing a wrist-watch or stoned rings,
wearing short sleeved garments or be able to roll or push up sleeves when
delivering direct patient care and performing hand decontamination.
The second bullet point in this recommendation, ‘removing wrist and hand
jewellery’ is taken from the 2003 guideline. The specific evidence for wrist and
hand jewellery was not reviewed in this update and the GDG felt that this
should be left unchanged. The GDG wanted to reinforce the message that wrist
and hand jewellery should be removed, in addition to BBE, as they thought
that BBE may be interpreted only as rolling sleeves up.
Other considerations when policies are developed at local level include
equality and diversity issues, such as whether plain wedding bands and items
of cultural significance can be worn.
The GDG were aware that exposure of the forearms is not acceptable to some
staff because of their faith, such as with the Islamic faith. However, they
discussed the fact that the NHS has already issued guidance along with multi-
faith representatives, Department of Health and NHS employers70 to ensure
that local dress code policies are sensitive to the obligations of faith groups
whilst maintaining equivalent standards of decontamination. This guidance
states that uniforms may include provision for sleeves that can be full length
when staff are not engaged in direct patient care activity, uniforms can have
three-quarter length sleeves, but that any full or three-quarter length sleeves
must not be loose or dangling. Sleeves must be able to be rolled or pulled back
and kept securely in place during hand washing and direct patient care activity.
Also, disposable over-sleeves, elasticated at the elbow and wrist, may be used
but must be put on and discarded in exactly the same way as disposable
gloves. Strict procedures for washing hands and wrists must still be observed.
Because the advice for different cultural groups regarding hand
decontamination remains the same despite sensitivities to cultural or faith
81
dress requirements, the GDG did not feel that a separate recommendation was
necessary to address the issues outlined above.
6.6 Is hand decontamination technique important?

Investigations into the technique of hand decontamination are limited. Our systematic review
identified one RCT comparing different durations of handwashing and handrubbing on bacterial
reduction that found no significant differences between the two study groups152. One laboratory
study investigating methods of hand drying found no statistically significant differences between the
four methods studied.110
Recommendations are therefore based on existing expert opinion that the duration of hand
decontamination, the exposure of all aspects of the hands and wrists to the preparation being used,
the use of vigorous rubbing to create friction, thorough rinsing in the case of handwashing, and
ensuring that hands are completely dry are key factors in effective hand hygiene and the
maintenance of skin integrity.24,211
7. An effective handwashing technique involves three stages: preparation, washing and

rinsing, and drying. Preparation requires wetting hands under tepid running water before
applying liquid soap or an antimicrobial preparation. The handwash solution must come into
contact with all of the surfaces of the hand. The hands must be rubbed together vigorously
for a minimum of 10-15 seconds, paying particular attention to the tips of the fingers, the
thumbs and the areas between the fingers. Hands should be rinsed thoroughly before drying
with good quality paper towels. [2003]
8. When decontaminating hands using an alcohol handrub, hands should be free of dirt and
fingers, the thumbs and the areas between the fingers, until the solution has evaporated
and the hands are dry. [2003]
6.7 Does hand decontamination damage skin?

Expert opinion concludes that skin damage is generally associated with the detergent base of the
preparation and/or poor handwashing technique.24,211 However, the frequent use of hand
preparation agents may cause damage to the skin and normal hand flora is altered which may result
in increase carriage of pathogens responsible for healthcare-associated infection.24,211 In addition, the
irritant and drying effects of hand preparations have been identified as one of the reasons why
healthcare practitioners fail to adhere to hand hygiene guidelines.24,211 A previous systematic review
found no consistent evidence to suggest that any product currently in use caused more skin irritation
and damage than another.210
Our systematic review identified six studies of which three were RCT conducted in clinical
settings.23,144,282 They compared the use of alcohol-based preparations with soap and the self
assessment of skin condition by nurse. In these studies a greater level of irritation was associated
with the use of soap. Two further studies, one clinically based quasi experimental study and one
descriptive clinical study concluded that alcohol-based handrubs caused less skin irritation.90,144,205 A
laboratory study demonstrated a strong relationship between the frequency of handwashing with a
chlorhexidine preparation and dermatitis.205
82
Expert opinion suggests that hand care is an important factor in maintaining regular hand
decontamination practices and assuring the health and safety of healthcare practitioners.24,211
6.7.1.1 Recommendation
9. An emollient hand cream should be applied regularly to protect skin from the drying effects
of regular hand decontamination. If a particular soap, antimicrobial hand wash or alcohol
product causes skin irritation an occupational health team should be consulted. [2003]
6.8 Research recommendations

2. When clean running water is not available, what is the clinical and cost effectiveness of using
wipes, gels, handrubs or other products to remove visible contamination?
Why is this important?
Community healthcare workers often encounter challenges in carrying out hand decontamination
Update 2012
when there is no access to running water. This particularly affects ambulance service staff, who often
provide emergency care at locations where running water is not available. No evidence from
randomised controlled trials is available on the most effective way for community-based healthcare
workers to remove physical contamination, such as blood, from their hands in the absence of running
water. In recent years, hand decontamination products that can be used without running water, such
as gels, handrubs and wipes, have become available. However, their efficacy and suitability in actual
clinical practice for use with visibly dirty hands has not been determined. A randomised controlled
trial is required to compare hand wipes (detergent and disinfectant), hand gels and other hand
decontamination products that can be used without running water, to determine the most effective
way to remove physical dirt in the absence of running water, in order to make a recommendation for
their use in real situations. The primary outcome measure should be colony-forming units on the
basis of the adenosine triphosphate (ATP) surface test.
83
first
Control
Standard principles for the use of personal protective equipment
7 Standard principles for the use of personal

protective equipment
7.1 Introduction
• choice of gloves (latex, vinyl or nitrile)
• when to wear aprons or gowns.
No new review questions are included in this chapter. The recommendation about gloves conforming
Update
Update2012
to CE standards has been moved to the top of the gloves section (section 7.2.1.1), to emphasise its
importance.
2012
• when to wear gloves
• gloves as single-use items
• when to wear facemasks, eye protection and other facial protection.
The primary role of personal protective equipment (PPE) is to reduce the risk of transmission of
microorganisms between patients, healthcare workers and the environment. The recommendations
in this chapter are in line with Health and Safety requirements (Health and Safety Regulations 20024,
Health and Safety at work Act 19741).
Disposal of PPE is included in a separate general waste disposal chapter (see chapter 9).
This section discusses the evidence and associated recommendations for the use of personal
protective equipment by healthcare workers in primary and community care settings and includes
the use of aprons, gowns, gloves, eye protection and facemasks.
7.2 Infection Control Dress Code – protect your patients and yourself!
Expert opinion suggests that the primary uses of personal protective equipment are to protect staff
and patients, and reduce opportunities for the transmission of microorganisms in hospitals95,281.
However, as more healthcare is undertaken in the community,156,188,245 the same principles apply. A
trend to eliminate the unnecessary wearing of aprons, gowns and masks in general care settings has
evolved over the past twenty years due to the absence of evidence that they are effective in
preventing HCAI.95
The decision to use or wear personal protective equipment must be based upon an assessment of
the level of risk associated with a specific patient care activity or intervention and take account of
current health and safety legislation.62,86,113,114

84
10.Selection of protective equipment must x be based on an assessment of the risk of

transmission of microorganisms to the patient, and the risk of contamination of the
healthcare workers’ clothing and skin by patients’ blood, body fluids, secretions or
excretions. [2003]
7.3 Gloves: their uses and abuses

Since the mid-1980s the use of gloves as an element of personal protective equipment has become
an everyday part of clinical practice for healthcare workers.37,45,86,95,104,132 Expert opinion agrees that
there are two main indications for the use of gloves in preventing HCAI37,45,86,95:
• to protect hands from contamination with organic matter and microorganisms;
• to reduce the risks of transmission of microorganisms to both patients and staff.
7.3.1 To glove or not to glove?

Gloves should not be worn unnecessarily as their prolonged and indiscriminate use may cause
adverse reactions and skin sensitivity.45,211 As with all items of personal protective equipment the
need for gloves and the selection of appropriate materials must be subject to careful assessment of
the task to be carried out and its related risks to patients and healthcare practitioners45,211. Risk
assessment should include consideration of:
• who is at risk (whether it is the patient or the healthcare practitioner) and whether sterile or non-
sterile gloves are required;
• the potential for exposure to blood, body fluids, secretions or excretions;
• contact with non-intact skin or mucous membranes during general care and invasive procedures.
Gloves must be discarded after each care activity for which they were worn in order to prevent the
transmission of microorganisms to other sites in that individual or to other patients. Washing gloves
rather than changing them is not safe and therefore not recommended.45,211
7.3.2 Do gloves leak?

A previous systematic review provided evidence that gloves used for clinical practice leak when
apparently undamaged.210 In terms of leakage, gloves made from natural rubber latex (NRL)
performed better than vinyl gloves in laboratory test conditions. Revised standards (2000) relating to
the manufacture of medical gloves for single-use have been devised and implemented.28-30 These
require gloves regardless of material to perform to the same standard.
Expert opinion supports the view that the integrity of gloves cannot be taken for granted and
additionally, hands may become contaminated during the removal of gloves.37,45,86,95,211 Our
systematic review found evidence that vancomycin resistant enterococcus remained on the hands of
healthcare workers after the removal of gloves.257 Therefore, the use of gloves as a method of barrier
protection reduces the risk of contamination but does not eliminate it and hands are not necessarily
clean because gloves have been worn.
x
In accordance with current health and safety legislation (at the time of publication of the guideline [March 2012]):
85
11.Gloves used for direct patient care:

• must y conform to current EU legislation (CE marked as medical
gloves for single-use) z and
Recommendations • should be appropriate for the task. [new 2012]
Relative values of different The GDG agreed that healthcare worker preference and glove punctures were
outcomes the most important outcomes for this recommendation.
Trade off between clinical Although one study found that latex gloves had significantly fewer punctures
benefits and harms compared to nitrile gloves, all single-use gloves that meet BS EN 455, (1-4
Medical gloves for single-use)31 are required to meet the same resistance to
punctures or holes, irrespective of glove material.
BS EN 455-2 specifies the requirements and gives test methods for physical
properties of single-use medical gloves (i.e. surgical gloves and
examination/procedure gloves) in order to ensure that they provide and
maintain, when used, an adequate level of protection from cross
contamination for both patient and user.
Economic considerations The cost of gloves is the main economic consideration. If all gloves conform to
Update 2012
European Community standards and there is no clinical reason to prefer one
type of glove over another, the least costly option will represent the most cost-
effective.
Quality of evidence One low quality crossover trial with one outcome was identified. This study
was downgraded due to study limitations including no randomisation and
allocation concealment and a very low sample size of five dentists. See
evidence review in section 7.4.
Other considerations No evidence was identified for vinyl gloves, but the GDG considered that if
they met the relevant CE standards they could be used. This recommendation
is a ‘must’ as it is covered by legislation detailed in the footnotes in line with
the guidance from the NICE Guidelines Manual (2009).182 The GDG made
changes to the original recommendation based on a consensus decision that
gloves should be fit for purpose or ‘appropriate for the task’ (allow enough
sensitivity, for example to feel a vein to take blood), be the correct size and
take any allergy into consideration. It was important in light of health and
safety legislation to amend the recommendation to highlight the obligation for
healthcare workers to use gloves that conform to the relevant European and
British standard.
This recommendation has been moved to the beginning of the gloves section
as the GDG considered it to be very important. The evidence behind the
recommendation was searched for under the type of glove material in
question (section 7.4).
12.Gloves musty be worn for invasive procedures, contact with sterile sites and non-intact skin
or mucous membranes, and all activities that have been assessed as carrying a risk of
exposure to blood, body fluids, secretions or excretions, or to sharp or contaminated
instruments. [2003]
13.Gloves musty be worn as single-use items. They must be put on immediately before an
y
In accordance with current health and safety legislation (at the publication of the guideline [March 2012]): Health and
Safety at Work Act 1974, Management of Health and Safety at Work Regulations 1999, Health and Safety Regulations
2002, Control of Substances Hazardous to Health Regulations 2002, Personal Protective Equipment Regulations 2002,
and Health and Social Care Act 2008.
z
At the time of publication of the guideline [March 2012): BS EN 455 Parts 1 - 4 Medical gloves for single-use.
86
Gloves must be changed between caring for different patients, and between different care
or treatment activities for the same patient. [2003]
14. Ensure that gloves used for direct patient care that have been
exposed to body fluids are disposed of correctly, in
accordance with current national legislation aa or local policies.
Recommendations (see chapter 9) [new 2012]
Relative values of different The GDG considered the most important outcomes for making this
outcomes recommendation to be the safe disposal of clinical waste as addressed in
chapter 9.
Trade off between clinical The likelihood of cross contamination is greatly reduced by the immediate
benefits and harms disposal of gloves as clinical waste. Failure to comply with this
recommendation could result in legislative action.
Further recommendations for waste disposal are in chapter 9.
Economic considerations If healthcare organisations are currently improperly disposing of clinical waste
then compliance with this recommendation may be associated with
implementation costs.
Quality of evidence New guidance based on legislation72 informed this recommendation.
Other considerations This recommendation is a ‘must’ as it is covered by legislation detailed in the
footnote, in line with guidance from the NICE Guidelines Manual (2009)182. The
GDG considered it important to update the original recommendation as a
result of legislatory requirements in waste disposal and as part of the findings
Update 2012
from the review question considered in chapter 9.
The second half of the original recommendation has been removed (hands
decontaminated after the gloves have been removed) as this is now included
in the hand decontamination chapter, see recommendation 6.3.1.4.
7.4 Which types of gloves provide the best protection against

The following review question was prioritised to determine which type of gloves provides the best
protection against infection. A wide variety of gloves are available and it was considered that there is
currently variation in types of gloves used in practice. The GDG stated that hypersensitivity and user
preference were the most important outcomes for this question. Polythene gloves were included in
the search, however no studies were identified.
What is the clinical and cost effectiveness of healthcare workers wearing vinyl, latex or nitrile gloves
on user preference and reduction of hypersensitivity, blood borne infections, glove porosity and
tears?
One crossover trial was identified, comparing non-powdered nitrile gloves with non-powdered latex
gloves.177 This study was also included in the previous 2003 guideline for this review question. No
evidence was identified for vinyl gloves.
aa
For guidance see (at the time of the publication of the guideline [March 2012]): ’Safe management of healthcare waste’
87
Table 22: Non-powdered nitrile vs. non-powdered latex gloves - Clinical study characteristics
Number
of
Glove 1 Crossover Very serious No serious No serious No serious
punctures177 limitations(a) inconsistency indirectness imprecision
Blood borne 0 RCT or
infections observational
studies
Glove 0 RCT or
porosity observational
studies
Hypersensiti 0 RCT or
vity observational
studies
User 0 RCT or
preference observational
studies
Ability to 0 RCT or
Update 2012
perform task observational
studies
(a) Not randomised and no allocation concealment. Very low sample size (5 dentists), likely to be underpowered.
Table 23: Non-powdered nitrile vs. non-powdered latex gloves - Clinical summary of findings
Non-powdered Non-powdered
Outcome nitrile latex Relative risk Absolute effect Quality
(a) (a)
Glove 58/1020 (5.7%) 19/1000 (1.9%) RR 2.99 38 more per 1000 LOW
punctures (1.8 to 4.99) (15 more to 76 more)
(a) Numbers given are number of punctures from the total number of gloves used.
No cost-effectiveness evidence was identified in the update search.
No economic evidence was identified in the previous 2003 guideline. The previous guideline included
a table outlining the costs for each type of glove and recommends that ‘Healthcare personnel should
be aware of the cost differential in gloves and should select the most appropriate for the activity.’ In
the absence of any published cost-effectiveness analyses, current UK glove costs were presented to
the GDG to inform decision making.
Table 24: Glove costs

Latex Nitrile Vinyl
Cost per 100 gloves (£) 3.70 5.31 2.35
187
Source: Based on average NHS Supply Chain Catalogue prices.
88
Clinical There is a statistically significant and clinically important decrease in glove punctures
with latex gloves compared to nitrile gloves (LOW QUALITY).
No studies were identified that reported blood borne infections, glove porosity,
hypersensitivity, user preference or ability to perform tasks.
Economic No relevant cost-effectiveness data were identified.
15.Alternatives to natural rubber latex gloves must bb be available

for patients, carers and healthcare workers who have a
Recommendations documented sensitivity to natural rubber latex. [2012]
Relative values of different The GDG stated that hypersensitivity and user preference were the most
Update 2012
outcomes important outcomes for this recommendation.
Trade off between clinical The benefit of using non-latex gloves for those who have an allergy to latex
benefits and harms (contact urticaria) is that they avoid allergic reactions and future adverse
reactions by properly documenting their condition. This will require additional
occupational health assessments.
Economic considerations Because latex gloves are not a valid option for individuals with latex sensitivity,
the comparatively greater cost of nitrile gloves is not a relevant consideration.
Quality of evidence No clinical evidence found. One study compared latex to nitrile gloves, but
healthcare workers with latex allergy were randomised to the nitrile group. No
sensitivity to latex was reported by those healthcare workers using latex
gloves.
Other considerations The GDG thought that the latex sensitivity of anyone living with the patient
should be taken into consideration when deciding which glove type to use. The
Health and Safety Executive also provide information on the use of latex
gloves.117 This recommendation is a ‘must’ as it is covered by legislation
detailed in the footnote in line with guidance from the NICE Guidelines Manual
(2009).182
A minor change has been made to the order of wording of this
recommendation following update to the previous guideline.
bb
In accordance with current health and safety legislation (at the publication of the guideline [March 2012]): Health and
Safety at Work Act 1974, Management of Health and Safety at Work Regulations 1999, Health and Safety Regulations
2002, Control of Substances Hazardous to Health Regulations 2002, Personal Protective Equipment Regulations 2002,
and Health and Social Care Act 2008.
89
16.Do not use polythene gloves for clinical interventions. [new

Relative values of different The GDG stated that prevention of blood borne infections and bodily fluid
outcomes contamination were the most important outcomes for this recommendation
(and that hands are protected from harmful microorganisms).
Trade off between clinical Stating that ‘powdered gloves should not be used’ has been removed from this
benefits and harms recommendation as an update to the previous guideline. The recommendation
in the previous guideline referred to latex powdered gloves that are associated
with latex allergy. Corn starch used in powdered latex gloves is thought to be a
source of latex sensitisation, because the natural rubber latex easily binds to it,
transporting it through the skin and into the circulation. However, alternative
powdered gloves are now available that are non-latex and thus avoid this
problem.
Although no evidence for the use of polythene gloves was identified as part of
the update, GDG consensus was that polythene gloves are inappropriate for
clinical use as they do not provide sufficient protection against microorganisms
for healthcare workers or patients, and do not meet current British standards31
and as such should remain in the guideline as a ‘do not use’ recommendation.
Economic considerations Although polythene gloves may be less expensive than other types of gloves,
they are not appropriate for clinical interventions and do not represent a valid
alternative to latex, nitrile, or vinyl gloves. If healthcare workers are currently
using polythene gloves for clinical interventions, compliance with this
recommendation will be associated with an implementation cost.
Update 2012
Quality of evidence No clinical evidence was identified for polythene gloves.
Other considerations Polythene gloves may be appropriate for other tasks (such as food
preparation), but they are not suitable for clinical interventions.
7.5 When should plastic aprons or fluid repellent gowns be worn?

The following review question was prioritised to determine when a disposable apron should be worn
or when a fluid repellent gown was more appropriate. This question was highlighted by dental
practitioners during stakeholder consultation as an area that required updating. The GDG agreed that
the prevention of blood, bodily fluid contamination and transfer of pathogenic microorganisms were
important outcomes for this clinical question.
What is the clinical and cost effectiveness of healthcare workers wearing plastic aprons or fluid
repellent gowns vs. no aprons or gowns, gloves only or standard uniform on the reduction of blood,
bodily fluid and pathogenic microorganism contamination?
Two observational studies investigating contamination of uniforms when disposable plastic aprons
were worn were included for this review question,34,96 one of which was included in the previous
2003 guideline.34 Two intensive care based, observational, before and after studies were included,
comparing isolation procedures with gowns and gloves against isolation procedures with gloves
alone in preventing the acquisition of vancomycin resistant enterococci (VRE).216,246
90
Table 25: Disposable aprons vs. no aprons - Clinical study characteristics

Number
of
MRSA 1 Observational Very No serious No serious Serious
(a)
contamination studies serious inconsistency indirectness imprecision
(b)
of uniform
(Care
assistants;
aprons worn
when washing
and
changing)96
MRSA 1 Observational Very No serious No serious No serious
contamination studies serious(a) inconsistency indirectness imprecision
of uniform
(Care
assistants;
aprons worn
when
washing,
changing and
for meal
assistance)96
Update 2012
MRSA 1 observational Very No serious No serious Serious
(b)
of uniform
(Nurses;
aprons worn
for dressing)96
MRSA 1 Observational Very No serious No serious Serious
(b)
of uniform
(Nurses;
aprons worn
for dressing
and biological
sampling)96
Bacterial 1 Observational Very serious No serious Serious No serious
contamination studies limitations(c) inconsistency indirectness(d) imprecision
of uniform34 (e)
Bodily fluid 0 RCT or

contamination observational
(a) Study poorly reported. Not clear how the indications to wear aprons were allocated. Results were excluded for HCW who
did not use aprons where indicated on more than 5 occasions per shift.
(b) The relatively few events and few patients give wide confidence intervals around the estimate of effect. This makes it
(c) Study poorly reported. Study conducted in 2 wards but no baseline data reported regarding care activities for each ward,
patient characteristics (including numbers) or staffing in the 2 wards.
(d) Study conducted in hospital population not primary or community care.
(e) No standard deviation reported so confidence intervals are unknown, therefore unknown whether effect is precise or
not.
91
Table 26: Disposable aprons vs. no aprons - Clinical summary of findings

Outcome Aprons No aprons Relative risk Absolute effect Quality
MRSA contamination of 15/43 5/16 1.12 38 more per 1000 VERY
uniform (Care assistants; (34.9%) (31.3%) (0.48 to 2.57) (163 fewer to 491 more) LOW
aprons worn when
washing and changing)96
MRSA contamination of 7/80 5/16 0.28 225 fewer per 1000 VERY
uniform (Care assistants; (8.8%) (31.3%) (0.1 to 0.77) (72 fewer to 281 fewer) LOW
aprons worn when
washing, changing and
96
for meal assistance)
MRSA contamination of 7/22 7/16 0.73 118 fewer per 1000 VERY
uniform (Nurses; aprons (31.8%) (43.8%) (0.32 to 1.66) (298 fewer to 289 more) LOW
worn for dressing)96
MRSA contamination of 2/20 (10%) 7/16 0.23 337 fewer per 1000 VERY
uniform (Nurses; aprons (43.8%) (0.05 to 0.95) (from 22 fewer to 416 LOW
worn for dressing and fewer)
96
biological sampling)
Bacterial Contamination Mean Mean N/R N/R VERY
of uniform34 colony colony LOW
count in count in no
apron apron
Update 2012
group: group
59.40(a) 44.80(a)
(a) Only results for mean colony counts were provided in the paper. No details about standard deviation of results were
provided.
Table 27: Gowns and gloves vs. gloves alone- Clinical study characteristics
Number
of
Vancomycin 1 Observational Serious No serious Serious No serious
(a)
resistant limitations inconsistency indirectness imprecision
(b) (c)
enterococci
(VRE)
acquisition
rate (cases per
100 days at
risk)246
VRE 1 Observational Serious No serious Serious No serious
(a)
acquisition limitations inconsistency indirectness imprecision
(b) (c)
rate (cases per
1000 MICU
216
days)
Bodily fluid 0 RCT or
contamination observational
(a) Studies investigated impact of policy change over two consecutive periods of time. No blinding and so some bias due to
changes in behaviour could have occurred.
(b) Study conducted in hospital population not primary or community care.
(c) No standard deviation reported so confidence intervals are unknown, therefore unknown whether effect is precise or
not.
92
Table 28: Gowns and gloves vs. gloves alone - Clinical summary of findings
Outcome Gowns and gloves Gloves alone Relative risk Absolute effect Quality
(a) (a)
VRE acquisition 1.8 3.78 N/R N/R VERY
rate (cases per LOW
100 days at risk)
VRE acquisition 9.0(b) 19.6(b) N/R N/R VERY
rate (cases per LOW
1000 MICU days)
(a) Results expressed as cases per 100 days at risk.
(b) Results expressed as cases per 1000 MICU days.
Two economic studies were identified through the update search. One was excluded because it did
not include any relevant outcomes, used a costing method that is incompatible with the NICE
reference case , and as it was undertaken from a Turkish perspective, was considered a non-relevant
setting by the GDG.20
Results of a cost analysis by Puzniak et al., (2004)215 were presented to the GDG. The GDG were also
presented with current UK gown and apron costs to inform decision making.
No economic studies were identified in the previous 2003 guideline.
Table 29: Gowns vs. No gowns – Economic study characteristics
Update 2012
215 (b)
Puzniak 2004 Potentially serious Partial applicability ICU setting
limitations(a)
(a) Based on a before and after trial designed to assess the impact of a policy change, difficult to isolate the effect of gowns
as was part of an intervention package.
(b) USA hospital perspective; ICU isolation setting.
Table 30: Gowns vs. No gowns – Economic summary of findings

Study Incremental cost (£) Incremental effects ICER Uncertainty
215
Puzniak 2004 Gowns cost £67 567 per 58 cases of VRE Net benefit of Results were
year(a) colonisation and 6 £382 914 robust under
cases of VRE associated with exploratory
bacteraemia averted gowns analysis
with use of gowns
(a) Annualised hospital-wide cost; cost of intervention included the healthcare worker time needed to don and doff gowns.
Table 31: Gown and apron costs

Sterile fluid impervious Standard plastic
gowns Sterile standard gowns apron
Cost per gown/apron (£) 2.10 (disposable) 1.80 (+laundry/autoclave) 0.10 (disposable)
187
Source: Based on average NHS Supply Chain Catalogue prices.
Clinical It is uncertain whether there is any difference in mean bacterial colony count on
uniforms when wearing an apron compared with not wearing an apron (VERY LOW
QUALITY).
93
There is a statistically significant and clinically important reduction in MRSA

contamination of care assistant uniforms when aprons were used for washing, and
meal assistance in a long-term care facility compared with when no aprons were
used (VERY LOW QUALITY).
There is a statistically significant reduction of uncertain clinical importance in MRSA

contamination of nurses uniforms when aprons were used for dressing changes and
biological sampling compared with when no aprons were used (VERY LOW QUALITY).
There was a statistically significant reduction of uncertain clinical importance in VRE

acquisition when gowns and gloves were worn in isolation procedures compared to
when gloves alone were worn (VERY LOW QUALITY).
No studies were identified that reported bodily fluid contamination.
Economic Wearing a gown or apron is likely to be cost-effective where there is a risk of

infection transmission to the healthcare worker or between patients (POTENTIALLY
SERIOUS LIMITATIONS; PARTIALLY APPLICABLE).
No economic studies comparing gowns to aprons were identified.
7.5.1.4 Recommendations and link to evidence (2012)
17.When delivering direct patient care:

• wear a disposable plastic apron if there is a risk that clothing
may be exposed to blood, body fluids, secretions or excretions
Update 2012
or
• wear a long-sleeved fluid-repellent gown if there is a risk of
extensive splashing of blood, body fluids, secretions or
Recommendations excretions, onto skin or clothing. [2012]
Relative values of different The GDG agreed that prevention of blood, bodily fluid and pathogenic
outcomes microorganism contamination were important outcomes for this clinical
question.
Trade off between clinical Wearing disposable aprons and gowns should protect healthcare workers from
benefits and harms becoming contaminated whilst providing care and is also in line with health
1,3,4,115
and safety legislation. In turn, this should help prevent the spread of
microorganisms to other patients.
The GDG felt that potential clinical disadvantages may occur if the healthcare
worker becomes reliant on the aprons to protect themselves and does not
continue with other standard infection control best practice. The GDG
considered that poor practice, such as not wearing a clean uniform or not
wearing aprons for more than one patient care episode, should not occur.
Economic considerations The cost of disposable aprons, cost of uniforms, cost of laundering uniforms,
and consequences of infection were taken into consideration.
The GDG agreed that the cost associated with apron use would likely be
outweighed by the costs and consequences of not wearing an apron (staff time
and resource use associated with changing and laundering soiled uniforms, and
the risk of infection associated with exposure to blood, bodily fluid, excretions
or secretions).
The cost associated with fluid-repellent gown use should be considered
relative to the risk of contamination associated with each episode of direct
patient care. Where the risk of soiling or infection is high, the increased cost of
a fluid-repellent gown is likely to be justified.
Quality of evidence Four clinical studies were included. Two very low quality, poorly reported
94
observational studies investigated uniform contamination when an apron was

used compared to when no apron was used. Two very low quality comparative
observational studies investigated the impact of changing isolation procedures
in intensive care units on the acquisition of VRE. Both studies reported lower
VRE acquisition rates in the periods when gloves and gowns were used
compared to the periods when gloves alone were used.
The GDG agreed the changes to the recommendation by consensus.
Other considerations The GDG noted that before any task is started an assessment of the risks
should be undertaken to identify the risks of contamination to healthcare
workers. They noted that appropriate PPE should be selected based on the
task required. Employers are obliged to ensure that suitable PPE is available
and that there are proper facilities for its storage and disposal in line with
current legislation. The GDG thought that employees should be adequately
instructed and trained in the safe use of PPE, which includes appropriate
donning, doffing and disposal procedures. However, they did not feel it was
necessary to make a recommendation in this area as this is covered in
recommendation 5.2.1.1.
Update 2012
The GDG noted that healthcare workers should be protected from
contamination of bodily fluids that could cause infection. The level of
protection (disposable apron or full gown) should depend on the extent of
potential contamination.
The GDG acknowledged that ambulance staff wear aprons when required, but
it is unusual to wear full gowns in the community. Full gowns are generally only
available in exceptional circumstances, such as high risk transfers and/or
previously known risks or scenarios, which are rare. The GDG considered that
the recommendation is appropriate for the majority of healthcare workers in
the community.
The recommendation from the previous guideline explicitly stated that aprons
or gowns should be used to protect against body fluid contamination with the
exception of sweat. The GDG decided to remove ‘with the exception of sweat’
as, although they acknowledged that microorganisms in sweat were unlikely to
be pathogenic, the exception was confusing and unnecessary.
In addition, the brackets included in the recommendation made in the
previous guideline which provided the example of ‘when assisting with child
birth’ were removed as it was felt by the GDG to be unnecessary and may limit
the reader’s interpretation of the recommendation.
95
18.When using disposable plastic aprons or gowns:

• use them as single-use items, for one procedure or one episode
of direct patient care and
Recommendations • ensure they are disposed of correctly (see chapter 9). [2012]
Relative values of different The GDG agreed that prevention of blood and bodily fluid and pathogenic
outcomes microorganism contamination were important outcomes for this clinical
question.
Trade off between clinical The GDG noted that wearing disposable aprons and gowns protect healthcare
benefits and harms workers from becoming contaminated whilst providing care. This benefit is
negated if bad practice is adopted such as wearing aprons or gowns between
patients or wearing the same apron for different procedures on the same
patient.
Update 2012
Economic considerations The GDG agreed that any increased cost in apron and gown use associated
with single-use of these items is outweighed by the cost and quality of life
implications associated with infection transmission to healthcare workers and
between patients.
Quality of evidence The recommendation developed is in line with the available evidence which
investigated the use of single-use items which were discarded after each
patient use. The evidence that showed the use of gowns reduced the
acquisition of VRE in intensive care units, provided gowns that were not re-
used between patients. It is unclear from consideration of the evidence
reviewed whether the available gowns were disposable items.
Other considerations The GDG updated the recommendation from the previous guideline to
highlight that plastic aprons or gowns should be changed between ‘individual
episodes of patient care’ in order to prevent disposable aprons used for a
patient being re-donned when providing care for that same patient at a later
time.
Appropriate disposal of aprons and gowns is a legal requirement. The GDG
decided to separate the section of the recommendation which required the
healthcare worker to dispose of plastic aprons as ‘healthcare waste’ as this is
now considered in a separate recommendation (see chapter 9).
96
7.6 When is a facemask, eye protection or other facial protection

necessary?
Our previous systematic review failed to reveal any robust experimental studies that suggested any
clinical benefit from wearing surgical masks to protect patients during routine ward procedures such
as wound dressing or invasive medical procedures.211,212
Personal respiratory protection is required in certain respiratory diseases, e.g., HIV-related or

multiple drug-resistant tuberculosis260 and where patients who are severely immunocompromised
are at an increased risk of infection. In these instances, surgical masks are not effective protection
and specialised respiratory protective equipment should be worn, e.g., a particulate filter
mask.113,212,260
Our previous systematic review indicated that different protective eyewear offered protection
against physical splashing of infected substances into the eyes (although not on 100% of occasions)
but compliance was poor.212 Expert opinion recommends that face and eye protection reduce the risk
of occupational exposure of healthcare practitioners to splashes of blood, body fluids, secretion or
excretions.45,95,211
19.Face masks and eye protection must cc be worn where there is a risk of blood, body fluids,
secretions or excretions splashing into the face and eyes. [2003]
20.Respiratory protective equipment, for example a particulate filter mask, mustcc be used
when clinically indicated. [2003]
cc
In accordance with current health and safety legislation (at the time of the publication of the guideline [March 2012]):
97
Infection
field on theand
first
Control
Standard principles for the safe use and disposal of sharps
8 Standard principles for the safe use and disposal

of sharps
8.1 Introduction
• choice of safety cannulae
• choice of safety needles.
The choice of safety cannulae and needles were prioritised for update to determine whether newer
safety devices available since the publication of the previous guideline are effective at reducing
needle stick injury and associated infection.
Update 2012
No new review questions included in this chapter.
Sections not updated in this chapter are the safe handling of sharps (relating to the recommendation
on sharps not being passed directly from hand to hand, and handling being kept to a minimum).
Specific recommendations on disposal of sharps are included in this chapter and have been updated
following changes to legislation.64,67 General waste disposal recommendations are in chapter 9.
Waste disposal recommendations for personal protective equipment are in chapter 7.
This section discusses the evidence and associated recommendations for the safe use and disposal of
sharps in community and primary care settings and includes minimising the risks associated with
sharps use and disposal and the use of needle protection devices.
8.2 Sharps injuries – what’s the problem?

The safe handling and disposal of needles and other sharp instruments should form part of an overall
strategy of clinical waste disposal to protect staff, patients and visitors from exposure to blood borne
pathogens.119 The incidence of injuries caused by sharps varies across clinical settings and is difficult
to compare due to different denominators for data collection. Audit data suggests that of the
occupational injuries that occur in hospitals, 16% are attributable to sharps injuries.179 National
surveillance of occupational exposure to bloodborne viruses from 1997-2001 indicates that 68% of
percutaneous exposures were caused by sharps. Of the exposures followed up at 6 weeks, 7 percent
involved healthcare workers working in community and primary care settings.85 In the first year of
data collection the UK EpiNet sharps injury surveillance project provides data on 888 injuries
occurring in 12 NHS Trusts identifying that 80% of injuries involve contaminated sharps, with 43% of
injuries sustained by nursing staff and 24% by medical staff.223 In general clinical settings, sharps
injuries are predominantly caused by needle devices and associated with venepuncture,
administration of medication via intravascular lines and recapping of needles during the disassembly
of equipment.36 All sharps injuries are considered to be potentially preventable.
The average risk of transmission of bloodborne pathogens following a single percutaneous exposure
from a positive source has been estimated to be214:
• Hepatitis B Virus (HBV) 33.3 percent (1 in 3)
• Hepatitis C Virus (HCV) 3.3 percent (1 in 30)
• Human Immunodeficiency Virus (HIV) 0.31 percent (1 in 319)

98
The GDG acknowledge that there is existing guidance on HIV post-exposure prophylaxis from the
Update
2012
Department of Health.66
21.Sharps shoulddd not be passed directly from hand to hand, and handling should be kept to a
minimum. [2003, amended 2012]
22.Used needles:
• must not be bent or broken before disposal
• must not be recapped.
In denistry, if recapping or disassembly is unavoidable, a risk

assessment must be undertaken and appropriate safety devices
Recommendations should be used. [new 2012]
outcomes recommendation to be prevention of needlestick injury, blood contamination
and blood borne infection.
Trade off between clinical The GDG considered recapping, bending and breaking used needles to put
benefits and harms healthcare workers at risk from needlestick injuries and therefore the benefit
of this recommendation is to prevent such injuries.
The GDG were aware that a new EU Directive (2010/32/EU48) was introduced
in the United Kingdom (UK) in May 2010 entitled: prevention of sharps injuries
in hospitals and the healthcare sector. The UK will have until May 2013 to
implement the Directive into national legislation. The GDG noted that the
Update 2012
Directive aims to set up an integrated approach establishing policies in risk
assessment, risk prevention, training, information, awareness raising and
monitoring. The Directive states that “Where the results of the risk assessment
reveal a risk of injuries with a sharp and/or infection, workers’ exposure must
be eliminated by taking the following measures, without prejudice to their
order: the practice of recapping shall be banned with immediate effect...”.
Unavoidable situations for recapping, bending or breaking needles were
brought to the attention of the GDG by dental colleagues during the
stakeholder workshop. The GDG noted DH advice that some syringes used in
dentistry are not disposable and needles should be re-sheathed using the
needle guards provided.64
Economic considerations No relevant economic considerations were identified for this issue. Where
avoidable, recapping and disassembly is not considered a valid alternative.
Where unavoidable, ‘appropriate safety devices’, such as portable needle
sheath holding devices, are likely to already be present in care settings where
re-capping is routine and therefore implementation of this recommendation
will be associated with minimal cost.
Quality of evidence No clinical evidence was identified. Although a direct question was not asked
about recapping, bending or breaking needles, the sharps literature search for
other questions was considered to be wide enough to have captured this
evidence. No major changes have been made to this recommendation since
the last guideline, apart from the addition of situations where recapping or
disassembling needles is unavoidable. GDG consensus was that in these cases a
risk assessment should take place and appropriate safety devices (such as
dd
The updated recommendation contains 'should' rather than ‘must’ (which is in the 2003 guideline) because the GDG
considered that this is not covered by legislation (in accordance with the NICE guidelines manual, 2009).
99
recapping devices) should be used. This was considered to be especially

appropriate and in line with the EU directive noted above.
Other considerations Other considerations for the GDG included the training of all healthcare
workers in the safe management of sharps regardless of type used to aid
implementation of this recommendation, see also recommendation 26. In
addition, they felt that training should include awareness of safety issues when
sharps are kept in a patient’s home.
23.Used sharps must be discarded immediately into a sharps

container conforming to current standards ee by the person
Recommendations generating the sharps waste. [new 2012]
outcomes recommendation to be prevention of needlestick injury, blood contamination
and blood borne infection.
Trade off between clinical GDG consensus was that the likelihood of needlestick injury is greatly reduced
benefits and harms by the immediate disposal of sharps into an appropriate container. Failure to
comply with this recommendation could result in legislative action.
Further recommendations for waste disposal are in chapter 9.
Economic considerations People generating sharps waste should already have access to sharps
containers that conform to current standards. If not, then this
Update 2012
recommendation will be associated with an implementation cost.
Quality of evidence There was no clinical evidence review for this section.
The GDG considered that it was important for any recommendation
amendments to conform to the Safe Management of Healthcare Waste
Guidelines72 and the relevant EU and UK regulations and HTM-01-05
Decontamination in primary care dental practices.67 The GDG were aware that
the Royal College of Nursing had also published guidance in this area.224
Other considerations This recommendation has been updated to reflect current legislations and best
practices. The GDG considered that this recommendation relates to patient
safety and that the consequence of not implementing it mean that the risk of
adverse events are so severe, that the use of the word ‘must’ is appropriate in
line with the guidance from the NICE Guidelines Manual (2009).182
Clinical waste must be placed in the appropriate receptacle at source. This
should always be performed by the person immediately involved in the
generation of the waste. Passing used sharps from one person to another
increases the risk of injury. The GDG noted that the person generating the
sharps waste in a dental setting is the clinician (therefore, dentist, dental
therapist or hygienist), and that most sharps injuries in dental surgeries are
sustained by dental nurses.238
The GDG also considered that to ensure that risk of injury was minimised it was
important that the used sharps should be disposed of immediately after use
and made the appropriate amendment to the existing recommendation to
reflect this.
ee
At the time of publication of the guideline (March 2012): UN3291 and BS 7320.
100
24.Sharps containers:
• must ff be located in a safe position that avoids spillage, is at a
height that allows the safe disposal of sharps, is away from
public access areas and is out of the reach of children
• must notff be used for any other purpose than the disposal of
sharps
• must notff be filled above the fill line
• mustff be disposed of when the fill line is reached
• should be temporarily closed when not in use
• should be disposed of every 3 months even if not full, by the
Recommendations licensed route in accordance with local policy. [new 2012]
outcomes recommendation to be needlestick injury, blood contamination and blood
borne infection.
Trade off between clinical Compliance with this recommendation will reduce the risk of sharps injuries to
benefits and harms healthcare workers, patients, carers and the public. Failure to comply with this
recommendation could result in legislative action.
Economic considerations Individuals and organisations generating sharps waste should already be
Update 2012
compliant with this recommendation. If not, then this recommendation will be
associated with an implementation cost.
Quality of evidence There was no clinical evidence review for this section.
The GDG noted that any amendments to the original recommendation should
conform to the Safe Management of Healthcare Waste guidelines72 and the
relevant EU and UK regulations64 and HTM-01-05 Decontamination in primary
care dental practices.67 They were also aware that the Royal College of Nursing
have published guidance in this area.224
Other considerations Inappropriate disposal of sharps is an important cause of injury. This
recommendation is a ‘must’ as it is covered by legislation detailed in the
182
footnote in line with the NICE Guidelines Manual (2009).
The GDG discussed and considered the following aspects when making the
recommendations:
• Patients cared for at home: The Safe Management of Healthcare
72
Waste document makes it clear that sharps containers should be
prescribed for patients using sharps (injections/lancets) at home. It is
important not to just involve the patient but also other relevant
household members in training to ensure proper use of sharps and
sharps bins. They felt that it would not be acceptable for this group to
dispose of their sharps and lancets into the domestic waste stream
e.g. household black bag.
• Community nursing: For practicality reasons, community nurses may
want to use just a single sharps receptacle.
ff
101
8.3 Do safety cannulae reduce sharp injuries compared to standard

cannulae?
This question was asked to determine whether newer safety devices available since the publication
of the previous guideline are effective at reducing needle stick injury and associated infection.
What is the clinical and cost effectiveness of healthcare workers using safety needle cannulae vs.
standard cannulae on compliance and user preference, infection related mortality and morbidity and
sharps injuries?
Three RCTs were identified, two comparing active (requires pressing a button to trigger the
withdrawal of the needle in to a plastic sleeve using a spring) and passive (with a protective shield
that automatically covers the needlepoint during its withdrawal) safety cannulae to standard
cannulae16,213, and one RCT comparing active safeguarded needles with standard cannulae.47
Update 2012
Table 32: Active safety cannulae vs. standard cannulae - Clinical study characteristics
Number
Outcome of studies Design Limitations Inconsistency Indirectness Imprecision
Needle stick 2 RCT Serious No serious Serious No serious
injury16,213 limitations(a) inconsistency indirectness(b) imprecision
Catheterised on 3 RCT Serious No serious Serious No serious
first attempt limitations(c) inconsistency indirectness(b) imprecision
16,47,213
Blood 3 RCT Serious No serious Serious No serious

contamination of limitation(c) inconsistency indirectness(b) imprecision
patients or
healthcare
workers (HCWs)
16,47,213
Infection related 0 RCT

mortality and
morbidity
User preference 0 RCT
Compliance 0 RCT
(a) Lack of blinding and unclear randomisation and allocation in 1 study.
(b) Hospital setting rather than community.
(c) Lack of blinding and unclear randomisation in 2 studies.
102
Table 33: Active safety cannulae vs. standard cannulae - Clinical summary of findings
Safety Standard
Outcome cannulae cannulae Relative risk Absolute effect Quality
Needle stick injury 0/304 0/304 Not pooled Not pooled LOW
(0%) (0%)
Catheterised on first 426/515 374/423 RR 0.96 35 fewer per 1000
attempt (82.7%) (88.4%) (0.91 to 1.01) (80 fewer to 9 more) LOW
Blood contamination 77/515 32/423 RR 1.94 71 more per 1000
of patients or HCWs (15%) (7.6%) (1.32 to 2.86) (24 more to 141 more) LOW
Table 34: Passive safety cannulae vs. standard cannulae - Clinical study characteristics
Number
of
Needle stick 2 RCT Serious No serious Serious No serious
injury16,213 limitations(a) inconsistency indirectness(b) imprecision
Catheterised on 2 RCT Serious No serious Serious No serious
first attempt limitations(a) inconsistency indirectness(b) imprecision
16,213
Blood 2 RCT Serious No serious Serious Serious

contamination of limitations(a) inconsistency indirectness(b) imprecision(c)
patients or
HCWs16,213
Update 2012
mortality and
morbidity
User preference 0 RCT
Compliance 0 RCT
(a) Lack of blinding and unclear randomisation and allocation in 1 study.
(b) Hospital setting rather than community.
Table 35: Passive safety cannulae vs. standard cannulae - Clinical summary of findings
Passive
Outcome safety Standard Relative risk Absolute effect Quality
Needle stick injury 0/301 (0%) 0/304 not pooled not pooled LOW
(0%)
Catheterised on first 278/301 280/304 RR 1 0 more per 1000 LOW
attempt (92.4%) (92.1%) (0.96 to 1.05) (37 fewer to 46 more)
Blood contamination of 21/301 (7%) 20/304 RR 1.06 4 more per 1000 VERY
patients or HCWs (6.6%) (0.59 to 1.92) (27 fewer to 61 more) LOW
No cost-effectiveness evidence was identified.
No cost effectiveness evidence was identified in the previous 2003 guideline.
In the absence of any published cost-effectiveness evidence, estimates about the cost and quality of
life associated with needle stick injury was obtained from several review articles148-150 identified
103
through the economic literature search and presented to the GDG to inform decision making. The
GDG were also presented with the current UK cost of standard cannulae and safety cannulae.
Table 36: Cost of standard and safety IV cannulae

Type of cannula Average cost (£)
Standard cannula 0.86 each
Active safety cannula 1.05 each
Passive safety cannula 2.10 each
187
Source/Note: Based on average 2010 Supply Chain prices. Individual trusts may negotiate different contracts and
prices with suppliers.
Clinical It is unlikely that there is any difference in success of cannulation on first attempt
between active or passive safety cannulae compared to standard cannulae (LOW
QUALITY).
There were no sharps injuries for active or passive safety cannulae or standard
Update 2012
cannulae (LOW QUALITY).
There is a statistically significant and clinically important increase in blood

contamination of patients or HCWs with active safety cannulae compared to
standard cannulae (LOW QUALITY).
It is uncertain whether there is any difference in blood contamination of patients or

HCWs with passive safety cannulae compared to standard cannulae (VERY LOW
QUALITY).
No studies were identified that reported infection related mortality and morbidity,
user preference or compliance.
Economic No cost-effectiveness studies were identified.
The evidence for this review question was considered alongside the evidence for the following
question and recommendations were made considering all the evidence. See recommendations at
the end of this chapter 8.4.1.4.
104
8.4 Do safety needle devices reduce sharps injuries compared to

standard needles?
This question was asked to determine whether newer safety devices available since the publication
of the previous guideline are effective at reducing needle stick injury and associated infection.
What is the clinical and cost effectiveness of healthcare workers using safety needle devices (needle-
free, retractable needles, safety re-sheathing devices) vs. standard needles on compliance and user
preference, infection related mortality and morbidity and sharps injuries?
Five observational studies were identified. Three studies were before and after implementation
studies of safety devices for phlebotomy procedures.38,171,221 One study investigates the
implementation of a disposable safety syringe for dentistry286 compared to a non-disposable metal
syringe. The final study investigates the implementation of a self-retracting glucometer lancet
compared to a straight stick non-retracting lancet.198
Three studies from the previous 2003 guideline met the inclusion criteria for this review
question.38,198,286
Update 2012
Table 37: Safety devices for phlebotomy procedures vs. standard devices - Clinical study
characteristics
Number
of
Needle 1 Observational No serious No serious Serious No serious
stick studies limitations inconsistency indirectness(a) imprecision
injury171(d)
Needle 1 Observational No serious No serious Serious No serious
stick studies limitations inconsistency indirectness(a) imprecision
injury221
Needlestick 1 Observational No serious No serious Serious No serious
(a)
injury - studies limitations inconsistency indirectness imprecision
Winged
steel
38
needle
Needlestick 1 Observational No serious No serious Serious No serious
injury - studies limitations inconsistency indirectness(a) imprecision
Bluntable
vacuum
tube38
Needlestick 1 Observational No serious No serious Serious Serious
(a) (b)
injury - studies limitations inconsistency indirectness imprecision
Vacuum
tube with
recapping
sheath38
105
Number
of
User 1 Observational No serious No serious Serious No serious
preference3 studies limitations inconsistency indirectness(a) imprecision
8
User 1 Observational No serious No serious Serious No serious

preference1 studies limitations inconsistency indirectness(a) imprecision
71(c)
Blood 0 Observational
borne studies
infection
Infection 0 Observational
related studies
mortality
and
morbidity
Compliance 0 Observational
studies
(a) Hospital based rather than community.
(b) Wide confidence interval with low event number give a low confidence in the effect size.
(c) Taken from survey data, numbers given are those that preferred the safety needle, remaining respondents were
assumed to prefer the standard needle.
Update 2012
(d) Denominator is the total number of needles delivered to the department.
Table 38: Safety devices for phlebotomy procedures vs. standard devices - Clinical summary of
findings
Safety Standard
Outcome device device Relative risk Absolute effect Quality
Needle stick 28/436180 86/641282 RR 0.48 0 fewer per 1000 VERY
injury(a) (0%) (0%) (0.31 to 0.73) (0 fewer to 0 fewer) LOW
Needle stick - - RR 0.62 - VERY
injury(b) (0.51 to 0.72) LOW
Needlestick injury 34/2540500 53/1875995 RR 0.47 0 fewer per 1000 VERY
- Winged steel (0%) (0%) (0.31 to 0.73) (0 fewer to 0 fewer) LOW
needle
- Bluntable (0%) (0%) (0.03 to 0.66) (0 fewer to 0 fewer) LOW
vacuum tube
- Vacuum tube (0%) (0%) (0.14 to 1) (0 fewer to 0 more) LOW
with recapping
sheath
User preference 622/1939 882/1939 RR 0.71 132 fewer per 1000 VERY
(32.1%) (45.5%) (0.65 to 0.76) (109 fewer to 159 LOW
fewer)
User preference 199/536 337/536 RR 0.59 258 fewer per 1000 VERY
(37.1%) (62.9%) (0.52 to 0.67) (207 fewer to 302 LOW
fewer)
(a) Denominator is the total number of needles delivered to the department.
(b) Relative risk taken directly from paper. Total events and population not given for study period.
106
Table 39: Disposal safety syringe vs. non-disposable syringe - Clinical study characteristics
Number
of
Needle stick 1 Observational No serious No serious Serious No serious
injury286 studies limitations inconsistency indirectness(a) imprecision
Blood borne 0 Observational
infection studies
related studies
mortality and
morbidity
studies
(a) Dental school setting rather than community.
Table 40: Disposal safety syringe vs. non-disposable syringe - Clinical summary of findings
Outcome Safety syringe Non-disposable Relative risk Absolute effect Quality
Needle stick 0/1000 (0%) 21/1000 (2.1%) RR 0.02 21 fewer per 1000 VERY
injury (0 to 0.38) (13 fewer to 21 fewer) LOW
Table 41: Self-retracting glucometer lancet vs. straight stick non-retracting lancet - Clinical study
Update 2012
characteristics
Number
of
Needle stick 1 Observational No serious No serious Serious Serious
injury198 studies limitations inconsistency indirectness(a) imprecision
(b)
Blood borne 0 Observational

infection studies
related studies
mortality and
morbidity
studies
(a) The denominator used for needlestick injury was worker years rather than the actual number of lancets used.
(b) Wide confidence and low event number lead to low confidence in the effect size.
Table 42: Self-retracting glucometer lancet vs. straight stick non-retracting lancet - Clinical
summary of findings
Outcome Self-retracting Non-retracting Relative risk Absolute effect Quality
Needle stick injury 2/477 (0.4%) 16/954 (1.7%) RR 0.25 13 fewer per 1000 VERY
(0.06 to 1.08) (16 fewer to 1 more) LOW
107
The update search conducted as part of this review identified two studies; neither met inclusion
criteria. A cost analysis by Glenngard et al (2009)103 was excluded because costs were presented
nationally rather than individually and were considered specific to Sweden. A cost-effectiveness
analysis from Madagascar78 was excluded because neither the comparator nor the setting was
relevant to this question.
One study identified by the clinical evidence review in the previous 2003 guideline met inclusion
criteria for the update economic review. Peate and colleagues (2001)198 conducted a basic cost
analysis in their comparison of the use of self-retracting glucometer lancets to straight stick non-
retracting lancets among emergency medical system workers in the United States.
Additional estimates of the cost and quality of life impact associated with needle stick injury were
obtained from several review articles148-150 identified through the economic literature search and
presented to the GDG to inform decision making. The GDG were also presented with the current UK
cost of various standard and safety needles.
Table 43: Self-retracting glucometer lancet vs. straight stick non-retracting lancet - Economic
study characteristics
198 (b)
Peate 2001 Potentially serious Partial applicability
limitations (a)
Update 2012
(a) Resource use not reported, unit costs and cost source not reported, observational before-after study.
(b) USA setting.
Table 44: Self-retracting glucometer lancet vs. straight stick non-retracting lancet - Economic
summary of findings
Incremental cost Incremental
Study (£) effects ICER Uncertainty
198
Peate 2001 Self-retracting Self-retracting Self-retracting N/R
lancets cost £363 lancets resulted in lancets resulted in a
more per year fewer needlestick department-wide net
than non- injuries (RR 0.25) savings of £14 014
retracting lancets due to averted
(department-wide) treatment costs
Table 45: Cost of standard and safety needles

Type of needle Average cost (£)
Hypodermic syringes
Standard hypodermic syringe with standard needle 0.07 per 1ml syringe
Safety hypodermic syringe with retractable needle 0.17 per 1ml syringe
Safety hypodermic syringe with hinged shield needle 0.25 per 1ml syringe
Insulin syringes
Standard insulin syringe with standard needle attached 0.08 per 1ml syringe
Safety insulin syringe with retractable needle 0.25 per 1ml syringe
187
Source: Based on average 2010 Supply Chain prices. Individual trusts may negotiate different contracts and prices with
suppliers.
108
Clinical Phlebotomy devices
There is a statistically significant and clinically important reduction in needlestick

injuries with the safety devices compared to standard devices (VERY LOW QUALITY).
There is a statistically significant and clinically important increase in user preference

with the safety devices compared to standard devices (VERY LOW QUALITY).
Dental syringe
There is a statistically significant and clinically important reduction in needlestick

injuries with the safety devices compared to standard devices (VERY LOW QUALITY).
No studies were identified that reported blood borne infection, infection related
mortality and morbidity, or compliance.
Safety lancet
It is uncertain whether there is any difference in needlestick injuries with the safety
devices compared to standard devices (VERY LOW QUALITY).
Economic There is some evidence to suggest that safety lancets are more cost-effective than
standard lancets in certain settings (POTENTIALLY SERIOUS LIMITATIONS AND
PARTIAL APPLICABILITY). No other cost-effectiveness evidence was identified.
Update 2012
25.Use sharps safety devices if a risk assessment has indicated that

they will provide safer systems of working for healthcare
Recommendations workers, carers and patients. [new 2012]
outcomes recommendation to be needlestick injury, success of cannulation on first
attempt, blood contamination and blood borne infection.
Trade off between clinical The GDG noted that active safety cannula devices caused more blood
benefits and harms contamination of the surroundings, healthcare worker and/or the patient and
therefore passive devices with a simpler design could be considered. However
the GDG also noted that increased blood contamination was possibly related
to previously unidentified training needs and unfamiliarity with the new
devices.
Risk assessment may require additional resources (time etc), but that the
potential reduction in needlestick injuries outweighs this and provides a safer
working environment for healthcare workers.
Training is required to ensure safety devices are used correctly, and the
evidence showed that if implemented correctly these devices do reduce
needle stick injuries.
The GDG were aware that there is anxiety amongst healthcare workers
associated with taking a blood test to detect the presence of a blood borne
virus’ (for example, HIV, Hepatitis B and C). The GDG felt that minimising
needlestick injury from such tests using safety devices would be an additional
benefit.
Economic considerations Safety devices are more costly than standard devices. However, given the high
cost of investigation and treatment of needle stick injuries, the level of
healthcare worker anxiety associated with these injuries, and the frequency
with which they occur, the GDG agreed that the use of safety devices may
109
prove cost-effective in high risk situations or situations where risk assessment

has indicated their use.
Quality of evidence Three RCTS were identified comparing safety cannulae with standard cannulae,
which were all of low quality. Evidence from these studies was downgraded as
the studies were all in hospital settings and data was of low or very low quality.
No RCTs were identified for safety needle devices, but several observational
studies were identified. Before and after implementation studies were
identified; three for safety phlebotomy needles, one for safety lancet and one
study for safety disposable dental syringes. These studies had several
limitations and were all very low quality. In particular, the study implementing
the disposable dental syringe 286 was sponsored by the manufacturer which
introduced a large bias and excluded the first year of implementation from the
analysis as the authors stated a lack of training. In addition the study
implementing the safety lancet198 which had one relevant outcome,
needlestick injury, was downgraded for indirectness and imprecision.
Other considerations The GDG were aware that there are problems obtaining accurate needlestick
injury data due to under reporting of and possible reluctance to report injuries.
They felt that further information could support the implementation of their
recommendation and discussed what a risk assessment should include to
determine the need for a safety device. The GDG considered the Health and
Safety Executive document: Five Steps to Risk Assessment116 and how it might
contribute to supporting the implementation of risk assessment in the
following areas:
• the number of incidents and types of injuries
• the procedure and the environment in which it is undertaken
Update 2012
• the patient population’s demographics
• waste management and disposal
• availability of alternative products
• training.
26.Train and assess all users in the correct use and disposal of
Recommendations sharps and sharps safety devices. [new 2012]
outcomes recommendation to be needlestick injury, blood contamination and blood
borne infection.
Trade off between clinical The GDG noted that incorrect use and unfamiliarity with a new safety device
benefits and harms can lead to sharps injuries, as demonstrated by the clinical studies identified.
The GDG were also aware from considering the evidence in review question
8.3.1 that poor familiarity with device operation may lead to increased blood
contamination of the clinical area and healthcare workers. As shown by the
evidence review above, implementation of safety devices did not lead to the
complete elimination of sharps injuries. The GDG discussed the contribution
that training, along with assessment, could have on healthcare workers in
becoming familiar with the correct use of a device and correspondingly
minimising the risk to themselves or patients. The GDG felt that training should
also be available for those patients and carers who use sharps in the
community.
Economic considerations The GDG considered that training would be necessary in order to ensure that
the potential cost-effectiveness or cost savings associated with safety devices
is realised. When included as part of ongoing staff training programmes,
implementation of this recommendation should not be associated with any
additional cost.
Quality of evidence Five observational implementation studies were identified and were all very
low quality. The type of training varied across studies, for example hands on
110
simulated insertions and annual training updates171; and training sessions and
Update 2012
221
pamphlets in each ward .
Other considerations In considering the poor quality of the evidence reviewed, the GDG used
consensus to develop a recommendation on training. Training should be
considered for new staff and when new devices are implemented for all users.
111
Waste disposal
9 Waste disposal
9.1 Introduction
This chapter details general waste disposal recommendations and also lists the specific
recommendations relating to waste disposal of personal protective equipment and sharps, which are
described in more detail in chapters 7 and 8.
New legislation relating to waste disposal has been introduced since the previous guideline. The
Department of Health have published a guidance document; Safe Management of Healthcare Waste
version 1.072 as a best practice guide to the management of healthcare waste. Healthcare waste
refers to any waste produced by, and as a consequence of, healthcare activities. The document
replaces the Health Services Advisory Committee’s (1999) guidance document “Safe Disposal of
Clinical Waste” and HTM07-01 Safe Management of healthcare waste64, which has revised and
updated the previous documents to take into account the changes in legislation governing the
management of waste, its storage, carriage, treatment and disposal, and health and safety.
Key changes since the 2006 update include: an update to statutory requirements; a focus on the
waste hierarchy through procurement practices; a drive to address the carbon impact related to
waste; the integration of new sector guides on GPs, dental practices, and community pharmacies; an
emphasis on practical advice through case study examples (in particular on offensive waste streams),
and more by way of staff training material; and, a review of terminology used for healthcare, clinical
and non-clinical wastes.
Update 2012
Throughout the guideline, “healthcare waste” refers to any waste produced by, and as a
consequence of, healthcare activities. “Clinical waste” is defined as “. . . any waste which consists
wholly or partly of human or animal tissue, blood or other body fluids, excretions, drugs or other
pharmaceutical products, swabs or dressings, syringes, needles or other sharp instruments, being
waste which unless rendered safe may prove hazardous to any person coming into contact with it;
and any other waste arising from medical, nursing, dental, veterinary, pharmaceutical or similar
practice, investigation, treatment, care, teaching or research, or the collection of blood for
transfusion, being waste which may cause infection to any person coming into contact with it”.72
9.1.1.1 Review questions
The clinical questions for this chapter are also in the personal protective equipment (PPE) chapter
and the sharps chapter, see chapters 7 and 8. The two questions are:
Are there any changes in the legislations which affect the disposal of personal protective equipments
in relation to patient care in the primary and community care settings?
Are there any changes in the legislations which affect the disposal of sharp instruments and needles
in relation to patient care in the primary and community care settings?
A literature search was not performed for these questions as the objective was to review and update
the current recommendations about the safe disposal of personal protective equipment and safe
disposal of sharps in line with patient care and with the European Union (EU) and national
legislations.
The Department of Health guidance; Safe Management of Healthcare Waste version 1.072 was
reviewed.
112
Waste disposal
27.Healthcare waste must be segregated immediately by the

person generating the waste into appropriate colour-coded
storage or waste disposal bags or containers defined as
compliant with current national legislation gg and local policies.
Recommendations [new 2012]
outcomes recommendation to be the reduction in risks through the safe segregation and
disposal of healthcare waste.
Trade off between clinical Correct healthcare waste segregation and disposal into the correctly colour
benefits and harms coded containers or bags is necessary to meet legislations. Failure to comply
with this recommendation could result in legislative action.
Economic considerations If healthcare organisations are currently improperly segregating, storing and
disposing of clinical waste then compliance with this recommendation may be
associated with implementation costs.
Quality of evidence No clinical evidence review was conducted.
Update 2012
This recommendation was developed based on the consideration of current
best practice guidance from Department of Health; Safe Management of
Healthcare Waste version 1.072 and the relevant EU and UK legislation.
Other considerations The management of waste, its storage, carriage, treatment and disposal are
governed by local policies and legislation at the national and European level. In
addition to legislation specific to infection control and health and safety (e.g.
Health and Safety Act), there are several transport, environmental, and waste
disposal laws which are applicable to this question (e.g. Environment
Protection Act).
Complying with these recommendations is necessary to meet the
requirements of local and national legislation. Therefore, this recommendation
is a ‘must’. This choice of wording is in line with guidance from the NICE
Guidelines Manual (2009).182
The GDG discussed the importance of emphasising that the person generating
the waste must segregate and dispose of it immediately into appropriate
containers, rather than passing it on to another person to dispose of. The
appropriate choice of waste disposal bags or receptacles takes into account
among other factors, the type of waste and capacity of the containers.
The GDG also discussed the importance of ensuring that patients and
healthcare workers caring for patients in their own homes are provided with
appropriate receptacles for the disposal of clinical waste.
See recommendations regarding sharps and waste disposal in chapters 7 and
8, respectively.
gg
(2011); available from
www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_126345
113
Waste disposal
28.Healthcare waste must be labelled, stored, transported and

disposed of in accordance with current national legislation hh
Recommendations and local policies. [new 2012]
outcomes recommendation to be the reduction in risks through the safe disposal of
healthcare waste.
Trade off between clinical The correct segregation, storage, transport and disposal of healthcare waste is
benefits and harms necessary to meet legislation. Failure to comply with this recommendation
could result in legislative action.
Economic considerations If healthcare organisations are currently improperly storing, transporting and
Recommendation was developed based on the GDG’s consideration of current
Healthcare Waste version 1.072 and the relevant EU and UK regulations.
Other considerations The management of healthcare waste, its storage, carriage, treatment and
disposal are governed by local policies and legislations at the national and
European level. In addition to legislation specific to infection control and
health and safety (e.g. Health and Safety Act), there are several transport,
environmental, and waste disposal laws which are applicable to this question
Update 2012
(e.g. Environment Protection Act).
Complying with these recommendations is necessary to meet the
requirements of local and national legislation. Therefore, this recommendation
is a ‘must’. This choice of wording is in line with guidance from the NICE
Guidelines Manual (2009).182 The GDG discussed the importance for trusts and
healthcare providers to be aware of and compliant with specific local policies
regarding waste segregation, storage, transport and disposal.
For definitions of healthcare waste and clinical waste, see glossary. See
recommendations regarding sharps and waste disposal in chapters 7 and 8,
respectively.
29.Educate patients and carers about the correct handling, storage

Recommendations and disposal of healthcare waste. [new 2012]
outcomes recommendation to be the reduction in risks through the safe handling,
storage and disposal of healthcare waste.
Trade off between clinical The correct segregation, storage, and disposal of healthcare waste is necessary
benefits and harms to meet regulations; patients and carers need to be equipped with the
knowledge to do this appropriately.
Economic considerations If healthcare organisations are currently improperly storing, transporting and
Recommendation was developed based on the GDG’s consideration of current
hh
For guidance see (at the time of the publication of the guideline [March 2012]): ’Safe management of healthcare waste’
(2011); available from
www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_126345
114
Waste disposal
72
Healthcare Waste and the relevant EU and UK regulations.
Other considerations The GDG discussed the importance for trusts and healthcare providers to be
aware of specific local policies regarding healthcare waste segregation, storage
and disposal, and their role in helping patients cared for in their own homes to
do so. Healthcare waste covers both clinical and non-clinical waste. Most of
the waste in the community setting is non-clinical waste, such as packaging,
and offensive waste. The correct disposal of clinical waste begins with the
appropriate segregation of healthcare waste into the appropriate categories.
The GDG felt that patients and carers need information about how to handle,
Update 2012
segregate and store clinical waste so that they can safely comply with local and
national regulations.
Also see recommendations regarding sharps and waste disposal in chapters 7
and 8, respectively.
Also see the other related recommendations in the sharps (see chapter 7) and PPE (see chapter 8)
chapters.
9.1.2 Research recommendations

The GDG did not identify any research recommendations.
115
Infection
field on theand
first
Control
Long-term urinary catheters
10 Long term urinary catheters

10.1 Introduction
• types of catheter
• bladder instillations and washouts
• antibiotic use when changing long-term indwelling catheters.
These review questions were prioritised as it was considered that new evidence had emerged since
the 2003 guideline.
included in Appendix D.6. and D.9. No new review questions are included in this chapter.
Update 2012
• education of patients, carers and healthcare workers
• assessing the need for catheterisation
• catheter drainage options
• catheter insertion
• catheter maintenance (closed systems).
The GDG recognised that hand decontamination is an important part of catheter management. See
Section 6 for further details.
In addition the GDG acknowledged that Medical Device Regulations169 implement the EC Medical
Devices Directives into UK law. They place obligations on manufacturers to ensure that their devices
are safe and fit for their intended purpose before they are CE marked and placed on the market in
any EC member state. The GDG noted that guidance168 on the MHRA's adverse incident reporting
system is available for reporting adverse incidents involving medical devices.
The GDG has prioritised three recommendations in this chapter as a key priorities for
implementation, see recommendations 39, 42 and 58.
In the community and primary healthcare settings, long-term (>28 days) urinary catheterisation (LTC)
is most commonly used in the management of the elderly and patients with neurological conditions.
The prevalence of LTC in the United Kingdom (UK) has been estimated as 0.5 percent in those over
75 years old135 and 4 percent in people undergoing domiciliary care.98 Some patients may require
continuous bladder drainage using urethral or suprapubic catheters. Alternatively, patients or carers
may insert and remove urethral catheters at regular intervals (intermittent catheterisation).
Catheter care in the community is time consuming and expensive.98,135,230 LTC should be regarded as
a ‘method of last resort’ in the management of urinary problems as the burden both to the health
service and to individual patients is high.84 However, there will remain a group of patients for whom
LTC is the best option.
The method of catheterisation will depend on each patient’s individual requirements, available
clinical expertise and services. Infection is a major problem in LTC although there are other non-
infectious complications associated with LTC, including physiological/structural damage,271 urological
cancer61 and psycho-social problems.209 In selecting particular strategies to manage urinary
problems, healthcare practitioners must take account of all of these complications. These guidelines

116
focus on preventing infection. However, because infection has a complex inter-relationship with
encrustation and blockage, these aspects of catheter management are also addressed.
These guidelines apply to adults and children and should be read in conjunction with the guidance on
Standard Principles (see chapters 7 to 8). These recommendations are broad principles of best
practice and are not detailed procedural protocols. They need to be adapted and incorporated into
local practice guidelines. The recommendations are divided into five distinct interventions:
1. Education of patients, their carers and healthcare workers
2. Assessing the need for catheterisation
3. Selection of catheter type and system
4. Catheter insertion
5. Catheter maintenance.
The systematic review process is described in Appendix D.1.
10.2 Education of patients, carers and healthcare workers

Given the prevalence of LTC and the associated risk of clinical urinary tract infection, it is important
that everyone involved in catheter management is educated about infection prevention. As many
people, including children, will manage their own catheters, they must be confident and proficient in
the procedure, aware of the signs and symptoms of clinical infection and how to access expert help
when difficulties arise.79,97,140,283
30.Patients and carers should be educated about and trained in techniques of hand
management before discharge from hospital. [2003]
31.Community and primary healthcare workers must be trained in catheter insertion, including
suprapubic catheter replacement and catheter maintenance. [2003]
32.Follow-up training and ongoing support of patients and carers should be available for the
duration of long-term catheterisation. [2003]
10.3 Assessing the need for catheterisation

Catheterising patients increases the risk of acquiring a urinary tract infection. The longer a catheter is
in place, the greater the danger.
The highest incidence of healthcare-associated infection is associated with indwelling urethral

catheterisation.247 Many of these infections are serious and lead to significant morbidity. In acute
care facilities, 20-30% of catheterised patients develop bacteriuria, of whom 2-6 percent develop
symptoms of urinary tract infection (UTI).247 The risk of acquiring bacteriuria is approximately 5
percent for each day of catheterisation,92,94 and therefore most patients with LTC are bacteriuric
after 20 days of catheterisation.272
A study of patients in long-term care facilities demonstrated significantly higher morbidity and
mortality in catheterised patients than in matched non-catheterised controls.140 Duration of
catheterisation is strongly associated with risk of infection, i.e., the longer the catheter is in place,
the higher the incidence of UTI.247
117
Best practice emphasises that all procedures involving the catheter or drainage system and the
related batch codes of these devices are recorded in the patient's records.283 Patients should be
provided with adequate information in relation to the need, insertion, maintenance and removal of
their catheter by the person planning their care.283
33.Indwelling urinary catheters should be used only after alternative methods of management
have been considered. [2003]
34.The patient’s clinical need for catheterisation should be reviewed regularly and the urinary
catheter removed as soon as possible. [2003]
35.Catheter insertion, changes and care should be documented. [2003]
10.4 Catheter drainage options

10.4.1 How to select the right system
Choosing the right system for any given patient will depend on a comprehensive individual patient
assessment.
Our search identified one systematic review239 concerning the approaches to catheterisation. This
reported a higher rate of infection associated with indwelling rather than intermittent
catheterisation. This finding is reflected in a recent position paper189 on urinary tract infections in
long-term care facilities by the Society for Healthcare Epidemiology of America (SHEA) who
recommended that “where clinically appropriate, intermittent catheterisation should be used for
urinary drainage rather than a chronic indwelling catheter.”
Two studies were identified in our search which compared catheter options.125,258 The first focussed
on the risk of Meticillin-resistant Staphylococcus aureus (MRSA) colonisation and infection in nursing
home patients.258 This study concluded that indwelling catheters posed a greater risk of infection
than intermittent catheters. The second studied men with prostatic enlargement and reported a
significantly lower rate of infection in those with suprapubic rather than urethral catheters, despite
the former being used for two weeks longer.125 A non-comparative study of patients with
neuropathic bladder demonstrated a low rate of infection (6 percent) associated with the use of
long-term suprapubic catheters.240 However, 30% of patients in this study reported other catheter-
related complaints. Economic opinion suggests that if staff and resource use are the same,
suprapubic catheterisation is more cost effective.229,240
Eight studies were identified which focussed exclusively on the use of intermittent catheterisation.
The study populations encompassed a wide range of patient groups and ages.17-19,42,79,174,200,274 One
theme emerging from these studies was that the prevalence of bacteriuria is equal between men and
women17,18 though the incidence of clinical UTI appears to be higher in women.18,19 There is also
some evidence that bacteriuria rates are similar between adults and children.57
Generally, large studies indicated that the rates of infection associated with intermittent
catheterisation were low,200,274 1 per 87 months,274 and that hydrophilic catheters were associated
with a further reduction in infection risk.19,42
A possible alternative to indwelling and intermittent catheterisation is the penile sheath (condom
catheter). Whilst our systematic review did not include a specific question related to the use of
penile sheath catheters, there is evidence that this type of device may be preferable in men who are
118
able to empty their bladder and are unlikely to manipulate the system.57,229 To date there are no
controlled studies comparing penile sheaths with indwelling devices.
36.Following assessment, the best approach to catheterisation that takes account of clinical
be selected. [2003]
37.Intermittent catheterisation should be used in preference to an indwelling catheter if it is

clinically appropriate and a practical option for the patient. [2003]
10.5 Types of long-term catheters

10.5.1 Review question – intermittent catheters
Long-term urinary catheterisation is considered an important area where updated guidance is
required.
The following two questions both address the clinical and cost effectiveness of intermittent self-
catheterisation. They were addressed independently for the clinical evidence review, but
incorporated into the same economic model.
1. What is the clinical and cost effectiveness of different types of long-term intermittent urinary
catheters (non-coated, hydrophilic or gel reservoir) on symptomatic urinary tract infections,
bacteraemia, mortality, and patient preference?
2. In patients performing intermittent catheterisation, what is the clinical and cost effectiveness
of non-coated catheters reused multiple times compared to single-use on urinary tract
Update 2012
infections, bacteraemia, mortality, and patient preference?
Question 1. Non-coated vs. hydrophilic vs. gel reservoir catheters:
Six studies were identified, five of which investigated hydrophilic catheters compared to non-coated
catheters35,59,193,254,265 and one that compared non-hydrophilic gel reservoir catheters to non-coated
catheters.99 None of the studies from the previous 2003 guideline met the inclusion criteria for this
review question.
The non-coated catheters were used as a single-use product in Cardenas et al., 2009,35 as a multi use
product (reused up to 5 times a day, with a new catheter used each day) in Vapnek et al., 2003265 and
Pachler et al., 1999193 and not stated in Gianntoni et al., 200199 and Sutherland et al., 1996254 and
DeRidder et al., 2005.59 In order to allow accurate incorporation of the data from these studies into
the economic model, the authors of these studies were contacted for clarification. DeRidder et al.,
replied that the catheters used in the study were single-use. No reply was obtained from Giantonni
et al., and Sutherland et al., it was assumed that these studies also used single-use non-coated
catheters.
119
Table 46: Hydrophilic coated vs. non-coated catheters for long term intermittent self
catheterisation – Clinical study characteristics
Number
of
Mean monthly 1 RCT Serious No serious No serious No serious
urinary tract limitations(a) inconsistency indirectness imprecision
infection - 12
months265
Total urinary tract 1 RCT Serious No serious No serious No serious
(b)
infections - 1 year limitations inconsistency indirectness imprecision
35
Patients with ≥1 2 RCT Serious No serious No serious Serious

(b,
urinary tract limitations inconsistency indirectness imprecision (c)
d)
infection – 1
35,59
year
Patients/helpers 1 RCT Serious No serious No serious Serious
very satisfied with limitations (d) inconsistency indirectness imprecision (c)
the catheter – 6
months 59
Patients/helpers 1 RCT Serious No serious No serious Serious
very satisfied with limitations (d) inconsistency indirectness imprecision (c)
the catheter – 1
year 59
Patient satisfaction 1 RCT Serious No serious No serious Serious
Update 2012
254
(visual analogue limitations (e, inconsistency indirectness imprecision (c)
g)
scale, 10 = least
favourable)
Problems 1 RCT Serious No serious No serious Serious
introducing limitations (f) inconsistency indirectness imprecision (c)
catheter193
Burning sensation 1 RCT Serious No serious No serious Serious
when introducing limitations (f) inconsistency indirectness imprecision (c)
193
the catheter
Pain when 1 RCT Serious No serious No serious Serious
(f) (c)
introducing the limitations inconsistency indirectness imprecision
193
catheter
Burning sensation 1 RCT Serious No serious No serious Serious
or pain after limitations (f) inconsistency indirectness imprecision (c)
removal of the
catheter193
Bacteraemia 0 RCT
Mortality 0 RCT
(a) Method of randomisation not stated. Number of urinary tract infections at baseline is higher in intervention compared
to the control. Catheters re-used up to 5 times a day for control, where as intervention did not reuse catheters.
(b) Method of randomisation not stated and unclear allocation concealment. Higher number of women in control group
35
compared to the intervention .
59
(d) High dropout rate in DeRidder et al., 2005 (54%) due to restored urinary function and thus no further need for
catheterisation, change of bladder management to an indwelling catheter and withdrawal of consent.
254
(e) Sutherland et al., 1996 population is all male mean age 12 years old.
(f) Unclear allocation concealment.
(g) Crossover study. No details of allocation concealment or assessor blinding.
120
Table 47: Hydrophilic coated vs. non-coated catheters for long term intermittent self
catheterisation - Clinical summary of findings
Hydro- Non-
Outcome philic coated Relative risk Absolute effect Quality
Mean monthly urinary 31 31 - MD 0.01 lower MODERATE
tract infection - 12 (0.11 lower to 0.09
months higher)
Total urinary tract 22 23 - MD 0.18 higher MODERATE
infections - 1 year (0.5 lower to 0.86
higher)
Patients with 1 or 51/83 65/85 RR 0.8 153 fewer per 1000 LOW
more urinary tract (61.4%) (76.5%) (0.65 to 0.99) (8 fewer to 268 fewer)
infection – 1 year
Patients/helpers very 10/55 6/59 RR 1.79 80 more per 1000 LOW
satisfied with the (18.2%) (10.2%) (0.7 to 4.59) (31 fewer to 365 more)
catheter – 6 months
Patients/helpers very 9/55 7/59 RR 1.38 45 more per 1000 LOW
satisfied with the (16.4%) (11.9%) (0.55 to 3.45) (53 fewer to 291 more)
catheter – 1 year
Patient satisfaction 17 16 - MD 0.6 lower LOW
(visual analogue scale, (2.36 lower to 1.16
10 = least favourable) higher)
Problems introducing 1/32 2/32 RR 0.5 31 fewer per 1000 LOW
catheter (3.1%) (6.3%) (0.05 to 5.24) (59 fewer to 265 more)
Update 2012
Burning sensation 2/32 1/32 RR 2 31 more per 1000 LOW
when introducing the (6.3%) (3.1%) (0.19 to 20.97) (25 fewer to 624 more)
catheter
Pain when introducing 3/32 2/32 RR 1.5 31 more per 1000 LOW
the catheter (9.4%) (6.3%) (0.27 to 8.38) (46 fewer to 461 more)
Burning sensation or 2/32 2/32 RR 1 0 fewer per 1000 LOW
pain after removal of (6.3%) (6.3%) (0.15 to 6.67) (53 fewer to 354 more)
the catheter
Table 48: Gel reservoir vs. non-coated catheters for long term intermittent self catheterisation –
Clinical study characteristics
Number
of
Patients with ≥1 1 RCT Very No serious No serious Serious
urinary tract serious(a) inconsistency indirectness imprecision (c)
infection – 7
weeks99
Patient comfort 1 RCT Very No serious No serious No serious
(visual analogue serious(b) inconsistency indirectness imprecision
scale, low = more
comfortable)99
Bacteraemia 0 RCT
Mortality 0 RCT
(a) Crossover study, the outcomes measured 3 times per patient and reported for 3x the number of total patients in the
group i.e. 54 instead of 18. No details of allocation concealment or assessor blinding.
(b) Crossover study. No details of allocation concealment or assessor blinding. Small number of patients in each arm.
121
Table 49: Gel reservoir vs. non-coated catheters for long term intermittent self catheterisation -
Clinical summary of findings
Outcome Gel reservoir Non-coated Relative risk Absolute effect Quality
Patients with 1 or 4/54 12/54 RR 0.33 149 fewer per 1000 VERY
more urinary tract (7.4%) (22.2%) (0.11 to 0.97) (7 fewer to 198 fewer) LOW
infection – 7 weeks
Patient comfort 18 18 - MD 2.39 higher VERY
(visual analogue (1.29 to 3.49 higher) LOW
scale, low = more
comfortable)
Question 2. Single-use non-coated vs. multiple-use non-coated catheters (see section 10.5.1):
Two RCTs were identified for inclusion comparing multiple-use non-coated catheters to single-use
catheter for intermittent catheterisation, where the multiple-use arm had new catheters once a
week79 or every 24 hours.134 None of the studies from the previous 2003 guideline met the inclusion
criteria for this review question.
Table 50: Non-coated catheters reused multiple times vs. single-use – Clinical study characteristics
Number of
Update 2012
Symptomatic 2 RCT Serious No serious No serious No serious
UTI79,134 limitations(a) inconsistency indirectness imprecision
Frequency of 1 RCT Serious No serious No serious Serious
catheterisations limitations(a) inconsistency indirectness imprecision(b)
per day 79
Bacteraemia 0 RCT
Mortality 0 RCT
Patient 0 RCT
preference and
comfort
(a) Unclear randomisation, allocation concealment and blinding. The length of follow up varied from 1-107 days.
Table 51: Non-coated catheters reused multiple times vs. single use - Clinical summary of findings
Outcome Reused Single-use Relative risk Absolute effect Quality
Symptomatic UTI 34/61 38/65 RR 0.98 12 fewer per 1000 MODERATE
(55.7%) (58.5%) (0.77 to 1.25) (134 fewer to 146 more)
Frequency of 38 42 - MD 0.2 higher LOW
catheterisations (0.28 lower to 0.68 higher)
per day
No cost-effectiveness studies were identified in the previous 2003 guideline.
122
This question was identified as a high priority area for economic modelling and an original cost-utility
model was developed to inform the cost-effectiveness evidence for this question.
10.5.1.3 Cost-effectiveness evidence – original economic model
Methods
A cost-utility analysis was undertaken to evaluate the cost-effectiveness of different types of

intermittent catheters. A Markov model was used to estimate the lifetime quality-adjusted life years
(QALYs) and costs from a UK NHS and personal social services perspective. Both costs and QALYs
were discounted at a rate of 3.5% per annum in line with NICE methodological guidance. The model
was built probabilistically to take into account uncertainty surrounding each of the model input
parameters.
Population & comparators
The population evaluated in the base case analysis was people with bladder dysfunction caused by
spinal cord injury (SCI). This population was chosen for the base case as it most closely matched the
population considered by the majority (4/5) of the RCTs included in the clinical review and because
this group of patients is one of the largest users of intermittent catheters. The average age of the
population entering the model was 40 years and 80% were assumed to be male; this is the average
age at injury and gender composition of the UK population of people with SCI.
A similar model exploring the cost-effectiveness of intermittent catheterisation in patients with

bladder dysfunction not due to SCI was considered as part of the sensitivity analysis.
Update 2012
The comparators selected for the model were the types of intermittent catheter available to patients
living or being cared for in the community:
• Single-use hydrophilic catheters

• Single-use gel reservoir catheters
• Single-use non-coated catheters
• Clean multiple-use non-coated catheters
The GDG indicated that there may be situations in which it would not be practical or advisable for
patients to wash and reuse catheters (such as when facilities are not available or patients are unable
to wash and dry catheters, or if patients are catheterised by others). Therefore, two models were
constructed; they varied only in the inclusion/exclusion of clean multiple-use non-coated catheters
as a comparator.
The GDG also noted that in children and young people (≤ 16 years old), symptomatic UTI can cause
progressive renal scarring which may lead to renal failure later in life. Renal failure carries a high risk
of mortality and morbidity, is associated with very high cost and decreased quality of life. The most
recent NICE guideline for Urinary Tract Infection in Children181 concluded that it was not possible to
estimate the true risk of renal failure as a result of childhood UTI, did not identify any quality of life
values for children with UTI, and did not consider economic modelling a valid option in this
population. The current GDG agreed with this decision and noted that none of the studies included in
the clinical review which contained symptomatic UTI as an outcome were conducted in children.
Given the uncertain risk of harm as a result of symptomatic UTI in childhood, the GDG decided to
employ the precautionary principle in their approach to intermittent self-catheterisation (ISC) in
children. Therefore, only single-use catheters were considered an option for ISC in children and
modelling was not explicitly undertaken in this population.
123
Approach to modelling
Symptomatic UTI was considered the most important outcome for evaluating the efficacy of different
types of intermittent catheters. The GDG also considered the costs and consequences arising from
antimicrobial resistant UTIs and catheter-associated bacteraemia to be an important factor to
include when assessing the downstream effects of symptomatic UTI. In the absence of any
comparative clinical evidence, in the base case analysis it was assumed that urethral complications
do not vary between catheter types. This assumption was explored in sensitivity analysis.
The main simplifying assumption of the model was that the probability of antibiotic resistance does
not change over time. This assumption was necessary due to a lack of available data about current
and historical resistance rates, the complexity of forecasting antibiotic resistance trends over time
and within populations, and a lack of examples on which to base methodological approaches.49
Different rates of resistance were explored in sensitivity analysis.
Results
This analysis found that clean multiple-use non-coated catheters are the most cost-effective type of
intermittent catheter. Although gel reservoir catheters were found to be slightly more effective than
clean non-coated catheters, they were associated with a much greater cost. Dividing the incremental
cost by the incremental effectiveness results gives a cost-effectiveness ratio of £51,345 per QALY
gained. This value far exceeds the £20,000 per QALY threshold set by NICE. By taking into account the
standard error of each model input, probabilistic analysis revealed that clean multiple-use non-
coated catheters are the most cost-effective option in 99.6% of model iterations.
In patients who are unable to use clean non-coated catheters, gel reservoir catheters were found to
Update 2012
be the most cost-effective option, at approximately £3,270 per QALY gained. Compared to
hydrophilic catheters, gel reservoir catheters are most cost-effective in 84.2% of model iterations.
In both scenarios, hydrophilic catheters were found to be slightly less effective than gel reservoir
catheters. They are also less costly, although their incremental cost is still much greater than the cost
of clean non-coated multiple-use catheters. Therefore, hydrophilic catheters are excluded from the
further considerations due to extended dominance. Single-use non-coated catheters were found to
be slightly less effective and more costly than multiple-use non-coated catheters. They are therefore
said to be ‘dominated’ by the more effective, less costly alternatives under consideration.
Figure 2: Base case analysis results (probabilistic)

All four comparators Single use catheters only
£50,000 £50,000
Incremental costs (2009/2010)
Incremental cost (2009/2010)
£45,000 £45,000
£40,000 £40,000
£35,000 £35,000
£30,000 £30,000
£25,000 £25,000
£20,000 £20,000 ICER £3, 270
£15,000 £15,000
£10,000 £10,000
ICER £51, 345
£5,000 £5,000
£0 £0
-0.200 0.000 0.200 0.400 0.600 0.800 -0.2 0.0 0.2 0.4 0.6 0.8
Incremental QALYs Incremental QALYs
Legend: Non-coated catheter used multiple times; Non-coated catheter used once only;
Hydrophilic catheter; Gel reservoir catheter.
124
Results for each subgroup are plotted on the incremental cost-effectiveness ratio axis. The non-coated multi-use catheter is
the least costly strategy and has been used as the baseline comparator. Therefore, it is plotted at the axis. The slope of the
line is the ICER.
Table 52: Base case analysis results (probabilistic)

Total Incremental Incremental Probability
Catheter Total cost QALYs cost* QALYs* ICER CE
In cases where non-coated catheters can be washed and reused
Non-coated used £11, 984 11.896 Baseline Baseline Baseline 99.6%
multiple times
Hydrophilic £38, 883 12.005 £26, 899 0.109 ED 0.00%
Gel reservoir £40, 346 12.449 £28, 326 0.552 £51, 345 0.4%
Non-coated used £43, 611 11.882 £31, 627 -0.014 D 0.00%
once only
In cases where non-coated catheters cannot be washed and reused
Hydrophilic £38, 936 12.002 Baseline Baseline Baseline 15.1%
Gel reservoir £40, 391 12.446 £1, 454 0.445 £3, 270 84.2%
Non-coated used £43, 642 11.879 £4, 705 -0.122 D 0.7%
once only
The health gain to individuals using ISC is presented in terms of total and incremental QALYs. Cost is presented as total and
incremental cost per catheter strategy. These values are used to calculate the ICER. Because single-use non-coated catheters
are less effective and more expensive than non-coated catheters used multiple times, they are said to be dominated and are
eliminated from further analysis. Similarly, hydrophilic catheters are excluded by extended dominance. QALYs = quality
adjusted life years; ICER = incremental cost-effectiveness ratio; ED = extended dominated; D = dominated; CE = cost-effective
at a threshold of £20,000.
Update 2012
*Incremental costs and QALYs are calculated compared to the option with the lowest cost – non-coated multiple-use
catheters and hydrophilic catheters, respectively.
Scenario and sensitivity analyses
Intermittent self-catheterisation (ISC) in patients with bladder dysfunction not due to spinal cord
injury
A separate set of probabilities and utilities was collected in order to run a scenario analysis for
patients with bladder dysfunction that is not caused by SCI. Assuming that each type of catheter
exhibits the same relative efficacy in this population, the conclusion of this scenario analysis is the
same as that for patients with SCI: where it is possible to wash and re-use non-coated catheters (in
this population gel reservoir catheters are associated with a cost of £149, 559 per QALY gain and so
do not represent an efficient use of NHS resources); however, when re-use of non-coated catheters
is not an option, gel reservoir catheters represent the most cost-effective option. In both cases,
single-use non-coated catheters are excluded from the analysis by dominance and hydrophilic
catheters by extended dominance.
Urethral complications
When the relative risk of urethral complications associated with each type of coated catheter is
reduced to zero and the cost of complications is doubled (i.e. hydrophilic catheters prevent 100% of
urethral complications and those that occur with the use of other catheter types are twice as
expensive as assumed in the base case), the conclusion of the analysis is unchanged. This is true
regardless of whether or not multiple-use non-coated catheters are considered an option.
Antimicrobial resistance
The conclusions of the model were robust to simultaneously varying the probability of the risk of
treatment failure and multidrug resistant UTI to the upper limit of each input’s 95% confidence
125
interval. This shows that given current understanding of the scope of antibiotic resistance, multiple-
use non-coated catheters are the most cost cost-effective option for ISC.
This analysis did not take into account the dynamic and extremely complex nature of antimicrobial
resistance. Although the GDG sought to use the most current, relevant estimates to inform this
analysis, data about the prevalence and mortality associated with antibiotic resistant UTI is limited
and it is impossible to predict the future of this phenomenon. If the prevalence, clinical and
economic impact of antimicrobial resistance increases beyond the extreme values used in this model,
then the cost-effectiveness of clean intermittent catheterisation in this population may have to be
re-visited.
Number of non-coated catheters used
The number of clean non-coated catheters used per year was varied between an average of 60 per
year (average 5 per month) and 1825 per year (average 5 per day) in a threshold analysis. Clean ISC
ceases to be the most cost-effective option when an average of 208 non-coated catheters is used per
year; this equivalent to approximately 17.3 catheters per month or 4 per week.
Interpretation and limitations
This analysis combines the best available evidence about the costs and consequences of each type of
catheter used for intermittent catheterisation. Based on the results of the model, we can conclude
that the small decrease in symptomatic infections associated with single-use gel reservoir and
hydrophilic catheters is not enough to justify the large increase in the cost of these catheters
compared to multiple-use non-coated catheters. As a result, clean multiple-use non-coated catheters
Update 2012
represent the most cost-effective type of catheter for ISC. This conclusion was robust to a wide range
of sensitivity analyses, including the increased probability of urethral complications that may be
associated with the use of non-coated catheters. However, multiple-use non-coated catheters cease
to be the most cost-effective choice when patients use an average of more than two catheters per
day. Compliance and behaviour are therefore important factors for healthcare workers to consider
when prescribing an ISC regime.
Healthcare workers must also consider other patient-specific situations when deciding which
catheter to prescribe. Under the current decision rule, the recommended treatment is identified as
that with the highest ICER that falls below the cost-effectiveness threshold. Preferences are
incorporated into the cost-utility analysis through the values that are attached to each health state;
these values represent the average weight attached to each health state by the general population
and are assumed to be independent of factors related to the health care process.
The use of societal values creates the potential for conflict where individual patients hold a strong
preference for a particular treatment that is not reflected in the decision made at the societal level.26
It has been suggested that one way to incorporate individual patient preference into cost-
effectiveness decisions would be to adopt a two-part decision process which gives the patient the
choice of the most cost-effective treatment plus all cheaper options.77
Of the five RCTs included in our review of clinical efficacy, three included a measure of patient
preference and comfort; none found any difference between catheter types. Nevertheless, it is still
possible that patients may find one type of catheter more comfortable or easier to use than another
and therefore derive a benefit from the catheter that is not captured in the model.76 When deciding
between gel reservoir and hydrophilic catheters for patients who cannot use multiple-use non-
coated catheters, the GDG did not wish to force the consumption of more costly gel reservoir
catheters. If a patient has a strong preference for hydrophilic catheters then the GDG agreed that
they should be able to choose this less costly option.
126
Clinical Question 1. Non-coated vs. hydrophilic vs. gel reservoir catheters
It is unlikely that there is any difference in mean monthly urinary tract infections or
total urinary tract infections at 1 year for hydrophilic coated catheters compared to
non-coated catheters for long-term intermittent catheterisation (MODERATE
QUALITY).
It is uncertain whether there is any difference in patient/helper satisfaction with

catheters and catheter preference for hydrophilic coated catheters compared to non-
coated catheters for long-term intermittent catheterisation (LOW QUALITY).
There is a statistically significant decrease of uncertain clinical importance in the

number of patients with 1 or more urinary tract infection(s) at 1 year with hydrophilic
coated catheters compared to non-coated catheters for long-term intermittent
catheterisation (LOW QUALITY).
There is a statistically significant decrease of uncertain clinical importance in the

number of patients with 1 or more urinary tract infection(s) at 7 weeks for gel
reservoir catheters compared to non-coated catheters for long-term intermittent
catheterisation (VERY LOW QUALITY).
There is a statistically significant increase of uncertain clinical importance in patient

comfort for gel reservoir catheters compared to non-coated catheters for long-term
Update 2012
intermittent catheterisation (VERY LOW QUALITY).
No studies were identified that reported bacteraemia or mortality.
Question 2. Single-use non-coated vs. multiple-use non-coated catheters
It is unlikely that there is any difference in symptomatic urinary tract infections with
clean vs. sterile uncoated catheters for long-term intermittent catheterisation
(MODERATE QUALITY).
It is uncertain whether there is any difference in frequency of catheterisations per

day with clean vs. sterile non-coated catheters for long-term intermittent
No studies were identified that reported bacteraemia, mortality or patient

preference and comfort.
Economic New economic analyses comparing single-use hydrophilic, single-use gel reservoir,
single-use non-coated, and clean multiple-use non-coated catheters found that
washing and re-using non-coated catheters is the most cost-effective option for
intermittent self-catheterisation. In situations where it may not be feasible or
appropriate to wash and reuse non-coated catheters, gel reservoir catheters appear
to be the most cost-effective catheter type. However, if patients prefer hydrophilic
catheters to gel reservoir catheters, they may also be considered cost-effective.
Single-use non-coated catheters are never a cost-effective option for intermittent
self-catheterisation. The conclusion was robust to a wide range of scenario and
sensitivity analyses, including varying the probability and cost of urethral
complications (MINOR LIMITATIONS AND DIRECTLY APPLICABLE).
127
38. Offer a choice of either single-use hydrophilic or gel reservoir

Recommendations catheters for intermittent self-catheterisation. [new 2012]
Relative values of different The GDG considered the most important outcomes to be symptomatic UTIs
outcomes (recurrent and total), patient preference or comfort and mortality. The risk of
long-term complications as a result of childhood UTI was considered the most
important outcome in people under 16. Other outcomes also searched for
were allergic reactions and bacteraemia.
Trade off between clinical Based on the evidence included in the clinical review, different types of
benefits and harms intermittent catheters are associated with slightly different rates of
symptomatic urinary tract infection. Although some of these differences are
statistically significant, all are associated with wide and overlapping confidence
intervals, conferring a degree of uncertainty as to whether the effect is of
clinical significance. The risk ratio for one or more UTIs for hydrophilic vs.
single-use non-coated is 0.80 (95% CI 0.65 – 0.99);35,59 gel reservoir vs. single-
99
use non coated is 0.33 (95% 0.11 – 0.97); and multiple-use non-coated vs.
single-use non-coated is 0.98 (95% 0.77 – 1.25).79,134
Although there was a statistically significant increase in scores for comfort
using gel reservoir catheters compared to single-use non-coated catheters,99 it
is uncertain if this is clinically important as the scores are un-validated. No
difference was reported between hydrophilic and single-use non-coated
catheters;59,193,254 and there was no evidence for single-use non-coated
compared to multiple-use non-coated catheters in terms of patient comfort or
preference.
Update 2012
A probabilistic model was constructed to take into account the uncertainty
surrounding the relative efficacy of each catheter at preventing infection, the
cost of each type of catheter regime, the cost of catheter-associated
infections, and quality of life associated with catheter-associated urinary tract
infection.
The GDG considered that there may be situations in which it is difficult for
patients to wash, dry and store multiple-use non-coated catheters, for
example patients with communal washing facilities. On this basis, the GDG
agreed that there are situations in which it is not appropriate for patients to
use multiple-use non-coated catheters. For patients in whom single-use
catheters represent the most appropriate option, the strategy for multiple-use
non coated catheters was removed from the model.
The GDG noted that symptomatic UTI in childhood carries the risk of serious
kidney damage in the long-term. In light of the absence of evidence related to
the use of single- vs. multiple- use non-coated catheters in children, and the
uncertainty surrounding the real lifetime risk of established renal failure as a
result of childhood UTI, the GDG decided to adopt a precautionary approach
when making this recommendation.
The GDG discussed the health economic evidence at length and acknowledged
the model findings. The GDG felt it important to reflect the strength of the low
quality clinical evidence in drafting their recommendation for consultation.
They felt it appropriate to recommend that this choice of catheter was
therefore ‘considered’ rather than ‘offered’ in line with advice that is defined
182
in the NICE guidelines manual (2009) for ‘recommendations on interventions
that 'could' be used, i.e. the GDG is confident that the intervention will do
more good than harm for most patients, and will be cost effective’.
The consultation recommendation stated that those patients in residential or
nursing homes should be offered a choice of single-use hydrophilic or gel
128
reservoir catheters and not be offered single-use non-coated catheters. There

may be a higher risk of infections in settings where patients share facilities and
as such the GDG considered that a cautionary approach be followed. The GDG
considered that in residential or nursing homes the healthcare workers care
for many patients during their work and there is consequently a greater risk of
infection and reusable catheters would therefore not be appropriate. The GDG
felt that healthcare workers should consider using single-use intermittent
catheters in this setting.
The GDG discussed the clinical and cost-effectiveness evidence and
acknowledged the model findings. The GDG drafted the recommendation for
consultation which reflected the results of the clinical review and cost-
effectiveness evaluation. This recommendation proposed that non-coated
intermittent catheters for multiple-use be prescribed providing the following
conditions were met: this is considered clinically appropriate after assessment;
the patient is aged 16 years or over; the patient is able to wash and dry
catheters; suitable facilities to wash, dry and store catheters are readily
available; catheterisation is performed by the patient or a close family
member; and the patient is not in a residential or nursing home.
Following stakeholder consultation, the GDG reviewed their recommendation
in light of comments received. Stakeholders expressed concern that it would
not be possible to implement the recommendation due to the single-use logo
on intermittent catheters. Despite legal advice received in advance of
consultation that this recommendation was acceptable, stakeholders were
concerned that the re-use of these items would make practitioners liable for
any catheter-associated infections caused by the multiple-use of a catheter
intended for single-use (see other considerations below). There was also
concern that recommending that patients disregard the single-use symbol for
this device may lead to confusion and safety implications in other areas.
Update 2012
Therefore, it was agreed that this recommendation would be amended for the
final guideline publication, as the GDG feel that too many barriers remain in
practice to achieve successful implementation of the consultation
recommendation at this time.
Multiple-use catheters remain in the clinical and health economic write up of
this guideline and were considered by the GDG when developing the
consultation recommendation.
Reusing a device labelled as single-use in this context is considered similar to
making an “off label” recommendation where robust clinical and cost-
effectiveness evidence is required. The GDG noted that although the results of
the cost-effectiveness evaluation suggest that multiple-use catheters are the
most cost effective option for ISC, the model was based on low or very low
quality clinical evidence.
In addition to concerns regarding the single-use symbol, two other areas
(frequency of catheter change and cleaning and drying of catheters for reuse)
which were not included within the scope of this update were highlighted as
relevant to the implementation of this recommendation. Further work is
required in future updates of this guidance to clarify some of the 2003
recommendations related to catheters. For example, the original 2003
recommendations state that ‘catheters should be changed only when clinically
necessary or according to manufacturer’s current recommendations [2003]’,
but the GDG are aware that manufacturer’s instructions vary. This is also the
case with the recommendation that states ‘reusable intermittent catheters
should be cleaned with water and stored dry in accordance with the
manufacturer’s instructions [2003]’. As such the GDG feel it important at this
time to remove the recommendation about cleaning and storing reusable
catheters from this update, to minimise confusion in practice.
A research recommendation has been made to gain higher quality clinical
evidence in this area (see section 10.12). If the results of additional research
129
support the conclusions reached by the current clinical and cost-effectiveness

evaluation, then the use of non-coated catheters for multiple-use represents a
significant cost saving to the NHS.
Economic considerations This section reports directly the development and findings of the health
economic model that informed the consultation recommendation.
Based on the results of the original economic model developed for this update
review, gel reservoir catheters are associated with an incremental cost per
QALY gain of £51, 345. Because this exceeds the NICE cost-effectiveness
threshold of £20, 000 (and given that hydrophilic catheters and single-use non-
coated catheters are excluded by extended dominance and dominance,
respectively), clean multiple-use non-coated catheters are the most cost-
effective type of intermittent catheter. This conclusion was robust to a wide
range of sensitivity analyses, including exploratory analysis surrounding the
issue of urethral trauma and strictures. The base case model assumed that
patients use an average of five catheters per month (1.2 per week). When a
threshold analysis was run for this parameter, multiple-use non-coated
catheters cease to be the most cost effective option when patients use more
than an average of 17.3 per month (4 per week).
In situations where multiple-use non-coated catheters are not considered a
valid option, gel reservoir catheters may be most cost-effective with an
incremental cost per QALY gain of £3, 270 compared to hydrophilic catheters.
However, not all patients find gel reservoir catheters suitable, so flexibility is
needed to allow the use of hydrophilic catheters in this situation. The NICE
guideline ‘Urinary Tract Infection in Children’181 concluded that it is currently
impossible to accurately establish the risk of long-term complications as a
result of childhood UTI. The GDG considered that given the current level of
understanding of the long-term risks of childhood UTI and the lack of evidence
about quality of life in children with UTI, it would be invalid to attempt to
Update 2012
model this process. The GDG for this partial update agreed with this decision
and noted that none of the studies included in the clinical review which
contained symptomatic UTI as an outcome were conducted in children. Given
the uncertain risk of harm as a result of symptomatic UTI in childhood, the
GDG decided to employ the precautionary principle in their approach to ISC in
children. Therefore, only single-use catheters were considered an option for
ISC in children and modelling was not explicitly undertaken in this population.
Quality of evidence This section reports the clinical evidence that informed the consultation
recommendation.
Two RCTs were identified investigating single-use versus multiple-use non-
coated catheters that were of low to moderate quality. These studies varied in
length of follow up between patients and had unclear randomisation,
allocation concealment and blinding.
Five RCTs and one crossover trial looked at hydrophilic coated or gel reservoir
catheters versus single-use non-coated catheters for intermittent
catheterisation. The quality of the evidence is low to moderate.
Several of the outcomes for this recommendation were imprecise and
although, for example, there is a statistically significant decrease in the
number of patients with 1 or more urinary tract infection at 1 year with
hydrophilic coated catheters compared to non-coated catheters, there is
uncertainty whether this is clinically important because of the wide confidence
intervals for this outcome. The 95% confidence interval for the reduction of
number of patients with 1 or more urinary tract infection ranged from 6 to 268
fewer in the hydrophilic catheter group. It was difficult to interpret the
meaning of the increase in patient comfort score because invalidated tools
were used. For example, it is unclear what it means for patients when the
score for patient comfort increased 2.39 points, 95% CI of 1.29 to 3.49) for
non-hydrophilic gel reservoir catheter compared to non coated catheters, and
130
whether this is of clinical importance.

No clinical evidence was found for multiple versus single-use catheters in
children and adolescents. UTIs were not reported in the single study identified
in children254 which investigated hydrophilic catheters versus non-coated PVC
254
catheters in children (mean age 12 years). This study did suggest that there
is no difference in patient satisfaction between the catheter types although
this evidence was low quality. In the absence of evidence, the GDG made a
consensus recommendation for consultation that people under 16 should not
use non-coated catheters.
Other considerations This section provides detail on the recommendation amended following
consultation.
The GDG were aware that the majority of non-coated intermittent catheters
bear a symbol on their packaging indicating that they are single-use devices.
This symbol means that the manufacturer:
• Intends the device to be used once and then discarded
• Considers that the device is not suitable for use on more than one occasion
• Has evidence to confirm that re-use would be unsafe.
However, the GDG considered this to be contradictory for several reasons:
• Some manufacturers provide instructions for cleaning non-coated
catheters.
• There is no evidence to suggest that re-use of non-coated catheters is
unsafe. On the contrary, the only direct evidence suggests that single-use
non-coated catheters are associated with a non-significant increase in
symptomatic urinary tract infections compared to multiple-use non-coated
catheters.
• The NHS Drug Tariff states that non-coated catheters can be re-used for up
Update 2012
to one week. The GDG did not feel that there was any further evidence that
would support a recommendation on the guidance of frequency of change
of multiple-use catheters outside of the existing drug tariff.
Discussion of these issues informed the GDG’s consultation recommendation
for multiple-use of non-coated intermittent catheters. Following the
stakeholder consultation and the NICE guideline review panel feedback (GRP)
the GDG reviewed their recommendation for non-coated intermittent
catheters for multiple-use and made revisions. The reasons for this are
discussed in the trade off between clinical benefits and harms section above.
If the single-use logo on these intermittent catheters is removed or if higher
quality clinical evidence is published prior to the next scheduled review for
update, then this recommendation may warrant an exceptional update, as
described in the NICE guidelines manual:182 “Exceptionally, significant new
evidence may emerge that necessitates a partial update of a clinical guideline
before the usual 3-year period… This evidence must be sufficient to make it
likely that one or more recommendations in the guideline will need updating in
a way that will change practice significantly.“
In drafting the revised recommendation, the GDG noted the following issues of
importance:
The GDG feel it important to consider privacy and dignity issues when
recommending a type of intermittent catheter and considered issues such as
shared toilets in work places or other public spaces.
The GDG considered that during the healthcare worker’s assessment of the
patient (see recommendation 36), they would discuss the choice of catheter
that would appropriately maintain their patient’s independence and not
restrict their everyday activities.
The GDG thought the patient’s physical ability, including problems with manual
dexterity or mobility, including wheelchair users, should be taken into
131
consideration. Other equality issues such as cognitive and visual impairment

would be taken into consideration prior to selecting an intermittent catheter,
when assessing the patient for type of catheterisation,(see recommendation
36: ‘Following assessment, the best approach to catheterisation that takes
account of clinical need, anticipated duration of catheterisation, patient
preference and risk of infection should be selected’ [2003]).The GDG
acknowledged that patient preference is an important issue and this was
clearly highlighted as an important outcome in the evidence review; and that
recommendation 36 is worded to prompt discussion between clinician and
patient so that they may both decide which type of catheter is best suited to
an individual’s needs and circumstances. Patient preference, clinical
assessment, clinical and cost effectiveness should all be considered when
selecting an intermittent catheter.
Although the results of the economic model indicate that gel reservoir
catheters are more cost effective than hydrophilic, the GDG considered that
patients should be able to choose a less effective, less expensive option if it is
their preference. The GDG have therefore recommended that healthcare
workers ‘offer a choice of single-use hydrophilic or gel reservoir catheters’.
This is in line with the NHS constitution which details that patients “have the
right to make choices about [their] NHS care and to information to support
these choices. The options available to you will develop over time and depend
on your individual needs.”69 The GDG also took this into account when cross
referring to an earlier recommendation about clinician assessment, which
includes patient preference (see recommendation 36).
No evidence was reviewed regarding the frequency of change for non-coated
catheters. The GDG did not feel it was appropriate to make a recommendation
Update 2012
regarding the frequency of change of catheters as this was likely to be
influenced by other factors such as comfort or efficacy which would be
routinely discussed as part of the normal patient-clinician interaction.
Patient compliance was also identified as an important factor when deciding
which type of intermittent catheter to recommend. No clinical evidence was
identified regarding this; however it was felt that this could also form part of
the discussion with the patient regarding clinically appropriate options.
Urinary tract infection in childhood may carry special significance, as discussed
in the Urinary Tract Infection in Children guideline.181 This includes the risks of
acute clinical deterioration and long-term renal damage. Although the vast
majority of children who have a urinary tract infection recover promptly and
do not have any long-term complications, there is a small subgroup at risk of
significant morbidity, including children with congenital abnormalities of the
urinary tract.
The GDG also considered the social impact upon children and young people of
non-coated catheters for multiple-use. Children and young people requiring
intermittent self-catheterisation may have difficulties accessing adequate
facilities to wash, dry and store their catheters. The GDG recognised the
difficulties in ensuring privacy and dignity where shared toilet facilities are
used, such as in schools and colleges. Even where these facilities are provided
and accessed, issues such as peer pressure and embarrassment in schools
could have an adverse impact on the child or young person’s self-esteem, and
potentially reduce compliance with intermittent catheterisation and
appropriate hygiene. The revised recommendation also applies to children.
The GDG have also made a research recommendation in this area, see section
10.12.
132
10.5.2 Review question – long-term indwelling catheters

What is the clinical and cost effectiveness of different types of long-term indwelling urinary catheters
(non-coated silicone, hydrophilic coated, or silver or antimicrobial coated/impregnated) on urinary
tract infections, bacteraemia, frequency of catheter change, encrustations and blockages, mortality,
and patient preference?
One RCT was identified, which investigated hydrophilic catheters compared to silicone elastomer
catheters.32 None of the studies from the previous 2003 guideline met the inclusion criteria for this
review question.
Table 53: Hydrophilic coated vs. silicone catheters for long term indwelling catheterisation –
Clinical study characteristics
Number
of
Mean catheter 1 RCT Serious No serious No serious No serious
time in situ32 limitations(a) inconsistency indirectness imprecision
Encrustations 1 RCT Serious No serious No serious Serious
leading to limitations (a) inconsistency indirectness imprecision(b)
Update 2012
catheter change32
Catheter related 1 RCT Serious No serious No serious Serious
adverse events32 limitations (a) inconsistency indirectness imprecision(b)
Symptomatic UTI 0 RCT
Bacteraemia 0 RCT
Frequency of 0 RCT
catheter change
Mortality 0 RCT
Patient 0 RCT
preference and
comfort
(a) Unclear allocation concealment and selective outcome reporting where full data is not provided.
Table 54: Hydrophilic coated vs. silicone catheters for long term indwelling catheterisation -
Clinical summary of findings
Outcome Hydrophilic Silicone Relative risk Absolute effect Quality
Mean catheter 36 33 - MD 32.91 higher MODERATE
time in situ (15.14 to 50.68 higher)
(days)
Encrustations 11/36 9/33 RR 1.12 33 more per 1000 LOW
leading to (30.6%) (27.3%) (0.53 to 2.36) (128 fewer to 371 more)
catheter change
Catheter related 1/36 7/33 RR 0.13 185 fewer per 1000 LOW
adverse events (2.8%) (21.2%) (0.02 to 1.01) (208 fewer to 2 more)
133
No cost-effectiveness evidence was identified in the previous 2003 guideline.
In the absence of any published cost-effectiveness analyses, current UK catheter and infection-
related costs were presented to the GDG to inform decision making. The GDG were also presented
with the costs and quality of life associated with UTI and UTI-associated complications (see economic
model in Appendix J and K).
Table 55: Cost of long-term indwelling urinary catheters

Foley catheter type Product description Average cost (£)
PTFE coated latex Self-retaining 2-way long-term PTFE coated latex 3.87
connected to 2 litre drainage bag
Non-coated silicone Self-retaining 2-way long-term silicone connected 4.87
to 2 litre drainage bag
Hydrophilic coated silicone Self-retaining 2-way long-term hydrogel coated 4.95
silicone connected to 2 litre drainage bag
Silver coated silicone Self-retaining 2-way long-term silicone hydromer 7.17
Update 2012
coated silver connected to 2 litre drainage bag
Source: Based on average 2010 Supply Chain187 prices.
Abbreviations: PTFE = polytetrafluoroethylene
Clinical There is a statistically significant and clinically important increase in mean catheter
time in situ for hydrophilic catheters compared to silicone catheters for long-term
indwelling catheterisation (MODERATE QUALITY).
It is uncertain whether there is any difference in encrustations leading to catheter

change for hydrophilic catheters compared to silicone catheters for long-term
indwelling catheterisation (LOW QUALITY).
It is unlikely that there is any difference in catheter related adverse events for
hydrophilic catheters compared to silicone catheters for long-term indwelling
No studies identified reported symptomatic urinary tract infections, bacteraemia,

frequency of catheter change, mortality or patient preference and comfort.
Economic No relevant economic studies were identified.
134
39.Select the type and gauge of an indwelling urinary catheter

based on an assessment of the patient’s individual
characteristics, including:
• age
• gender
Recommendations • reason for catheterisation. [new 2012]
Relative values of different Prevention of urinary tract infections was considered the most important
outcomes outcome. Encrustations and blockages were also seen as an important
outcome.
Trade off between clinical The GDG considered the trade off in time involved in selecting an appropriate
benefits and harms catheter and the benefit of increased patient satisfaction. The GDG also
considered the risk of infection if choosing an inappropriate catheter balanced
against the need for patient comfort and choice. The GDG discussed the clinical
and economic evidence, but felt that there was not sufficient evidence to
recommend one type of catheter over another. The GDG discussions centred
Update 2012
around the key factors that would influence choice of catheter in practice and
chose to make a recommendation based on a consensus agreement of these
factors, which are discussed under other considerations.
Economic considerations In the absence of high-quality evidence of effectiveness, there is little on which
to assess the relative cost-effectiveness of different types of long-term
indwelling catheters.
Quality of evidence Only one RCT was identified for types of indwelling catheters. The evidence
was of low to moderate quality. There were serious study limitations (unclear
allocation concealment and selective outcome reporting, where full data was
not provided).
Other considerations Healthcare workers must be competent to assess the need for catheterisation
(see Assessing the need for catheterisation) and select the appropriate
catheter. The factors within the current recommendation are listed in
alphabetical order rather than by order of priority and should not be
considered an exhaustive list.
This list was largely made by GDG consensus and the reasoning behind the
inclusion of each factor is discussed below:
• Age – the length and gauge of the catheter should be appropriate for the
patient. For example, the size should be appropriate for the age or size of
the child.
• Catheter material sensitivity/ allergy – latex-containing catheters are
inappropriate for patients with latex allergies.
• Gender – males and females require catheters of different length.
• History of symptomatic UTI – a previous history of a symptomatic UTI with a
certain type of catheter may influence selection.
• Patient preference/comfort –many patients find that a small catheter gauge
is more comfortable than a large gauge. A larger catheter gauge may be used
if the patient has a specific catheter need.
• Previous catheter history – a previous history of catheter related
135
complications (discomfort or blockage) with a certain type of catheter may

influence selection.
• Reason for catheterisation – the type of catheter should be based on clinical
reason for catheterisation, such as bladder cancer or chronic retention.
outcomes, leads to a more efficient use of NHS resources, promotes patient
choice and means that patients reach critical points in the care pathway more
quickly, see section 4.1.
10.5.3 Is one catheter better than another?

There is some evidence that the balloon material on all silicone Foley catheters has a greater
tendency to “cuff” on deflation than latex catheters, particularly when used suprapubically. Cuffing
can cause distress and injury to patients when the catheter is removed.165 Our systematic review
showed that smaller gauge catheters (12-14 Ch) with a 10 ml balloon minimise urethral trauma,
mucosal irritation and residual urine in the bladder, all factors which predispose to catheter-
associated infection.220,229 A non-systematic review of the literature confirmed this.248 For suprapubic
catheterisation, a 16 Ch gauge catheter is usually preferable to avoid blockage.162 Where there is no
difference in the quality of the catheter, the least expensive option should be used.73
One study280 identified by our systematic review compared the use of catheter valves with a standard
drainage system and found no significant difference in urinary tract infection but a patient
preference for the catheter valve. The Medical Device Agency (now Medicines and Healthcare
products Regulatory Agency) suggests patients need to be assessed for their mental acuity, manual
dexterity, clothing preferences and use of night drainage bags when considering using catheter
valves.164
40.In general, the catheter balloon should be inflated with 10 ml of sterile water in adults and
3-5 ml in children. [2003]
41.In patients for whom it is appropriate, a catheter valve can be used as an alternative to a
drainage bag. [2003]
136
10.6 Asepsis
The following question was asked as this was not included in the previous guideline and it was
highlighted by stakeholders during the scoping consultation that where aseptic techniques were
referred to in recommendations the terminology may be out-of-date. Asepsis is also covered in the
PEG and VAD chapters (see chapters 11 and 12).

What is the most clinically and cost effective technique (aseptic technique, non-touch, aseptic non
touch technique or a clean technique) when handling long-term urinary catheters to reduce colony
forming units, urinary tract infections, compliance, MRSA or C. diff reduction and mortality?
Update 2012
No clinical evidence was identified. No clinical evidence was identified in the previous 2003 guideline.
No cost-effectiveness evidence was identified. No cost-effectiveness evidence was identified in the

The GDG decided not to make any new recommendations or to change any other specific
recommendations in this chapter relating to aseptic or clean techniques. Also see recommendations
in section 10.7.1.1.
137
10.7 Catheter Insertion

10.7.1 Catheterisation is a skilled procedure
Principles of good practice, clinical guidance270,284 and expert opinion74,75,131,141,247 agree that urinary
catheters must be inserted using sterile equipment and an aseptic technique. Expert opinion
indicates that there is no advantage in using antiseptic preparations for cleansing the urethral
meatus prior to catheter insertion.93,139 Urethral trauma and discomfort will be minimised by using an
appropriate sterile, single-use lubricant or anaesthetic gel. The insertion of urinary catheters by
healthcare workers who are competent in the procedure will minimise trauma, discomfort and the
potential for catheter-associated infection.75,93,141,270
With regard to self-catheterisation, our systematic review found that in a study examining the safety
of clean versus sterile intermittent catheterisation in male adults aged 36-96 years, no significant
differences were found in infection rates, time to first infection or number of episodes.79 A
systematic review identified three controlled trials regarding the benefits of sterile or “non-touch
techniques” for intermittent catheterisation vs. conventional clean intermittent catheterisation.239
Data “neither supports nor refutes the need to utilize sterile, as opposed to clean, intermittent
catheterisation.” Economic analysis suggests that clean intermittent catheterisation is unlikely to
lead to additional infections and the additional cost of sterile catheterisation is unlikely to be
justified.79,274
42.All catheterisations carried out by healthcare workers should be aseptic procedures. After
types of procedures. [2003]
43.Intermittent self-catheterisation is a clean procedure. A lubricant for single-patient use is

required for non-lubricated catheters. [2003]
44.For urethral catheterisation, the meatus should be cleaned before insertion of the catheter,
in accordance with local guidelines/policy. [2003]
45. An appropriate lubricant from a single-use container should be used during catheter
insertion to minimise urethral trauma and infection. [2003]
10.8 Catheter Maintenance

10.8.1 Leave the closed system alone!
Maintaining a sterile, continuously closed urinary drainage system is central to the prevention of
catheter-associated infection.75,101,141,261,270,284 The risk of infection reduced from 97% with an open
system to 8-15% when a sterile closed system was employed as standard practice.93,100,139 However,
breaches in the closed system such as unnecessary emptying of the urinary drainage bag or taking a
urine sample increase the risk of catheter-related infection and should be avoided.139,208,270 Hands
must be decontaminated and healthcare workers should wear clean, non-sterile gloves before
manipulation.
Reflux of urine is associated with infection and, consequently, best practice suggests catheters are
secured to avoid trauma and drainage bags should be positioned in a way that prevents back-flow of
138
urine.75,270 Expert opinion also recommends that urinary drainage bags should be supported in such a
way that prevents contact with the floor.139 For night drainage, a link system should be used to
maintain the original closed system, i.e., a bag attached to the end of the day system.249
Drainable urinary drainage bags should be changed in line with the manufacturer’s
recommendations, generally every 5-7 days, or sooner if clinically indicated, e.g. malodorous or
damaged. Bags that are non-drainable should be used once, e.g., overnight, and emptied before
disposal.
46.Indwelling catheters should be connected to a sterile closed urinary drainage system or

catheter valve. [2003]
47.Healthcare workers should ensure that the connection between the catheter and the urinary
drainage system is not broken except for good clinical reasons, (for example changing the
bag in line with manufacturer’s recommendations). [2003]
48.Healthcare workers must decontaminate their hands and wear a new pair of clean, non-
after removing gloves. [2003]
49.Patients managing their own catheters, and their carers, must be educated about the need
for hand decontamination ii before and after manipulation of the catheter, in accordance
with the recommendations in the standard principles section (chapter 6.). [2003, amended
2012]
50.Urine samples must be obtained from a sampling port using an aseptic technique. [2003]
51.Urinary drainage bags should be positioned below the level of the bladder, and should not
be in contact with the floor. [2003]
52.A link system should be used to facilitate overnight drainage, to keep the original system
intact. [2003]
53.The urinary drainage bag should be emptied frequently enough to maintain urine flow and
prevent reflux, and should be changed when clinically indicated. [2003]
10.8.2 Appropriate maintenance minimises infections
10.8.2.1 Meatal cleansing with antiseptic solutions is unnecessary
One systematic review considered six acceptable studies that compared meatal cleansing with a
variety of antiseptic/antimicrobial agents or soap and water.211 No reduction in bacteriuria was
demonstrated when using any of these preparations for meatal care compared with routine bathing
or showering. Expert opinion75,139,284 and another systematic review229 support the view that vigorous
meatal cleansing is not necessary and may increase the risk of infection. Washing the meatus with
soap and water during daily routine bathing or showering is all that is needed.
ii
The text ‘Patients managing their own catheters, and their carers, must be educated about the need for hand
decontamination…’ has replaced ‘Carers and patients managing their own catheters must wash their hands…' in the
2003 guideline.
139
54.The meatus should be washed daily with soap and water. [2003]
10.9 Do bladder instillations or washouts reduce catheter associated

symptomatic urinary tract infections?
The terminology regarding bladder instillations, irrigations and washouts can be confusing. Bladder
irrigation refers to the continuous introduction of a sterile fluid into the bladder for the purpose of
draining blood and debris; bladder instillation refers to the introduction of a sterile fluid into the
bladder and leaving it there for a variable period of time in order to dissolve encrustations, alter
bladder pH, or suppress bacterial growth; bladder washout refers to the introduction of a sterile fluid
which is allowed to drain immediately for the purpose of diluting bladder contents or unblocking an
obstruction. Bladder irrigation is not performed in primary and community settings and is therefore
outside the scope of this guideline. However, in the literature the term ‘irrigation’ is sometimes used
to refer to what is actually an instillation. Therefore, the term ‘irrigation’ was included as a search
term to ensure that studies in which the terminology may have been confused were identified. These
papers were also reviewed by a GDG member to ensure that only studies reporting on bladder
instillations were included.
Update 2012
What is the clinical and cost effectiveness of bladder instillations or washouts on reduction of
catheter associated symptomatic urinary tract infections and encrustations and blockages?
Four studies were identified. The terms instillations, washouts and irrigations were not defined or
used consistently in the studies. The studies have been categorised into those that compare one type
of washout to another and those that compare a washout to no washout.
One randomised crossover trial, which was included in the previous guideline, compared saline,
Solution G (active ingredients: citric acid, magnesium oxide and sodium bicarbonate) and Solution R
(active ingredients: citric acid, magnesium carbonate and gluconolactone)133 instillations/washouts
twice a week. One RCT compared saline and acetic acid instillations/washouts twice a week.269 One
RCT compared Solution G and saline instillations/washouts once a week to no instillation/washout.173
One randomised crossover trial compared saline once a day to no instillation/washout.176
Only one study133 from the previous 2003 guideline met the inclusion criteria for this review
question.
See Evidence Tables G.5.3, Appendix G, Forest Plots in Figure 43-59, Appendix I.
140
Comparison of solutions for instillation/washout
Table 56: Solution G vs. saline washout (twice a week) – Clinical study characteristics
Number
of
Catheter 1 RCT Serious No serious No serious Serious
blockage limitations(a, b) inconsistency indirectness imprecision(c)
133
Partially 1 RCT Serious No serious No serious Serious

(a, b) (c)
blocked limitations inconsistency indirectness imprecision
catheter
133
Catheters not 1 RCT Serious No serious No serious Serious

(a, b) (c)
encrusted limitations inconsistency indirectness imprecision
133

removal/ limitations(a, b) inconsistency indirectness imprecision(c)
replacement
133
Update 2012
Symptomatic 0 RCT
UTI
Bacteraemia 0 RCT
Mortality 0 RCT
Patient 0 RCT
preference
and comfort
(a) Crossover trial. Allocation concealment and blinding not reported
(b) Randomised catheters rather than patients, therefore patients were included in the study more than once.
(c) Wide confidence intervals crossing MID. This makes it difficult to know the true effect size for this outcome.
Table 57: Solution G vs. saline washout (twice a week)- Clinical summary of findings
Outcome(a) Solution G Saline Relative risk Absolute effect Quality
Catheter blockage 14/29 18/44 RR 1.18 74 more per 1000 LOW
(48.3%) (40.9%) (0.7 to 1.98) (123 fewer to 401 more)
Partially blocked 12/29 14/44 RR 1.3 95 more per 1000 LOW
catheter (41.4%) (31.8%) (0.71 to 2.4) (92 fewer to 445 more)
Catheters not 3/29 12/44 RR 0.38 169 fewer per 1000 LOW
encrusted (10.3%) (27.3%) (0.12 to 1.23) (240 fewer to 63 more)
Catheter removal/ 14/84 16/84 RR 0.88 23 fewer per 1000 LOW
replacement (16.7%) (19%) (0.46 to 1.68) (103 fewer to 130 more)
(a) Catheters outcomes reported per number of catheters rather than number of study participants
141
Table 58: Solution R vs. saline washout (twice a week) – Clinical study characteristics
Number
of
Catheter blockage 1 RCT Serious No serious No serious Serious
133 limitations(a, inconsistency indirectness imprecision(c)
b)
Partially blocked 1 RCT Serious No serious No serious Serious

(a,
catheter133 limitations inconsistency indirectness imprecision(c)
b)
Catheters not 1 RCT Serious No serious No serious Serious

encrusted133 limitations(a, inconsistency indirectness imprecision(c)
b)
Catheter removal/ 1 RCT Serious No serious No serious Serious

replacement
133 limitations(a, inconsistency indirectness imprecision
(c)
b)

Bacteraemia 0 RCT
Update 2012
Mortality 0 RCT
Patient preference 0 RCT
and comfort
(a) Crossover trial. Allocation concealment and blinding not reported.
Table 59: Solution R vs. saline washout (twice a week) - Clinical summary of findings
Outcome(a) Solution R Saline Relative risk Absolute effect Quality
Catheter 7/27 18/44 RR 0.63 (0.31 to 151 fewer per LOW
blockage (25.9%) (40.9%) 1.31) 1000 (from 282
fewer to 127 more)
Partially blocked 10/27 (37%) 14/44 RR 1.16 (0.6 to 2.24) 51 more per 1000 LOW
catheter (31.8%) (from 127 fewer to
395 more)
Catheters not 10/27 (37%) 12/44 RR 1.36 (0.68 to 2.7) 98 more per 1000 LOW
encrusted (27.3%) (from 87 fewer to
464 more)
Catheter 14/84 16/84 (19%) RR 0.88 (0.46 to 23 fewer per 1000 LOW
removal/ (16.7%) 1.68) (from 103 fewer to
replacement 130 more)
(a) Catheters outcomes reported per number of catheters rather than number of study participants.
142
Table 60: Solution G vs. solution R washout (twice a week) – Clinical study characteristics
Number
of
Catheter 1 RCT Serious(a, b) No serious No serious Serious
blockage133 inconsistency indirectness imprecision(c)
Partially blocked 1 RCT Serious(a, b) No serious No serious Serious
133 (c)
catheter inconsistency indirectness imprecision
Catheters not 1 RCT Serious(a, b) No serious No serious Serious
133 (c)
encrusted inconsistency indirectness imprecision
Catheter 1 RCT Serious(a, b) No serious No serious Serious
removal/ inconsistency indirectness imprecision(c)
133
replacement
Bacteraemia 0 RCT
Mortality 0 RCT
Patient 0 RCT
Update 2012
preference and
comfort
(a) Crossover trial. Allocation concealment and blinding not reported.
Table 61: Solution G vs. solution R washout (twice a week) - Clinical summary of findings
Outcome(a) Solution G Solution R Relative risk Absolute effect Quality

Catheter 14/29 7/27 RR 1.86 223 more per 1000 LOW
blockage (48.3%) (25.9%) (0.89 to 3.9) (29 fewer to 752 more)
Partially 12/29 10/27 RR 1.12 44 more per 1000 LOW
blocked (41.4%) (37%) (0.58 to 2.15) (156 fewer to 426 more)
catheter
Catheters not 3/29 10/27 RR 0.28 267 fewer per 1000 LOW
encrusted (10.3%) (37%) (0.09 to 0.91) (33 fewer to 337 fewer)
Catheter 14/84 14/84 RR 1 0 fewer per 1000 LOW
removal/ (16.7%) (16.7%) (0.51 to 1.97) (82 fewer to 162 more)
replacement
(a) Catheters outcomes reported per number of catheters rather than number of study participants.
143
Table 62: Acetic acid vs. saline washout (twice a week) – Clinical study characteristics
Number
of
Symptomatic 1 RCT Serious No serious No serious Serious
UTI269 limitations(a, b) inconsistency indirectness imprecision(c)
Adverse 1 RCT Serious No serious No serious Serious
269 (a, b) (c)
effects limitations inconsistency indirectness imprecision
Encrustations 0 RCT
and blockages
Bacteraemia 0 RCT
Mortality 0 RCT
Patient 0 RCT
preference and
comfort
Encrustations 0 RCT
and blockages
(a) Randomised non-controlled trial. Sequence generation not clear and allocation concealment not reported.
(b) Blinding not clear.
Table 63: Acetic acid vs. saline washout (twice a week) - Clinical summary of findings
Outcome Acetic acid Saline Relative risk Absolute effect Quality
Update 2012
Symptomatic UTI 6/30 (20%) 1/29 (3.4%) RR 5.8 166 more per 1000 LOW
(0.74 to 45.26) (9 fewer to 1526 more)
Adverse effects 1/30 (3.3%) 0/29 (0%) RR 2.9 0 more per 1000 LOW
(0.12 to 68.5) (0 fewer to 0 more)
Table 64: Solution G vs. saline washout (once a week) – Clinical study characteristics
Number
of
Symptomatic 1 RCT Very serious No serious No serious Very serious
UTI173 limitations inconsistency indirectness imprecision(c)
(a)(b)
Mean time to 1 RCT Very serious No serious No serious Very serious

first catheter limitations inconsistency indirectness imprecision (c)
(a)
change
(weeks)173
Encrustations 0 RCT
and blockages
Bacteraemia 0 RCT
Mortality 0 RCT
Patient 0 RCT
preference and
comfort
Encrustations 0 RCT
and blockages
(a) Open label study. Blinding not possible due to nature of sterile packaging.
144
(b) 2-3 patients in each group did not complete data collection due to self reported UTI and initiation of antibiotic
treatment, but none met study criteria for symptomatic UTI.
(c) Very low number of patients in each study arm, likely to be underpowered.
Table 65: Solution G vs. saline washout (once a week) - Clinical summary of findings
Outcome Solution G Saline Relative risk Absolute effect Quality
Symptomatic UTI 0/17 (0%) 0/16 (0%) not pooled N/A VERY
LOW
Mean time to 17 16 - MD 0.43 lower VERY
first catheter (2.32 lower to 1.46 LOW
change (weeks) higher)
Comparison of solutions for instillation/washout vs. no instillation/washout
Table 66: Solution G (once a week) vs. no washout – Clinical study characteristics
Number
of
Update 2012
UTI173 limitations (a) inconsistency indirectness imprecision (b)
first catheter limitations (a) inconsistency indirectness imprecision (b)
change
(weeks)173
Encrustations 0 RCT
and blockages
Bacteraemia 0 RCT
Mortality 0 RCT
Patient 0 RCT
preference
and comfort
(a) Open label study - blinding not possible due to nature of sterile packaging
(b) Very low number of patients in each study arm, likely to be underpowered.
Table 67: Solution G (once a week) vs. no washout - Clinical summary of findings
No
Outcome Solution G washout Relative risk Absolute effect Quality
Symptomatic UTI 0/17 (0%) 0/20 (0%) not pooled not pooled VERY LOW
Mean time to first 17 20 - MD 0.2 higher (1.58 VERY LOW
catheter change lower to 1.98 higher)
(weeks)
145
Table 68: Saline washout (once a week) vs. no washout – Clinical study characteristics
Number
of
UTI173 limitations inconsistency indirectness imprecision(c)
(a, b)

first catheter limitations inconsistency indirectness imprecision(c)
(a)
change
173
(weeks)
Encrustations 0 RCT
and blockages
Bacteraemia 0 RCT
Mortality 0 RCT
Patient 0 RCT
preference and
comfort
(a) Open lable study - blinding not possible due to nature of sterile packaging.
(b) 2-3 patients in each group did not complete data collection due to self reported UTI and initiation of antibiotic
treatment, but none met study criteria for symptomatic UTI.
(c) Very low number of patients in each study arm, likely to be underpowered.
Table 69: Saline washout (once a week) vs. no washout - Clinical summary of findings
Update 2012
Saline
Outcome washout No washout Relative risk Absolute effect Quality
Symptomatic UTI 0/16 (0%) 0/20 (0%) not pooled N/A VERY
LOW
Mean time to 16 20 - MD 0.63 higher VERY
first catheter (1.28 lower to 2.54 LOW
change (weeks) higher)
Table 70: Saline washout (once a day) vs. no washout – Clinical study characteristics
Number
of
replacement limitations(a, b, c) inconsistency indirectness imprecision
per 100 days of (d)
catheterisation
176
Encrustations 0 RCT
and blockages
Bacteraemia 0 RCT
Mortality 0 RCT
Patient 0 RCT
preference and
comfort
Symptomatic 0 RCT
UTI
(a) Crossover trial. Sequence generation and allocation concealment not clear.
146
(b) 23 patients participated in full duration of trial, but 32 patients (crossover and partial crossover patients) included in
analysis.
(c) Blinding not reported.
(d) Wide confidence intervals crossing MID. This makes it difficult to know the true effect size for this outcome.
Table 71: Saline washout (once a day) vs. no washout - Clinical summary of findings
No
Outcome Saline washout Relative risk Absolute effect Quality
(a) (a)
Catheter replacement per 5.5 4.7 N/A N/A LOW
100 days of catheterisation N = 32 N = 32
(a) Value not estimated as SD not reported.
No cost-effectiveness evidence was identified in the previous 2003 guideline.
In the absence of any published cost-effectiveness analyses, the current UK cost of bladder
instillations and washouts, nurse time, and catheter-related infections were presented to the GDG to
inform decision making.
Table 72: Cost of bladder instillation and washout solutions

Solution Dose Average cost (£)
3.23% Citric Acid 100 ml 3.35
Update 2012
6.00% Citric Acid 100 ml 3.35
0.9% Saline 100 ml 3.26
Sterile water 100 ml 3.30
Source: NHS Drug Tariff 2010186; Infection-related costs – see economic model in Appendix J. Acetic acid (used in the
included clinical trials) was not identified in either the BNF or NHS Drug Tariff and was therefore not included in this table.
Clinical It is uncertain whether there is any difference between saline, Solution G or

Solution R washout (twice a week) for catheter encrustations, catheter blockage and
catheter removal or replacement (LOW QUALITY).
It is uncertain whether there is any difference between saline and acetic acid (twice a
week) for symptomatic UTI or adverse effects (LOW QUALITY).
It is uncertain whether there is any difference between saline washout and Solution
G (once a week) and no washout for symptomatic UTI and mean time to first
catheter change (VERY LOW QUALITY).
It is uncertain whether there is any difference between saline washout (daily) and no
washout in the number of catheter replacements per 100 days of catheterisation
(VERY LOW QUALITY).
No studies were identified that reported bacteraemia, mortality and patient

preference or comfort.
Economic No evidence of the cost-effectiveness of instillations or washouts was identified.
147
There is little cost difference between different types of solutions. It is more

expensive (in terms of solution cost and nurse time) to use an instillation or washout
than to not use an instillation or washout.
55.To minimise the risk of blockages, encrustations and catheter-

associated infections for patients with a long-term indwelling
urinary catheter:
• develop a patient-specific care regimen
• consider approaches such as reviewing the frequency of
planned catheter changes and increasing fluid intake
Recommendations • document catheter blockages. [new 2012]
Relative values of different The number of symptomatic UTIs was considered the primary outcome of
outcomes interest. Catheter replacement/frequency of catheter change, encrustations,
and blockages were also considered important outcomes.
Trade off between clinical The GDG considered a trade off between the potential for
benefits and harms instillations/washouts to reduce the incidence of blockages and encrustations
and the increased risk of infection associated with breaking a closed system.
The GDG considered the potential for increased fluid intake to reduce
encrustations, blockages and UTIs, and the risk of fluid overload (i.e. excessive
fluid consumption) that may occur as a result of patients being encouraged to
increase fluid intake.
Update 2012
The GDG considered that the use of bladder instillations and washouts as a
prophylactic measure to prevent infections was not appropriate. After careful
consideration, the GDG acknowledged that there is insufficient evidence to
make a recommendation regarding the use of instillations and washouts to
minimise the risk of blockages and encrustations.
Economic considerations The GDG considered the cost of bladder instillation and washout solutions as
well as the nurse time needed to perform these procedures. They also took
into account the cost and QALY loss associated with UTIs, risk of fluid overload,
and the resource use associated with catheter changes resulting from
encrustations and blockages.
The GDG thought that performing bladder instillations and washouts is likely to
lead to an increase in infections due to the risk associated with breaking a
closed system. It is also more expensive to administer an instillation or
washout than to not administer an instillation or washout. Instillations and
washouts are therefore very unlikely to be cost-effective as a prophylactic
measure to prevent infections.
The GDG thought that taking the time to develop patient-specific care plans,
reviewing the frequency of planned catheter changes, and encouraging an
increase in fluid intake would likely be a more cost-effective use of nurse time.
Quality of evidence This recommendation was based on GDG consensus, as the evidence was
deemed poor quality due to study limitations and inconclusive outcomes.
Other considerations The GDG considered approaches other than instillations and washouts that
could be effective in reducing blockages, encrustations and catheter associated
infections. These approaches included the development of patient specific care
regimens, reviewing the frequency of planned catheter changes, and
encouraging increased fluid intake. The GDG considered these approaches to
be good practice for the care of patients using long-term indwelling catheters.
The GDG acknowledged that therapeutic intervention, such as instillations for
patients undergoing chemotherapy, was an area beyond the scope of the
guideline.
148
Patient preference and quality of life were considered important.
56.Bladder instillations or washouts must not be used to prevent catheter-associated

infections. [2003]
10.9.2 Changing catheters

There is no definitive evidence as to the optimal interval for changing catheters in patients
undergoing long-term urinary drainage via either the urethral or suprapubic route. Our search
identified a study which suggested that a higher rate of infection was associated with frequent
catheter changes, though evidence is not definitive.277 Expert opinion suggests changing the catheter
according to the clinical needs of the patient or as recommended by the catheter manufacturer
(usually every 12 weeks).270,284 Our systematic review identified a study that showed if catheter
blockage occurs within a shorter interval, catheters should be changed more frequently to avert a
future clinical crisis.97 An economic analysis suggested that there may be a cost saving in changing a
catheter at six weeks when there is an increased likelihood of blockage (>50%).185
57.Catheters should be changed only when clinically necessary, or according to the

manufacturer’s current recommendations. [2003]
10.10 Use of antibiotics when changing long-term urinary catheters

Antibiotic use when changing indwelling catheters is considered an area of disparity and associated
with mixed views regarding antibiotic resistance and patient safety. This update aims to determine
the need for prophylactic antibiotics and their impact on the reduction of urinary tract infections.

In patients with long-term urinary catheters (more than 28 days), what is the clinical and cost
effectiveness of prophylactic antibiotics (single dose or short course) during catheter change on
reduction of urinary tract infections?
One RCT conducted in elderly patients using an open urinary collecting catheter system and silicone Update 2012
coated catheters was identified.89 No studies from the previous 2003 guideline met the inclusion
criteria for this review question.
Table 73: Antibiotic prophylaxis vs. no treatment - Clinical study characteristics

Number
of
Antibiotic 1 RCT Serious No serious Serious Very serious
resistance89 limitations(a) inconsistency indirectness(b) imprecision(c)
Mortality89 1 RCT Serious No serious Serious Very serious
limitations(a) inconsistency indirectness(b) imprecision(c)
89
Bacteraemia 1 RCT Serious No serious Serious Very serious
(a) (b) (c)
limitations inconsistency indirectness imprecision
149
Number
of
Symptomatic 0 RCT
UTI
Upper UTI 0 RCT
(pylonephritis)
Patient 0 RCT
preference
(a) Randomisation allocation and concealment method not reported. Not double blinded.
(b) The patients in the study were elderly in a home, and used an open urinary collecting catheter system; the antibiotic
prophylaxis used was meropenem (1gm given intravenously 30 minutes prior to catheterisation). Meropenem is a broad
spectrum antibiotic normally reserved as a second line treatment in the UK. It is highly uncertain whether this evidence is
applicable to prophylaxis in the community for UK patients.
(c) Sparse data and confidence intervals crossed MID. Sample size was too small to detect statistical significance for rare
events.
Table 74: Antibiotic prophylaxis vs. no treatment - Clinical summary of findings

IV No
Outcome meropenem treatment Relative risk Absolute effect Quality
Antibiotics 0/36 0/34 Not estimable 0 fewer per 1000 VERY LOW
resistance (0%) (0%) (0 fewer to 0 fewer)
Mortality 1/36 (2.8%) 2/34 (5.9%) RR 0.47 31 fewer per 1000 VERY LOW
(0.04 to 4.97) (56 fewer to 234 more)
Update 2012
Bacteraemia 0/36 0/34 Not estimable 0 fewer per 1000 VERY LOW
(0%) (0%) (0 fewer to 0 fewer)
10.10.2 Cost-effectiveness evidence

No cost-effectiveness evidence was identified. No cost effectiveness evidence was identified in the
From an economic perspective, questions surrounding the use of antibiotic prophylaxis are very
complex. A recent Health Technology Assessment performed a literature search in order to develop a
conceptual evaluative framework for the economic evaluation of policies against MRSA49. Many of
the considerations discussed within this review were relevant to the current question and provided a
useful background for GDG discussions related to the cost-effectiveness of antibiotic prophylaxis for
changing long-term indwelling urethral catheters.
The GDG were also presented with current UK antibiotic and infection-related costs (see economic
model in Appendix J).
Table 75: Cost of antibiotics commonly used for prophylaxis when changing long-term indwelling
urinary catheters
Antibiotic Standard prophylactic dose Cost per dose (£)
Gentamicin 80mg intramuscular 1.48
Ciprofloxacin 20mg x 2 per oral 0.22
Nitrofuratonin 50mg x 4 per oral 0.38
Trimethoprim 200mg x 2 per oral 0.02
186
Source: Drug and dosing data based on expert advice; costs obtained from the NHS Drug Tariff prices.
150
10.10.3 Evidence statements

Clinical It is uncertain whether there are any differences between providing single dose
antibiotics vs. not providing antibiotics in mortality, bacteraemia and antibiotic
resistance when changing urinary catheters (VERY LOW QUALITY).
No studies were identified that reported symptomatic lower UTI, symptomatic upper
UTI, or patient preference.
Economic No evidence comparing the cost-effectiveness of providing antibiotic prophylaxis vs.

not providing prophylactic antibiotics while changing urinary catheters was
identified.
58.When changing catheters in patients with a long-term

indwelling urinary catheter:
• consider antibiotic prophylaxis jj for patients who:
i. have a history of symptomatic urinary tract infection
after catheter change or
ii. experience trauma kk during catheterisation. [new 2012]
Update 2012
Recommendations
Relative values of different Prevention of symptomatic UTI was considered the most important outcome.
outcomes UTI-associated mortality, bacteraemia and pylonephritis or upper UTIs were
also considered important outcomes.
Trade off between clinical Symptomatic UTI carries the risk of serious complications such as bacteraemia
benefits and harms and death. There is a clear clinical benefit to be gained from the prevention of
symptomatic UTI in patients with long-term indwelling catheters. However, the
risk of using antibiotics as a form of prophylaxis is that it may lead to an
increase in resistance to that drug which, in turn, may reduce the available
treatments for patients with clinical infections in the future.
Antibiotics also carry a risk of adverse reaction in individual patients.
The recommendation was based on GDG consensus as the strength of
evidence was insufficient to indicate an overall benefit from routine antibiotic
prophylaxis.
Economic considerations Assessing the cost-effectiveness of antibiotic prophylaxis is very complex.
Within the past decade there has been a large increase in the prevalence of
multi-drug resistant UTIs in the community. The use of antibiotics is
undoubtedly a factor in this phenomenon. There is a need to consider the
potential economic consequences across the patient population rather than
simply considering the cost-effectiveness for individuals. However, predicting
the development of antibiotic resistance within individuals and between
populations is an area characterised by extreme uncertainty.
The GDG thought that is likely that the effect of antibiotic prophylaxis on
antibiotic resistance will depend on the extent of usage. Given the high cost
and QALY loss associated with UTI and UTI-associated complications, the GDG
thought that among patients at higher risk of UTI during catheter change, and
the low cost of a single dose of antibiotics, prophylactic antibiotic use for
indwelling catheter change would likely be cost-effective. Given the long-term
jj
indication. Informed consent should be obtained and documented.
kk
151
risks to the patient and the population associated with antibiotic resistance,
the GDG decided that the routine use of antibiotic prophylaxis would likely
represent an inefficient use of resources.
Quality of evidence The evidence was of very low quality; any estimates of effect sizes obtained
were highly uncertain. Only one small RCT conducted in elderly patients using
an open urinary collecting catheter system and silicone coated catheters was
identified. This study had serious limitations. There was serious imprecision
and indirectness of the population (i.e. applicability to the guideline
population), type of intervention used (meropenem, which is normally a
second-line therapy antibiotic) and type of catheterisation used in the study.
This recommendation is based on GDG consensus and input of expert advisors
on the interpretation of the evidence.
Other considerations The GDG considered the opinion of the microbiologist expert advisor who
worked with the GDG to interpret the evidence and provide advice on the
current practices in this area.
Although there was no evidence of effectiveness for short course/single dose
antibiotic prophylaxis, the GDG thought that antibiotics may be considered in
certain groups (where there is a high risk of UTI or the consequences of
complications from UTI are particularly high).
The GDG felt that in these groups, the potential benefit of risk reduction from
antibiotic prophylaxis may outweigh the potential disadvantages associated
with its use.
• Both groups are at an increased risk of getting UTI during catheter change.
The numbers needed to treat in order to prevent infections in this group
Update 2012
may be lower if their baseline risks are higher. This would tip the balance
of benefits vs. harms to favour considering antibiotics.
• Prophylactic antibiotics are normally offered as a single dose (and very
rarely, as a short course). Adequate efforts to ensure appropriate use and
good adherence may be helpful to minimise the risk of bacterial
resistance.
For these groups, the concerns about patient safety were paramount.
There is no existing widely accepted definition of “trauma” from repeated or
difficult catheterisation. The definition provided (frank haematuria following
catheterisation or two or more attempts of catheterisation) is formed by GDG
consensus, with expert input, and intended to capture the concern that
traumatic catheterisation led to tissue damage which could increase the risk of
infection becoming systemic.
The GDG also discussed patients with a high risk of bacteraemia, such as
immunosuppressed patients, and that they could also be considered for
antibiotic prophylaxis.
The choice of antibiotics has not been specified because resistance patterns
could vary based on locality and over time. It is assumed that clinicians will
follow local guidance and prescribe an effective antibiotic with the lowest
acquisition cost unless otherwise indicated.
None of the antibiotics are licensed for single dose or short course prophylaxis
of urinary tract infections when changing long-term urinary catheter. It is
important to fully inform patients about the advantages and disadvantages of
using antibiotics for their individual circumstances, and the importance of fully
adhering to the antibiotic prophylaxis regimen to reduce the risk of bacterial
resistance. Patients should be asked their preference and to consent on the
course of antibiotic prophylaxis prescribed.
Other linked recommendations:
Prophylaxis against infective endocarditis: antimicrobial prophylaxis against
infective endocarditis in adults and children undergoing interventional
152
procedures CG 64 (http://guidance.nice.org.uk/CG64).
The GDG have also made a research recommendation in this area, see section
10.12.
implementation as they consider that it has a high impact on outcomes that
outcomes and leads to a more efficient use of NHS resources, see section 4.1.
10.11 Areas for Further Research

In developing the recommendations we identified several areas that were inadequately addressed in
the literature. The following recommendations for research are therefore made.
Assessing the need for catheterisation
Epidemiological studies of the prevalence and incidence of bacteriuria/clinical urinary tract infection
during long-term catheterisation in different populations and different care settings. These should at
least encompass the predominant populations; older people and those with neurological deficits in
both institutional and domiciliary settings. There needs to be clear definition of the ‘cases’ and the
populations from which they are drawn.
Catheter drainage options
Randomised controlled trials of different approaches to urinary drainage. These should compare
urethral indwelling catheterisation with and without a drainage bag (i.e., a valve); urethral
intermittent catheterisation; suprapubic catheterisation; penile sheath drainage and incontinence
pads in appropriate populations. Outcome measures need to include rates of bacteriuria/clinical UTI;
tissue damage; patient/carer satisfaction; and cost-benefit.
Randomised controlled trials of the efficacy of antimicrobial impregnated urethral catheters for long-
term use.
Catheter maintenance
Randomised controlled trials of strategies to reduce/prevent/manage encrustation and blockage.

These need to determine whether catheter maintenance solutions (washouts/installations) are
effective in reducing encrustation; blockage; urethral trauma; frequency of catheter replacement;
and interventions/visits by healthcare practitioners. The rates of these complications when catheter
valves are used in place of drainage bags also needs to be compared.
Cohort studies to determine whether monitoring of urinary pH can be used to predict time to
blockage. These need to be undertaken in defined and representative groups.
Randomised controlled trials to establish the optimum time interval between changing equipment.
There is a particular need to determine whether the frequency of changing leg bags or catheter
valves influences the rates of bacteriuria/clinical UTI.
153
10.12 Research Recommendations

3. For patients performing intermittent self-catheterisation over the long term, what is the
clinical and cost effectiveness of single-use non-coated versus single-use hydrophilic versus
single-use gel reservoir versus reusable non-coated catheters with regard to the following
outcomes: symptomatic urinary tract infections, urinary tract infection-associated bacteraemia,
mortality, patient comfort and preference, quality of life, and clinical symptoms of urethral
damage?

Long-term (more than 28 days) intermittent self-catheterisation is performed by many people living
in the community. It is important that the choice between intermittent catheters is informed by
robust evidence on clinical and cost effectiveness.
The cost-effectiveness model developed for this guideline combined evidence of clinical
effectiveness, costs and quality of life with respect to symptomatic urinary tract infection and
associated complications. The results of the analysis showed that reusable non-coated catheters
were the most cost-effective option for intermittent self-catheterisation. However, the clinical
evidence informing this model was of low to very low quality. Currently, non-coated catheters are
considered to be single-use devices. In order to make an ‘off-licence’ recommendation for the use of
these catheters, better quality evidence is needed.
Update 2012
A four-arm randomised controlled trial is required. The trial population should be diverse, including
wheelchair users, people with spinal cord injuries and people over 16 who regularly self-catheterise.
The primary outcome measures should be incidence of symptomatic urinary tract infections, urinary
tract infection-associated bacteraemia, mortality, patient comfort and preference, quality of life,
clinical symptoms of urethral damage, and costs.
4. For patients using a long-term indwelling urinary catheter, what is the clinical and cost
Long-term indwelling catheters (both urethral and suprapubic) are commonly used in both hospital
and community care settings. Long-term catheterisation carries a significant risk of symptomatic
urinary tract infection, which can lead to more serious complications. Several different types of
impregnated and hydrophilic long-term indwelling catheters on the market claim to be more
effective than non-coated catheters, but are also more expensive.
The clinical evidence review for the guideline revealed an absence of evidence for the effectiveness
of indwelling catheters over the long-term. A comparison of impregnated (for example, with silver)
catheters, hydrophilic catheters and silicone catheters is needed. The primary outcome measures
should be symptomatic urinary tract infections, encrustations, blockages, cost/resource use and
quality of life. Secondary outcome measures should include the mean number of days the catheter
remains in situ (mean dwell time) and patient comfort.
154
5. When recatheterising patients who have a long-term indwelling urinary catheter, what is the
clinical and cost effectiveness of single-dose antibiotic prophylaxis in reducing symptomatic
urinary tract infections in patients with a history of urinary tract infections associated with
catheter change?
The immediate clinical and economic impact of urinary tract infection is so great that patients at risk
Update 2012
of infection are sometimes offered the option to receive prophylactic antibiotics. However, the
widespread use of antibiotics, including their prophylactic use, has been identified as a major factor
in the increasing levels of antibiotic resistance observed across England and Wales. There is currently
an absence of evidence about the short-term and long-term effects of prophylactic antibiotic use
during catheter change. The GDG identified this as an important area for research to establish the
benefits and harms of this practice in order to develop future guidance (the recommendation on this
topic in the current guideline was based on GDG consensus).
A randomised controlled trial or cohort trial to compare single-dose antibiotic prophylaxis with
selected major antibiotic groups is needed. The primary outcome measures should be symptomatic
urinary tract infection, cost and quality of life. This is an important area for patients as it could
minimise the inappropriate use of antibiotics.
155
Enteral feeding
11 Enteral feeding
11.1 Introduction
• aseptic techniques
• care of the enteral feeding tube.
Asepsis was considered as a priority to be included in this update as this area was not included in the
previous guideline. The previous guideline did refer to aseptic techniques in the recommendations,
but the terminology was considered to be incorrect or out-of-date by the scoping group. This area
was also highlighted many times by various stakeholders during the scoping consultation as an area
that should be included in the scope. The use of syringes (single-use syringes vs. single patient use
(reusable) syringes) was also highlighted during the scoping phase as an area for update.
No new evidence was found, however changes were made to recommendations in section 11.4.2.3
and 11.5.2.4.
Update 2012
No new review questions are included in this chapter.
The GDG recognised that hand decontamination is an important part of enteral feeding. See chapter
6 for further details.

• preparation of storage feeds
• administration of feeds
• care of the insertion site.
In addition the GDG acknowledge that Medical Device Regulations169 implement the EC Medical
any EC member state. The GDG noted that guidance on the MHRA's adverse incident reporting
system is available for reporting adverse incidents involving medical devices.168
Once enteral feeding (EF) in hospital became common practice in the late 1980s, it was inevitable
that those requiring prolonged feeding would continue this treatment at home. Enteral feeding is
usually prescribed for patients in hospital requiring artificial nutrition support (ANS) for 7-10 days
and long-term feeding/home enteral tube feeding (HETF) may be considered for patients needing
ANS for more that 30 days.8 HETF has expanded rapidly and by the end of 2000, 11,817 adult patients
receiving HETF were registered with the British Artificial Nutrition Survey (BANS).82 Of these, 46.5%
were over 70 years of age. Over 60% of the patients were receiving tube feeds because of disorders
of the central nervous system, of which cerebral vascular accident accounted for 34%. It was
reported that over half the adult patients and virtually all children starting home enteral feeding lived
in their own home and 40% of adults lived in nursing homes.
Nutrition Support Teams (NST) are recommended to support patients receiving artificial nutrition.82
However, only 22% of NST stated that they were responsible for HETF and 47% stated that they were
never responsible.82 In addition, only one third felt that they had sufficient time to train patients on
156
Enteral feeding
HETF prior to discharge from hospital. It is therefore not surprising that enteral feeding places a
growing workload on community healthcare workers158 and an audit of patients on HETF highlighted
a need for continuing support.142 Contamination of feeds is a key concern in HETF as it has been
found that more than 30% of feeds in hospital and home are contaminated with a variety of
microorganisms, largely due to the preparation or administration of feeds,10 and this has been linked
to serious clinical infection.203 The rates of contamination are highest in home settings and reinforces
the need for infection prevention guidelines.10
Despite searching for infection prevention measures associated with nasogastric and jejunostomy
feeding, most of the evidence related to gastrostomy or percutaneous endoscopic gastrostomies
(PEG feeds). Although these guidelines have been developed for gastrostomy feeding, the Guideline
Development Group felt that most of these principles could also be applied to other feeding systems.
These guidelines apply to adults and children over 1 year old and should be read in conjunction with
the guidance on Standard Principles. These recommendations are broad principles of best practice
and are not detailed procedural protocols. They need to be adapted and incorporated into local
practice guidelines. The recommendations are divided into four distinct interventions:
1. Education of patients, their carers and healthcare workers
2. Preparation and storage of feeds
3. Administration of feeds
4. Care of insertion site and enteral feeding tube.
11.2 Education of patients, carers and healthcare workers

Although not a specific question for our systematic review, it has become evident from our research
that the responsibility for preparing and administering HETF lies usually with the patient, their carers
and in some cases, community healthcare workers. An audit of the nursing knowledge of
percutaneous endoscopic gastrostomy (PEG)126 of hospital nurses in a district general hospital
identified gaps in their knowledge and management of enteral feeding systems and a similar
situation was noted in the community.276 The BANS survey noted the less than optimum support
people on HETF receive82 despite expert opinion stressing the need for education and training.2,166
Given that nutrition is a key Department of Health patient-focused benchmark for healthcare
practitioners,63 it is of concern that this does not include those receiving artificial nutrition and
consequently support and preparation for these patients is not widely available.
A system known as Hazard Analysis and Critical Control Point (HACCP) is employed widely in the food
industry to highlight areas where food safety may be at risk. The Parenteral & Enteral Nutrition
Group of the British Dietetic Association supports the use of HACCP in enteral feeding to increase
safety and as an educational tool.9
59.Patients and carers should be educated about, and trained in the techniques of hand
being discharged from hospital. [2003]
60.Healthcare workers should be trained in enteral feeding and management of the

administration system. [2003]
61.Follow-up training and ongoing support of patients and carers should be available for the
duration of home enteral tube feeding. [2003]
157
Enteral feeding
11.3 Preparation and storage of feeds

11.3.1 Select the right system
Our systematic review identified two randomised controlled trials, which demonstrated that closed
systems (i.e., sterile prefilled ready-to-use feeds that do not expose feed to the air during assembly)
as available from all major manufacturers, have lower contamination rates than open systems.120,268
The design of the system is also important in order to minimise handling.22,161,275
62.Wherever possible pre-packaged, ready-to-use feeds should be used in preference to feeds

requiring decanting, reconstitution or dilution. [2003]
63.The system selected should require minimal handling to assemble, and be compatible with
the patient’s enteral feeding tube. [2003]
11.3.2 Hygienic preparation of feeds is essential

Hand hygiene is critical and hand decontamination is discussed more fully in Standard Principles
(chapter 6). The International Scientific Forum on Home Hygiene has also published comprehensive
guidance on food preparation and cleanliness in the home.235 Our systematic review identified three
studies11,12,147 concerned with feed preparation. The evidence on the use of gloves is contradictory.
Two studies11,12 suggested that gloves were preferable and one suggested bare hands if properly
decontaminated were acceptable.147 However all three studies linked contamination to the amount
of manipulation a system required and reinforces the guidance above.
Standard principles stress the importance of hand decontamination and expert opinion9,166,242
stresses the need to prepare the work surface and, where necessary the equipment for
reconstituting or diluting the feed. Equipment used for either opening sterile feeds or preparing
feeds should be dedicated for enteral feeding use only. It should be cleaned in a dishwasher or
washed with hot soapy water, rinsed and then dried and stored covered until required. Cooled boiled
water or freshly opened sterile water should be used to prepare feeds in the home.9,278
64.Effective hand decontamination must be carried out before starting feed preparation. [2003]
65.When decanting, reconstituting or diluting feeds, a clean working area should be prepared
and equipment dedicated for enteral feed use only should be used. [2003]
66.Feeds should be mixed using cooled boiled water or freshly opened sterile water and a no-
touch technique .[2003]
11.3.3 Store feeds safely

Expert opinion242 and manufacturers5,91 advise that ready-to–use, prepackaged feeds should be
stored in a clean environment, protected from extremes of temperature. Stock should be rotated to
avoid feeds exceeding their best before date.
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Enteral feeding
Where feeds need to be reconstituted or diluted they can be made up for 24 hours. All feeds not
required for immediate use must be stored in a refrigerator at a temperature not exceeding 4
degrees Celsius and discarded after 24 hours.5,91
67.Feeds should be stored according to manufacturer’s instructions and, where applicable, food
hygiene legislation. [2003]
68.Where ready-to-use feeds are not available, feeds may be prepared in advance, stored in a
refrigerator, and used within 24 hours. [2003]
11.4 Administration of feeds

11.4.1 Minimal handling reduces risk
Four reports,108,147,160,197 which studied enteral feeds delivered in a variety of settings, demonstrated
that the risk of contamination is related to the manipulation of the system and the system design.
This reinforces earlier guidance about selecting a system that requires minimal handling.
When assembling the system, first assess the condition of the connection. A no-touch technique
should be used to connect the feed container to the administration set using the minimum number
of connectors possible. Contact with the patient’s clothes should be avoided when attaching the
administration set to the enteral feeding tube.9
Administering feeds for the maximum time possible reduces handling to a minimum. Sterile ready-to-
hang feeds can be left for a maximum time 24 hours and non-sterile (reconstituted) feeds for 4
hours.9,227 However even closed systems can become contaminated if hands are not adequately
decontaminated.197
Bacterial contamination has been associated with the re-use of feed bags and administration sets.8
One study in a long-term care facility108 suggested that administration set changes could be left up to
72 hours but other studies83,136,227,232 suggested that 24 hours is the maximum time acceptable. Three
experimental, in vitro studies13,109,244 considered the re-use of equipment but none identified a
satisfactory system for disinfecting equipment that might be acceptable in practice. As evidence
suggests re-use is not advisable, the administration system should be considered single-use only and
discarded after each session.
Currently there appears to be a debate on the re-use of single-use syringes used to flush enteral
feeding tubes. Our systematic review found no evidence to either support or refute the reuse of
syringes. The Medicines and Healthcare Products Regulatory Agency’s current guidance is that
medical devices labelled single-use must not be reused under any circumstances and the reuse of
such medical devices has legal implications.167
159
Enteral feeding

The following question was asked to determine which technique should be used when handling PEGs
as this was identified as an area where there is confusion in terminology. The GDG identified
diarrhoea, vomiting, peritonitis and gastrostomy site infection as the primary outcomes of interest.
What is the most clinically and cost effective technique (such as aseptic technique, non-touch
technique, aseptic non touch technique or a clean technique) when handling PEGs to reduce
No clinical evidence was identified in this update. No clinical evidence was identified in the previous
2003 guideline.
No cost-effectiveness evidence was identified in this update. No cost-effectiveness evidence was

identified in the previous 2003 guideline.
Update 2012
69.Use minimal handling and an aseptic technique to connect the
Recommendations administration system to the enteral feeding tube. [new 2012]
Relative values of different The GDG considered diarrhoea, vomiting, peritonitis and gastrostomy site
outcomes infection the most important outcomes for this question. However, no
evidence was identified which reported these outcomes.
Trade off between clinical The GDG recognised the potential for contamination when assembling a
benefits and harms feeding system. Consequently adopting an aseptic technique, in which no key
parts are touched, when assembling the equipment was considered the most
important practice, regardless of how this is achieved. An example of this is
that no open part of the enteral feeding delivery system, feed or enteral tube
should be in contact with the hands, clothes, skin or other non-disinfected
surface.
Economic considerations The GDG did not think that adopting an aseptic technique would be associated
with any additional time or resource requirements.
Quality of evidence No clinical or economic evidence was identified.
Other considerations A minor change was made during the update in that the term ‘no-touch’ was
removed. The GDG noted that this terminology can cause confusion. The GDG
chose the term ‘aseptic technique’ as its preferred option for describing this
approach. It was acknowledged that connecting the administration system to
the enteral feeding tube is a procedure that should be carried out in a manner
that maintains and promotes the principles of asepsis.
See also the sections on asepsis discussed in LTC (section 10.6) and VAD
(section 12.3) chapters.
70.Ready-to-use feeds can be given for a whole administration session, up to a maximum of 24

hours. Reconstituted feeds should be administered over a maximum 4-hour period. [2003]
71.Administration sets and feed container are for single use and must be discarded after each
feeding session. [2003]
160
Enteral feeding
11.5 Care of insertion site and enteral feeding tube

11.5.1 Keep the tube clear
Our systematic review searched for evidence regarding the stoma site as a source of infection.
Although some evidence related to infection immediately after insertion of the first tube, we have
found no evidence relating to infections in a healed stoma.137,253 However, after the stoma site has
healed, usually 10-12 days after placement, no dressings are necessary. Instead the site should be
inspected and cleaned daily, and dried thoroughly. The tube should be rotated 360 degrees regularly
to avoid infections related to ‘buried bumper syndrome’.242
72.The stoma should be washed daily with water and dried thoroughly. [2003]

The following recommendation was prioritised for update to determine the most suitable type of
syringe for flushing enteral tubes. The GDG identified the most important outcomes for the question
as the number of blockages/ tube occlusions and fungal colonisation.
What is the clinical and cost effectiveness of single vs. reusable syringes used to flush percutaneous
endoscopic gastrostomy tubes on reduction of tube blockages, diarrhoea, fungal colonisation,
gastrostomy site infection, peritonitis and vomiting?
2003 guideline.
Update 2012
In the absence of any published cost-effectiveness analyses, current UK syringe and infection-related
costs were presented to the GDG to inform decision making.
Table 76: Cost of single use and single patient use (reusable) enteral syringes
Healthcare professional Cost per syringe (£) Approximate cost per week (£)(a)
Single patient use (reusable) 0.22 0.22
syringe
Single-use syringe 0.16 5.60
(a) Estimate only - based on the assumption that each reusable syringe is used for up to one week and five single use
syringes are used per day.
186
Source: Based on average 2010 NHS Drug Tariff prices.
Possible infections arising from PEG tubes include: fungal colonisation, gastrostomy site infection,
and peritonitis, with symptoms ranging from vomiting and diarrhoea to bloodstream infection and
sepsis. Cost and quality of life implications are potentially large.
161
Enteral feeding
Clinical No clinical studies were identified.
73.To prevent blockages, flush the enteral feeding tube before and
after feeding or administering medications using single-use
syringes or single patient use (reusable) syringes according to
the manufacturer’s instructions. Use:
• freshly drawn tap water for patients who are not
immunosuppressed
• either cooled freshly boiled water or sterile water from a freshly
opened container for patients who are immunosuppressed.
Recommendation [new 2012]
Relative values of different The number of blockages/tube occlusions and fungal colonisation were
outcomes considered to be the key outcomes. Diarrhoea, vomiting, peritonitis and
gastrostomy site infection were also considered to be important outcomes by
the GDG.
Trade off between clinical Single-use syringes and single patient use syringes are both deemed feasible to
benefits and harms use in primary and community care, provided use is in accordance with
Update 2012
manufacturer’s instructions. Although the use of oral/enteral syringes is
associated with a risk of infection, the GDG did not consider there to be a
greater risk associated with one type of syringe compared to the other. In
order to address concerns over immunosuppresed patients, the GDG decided
to highlight the importance of using cooled freshly boiled water or sterile
water from a freshly opened container to reduce the risk of infection in this
highly susceptible group.
Economic considerations The GDG considered the difference in cost between single-use syringes and
single patient use (reusable) syringes. The cost and quality of life associated
with acquiring an infection was also considered. Because there is an absence of
evidence related to the infection rate associated with each type of oral/enteral
syringe, it is not possible to evaluate which type of syringe is most cost
effective. If both are equally effective, then the question becomes one of cost
minimisation and the least costly option should be chosen.
Quality of evidence No clinical or economic evidence was identified. The recommendation was
formulated using GDG expert opinion.
Other considerations Since March 2007 the National Patient Safety Agency (NPSA)184 has advised the
use of clearly labelled ‘oral/enteral syringes’ (popularly known as purple
syringes due to their purple coloured plungers or syringe barrels) for the
oral/enteral administration of liquids to reduce the risk of accidental
parenteral administration. Oral/enteral syringes can be sterile or non sterile
devices and may be for single-use or single patient use.
In the absence of evidence for any of the outcomes for the use of single and
single patient use oral/enteral syringes, the GDG felt that individual patient
characteristics would play a role in this decision and that the choice of syringe
should be assessed on an individual basis taking into account susceptibility to
infection and patient care setting.
The GDG did not think that the type of solution that the tubes were flushed
with should change from the recommendation in the previous guideline.
The GDG considered the wording of the recommendation in the previous
162
Enteral feeding
infection control guideline and felt that restructuring the recommendation

would make the advice for immunosuppressed patients clearer.
The GDG considered that the term ‘immunosuppressed’ included people with
a jejunostomy as the natural protective effect of gastric acid is bypassed when
administering feeds or medication.

In developing the recommendations we identified several areas that were inadequately addressed in
the literature. The following recommendations for research are therefore made.
Although comprehensive data is available on the use of HETF in the United Kingdom, very little
information is documented about enteral feeding practices. Anecdotal reports suggest a wide
variation in practice that may or may not be safe. The use of risk assessment, including HACCP has
been reported as a means of reducing risks but little is known about healthcare workers’ knowledge
and use of risk assessment tools.
Descriptive studies of enteral feeding practices in a range of primary care trusts. This should include
healthcare workers, patients and carers, their preparation to undertake enteral feeding and ongoing
support, availability and use of equipment. Data should also be collected on the incidence of stoma
site infections.
A qualitative study of healthcare practitioners’ understanding and use of risk assessment in practice.
Ideally this should be a series of interviews with a range of healthcare workers about their
knowledge of risk assessment and the tools they use. This could be applied to other areas where risk
assessment is used.
Randomised controlled trials to assess the effectiveness of HACCP in reducing the incidence of
enteral feeding related infection. These should focus on HETF in a variety of settings and involving a
range of patients and healthcare workers.
11.6.1 Preparation and storage of feeds

Epidemiological studies of the incidence of clinical infection associated with reconstituting enteral
feeds for different populations and in different care settings. These should at least encompass the
predominant populations - older people and those with neurological deficits in both institutional and
domiciliary settings and children. There needs to be clear definition of the ‘cases’ and the
populations from which they are drawn.
11.6.2 Administration of feeds

Randomised controlled trials of single-use, single patient use and reusable syringes. Outcome
measures need to include rates of clinical infection, patient/carer satisfaction and cost effectiveness.
Randomised controlled trial comparing the use of cooled boiled water versus sterile water to flush
enteral feeding tubes. Outcome measures need to include rates of clinical infection; patient/carer
satisfaction, and cost effectiveness.
163
Vascular access devices
12 Vascular access devices

12.1 Introduction
• aseptic techniques
• types of dressings
• frequency of dressing change
• decontamination of skin when changing dressings (central and peripheral vascular access devices
(VADs).
• decontamination of inserted catheter ports and hubs before access (central and peripheral VADs).
New review questions included in this chapter are:

• skin decontamination prior to insertion of peripheral VADs
• single versus multiuse vials.

• in line filters
• antibiotic lock solutions
• system anticoagulation.
Update 2012
Community based infusion therapy is an increasingly viable option as technology, treatment regimes
and healthcare policy advances. The various vascular access devices; peripheral cannulae (VAD
inserted into an extremity whereby the catheter tip does not sit in a centrally located vein), midline
catheters and central venous access devices (the catheter sits within a centrally located vein with the
tip residing in the vena cava), provide options that can meet the clinical and lifestyle requirements of
patients. Furthermore, in the community the insertion of peripheral VADs such as cannulae and
midlines is rising. Central lines are not inserted in community settings and therefore have not been
included in the review of evidence for skin decontamination prior to insertion. However, patients in
the community may have long-term central VADs, and therefore all other questions related to
vascular catheter management, such as skin decontamination during dressing changes and type of
dressing and frequency of dressing change, have been updated to reflect this. As a result, the care
and management of both peripheral and central VADs is pertinent.
VADs are one of the most important causes of healthcare acquired infection. Millions of vascular
catheters are used each year, putting large numbers of patients at risk of phlebitis and catheter-
related blood stream infection. The attributable mortality of catheter-related blood stream infections
is approximately 15%, and catheter-related bloodstream infections have been associated with
significant costs.157,266 The aim of this chapter was to review the clinical and cost-effectiveness
evidence for several strategies that have been found to decrease the incidence of catheter-
associated infections. The GDG has prioritised three recommendations in this chapter as key
priorities for implementation, see recommendations 74, 75 and 79.
Note: Since the publication of the guideline in 2003, a newer version of the CDC guideline had been
published.190
164
Two recommendations from the 2003 version of this guideline have been removed in this update
(see Appendix D.10). These deleted recommendations are already covered by recommendations in
the hand decontamination (see 6.3) and PPE (see 7.4) chapters.
Update 2012
In addition the GDG acknowledged that Medical Device Regulations169 implement the EC Medical
any EC member state. The GDG noted that guidance on the MHRA's adverse incident reporting
system is available for reporting adverse incidents involving medical devices.168
12.1.1 Expert review of evidence

These guidelines are primarily based upon an expert review of evidence-based guidelines for
preventing intravascular device-related infections developed at the Centers for Disease Control and
Prevention (CDC) in the United States of America by the Healthcare Infection Control Practices
Advisory Committee (HICPAC).39,191 Using a validated guideline appraisal instrument developed by
the AGREE collaboration,259 three experienced appraisers independently reviewed these guidelines,
taking into consideration supplementary information provided by HICPAC at our request (see
Appendix D.5). We concluded that the development processes were valid and that the guidelines
were: evidence-based; categorised to the strength of the evidence examined; reflective of current
concepts of best practice; and acknowledged as the most authoritative reference guidelines currently
available. They were subsequently recommended as the principal source of evidence for developing
the guidance below.
12.2 Education of patients, carers and healthcare professionals

To improve patient outcomes and reduce healthcare costs, it is essential that everyone involved in
caring for patients with a vascular access device is educated about infection prevention. Healthcare
workers, patients and their carers need to be confident and proficient in infection prevention
practices and to be equally aware of the signs and symptoms of clinical infection and how to access
expert help when difficulties arise. Well-organised educational programmes that enable healthcare
workers to provide, monitor, and evaluate care and to continually increase their competence are
critical to the success of any strategy designed to reduce the risk of infection. Evidence reviewed by
HICPAC consistently demonstrated that the risk for infection declines following the standardisation of
aseptic care and increases when the maintenance of intravascular catheters is undertaken by
inexperienced healthcare workers.191
74.Before discharge from hospital, patients and their carers should be taught any techniques
they may need to use to prevent infection and safely manage a vascular access device ll.
[2003, amended 2012]
75.Healthcare workers caring for a patient with a vascular access devicell should be trained,
and assessed as competent, in using and consistently adhering to the infection prevention
practices described in this guideline. [2003, amended 2012]
76.Follow-up training and support should be available to patients with vascular access
devicesll and their carers. [2003, amended 2012]
ll
165
12.3 Aseptic technique

Asepsis was considered as a priority to be included in this update as this area was not included in the
previous guideline. The previous guideline did refer to aseptic techniques in the recommendations,
but the terminology was considered to be incorrect or out-of-date by the scoping group. This area
was also highlighted many times by various stakeholders during the consultation as an area that
should be included in the scope.

What is the most clinically and cost effective technique (such as aseptic technique, non-touch
technique, aseptic non-touch technique or a clean technique) when handling vascular access devices
to reduce infection related bacteraemia, phlebitis, compliance, MRSA or C. diff reduction and
mortality?
2003 guideline.

Update 2012
77.Hands must be decontaminated before accessing or dressing a

Recommendations vascular access device. [new 2012]
Relative values of different As stated in the hand decontamination recommendation regarding when to
outcomes wash your hands (see section 6.3) the GDG considered the most important
outcomes to be healthcare-associated infections and colony forming units
(CFUs).
Trade off between clinical There is no direct evidence for this recommendation and therefore this
benefits and harms recommendation is based on GDG consensus. Hand decontamination may
reduce the risk of infection. There are no obvious clinical harms to the patient
for conducting this step.
The evidence in section 6.3 shows that there is an increase in hand
decontamination compliance before patient contact with the implementation
of the WHO 5 Moments and with the implementation of the CDC 2002
guideline. Catheter associated UTIs and nosocomial infections per 1000 bed
days were shown to decrease with the implementation of the CDC 2002 and
APIC guidelines, respectively.
Economic considerations Vascular catheter-related infections are associated with a large cost, decreased
quality of life, and high risk of mortality. The GDG agreed that the prevention
of vascular catheter-associated infections is likely to offset the marginal
increase in staff time and product cost associated with compliance to hand
hygiene guidance.
Quality of evidence The evidence is reviewed in section 6.3 of the hand decontamination chapter
for when to decontaminate hands. Four very low quality cohort studies were
identified. The population is indirect (not in community settings) and one study
7
is based in a low income country.
166
In section 6.3, three very low to low quality RCTs were identified comparing
alcohol rubs to hand washing with soap and water. All of these studies were
downgraded for indirectness as they are hospital based and not in community
settings. These studies all had relatively small sample sizes and an imprecise
estimate of effect.
the guidance from the NICE Guidelines Manual (2009).182
The GDG decided to update this recommendation to be consistent with the
evidence reviewed in the hand decontamination chapter and to emphasise the
importance of hand decontamination for VAD management.
The GDG have removed ‘either by washing with an antimicrobial liquid soap
and water, or by using an alcohol handrub’ from the original recommendation.
Although no search was performed for this recommendation, the review
questions in the hand decontamination chapter (see section 6.3) are directly
relevant to this recommendation. The product that should be used to
decontaminate hands is discussed in recommendation 6.3 of the hand
decontamination chapter. Please refer to the hand decontamination chapter
for a detailed explanation of products to use for hand decontamination.
This recommendation is in line with the recommendations in the hand
decontamination chapter and is included in the VAD chapter to emphasise the
importance of hand decontamination. This recommendation is consistent with
the ‘when to wash your hands’ recommendation (see section 6.3), which states
‘decontaminate hands immediately before every episode of direct patient
contact or care’.
Update 2012
This recommendation is also consistent with the WHO 5 moments of hand
hygiene and the potential benefit of this recommendation is the prevention of
infection.
A recommendation from the earlier 2003 guideline was removed following this
update: “Following hand antisepsis, clean gloves and a no-touch technique or
sterile gloves should be used when changing the insertion site dressing’. The
GDG considered that this recommendation was no longer required as it is
already captured in the existing recommendations.
78.An aseptic techniquemm must be used for vascular access

device catheter site care and when accessing the system. [new
Relative values of different The GDG considered bacteraemia, phlebitis and MRSA and C. diff reduction as
outcomes the most important outcomes.
Trade off between clinical None of the outcomes identified as important were reported in the literature.
benefits and harms The aim of all aseptic techniques is to prevent infection. To date, there is no
evidence (RCT or cohort) that one aseptic technique is more clinically or cost-
effective than another.
Economic considerations The GDG considered the cost of staff time, training, equipment, and infections
when making this recommendation. The GDG agreed that any increase in cost
associated with an aseptic technique would likely be outweighed by the
prevention of catheter-associated infections.
The GDG thought that the difference in staff time and resource use between
mm
The GDG considered that Aseptic Non Touch Technique (ANTT™) is an example of an aseptic technique for vascular
access device maintenance, which is widely used in acute and community settings and represents a possible framework
for establishing standardised aseptic guidance.
167
different aseptic techniques is likely to be minimal. Therefore, the most

effective technique will also certainly be the most cost-effective.
Quality of evidence No clinical or economic evidence was identified.
the guidance from the NICE Guidelines Manual (2009).182
Minor changes to this recommendation have been made during this update
based on GDG consensus. The term ‘vascular access device’ has been inserted
to avoid confusion as urinary catheters are also discussed in the guideline. This
addition ensures that this recommendation can be read as a standalone
recommendation.
ANTT™ (www.antt.org.uk) was also added to the footnote of the
recommendation as a possible aseptic technique for VAD maintenance. It was
the opinion of the GDG that standardisation of aseptic techniques would
reduce confusion among healthcare workers and lead to better training about
the principles of asepsis. The GDG considered that ANTT™ is widely used in
acute and community settings and represents a possible framework for
establishing aseptic guidance. The GDG felt that protocols for aseptic
technique could be established in organisational policies to support this
approach but did not feel that a separate recommendation was required.
See also recommendations regarding asepsis discussed in the Long term
urinary catheters and Enteral feeding chapters.
12.4 Skin decontamination prior to insertion of peripheral vascular

access devices
Update 2012
This is a new section added to the guideline as peripheral VADs are inserted in the community.
Central VADs are not inserted in the community and therefore are not within the remit of this
guideline. Care of VAD sites (such as changing dressings), both peripheral and central, is included in
section 12.5.
The following review question was prioritised for update to determine the most effective
decontamination solution for skin decontamination prior to insertion of peripheral vascular access
devices, as it was felt there are more types of decontamination products are available since 2003. In
particular, stakeholders highlighted uncertainty regarding what is the most appropriate
concentration for chlorhexidine gluconate (CHG).

What is the most clinical and cost effective product or solution for decontamination of the skin prior
to insertion of peripherally inserted VADs on catheter tip colonisation, infection related mortality,
frequency of line removal, septicaemia, bacteraemia, local or soft tissue infection and phlebitis?
Three RCTs were found comparing the effectiveness of different antiseptic solutions for the insertion
of peripheral VADs.46,60,243 These studies provide different levels of detail about the type of antiseptic
used, and the descriptions used in this section reflect the information provided in the papers. For
examples, in some comparisons, the type and concentration of alcohol used is specified whereas
others just noted “alcohol”.
168
2% Iodine in 70% alcohol vs. 70% alcohol
Table 77: 2% Iodine in 70% alcohol vs. 70% alcohol – Clinical study characteristics
Number
of
VAD related 1 RCT No serious No serious Serious Serious
phlebitis46,60,243 limitations(a) inconsistency indirectness(b) imprecision(c)
mortality
Septicaemia 0 RCT
VAD related 0 RCT
bacteraemia
VAD related local 0 RCT
infection
Catheter tip 0 RCT
colonisation
VAD line removal 0 RCT
(a) Open label study, but randomisation and allocation concealment methods were clearly reported.
(b) Downgrading for indirectness (population among hospitalised COPD patients receiving prednisolone).
(c) Confidence intervals crossed MIDs.
Table 78: 2% Iodine in 70% alcohol vs. 70% alcohol - Clinical summary of findings
Update 2012
2% iodine in 70% Relative risk
Outcomes 70% alcohol alcohol (95% CI) Absolute risk Quality
VAD related 12/54 6/55 2.04 113 more per 1000 LOW
phlebitis (22.6%) (10.6%) (0.82, 5.04) (20 fewer to 441 more)
0.5% Chlorhexidine gluconate(CHG) in 70% alcohol vs. povidone iodine(PVP-I) and 70% alcohol
Table 79: 0.5% Chlorhexidine gluconate (CHG) in 70% isopropyl alcohol (IPA) vs. povidone iodine
(PVP-I) and alcohol – Clinical study characteristics
Outcomes No of Design Limitations Inconsistency Indirectness Imprecision
studies
VAD related 1 RCT Serious No serious Serious Serious
phlebitis46 limitations
(a)
inconsistency indirectness
(b)
imprecision
(c)
Catheter tip 1 RCT Serious No serious Serious Serious

colonisation46 limitations
(a)
inconsistency indirectness
(b)
imprecision
(c)

mortality
infection
Septicaemia 0 RCT
VAD related 0 RCT

bacteraemia
(a) Number of patients analysed or lost to follow up not reported. Study not blinded because interventions are physically
different.
(b) Large proportion of hospitalised patients in study; actual proportion of inpatients in the study not reported.
(c) Actual numbers of patients with an outcome and number of patients analysed not reported. Only the P values were
reported in for some outcomes and 95% confidence intervals were not available.
169
Table 80: 0.5% Chlorhexidine gluconate(CHG) in 70% isoprophyl alcohol (IPA) vs. povidone
iodine(PVP-I) and 70% alcohol - Clinical summary of findings
70% alcohol PVP-I
0.5% CHG in followed by followed by Relative risk Absolute
Outcome 70% IPA PVP-I 70% alcohol (95% CI) effect Quality
Catheter tip N/R N/R N/R N/R P=0.62 VERY LOW
colonisation (reported by
authors)
VAD related 1.2% 12.5% 9.88% N/R P=0.008 VERY LOW
phlebitis overall
(reported by
authors)
2% Chlorhexidine gluconate (CHG) in 70% isopropyl alcohol (IPA) vs. 70% isopropyl alcohol (IPA)
Table 81: 2% Chlorhexidine gluconate (CHG) in 70% isopropyl alcohol (IPA) vs. 70% isopropyl
alcohol (IPA) - Clinical study characteristics
Number
of
Infection related 1 RCT Serious(a, b) No serious Serious Serious
mortality243 inconsistency indirectness(c) imprecision(d)
VAD related blood 1 RCT Serious(a, b) No serious Serious Serious
bacteraemia243 inconsistency indirectness(c) imprecision(d)
VAD related local 1 RCT Serious(a, b) No serious Serious Serious
infection243 inconsistency indirectness(c) imprecision(d)
Update 2012
Catheter tip 1 RCT Serious(a, b) No serious Serious No serious
colonisation243 inconsistency indirectness(c) imprecision
VAD line removal243 1 RCT Serious(a, b) No serious Serious Serious
inconsistency indirectness(c) imprecision(d)
VAD related 0 RCT
phlebitis
Septicaemia 0 RCT
(a) Methods of randomisation and allocation concealment not reported. Study not blinded because interventions are
physically different.
(b) The paper reported “no evidence of infection found”. Communication with authors clarified that they looked for VAD
related blood stream infection but there were no cases.
(c) Patients were hospitalised and undergoing elective cardiology interventions.
(d) Small sample size – not powered to detect a difference that reaches the minimal important difference.
Table 82: 2% Chlorhexidine gluconate (CHG) in 70% isopropyl alcohol (IPA) vs. 70% isopropyl
alcohol (IPA) - Clinical summary of findings
Outcomes 2% CHG in 70% 70% IPA Relative risk Absolute risk or Quality
IPA (95% CI) mean difference
Infection related 0/91(0%) 0/79 (0%) Not Not estimable VERY LOW
mortality estimable
VAD related 0/91(0%) 0/79 (0%) Not Not estimable
bacteraemia estimable VERY LOW
VAD related local 0/91(0%) 0/79 (0%) Not Not estimable
infection estimable VERY LOW
Catheter tip 18/91(19.8%) 39/79(49.4%) 0.40 (0.25, 296 fewer LOW
colonisation 0.64) (178 to 370 fewer)
VAD line removal 2.3 days 2.2 days Not 0.1 day VERY LOW
(range 1-6 days) (range 1-4 days) applicable
N=91 N=79
170
No cost-effectiveness evidence was identified in the previous 2003 guideline related to this topic.
One cost-effectiveness analysis by Chaiyakunapruk and colleagues (2003)40 was identified in this
update. However, the majority of the studies used to inform clinical effectiveness parameters in this
model had evaluated central VADs; the remainder were either unpublished posters or conference
abstracts. Therefore, this study was excluded.
In the absence of any economic evidence which met inclusion criteria, current UK decontamination
product costs and estimated infection-related costs and quality of life data were presented to the
GDG to inform decision making.
Table 83: Skin decontamination product costs

Decontamination product Total product cost Unit cost
7% Povidone Iodine in aqueous solution £2.50 per 500ml bottle + £0.27 per £0.32(a)
sterile dressing pack
10% Povidone Iodine in aqueous solution £2.50 per 500ml bottle + £0.27 per £0.32(a)
(a)
0.5% Chlorhexidine in 70% isopropyl alcohol £1.94 per 600ml bottle + £0.27 per £0.30
2.0% Chlorhexidine in 70% isopropyl alcohol £71.13 for 200 0.67ml preparations £0.36
187
Source: NHS Supply Catalogue 2010.
(a) Assumes that each application uses approximately 10ml of solution.
Update 2012
Table 84: Peripheral vascular catheter infection-related costs estimates
VAD related infection Cost estimate Note Source
Catheter tip colonisation £7 Based on the cost of a laboratory NHS Reference
culture. Costs71
Site infection/phlebitis £30 to ≥ £1 000 Includes the cost of a GP PSSRU 2010,53
consultation and course of NHS Drug
antibiotics. In some cases a line Tariff,186 expert
change may be necessary, which opinion
would incur a hospital visit and
possible inpatient admission.
Vascular catheter related ≥ £3 000 Based on the cost of an inpatient NHS Reference
blood stream infection admission for septicaemia with Costs,71 expert
intermittent complications plus opinion
the estimated cost of a line
change.
Source: The resource use used to calculate cost estimates was based on the input of the GDG and co-opted expert advisors.
Table 85: Vascular catheter infection-related quality of life estimates

Health state Utility estimate Note Source
Full health 0.80 Quality of life assigned to Marciante 2003157
patients with VADs in the only
identified cost-utility analysis for
venous access devices.
Site infection/phlebitis N/R No estimates of quality of life in N/R
people with VAD site infection or
phlebitis were identified.
171
Health state Utility estimate Note Source

Vascular catheter related 0.66 Based on an estimate of catheter- Halton 2009112
blood stream infection related blood stream
infection/sepsis identified in the
quality of life review undertaken
as part of the intermittent urinary
catheter model.
Source: These values were presented to the GDG as rough estimates only and were not identified systematically.
Clinical It is uncertain whether there is any difference between 2% iodine in 70% alcohol
compared to 70% alcohol in VAD related phlebitis (LOW QUALITY).
None of the studies identified reported infection related mortality, septicaemia, VAD
related bacteraemia, VAD related local infection, VAD line removal and catheter tip
colonisation for 2% iodine in 70% alcohol compared to 70% alcohol.
Update 2012
There was no statistically significant difference in the number of catheter tip
colonisation between 0.5% chlorhexidine gluconate (CHG) in 70% isopropyl alcohol
(IPA) compared to povidone iodine (PVP-I) and alcohol applied one after another
(VERY LOW QUALITY).
There were statistically significant fewer VAD related phlebitis for 0.5% CHG in 70%
IPA compared to PVP-I and alcohol applied one after another (VERY LOW QUALITY).
None of the studies identified reported infection related mortality, septicaemia, VAD
related bacteraemia, and VAD related local infection and VAD line removals for 0.5%
CHG in 70% IPA compared to PVP-I and alcohol applied one after another.
There is a statistically significant and clinically important reduction in catheter tip

colonisation among patients receiving 2% CHG in 70% IPA compared to 70% IPA.
It is uncertain whether there is any difference in infection related mortality, VAD

related blood stream infections, VAD related location infections and VAD related line
removal between 2% CHG in 70% IPA compared to 70% IPA.
None of the studies identified reported septicaemia, VAD related bacteraemia and
VAD related phlebitis for 2% CHG compared to 70% IPA.
Economic No economic studies were included.
172
79.Decontaminate the skin at the insertion site with

chlorhexidine gluconate in 70% alcohol before inserting a
peripheral vascular access device or a peripherally inserted
Recommendations central catheter. [new 2012]
Relative values of different The GDG considered VAD related phlebitis, infection related mortality,
outcomes septicaemia and soft tissue, skin or local infections as the most important and
relevant outcomes to patients. The frequency of VAD line removal and clinician
time involved are also important outcomes.
Trade off between clinical Reducing the risk of infections was considered the priority, balanced against
benefits and harms the very small risk of chlorhexidine hypersensitivity. Compared to alcohol on its
own or povidone iodine applied before or after 70% alcohol, the percentage of
patients with phlebitis seemed to be lower for patients who used 0.5%
chlorhexidine gluconate in 70% alcohol. Compared to alcohol on its own, there
were significantly fewer catheter tip colonisations for 2% chlorhexidine
gluconate in alcohol. Hypersensitivities were not reported in any of the studies
identified.
Economic considerations The GDG considered the greater cost of chlorhexidine solution compared to
alcohol and povidone iodine solution. The GDG agreed based on the limited
clinical evidence and consensus that chlorhexidine is the most effective
solution for the decontamination of skin prior to insertion of peripheral VADs,
and agreed that the cost savings and quality of life gain associated with
preventing VAD related infections would outweigh the incrementally greater
Update 2012
cost of alcoholic chlorhexidine.
Quality of evidence The amount of evidence available was very limited. For each comparison, low
or very low quality evidence from one small RCT was identified. These studies
had serious methodological limitations. In addition, data were collected from
hospitalised patients, and may not be applicable to the community setting.
The GDG reached the recommendation through analysis of the limited and low
quality evidence and consensus. Although the level of uncertainty in the
evidence found is high and it is difficult to conclude that one particular
antiseptic solution is better than another, the trend in the evidence suggests
that chlorhexidine gluconate in alcohol may be more effective than alcoholic
povidone iodine solutions. There is no RCT evidence comparing different
concentrations of chlorhexidine gluconate in alcohol.
Other considerations In the absence of direct comparisons between different concentrations of
chlorhexidine in alcohol it is unclear which is the optimal concentration for the
best balance of efficacy against potential risk of chlorhexidine hypersensitivity.
The GDG noted that this recommendation is consistent with current best
practices of using chlorhexidine gluconate in alcohol.
They also noted that the reduction of microorganisms and residual effect is
greater at higher concentrations of chlorhexidine gluconate. However, the
GDG decided not to specify the concentration of chlorhexidine gluconate in
alcohol in this recommendation having considered the lack of specific evidence
about concentrations. At the time of the development of the guidance, the
GDG were aware that the latest American Healthcare Infection Control
Practices Advisory Committee (HICPAC) guidance from CDC (available from:
http://www.cdc.gov/hicpac/BSI/BSI-guidelines-2011.html)190 had also not
specified the concentration of chlorhexidine gluconate for peripheral venous
catheter insertion but specified that the >0.5% CHG in alcohol used for
peripheral arterial catheter insertion. The GDG felt that the evidence reviewed
as part of this guideline development process did not allow for a more robust
recommendation about concentration to be made at this time. The GDG
173
79.Decontaminate the skin at the insertion site with

chlorhexidine gluconate in 70% alcohol before inserting a
peripheral vascular access device or a peripherally inserted
Recommendations central catheter. [new 2012]
recognised this remains a pertinent issue for clinical practice and as such made
a research recommendation (see section 12.11).
The correct technique and volume of decontamination solution was
considered critical to achieve skin decontamination, see section 6.6.
The GDG also considered the practicality of the different options for skin
decontamination presented by the evidence. Iodine preparation for the
purpose of disinfection is usually in the form of aqueous solution. Therefore,
iodine was considered as not practical in the community because it takes a
longer time to dry than chlorhexidine, has residual staining and there are risks
associated with iodine absorbed through the skin. The expert advisor
(microbiologist) to the GDG noted that iodine preparations stain the skin, and
that this staining may obscure clinical signs of infection present at the catheter
site. The GDG clinical experience was that this staining may obscure the Visual
Infusion Phlebitis (VIP) score, and this would be unsatisfactory clinically as
evidence of infection could be missed.
The GDG noted that in practice, it is important to recommend the same type of
disinfectant solutions for both decontaminating the skin and also the ports and
hubs. They noted that this could reduce the chance of confusion of which to
solution to use.
The GDG discussed what to use if the patient is allergic to chlorhexidine and
thought that alternatives, including iodine, could be discussed with the patient
Update 2012
taking into account patient history.
implementation as it has a high impact on outcomes that are important to
patients, has a high impact on reducing variation in care and outcomes and
mean patients reach critical points in the care pathway more quickly, see
section 4.1.
12.5 Types of vascular access device dressing

Dressings for peripherally and centrally inserted vascular access devices have been highlighted as an
area for updating as it was considered that more types of dressings are now available for use, since
2003. The following question aims to determine which types of dressing for peripherally or centrally
inserted vascular access device sites is the most effective at preventing healthcare-associated
infections.

What is the clinical and cost effectiveness of dressings (transparent semipermeable, impregnated or
gauze and tape) covering peripherally or centrally inserted vascular access device insertion sites,
including those that are bleeding or oozing, on catheter tip colonisation, frequency of dressing
change, infection related mortality, septicaemia, bacteraemia and phlebitis?
Four RCTs were identified for peripherally inserted VADs.50,124,154,262 Three studies investigated
transparent semipermeable membrane (TSM) dressing vs. gauze and tape, and one study compared
TSM dressings with iodophor antiseptic adhesive vs. gauze and tape.154 No studies from the previous
2003 guideline met the inclusion criteria for this review question.
174
Five RCTs were identified for centrally inserted VADs.25,154,262,279 One study was identified comparing
highly permeable transparent membrane dressings with gauze and tape.25 One study was identified
comparing highly permeable transparent membrane dressings with TSM dressings.279 Three studies
were identified comparing TSM dressings vs. gauze and tape.146,202,241 No studies from the previous
2003 guideline met the inclusion criteria for this review question.
No evidence was found relating to insertion sites that were bleeding or oozing.
See Evidence Table G.7.1-G.7.2, Appendix G, Forest Plots in Figure 65-76, Appendix I.
Clinical evidence for peripherally inserted VADs
Table 86: Transparent semi permeable membrane vs. gauze and tape – Clinical study
characteristics; peripherally inserted VADs
Number of
Catheter tip 2 RCT Serious No serious Serious Serious
colonisation50,124 limitations(a) inconsistency indirectness(b) imprecision(c)
Phlebitis124,154,262 3 RCT Serious No serious Serious Serious
limitations(d) inconsistency indirectness(b) imprecision(c)
Frequency of 0 RCT
dressing change
Mortality 0 RCT
Update 2012
Bacteraemia 0 RCT
(a) Unclear allocation concealment and blinding. Craven 198550 randomised catheter sites rather than patients, therefore
patients were included in the study up to 8 times.
(b) The studies are all hospital based rather than community settings.
154
(d) Unclear allocation concealment and blinding. Maki 1987 randomised catheter sites rather than patients, therefore
patients were included in the study more than once.
Table 87: Transparent semi permeable membrane vs. gauze and tape - Clinical summary of
findings; peripherally inserted VADs
Transparent Gauze and
Outcome dressing tape Relative risk Absolute effect Quality
Catheter tip 42/562 (7.5%) 34/645 (5.3%) RR 1.46 24 more per 1000 VERY LOW
colonisation (0.94 to 2.26) (3 fewer to 66 more)
Phlebitis 64/881 (7.3%) 67/889 (7.5%) RR 0.96 3 fewer per 1000 VERY LOW
(0.69 to 1.34) (23 fewer to 26 more)
Table 88: Transparent semi permeable membrane with iodophor antiseptic vs. gauze and tape –
Clinical study characteristics; peripherally inserted VADs
Number of
154
Phlebitis 1 RCT Serious No serious Serious Serious
Catheter tip 0 RCT
colonisation
Frequency of 0 RCT
dressing change
175
Number of
Mortality 0 RCT
Bacteraemia 0 RCT
(a) Randomised catheter sites rather than patients, therefore patients were included in the study more than once.
Table 89: Transparent semi permeable membrane with iodophor antiseptic vs. gauze and tape -
Clinical summary of findings; peripherally inserted VADs
Transparent
Outcome + antiseptic Gauze and tape Relative risk Absolute effect Quality
Phlebitis 49/498 50/544 RR 1.07 6 more per 1000 VERY LOW
(9.8%) (9.2%) (0.74 to 1.56) (24 fewer to 51 more)
Clinical evidence for centrally inserted VADs
Table 90: Highly permeable transparent membrane vs. gauze and tape – Clinical study
characteristics; centrally inserted VADs
Number
of
Update 2012
Catheter related 1 RCT Serious No serious Serious Serious
sepsis25 limitations(a) inconsistency indirectness(b) imprecision(c)
Exit site 1 RCT Serious No serious Serious Serious
infection25 limitations(a) inconsistency indirectness(b) imprecision(c)
Bacteraemia/ 1 RCT Serious No serious Serious Serious
fungaemia 25 limitations(a) inconsistency indirectness(b) imprecision(c)
Catheter tip 0 RCT
colonisation
Frequency of 0 RCT
dressing change
Mortality 0 RCT
(a) Unclear randomisation, allocation concealment and blinding.
(b) The study is hospital based rather than community settings.
Table 91: Highly permeable transparent membrane vs. gauze and tape - Clinical summary of
findings; centrally inserted VADs
Highly Gauze and
Outcome permeable tape Relative risk Absolute effect Quality
Catheter related 5/48 (10.4%) 1/53 (1.9%) RR 5.52 85 more per 1000 VERY LOW
sepsis (0.67 to 45.59) (6 fewer to 841 more)
Exit site infection 4/48 (8.3%) 2/53 (3.8%) RR 2.21 46 more per 1000 VERY LOW
(0.42 to 11.52) (22 fewer to 397 more)
Bacteraemia/ 3/48 (6.3%) 6/53 (11.3%) RR 0.55 51 fewer per 1000 (96 VERY LOW
fungaemia (0.15 to 2.09) fewer to 123 more)
176
Table 92: Highly permeable transparent membrane vs. transparent semi permeable membrane –
Clinical study characteristics; centrally inserted VADs
Number
of
sepsis 279 limitations(a) inconsistency indirectness(b) imprecision(c)
Catheter tip 0 RCT
colonisation
Frequency of 0 RCT
dressing change
Mortality 0 RCT
Skin infection 0 RCT
(a) Unclear randomisation, allocation concealment and blinding.
Table 93: Highly permeable transparent membrane vs. transparent semi permeable membrane -
Clinical summary of findings; centrally inserted VADs
Highly Semi
Outcome permeable permeable Relative risk Absolute effect Quality
Catheter related 1/51 (2%) 3/50 (6%) RR 0.33 40 fewer per 1000 VERY LOW
Update 2012
Table 94: Transparent semi permeable membrane vs. gauze and tape – Clinical study
characteristics; centrally inserted VADs
Number
of
sepsis241 limitations(a) inconsistency indirectness(b) imprecision(c)
Exit site infection 3 RCT Serious No serious Serious Serious
146,202,241 (a) (b) (c)
Bacteraemia146 1 RCT Serious No serious Serious Serious
Catheter tip 0 RCT
colonisation
Frequency of 0 RCT
dressing change
Mortality 0 RCT
(a) Unclear allocation concealment, blinding and randomisation.
(d) Unclear allocation concealment and blinding.
177
Table 95: Transparent semi permeable membrane vs. gauze and tape - Clinical summary of
findings; centrally inserted VADs
Gauze and
Outcome Transparent tape Relative risk Absolute effect Quality
Catheter related 1/51 (2%) 0/47 (0%) RR 2.77 0 more per 1000 VERY LOW
Exit site infection 6/87 (6.9%) 3/83 (3.6%) RR 1.81 29 more per 1000 VERY LOW
(0.54 to 6.1) (17 fewer to 184 more)
Bacteraemia 1/29 (3.4%) 2/29 (6.9%) RR 0.5 34 fewer per 1000 VERY LOW
(0.05 to 5.21) (66 fewer to 290 more)
12.5.1.2 Cost-effectiveness evidence for peripherally inserted VADs
No economic evidence was identified in the update search. No studies from the previous 2003
guideline met the inclusion criteria for this review question.
This topic was originally identified as a high-priority area for original economic modelling. However,
after reviewing the clinical evidence it was decided that there was insufficient comparative clinical
evidence to inform a cost-effectiveness model. In addition, the GDG did not consider each of the
dressings to represent true alternatives; certain dressings were considered to be more appropriate
for certain clinical indications than others.
In the absence of cost-effectiveness evidence, the GDG were presented with current UK dressing
Update 2012
costs and estimates of infection-related costs (see Table 84) to inform decision making.
Table 96: Cost of dressings for centrally and peripherally inserted VADs
Sterile gauze Transparent Chlorhexidine
(a)
Cost per dressing (£) 0.06 0.97 4.38
Number of dressings per box 5 50 10
Dispensing fee per box (£) 1.95 1.95 1.95
(a) For mid-size dressings measuring approximately 10cm x 12cm (transparent, gauze) or 2.4cm in diameter (chlorhexidine).
186 187
Source: Based on average 2010 NHS Drug Tariff and Supply Chain prices.
12.5.1.3 Cost-effectiveness evidence for centrally inserted VADs
Three studies were identified in the update search. One study was a cost analysis by Crawford et al
(2004)51,51 comparing chlorhexidine dressings to ‘standard’ dressings in patients with central venous
catheters. The other two were RCTs comparing the use of TSM dressings and gauze dressings in
patients undergoing bone marrow transplant241,241 and haemodialysis.146,146
For a list of excluded studies and reasons for exclusion, refer to Appendix L.
Table 97: Chlorhexidine dressing vs. transparent semi permeable membrane dressing - Economic
summary of findings; centrally inserted VADs
51 (a) (b)
Crawford 2004 Potentially serious Partially applicable Central line dressing
Hospital setting
(a) Clinical evidence based on an unpublished, industry funded trial which is not publicly available, time horizon is unclear,
risk of mortality from CRBSI is not accounted for, costs not reported incrementally.
178
(b) Hospital based setting (specific ward and patient population not reported), definition of ‘standard’ dressing unclear and
assumed to refer to transparent dressings, USA hospital perspective, industry funded study.
Table 98: Transparent semi permeable membrane dressing vs. gauze dressing - Economic
summary of findings; centrally inserted VADs
241 (a) (b)
Shivnan 1991 Potentially serious Partially applicable Central line dressing
Bone marrow transplant
patients
Le Corre 2003 146 Potentially serious (c) Partially applicable (d) Central line dressing
Haemodialysis
(a) Cost of infection not accounted for, industry funded study.
(b) Hospital based setting, USA hospital perspective.
(c) Cost of infection not accounted for, industry funded study.
(d) Hospital based setting, Canadian healthcare system perspective.
Table 99: Chlorhexidine vs. transparent - Economic summary of findings; centrally inserted VADs
51 (a)
Crawford 2004 N/R Chlorhexidine N/R Based on a series
dressings were of scenario
associated with fewer analyses, it was
site infections (28.14% estimated that
vs. 45.24%) and chlorhexidine
Update 2012
catheter-related BSI dressings were
(2.37% vs. 6.12%) associated with
£327 to £965
cost savings due
to decreased
infection (b)
(a) Cost of transparent dressing not reported, therefore it was not possible to analyse costs incrementally.
(b) Note that cost of transparent dressings is not reported, therefore it is not possible to determine true incremental costs;
costs adjusted to 2009/10 GBP; four scenario analyses were run in which the cost of treating a blood stream infection
was alternated.
Table 100: Transparent vs. gauze - Economic summary of findings; centrally inserted VADs
241
Shivnan 1991 Transparent dressings Transparent dressings N/A N/A
were £137 less costly in were associated with
terms of dressing a small increase in
materials and nurse local infection (3.9%
time (per patient per 30 vs. 2.1%) and
days) bacteraemia (1.9% vs.
0.0%)
Le Corre 2003146 Transparent dressings Transparent dressings Transparent N/A
were £3.11 less costly were associated with dressings were
(per patient per week) a decrease in local the dominant
infection (3.5% vs. intervention
10.3%) and
bacteraemia (3.5% vs
7%)
179
Table 101: Central vascular catheter infection-related costs estimates

VAD related infection Cost estimate Note Source
Catheter tip colonisation £7 Based on the cost of a laboratory NHS Reference
culture. Costs71
Site infection/phlebitis £3 000 Based on GDG estimate of the Expert opinion
cost of a central line change,
antibiotics and inpatient potential
admission.
Vascular catheter related £9 148 Estimate of the cost of central Hockenhull
123
blood stream infection venous catheter blood stream 2008
infection identified in a recent
HTA
Source: The resource use used to calculate cost estimates was based on the input of the GDG and co-opted expert advisors.
Clinical It is uncertain whether there is any difference in catheter tip colonisation or phlebitis
with transparent semipermeable membrane dressing compared to gauze and tape
for peripherally inserted VADs (VERY LOW QUALITY).
It is uncertain whether there is any difference in phlebitis with transparent
Update 2012
semipermeable membrane with iodophor antiseptic in the adhesive compared to
gauze and tape for peripherally inserted VADs (VERY LOW QUALITY).
It is uncertain whether there is any difference in catheter related sepsis, exit site
infection, bacteraemia/fungaemia with highly permeable transparent membrane
compared to gauze and tape for centrally inserted VADs (VERY LOW QUALITY).
It is uncertain whether there is any difference in catheter related sepsis with highly
permeable transparent membrane compared to transparent semipermeable
membrane dressings for centrally inserted VADs (VERY LOW QUALITY).
It is uncertain whether there is any difference in catheter related sepsis, exit site
infection or bacteraemia with transparent semipermeable membrane compared to
gauze for centrally inserted VADs (VERY LOW QUALITY).
No studies were identified that reported frequency of dressing change or VAD

related mortality.
Economic No studies were identified for peripherally inserted VADs
In patients with centrally inserted VADs, transparent semipermeable membrane

dressings appear to be cost-saving in terms of materials and nursing time
(POTENTIALLY SERIOUS LIMITATIONS AND PARTIAL APPLICABILITY).
Chlorhexidine dressings may be cost-effective compared to transparent

semipermeable membrane dressings (POTENTIALLY SERIOUS LIMITATIONS AND
PARTIAL APPLICABILITY).
180
80.Use a sterile transparent semipermeable membrane dressing

Recommendations to cover the vascular access device insertion site. [new 2012]
Relative values of different Catheter tip colonisation, infection-related mortality, septicaemia, VAD related
outcomes bacteraemia, phlebitis and skin infections were considered to be the most
important outcomes by the GDG.
Trade off between clinical Although the review did not provide evidence of any significant difference in
benefits and harms clinical outcomes, the GDG thought that transparent semipermeable
membrane dressings (TSM) dressings provide a more secure fix compared to
gauze and tape, allowing them to be kept in place for longer, whilst also
allowing staff to inspect the VAD insertion site for signs of infection without
removing the dressing. The GDG noted that gauze dressings provide
absorbency, but do not provide visibility or maintain sterility of the VAD
insertion site. From an equalities perspective, the GDG noted that TSM
dressings are well tolerated in clinical care, including paediatrics and elderly
patients.
Update 2012
Economic considerations The GDG considered the cost of dressings, staff time, and consequences of
infections associated with peripheral and centrally inserted VADs. The GDG
agreed that TSM dressings appear to be less costly and more effective
compared to gauze dressings. In the absence of any evidence to the contrary,
the GDG did not think that compared to TSM dressings chlorhexidine dressings
would be sufficiently effective to justify the greater cost of these dressings in
routine care in the community (the economic study identified for this question
was considered to be of very low quality and not directly relevant to the
community care setting).
Quality of evidence The identified studies were of very low quality. They were downgraded due to:
limitations in study design; indirectness as no community data was identified;
and imprecision due to wide confidence intervals and low event numbers.
No clinical evidence was identified for dressings on bleeding or oozing VAD
insertion sites.
No clinical evidence was identified for silver- or chlorhexidine-impregnated
dressings.
Cost-effectiveness evidence from two low quality studies was considered.
Neither study included all relevant comparators, costs, or outcomes.
Other considerations Dressing adherence and water resistance were considered important issues in
community settings as patients place a high value on being able to conduct
their daily tasks, such as showering and washing. The GDG considered that a
recommendation to use TSM dressings addressed these concerns.
181
81.Consider a sterile gauze dressing covered with a sterile

transparent semipermeable membrane dressing only if the
patient has profuse perspiration, or if the vascular access
device insertion site is bleeding or oozing. If a gauze dressing is
used:
• change it every 24 hours, or sooner if it is soiled and
• replace it with a transparent semipermeable membrane
Recommendations dressing as soon as possible. [new 2012]
Relative values of different The GDG considered VAD related phlebitis as the most important outcome.
outcomes They also considered dressing change or frequency of dressing change,
infection-related mortality, septicaemia, VAD related bacteraemia, phlebitis
and skin infections as important outcomes.
Trade off between clinical The advantage of a gauze dressing is its absorbency, which is required when
benefits and harms the site is oozing or bleeding. The trade offs are that it is more complex to
apply (requires tape over the top), provides less secure fixation of the VAD and
requires more frequent dressing changes than TSM dressings alone. It also
allows less visibility, meaning that a Visual Infusion Phlebitis (VIP) score can
only be undertaken during a gauze dressing change.
Economic considerations In patients with bleeding or oozing insertion sites, the GDG agreed that sterile
gauze dressings represent the only appropriate type of dressing. Under these
circumstances the GDG thought that the use of any other type of dressing
would represent an inefficient use of resources.
Update 2012
Quality of evidence No clinical evidence was identified for dressings on bleeding or oozing VAD
insertion sites or for frequency of gauze dressing changes.
No relevant cost-effectiveness studies were identified.
Other considerations The GDG were aware that skin damage from tape used to hold gauze in place
may be caused, particularly in patients with sensitive or fragile skin. They felt
gauze dressings should be changed to TSM dressings as soon as possible when
there was no bleeding or oozing from the site. Where gauze dressings
continued to be necessary the GDG considered by consensus that they should
be changed at least every 24 hours.
12.6 Vascular access device frequency of dressing change

The following question aims to determine the most appropriate frequency of dressing change for
peripherally or centrally inserted vascular access device sites with the aim of preventing healthcare-
associated infections.

What is the clinical and cost effectiveness of frequency of dressing change (from daily up to 7 days)
on catheter tip colonisation, infection related mortality, septicaemia, bacteraemia and phlebitis?
One RCT was identified for frequency of dressing change that compared semipermeable transparent
polyurethane dressing changed once weekly vs. twice weekly.267 No studies from the previous 2003
guideline met the inclusion criteria for this review question.
182
Table 102: Once weekly vs. twice weekly dressing changes – Clinical study characteristics
Number
of
Positive blood 1 RCT Serious No serious Serious Serious
culture267 limitations(a) inconsistency indirectness(b) imprecision(c)
CVC insertion site 1 RCT Serious No serious Serious Serious
inflammation267 limitations (a) inconsistency indirectness (b) imprecision(c)
Catheter tip 0 RCT
colonisation
Mortality 0 RCT
Phlebitis 0 RCT
(a) Only 58% of the dressing changes were performed to protocol for the intervention (mean interval was 5.4 days, instead
of 7 days) and 80% of the changes were performed to protocol for the control/twice weekly change (with a mean
interval of 3.8 days.
Table 103: Once weekly vs. twice weekly dressing changes - Clinical summary of findings
Once
Outcome weekly Twice weekly Relative risk Absolute effect Quality
Update 2012
Positive blood 8/39 9/42 RR 0.96 9 fewer per 1000 VERY LOW
culture (20.5%) (21.4%) (0.41 to 2.23) (126 fewer to 264 more)
CVC insertion site 10/39 23/42 RR 0.47 290 fewer per 1000 VERY LOW
inflammation (25.6%) (54.8%) (0.26 to 0.85) (82 fewer to 405 fewer)

identified in the previous 2003 guideline. In the absence of any published cost-effectiveness analyses,
current UK dressing costs, staff costs and infection-related cost estimates (Table 84 and Table 101)
were presented to the GDG to inform decision making.
Table 104: Healthcare staff costs

Healthcare professional Cost per home visit (£)
Community health visitor 35
GP practice nurse 13
Community clinical support nurse 9
53,55
Source: PSSRU 2007 .
Clinical There is a statistically significant decrease of uncertain clinical importance in central

venous catheter insertion site inflammation when changing transparent
semipermeable membrane dressings once weekly compared to twice weekly (VERY
LOW QUALITY).
183
It is uncertain whether there is any difference in positive blood cultures when

changing transparent semipermeable membrane dressings once weekly compared to
twice weekly (VERY LOW QUALITY).
No studies were identified that reported catheter tip colonisation, phlebitis or VAD
related mortality.
82.Change the transparent semipermeable membrane dressing

covering a central venous access device insertion site every 7
days or sooner if the dressing is no longer intact or moisture
Recommendations collects under it. [2012]
Relative values of different Catheter tip colonisation, infection-related mortality, septicaemia, VAD related
outcomes bacteraemia, phlebitis and skin infections were considered to be the most
important outcomes.
Trade off between clinical Transparent dressings provide a more secure fix allowing them to be kept in
benefits and harms place for longer, whilst also allowing staff to inspect the VAD insertion site for
Update 2012
signs of infection without removing the dressing. Transparent dressings are
well tolerated in clinical care, including paediatrics and elderly care. One
study267 met the inclusion criteria and identified that longer periods between
dressing changes (a mean interval of 5.4 days vs. 3.8 days) showed a significant
reduction in central venous catheter insertion site inflammation and no
difference in positive blood cultures.
Economic considerations The GDG agreed that less frequent dressing changes would be cost saving in
terms of staff time, resource use, and infection prevention than more frequent
dressing changes.
Quality of evidence Evidence from one RCT was considered, which was of very low quality. This
was downgraded due to: limitations in study design; indirectness as no
community data was identified; and imprecision due to wide confidence
intervals and low event numbers.
No clinical evidence was identified for frequency of dressing changes at
bleeding or oozing VAD insertion sites.
This recommendation was by GDG consensus.
Other considerations Dressing adherence and water resistance were considered important issues in
the community to enable patients to conduct their daily tasks, such as
showering and washing. Therefore, it is important to consider the balance
between maintaining an intact dressing and independence for patients to
perform daily tasks and any impact of frequent nursing care on restriction of
freedom.
184
83.Leave the transparent semipermeable membrane dressing

applied to a peripheral cannula insertion site in situ for the life
of the cannula, provided that the integrity of the dressing is
Recommendations retained. [new 2012]
Relative values of different The GDG considered VAD related phlebitis as the most important outcome.
outcomes They also considered dressing change or frequency of dressing change,
infection-related mortality, septicaemia, VAD related bacteraemia, phlebitis
and skin infections as important outcomes.
Trade off between clinical The advantage of leaving insertion sites intact is that the risk of infection is
benefits and harms reduced. No harms were identified, but dressings that are no longer intact
should be replaced as soon as possible to reduce the risk of infection.
Economic considerations It was the opinion of the GDG that less frequent dressing changes would be
Update 2012
cost saving in terms of staff time, resource use, and infection prevention
compared to more frequent dressing changes.
Quality of evidence No clinical evidence was found for frequency of dressing changes for
peripheral catheters.
Other considerations The GDG discussed that appropriate patient education is needed to ensure
that dressings are not tampered with or picked at in order to minimise the risk
of infection.
The GDG made this recommendation based on consensus opinion as no
evidence was identified. In practice, transparent semipermeable membrane
dressings applied to peripheral cannulae are left on for the life of the cannula;
a 72 hour cut off time is common and extension beyond that requires a robust
clinical rationale. In the absence of any contradictory evidence, the GDG
agreed that this time-limit was appropriate. The GDG noted that the
Department of Health Saving lives: reducing infection, delivering clean and safe
care, peripheral intravenous cannula care bundle 65 also recommends that
cannulae should be replaced in a new site after 72-96 hours or earlier if
indicated clinically.
84.Dressings used on tunnelled or implanted central venous catheter sites should be replaced
every 7 days until the insertion site has healed, unless there is an indication to change
them sooner. [2003]
185
12.7 Decontaminating skin when changing dressings

decontamination solution for skin when changing dressings, as it was felt there are more types of
decontamination products available since 2003. In particular, stakeholders highlighted uncertainty
regarding what is the most appropriate concentration for chlorhexidine gluconate (CHG).

What is the most clinical and cost effective product or solution for skin decontamination when
changing VAD dressings on catheter tip colonisation, infection related mortality, frequency of line
removal, septicaemia, bacteraemia and phlebitis?
What is the most clinical and cost effective duration of application of decontamination
product/solution to the skin prior to insertion of peripherally inserted VAD on catheter tip
colonisation, infection related mortality, frequency of line removal, septicaemia, bacteraemia, local
or soft tissue infection and phlebitis?
Five RCTs which compared the effectiveness of different antiseptic solutions for the decontamination
of skin during dressing changes were found. This included studies conducted in patients receiving
Update 2012
central venous catheters. See Evidence Table G.7.4, Appendix G, Forest Plots in Figure 77-95,
Appendix. The comparisons identified are shown below.
These studies provide different levels of details about the type of antiseptic used, and the
descriptions used in this section reflect the information provided in the papers. For examples, in
some comparisons, the type and concentration of alcohol used is specified whereas others just noted
“alcohol”.
Table 105: Number of RCTs comparing different types of antiseptic solutions

2% CHG in 0.5% CHG in 0.25% CHG in 10% PVP-I in 5% PVP-I in
aqueous alcohol aqueous* aqueous 70%
alcohol
0.5% CHG in 1 264
alcohol
0.25% CHG in None None
aqueous*
155,264 127,264
10% PVP-I in 2 2
aqueous
5% PVP-I in 70% None None 1 172 1 194
alcohol
70% isopropyl 1155 None None 1155 None
alcohol (IPA)
* This aqueous solution contains 0.25% chlorhexidine gluconate, 0.025 benzalkanium chloride, and 4% benzylic alcohol
(Biseptine TM, Bayer).
186
2% Chlorhexidine gluconate (CHG) in aqueous vs. 10% Povidone Iodine (PVP-I) in aqueous
Table 106: 2 % Chlorhexidine gluconate (CHG) in aqueous vs. 10% Povidone Iodine (PVP-I) in
aqueous – Clinical study characteristics
Number
of
VAD related 2 RCT Serious No serious No serious Serious
155,264 (a) (b)
bacteraemia limitations inconsistency indirectness imprecision
264 (a) (b)
septicaemia limitations inconsistency indirectness imprecision
Catheter tip 2 RCT Serious No serious No serious Serious
155,264 (a) (b)
colonisation limitations inconsistency indirectness imprecision
infection
VAD related 0 RCT
phlebitis
mortality
(a) Block randomisation followed by physically different interventions (not blinded) – unclear whether there were adequate
264
allocation concealment methods, randomisation (done per catheter instead of patients) sequence generation and
155
allocation concealment unclear.
(b) Confidence intervals wide- crossed threshold(s) of clinically important harms and benefits.
Update 2012
Table 107: 2% Chlorhexidine gluconate (CHG) in aqueous vs. 10% Povidone Iodine (PVP-I) in
aqueous - Clinical summary of findings
2% CHG in 10% PVP-I
Outcome aqueous in aqueous Relative risk Absolute effect Quality
VAD related 10/425 15/421 RR 0.63 13 fewer per 1000 LOW
bacteraemia(a) (2.4%) (3.6%) (0.29 to 1.41) (25 fewer to 15 more)
septicaemia(a) (8.1%) (9.8%) (0.44 to 1.54) (55 fewer to 53 more)
Catheter tip 135/543 179/556 RR 0.76 77 fewer per 1000 LOW
(a)
colonisation (24.9%) (32.2%) (0.64 to 0.90) (32 fewer to 116 fewer)
(a) Studies reported outcomes per catheter, instead of per patient.
2% Chlorhexidine gluconate (CHG) in aqueous vs. 70% Isopropyl alcohol (IPA)
Table 108: 2% Chlorhexidine gluconate (CHG) in aqueous vs. 70% isopropyl alcohol (IPA) – Clinical
study characteristics
Number
of
bacteraemia155 limitations (a) inconsistency indirectness imprecision (b)
colonisation155 limitations (a) inconsistency indirectness imprecision (b)
VAD related 0 RCT
phlebitis
VAD related 0 RCT
local infection
Infection 0 RCT
related
187
Number
of
mortality
Septicaemia 0 RCT
VAD line 0 RCT
removal
(a) Randomisation sequence generation and allocation concealment methods unclear, randomised per catheter instead of
per patient.
(b) Confidence intervals wide - crossed threshold(s) of clinically important harms and benefits.
Table 109: 2% chlorhexidine gluconate (CHG) in aqueous vs. 70% Isopropyl alcohol (IPA) - Clinical
summary of findings
2% CHG in
70% IPA
Outcome aqueous Relative risk Absolute effect Quality
VAD related 3/227 RR 0.35 9 fewer per 1000 LOW
bacteraemia (a) 1/214 (0.5%) (1.3%) (0.04 to 3.37) (13 fewer to 31 more)
Catheter tip 11/227 RR 0.48 25 fewer per 1000 LOW
colonisation (a) 5/214 (2.3%) (4.8%) (0.17 to 1.36) (40 fewer to 17 more)
2 % Chlorhexidine gluconate (CHG) in aqueous vs. 0.5% CHG in alcohol
Table 110: 2% Chlorhexidine gluconate (CHG) in aqueous vs 0.5% CHG in alcohol - Clinical study
characteristics
Update 2012
Number
of
bacteraemia264 limitations(a) inconsistency indirectness imprecision(b)
septicaemia264 limitations(a) inconsistency indirectness imprecision(b)
colonisation264 limitations(a) inconsistency indirectness imprecision(b)
infection
VAD related 0 RCT
phlebitis
mortality
(a) Block randomisation followed by physically different interventions (not blinded) – unclear whether there were adequate
allocation concealment methods.
(b) Confidence intervals wide - crossed threshold of clinically important harms and benefits.
Table 111: 2 % Chlorhexidine gluconate (CHG) in aqueous vs. 0.5% CHG in alcohol– Clinical
summary of findings
2% CHG in 0.5% CHG
Outcome aqueous in alcohol Relative risk Absolute effect Quality
Catheter tip 130/329 119/339 RR 1.13 46 more per 1000 LOW
(a)
colonisation (39.5%) (35.1%) (0.92 to 1.37) (28 fewer to 130 more)
VAD related 17/211 15/226 RR 1.21 14 more per 1000 LOW
(a)
septicaemia (8.1%) (6.6%) (0.62 to 2.37) (25 fewer to 91 more)
VAD related 9/211 RR 1.07 3 more per 1000 LOW
bacteraemia(a) (4.3%) 9/226 (4%) (0.43 to 2.65) (23 fewer to 66 more)
188
0.5% Chlorhexidine gluconate (CHG) in alcohol vs. 10% Povidone Iodine (PVP-I) in aqueous
Table 112: 0.5% Chlorhexidine gluconate (CHG) in alcohol vs. 10% Povidone Iodine (PVP-I) in
aqueous – Clinical study characteristics
Number
of
bacteraemia127,264 limitations(a) inconsistency indirectness imprecision(b)
VAD related local 1 RCT Serious No serious No serious Serious
infection 127 limitations(a) inconsistency indirectness imprecision(b)
127,264 (a) (b)
VAD related 0 RCT
phlebitis
mortality
Septicaemia 0 RCT
(a) Randomisation sequence generation and allocation concealment methods unclear.
(b) Confidence intervals wide - crossed threshold(s) of clinically important harms and benefits.
Table 113: 0.5% Chlorhexidine gluconate (CHG) in alcohol vs. 10% Povidone Iodine (PVP-I) in
Update 2012
aqueous – Clinical summary of findings
0.5% CHG in 10% PVP-I in
Outcome alcohol aqueous Relative risk Absolute effect Quality
Catheter tip 155/455 185/445 RR 0.82 75 fewer per 1000 LOW
colonisation(a) (34.1%) (41.6%) (0.69 to 0.97) (12 fewer to 129 fewer)
bacteraemia(a) (3.1%) (3.7%) (0.39 to 1.72) (23 fewer to 27 more)
VAD related local RR 0.1 20 fewer per 1000 LOW
infection(a) 0/193 (0%) 4/181 (2.2%) (0.01 to 1.92) (22 fewer to 20 more)
10% Povidone iodine (PVP-I) in aqueous vs. 5% PVP-I in 70% ethanol
Table 114: 10% Povidone iodine (PVP-I) in aqueous vs. 5% PVP-I in 70% ethanol – Clinical study
characteristics
Number
of
bacteraemia194 limitations (a) inconsistency indirectness imprecision(b)
colonisation194 limitations (a) inconsistency indirectness imprecision(b)
VAD related local 1 RCT Serious No serious No serious Serious
194 (a) (b)
infection limitations inconsistency indirectness imprecision
VAD related 0 RCT
phlebitis
mortality
Septicaemia 0 RCT
189
(a) Number of patients randomised into each arm unclear (only reported a total of 125 patients). The denominators
reported in this study are number of catheters, instead of number of patients.
(b) Confidence intervals wide- crossed threshold of clinically important harms and benefits.
Table 115: 10% Povidone iodine (PVP-I) in aqueous vs. 5% PVP-I in 70% ethanol - Clinical
summary of findings
10% PVP-I in 5% PVP-I in
Outcome aqueous 70% ethanol Relative risk Absolute effect Quality
Catheter tip 14/106 RR 2.65 218 more per 1000 LOW
colonisation(a) 41/117 (35%) (13.2%) (1.54 to 4.58) (71 more to 473 more)
VAD related RR 3.62 25 more per 1000 LOW
bacteraemia(a) 4/117 (3.4%) 1/106 (0.9%) (0.41 to 31.91) (6 fewer to 292 more)
VAD related local LOW
infection(a) 0 0 Not pooled Not pooled
(a) The denominators reported in this study are number of catheters, instead of number of patients.
10% Povidone Iodine (PVP-I) in aqueous vs. 70% Isopropyl alcohol (IPA)
Table 116: 10% Povidone iodine (PVP-I) in aqueous vs. 70% Isopropyl alcohol (IPA) - Clinical study
characteristics
Number
Update 2012
of
colonisation155 limitations(a) inconsistency indirectness imprecision(b)
VAD related 0 RCT
phlebitis
infection
mortality
Septicaemia 0 RCT
(a) Randomisation sequence generation and allocation concealment methods unclear.
Table 117: 10% Povidone Iodine (PVP-I) in aqueous vs. 70% Isopropyl alcohol (IPA) - Clinical
summary of findings
10% PVP-I
70% IPA
Outcome in aqueous Relative risk Absolute effect Quality
Catheter tip 21/227 11/227 RR 1.91 44 more per 1000 LOW
colonisation(a) (9.3%) (4.8%) (0.94 to 3.87) (3 fewer to 139 more)
VAD related 6/227 3/227 RR 2 13 more per 1000 LOW
(a)
bacteraemia (2.6%) (1.3%) (0.51 to 7.9) (6 fewer to 91 more)
190
0.25 % Chlorhexidine gluconate (CHG), 0.025% benzalkanium chloride, and 4% benzylic alcohol in
vs. 5% povidone Iodine(PVP-I) in 70% alcohol
Table 118: 0.25 % Chlorhexidine gluconate (CHG), 0.025% benzalkanium chloride, and 4% benzylic
alcohol in aqueous vs. 5% PVP-I in 70% alcohol – Clinical study characteristics
Number
of
172 (a) (b)
172 (a) (b)
phlebitis limitations inconsistency indirectness imprecision
VAD line removal172 1 RCT Serious No serious No serious Serious
(a) (b)
VAD related 0 RCT
septicaemia
Update 2012
infection
mortality
(a) Unit of randomisation is catheter, instead of patient. The study randomised consecutively inserted central venous
catheters, stratified by insertion site in blocks of 8. Allocation concealment potentially compromised.
Table 119: 0.25 % Chlorhexidine gluconate (CHG), 0.025% benzalkanium chloride, and 4% benzylic
alcohol in aqueous vs. 5% povidone iodine (PVP-I) in 70% alcohol – Clinical summary of findings
0.25% CHG 5% PVP-I
mixture in in 70%
Outcome aqueous alcohol Relative risk Absolute effect Quality
Catheter tip 28/242 53/239 RR 0.52 (0.34 106 fewer per 1000 (from LOW
colonisation(a) (11.6%) (22.2%) to 0.8) 44 fewer to 146 fewer)
VAD related 4/242 (1.7%) 10/239 RR 0.4 (0.13 to 25 fewer per 1000 (from LOW
bacteraemia(a) (4.2%) 1.24) 36 fewer to 10 more)
VAD related 64/242 64/239 0.99 [0.73, 268 fewer per 1000 (from LOW
(a)
phlebitis (26.4%) (26.8%) 1.33] 268 fewer to 268 fewer)
VAD line removal 242 239 - MD 0.1 lower (1.74 lower LOW
- mean duration catheters catheters to 1.54 higher)
of catheter
placement(a)
(a) The study randomised and reported outcomes per catheter, instead of per patient.
191
Clinical 2% Chlorhexidine gluconate (CHG) in aqueous vs. 10% povidone iodine

(PVP-I) in aqueous
There is a statistically significant reduction of uncertain clinical importance in

the number of catheter tip colonisation for 2% CHG in aqueous compared to
10% PVP-I in aqueous (LOW QUALITY).
It is uncertain whether there is any difference in number of VAD related

bacteraemia and VAD related septicaemia for 2% CHG in aqueous compared
to 10% PVP-I in aqueous(LOW QUALITY).
None of the studies identified reported VAD related phlebitis, VAD related
local infection, VAD line removal frequency, and infection related mortality
for2% CHG aqueous compared to 10% PVP-I in aqueous.
2% Chlorhexidine gluconate (CHG) in isopropyl aqueous vs. 70% isopropyl

alcohol
It was uncertain whether there is any difference in the number of VAD

related bacteraemia and catheter tip colonisation for 2% CHG in aqueous
compared to 70% isopropyl alcohol (LOW QUALITY).
Update 2012
local infection, septicaemia, VAD line removal frequency, and infection
related mortality for 2% CHG in aqueous compared to 70% isopropyl alcohol.
2% chlorhexidine gluconate (CHG) in aqueous vs. 0.5% chlorhexidine

gluconate (CHG) in alcohol

related bacteraemia, VAD related septicaemia and catheter tip colonisation
for 2% CHG in aqueous compared to 0.5% CHG in alcohol (LOW QUALITY).
local infection, VAD line removal frequency, and infection related mortality
for 2% CHG in aqueous compared to 0.5% CHG in alcohol.
0.5% Chlorhexidine gluconate (CHG) in alcohol vs. 10% povidone iodine

(PVP-I) in aqueous
It was uncertain whether there is any difference in number of VAD related

bacteraemia and VAD related local infection for 0.5% CHG in alcohol
compared to 10% PVP-I in aqueous (LOW QUALITY).
There is a statistically significant decrease of uncertain clinical importance in

the number of patients with catheter tip colonisation for 0.5% CHG in alcohol
compared to 10% PVP-I in aqueous (LOW QUALITY).
None of the studies identified reported VAD related phlebitis, septicaemia,

VAD line removal frequency, and infection related mortality for 0.5% CHG in
alcohol compared to 10% PVP-I in aqueous.
192
10% Povidone iodine (PVP-I) in aqueous vs. 5% povidone iodine(PVP-I) in

70% ethanol

related bacteraemia and VAD related local infection for 10% PVP-I in aqueous
compared to 5% PVP-I in 70% ethanol (LOW QUALITY).
There is a statistically significant and clinically important increase in the

number of patient with catheter tip colonisation for 10% PVP-I in aqueous
compared to 5% PVP-I in 70% ethanol (LOW QUALITY).
None of the studies identified reported VAD related phlebitis, septicaemia,

VAD line removal frequency, and infection related mortality for 10% PVP-I in
aqueous compared to 5% PVP-I in 70% ethanol.
10% Povidone iodine (PVP-I) vs. 70% isopropyl alcohol (IPA)

related bacteraemia and catheter tip colonisation for 10% PVP-I in aqueous
compared to 70% isopropyl alcohol (LOW QUALITY).
Update 2012
local infection, septicaemia, VAD line removal frequency, and infection
related mortality for 10% PVP-I in aqueous compared to 70% isopropyl
alcohol.
0.25% Chlorhexidine gluconate (CHG), 0.025% benzalkanium chloride and

4% benzylic alcohol in aqueous vs. 5% povidone iodine (PVP-I) in 70%
alcohol
It is uncertain whether there is any difference in number of VAD related

bacteraemia or VAD related phlebitis, or in the VAD line removal (measured
as duration of catheter placement) for a proprietary solution containing a
combination of 0.25% CHG and other disinfectants compared to 5% PVP-I in
alcohol (LOW QUALITY).
There is a statistically significant decrease of uncertain clinical importance in

the number of patient with catheter tip colonisation for a proprietary
solution containing a combination of 0.25% CHG and other disinfectants
compared to 5% PVP-I in alcohol (LOW QUALITY).
None of the studies identified reported VAD related local infection, VAD
related phlebitis, VAD line removal frequency, and infection related mortality
for 0.25% CHG and other disinfectants compared to 5% PVP-I in alcohol.
Economic No economic evidence was identified.
193
85.Healthcare workers should ensure that catheter-site care is compatible with catheter
materials (tubing, hubs, injection ports, luer connectors and extensions) and carefully
check compatibility with the manufacturer’s recommendations. [2003]
86.Decontaminate the catheter insertion site and surrounding

skin during dressing changes using chlorhexidine gluconate in
70% alcohol, and allow to air dry. Consider using an aqueous
solution of chlorhexidine gluconate if the manufacturer’s
recommendations prohibit the use of alcohol with their
Recommendations catheter. [2012]
Relative values of different The GDG considered the prevention of infection-related mortality, septicaemia
outcomes and VAD related infections such as septicaemia, bacteraemia and phlebitis as
the most important and relevant outcomes to patients. The frequency of VAD
line removal and clinician time involved are also important outcomes.
Trade off between clinical Reduction of infections was considered against the potential for developing
benefits and harms resistance against decontamination solutions, and costs.
Economic considerations The GDG considered the incremental cost of different decontamination
solutions as well as the cost and quality of life associated with VAD related
infections. The group agreed by consensus that the greater incremental cost of
alcoholic chlorhexidine solution would be justified by a decrease in vascular
catheter related infections.
Quality of evidence There were serious methodological limitations. Only one or two small studies
were found for some comparisons and there is no RCT comparing different
concentrations of chlorhexidine gluconate in alcohol for skin decontamination
Update 2012
during dressing change. These studies were conducted in hospitalised patients,
and may not be applicable to the community setting.
The GDG reached the recommendation through analysis of the limited and low
quality evidence and consensus. Although the level of uncertainty in the
evidence found was high and it is difficult to conclude that one particular
antiseptic solution is better than another, the trend in the evidence suggests
that chlorhexidine gluconate in alcohol may be more effective than alcoholic
povidone iodine solutions. There is no RCT evidence comparing different
concentrations of chlorhexidine gluconate in alcohol.
Among the non-alcoholic solutions reviewed, there was low quality evidence
suggesting that the risk of catheter tip infections for patients using 2%
chlorhexidine gluconate in aqueous was lower than those using 10% PVP-I. It is
uncertain whether there are any differences between 2% CHG aqueous
compared to 10% PVP-I aqueous for VAD related bacteraemia or septicaemia
because of the wide confidence intervals observed.
There was no direct comparison between different concentrations of
chlorhexidine when dissolved in the same solutions. One study comparing 2%
chlorhexidine gluconate in aqueous vs. 0.5% chlorhexidine gluconate in alcohol
did not provide any conclusive evidence related to whether there were any
difference in catheter tip colonisation, septicaemia and bacteraemia cases.
There were slightly more cases for patients using 2% chlorhexidine gluconate
in aqueous compared to 0.5% chlorhexidine gluconate in alcohol but this was
not statistically significant and there was uncertainty as to whether the effect
size was potentially clinically significant. The confidence intervals were very
wide.
In addition, the clinical importance of the results observed was difficult to
194
interpret because most of the studies had been randomised by catheters, and
reported the outcomes per catheter, rather than per patient.
Other considerations The GDG noted that the discussions that they had relating to the evidence
surrounding the most appropriate solution to use to decontaminate the skin at
the insertion site prior to the insertion of a peripheral vascular access device or
peripherally inserted central catheter (see recommendation 80) were broadly
applicable to the evidence reviewed as part of this recommendation.
In particular when considering the evidence behind this recommendation,
regarding the choice of disinfectant when changing dressings, the GDG noted
that in practice it is important to recommend the same type of disinfectant
solutions for both decontaminating the skin and also the ports and hubs of the
device that is already in situ. They noted that ensuring this could reduce the
chance of confusion around which to solution to use. Evidence for
Update 2012
decontamination prior to insertion suggested that chlorhexidine gluconate in
alcohol is the best option, and there is no specific evidence for
decontamination prior to accessing ports and hubs.
The GDG were aware, however, that some catheters and hubs are not
compatible with the use of alcohol and that some manufacturers prohibit the
use of alcohol with their catheter and therefore this should be taken into
account when decontaminating the skin during dressing changes. For these
patients, it remains important that the decontamination is carried out but that
a suitable non-alcoholic alternative is available. Based on the on the evidence
reviewed which showed there were fewer catheter tips with colonisation when
using 2% chlorhexidine gluconate in aqueous solution rather than 10%
povidone iodine in aqueous, and also considering the potential disadvantages
of staining from iodine solutions, the GDG considered chlorhexidine gluconate
remains the best option when only aqueous disinfectants could be used. The
GDG used consensus to agree the choice of solution given the limited directly
applicable evidence behind the use of non-alcohol based decontamination
where manufacturers prohibit the use of alcohol with their catheter.
87.Individual sachets of antiseptic solution or individual packages of antiseptic-impregnated

swabs or wipes should be used to disinfect the dressing site. [2003]
195
12.8 General Principles for management of vascular access devices

12.8.1 Decontaminating peripheral and centrally inserted catheter ports and hubs before
access
decontamination solution for decontaminating peripheral and centrally inserted catheter ports and
hubs before access, as it was felt there are more types of decontamination products are available
since 2003. In particular, stakeholders highlighted uncertainty regarding what is the most
appropriate concentration to use for chlorhexidine gluconate.

What is the most clinical and cost effective product or solution for decontaminating VAD ports and
hubs prior to access on catheter tip colonisation, infection related mortality, septicaemia,
bacteraemia and frequency of line removal?
Update 2012
No clinical studies were identified in this update. No clinical evidence was identified in the previous
2003 guideline.

In the absence of any published cost-effectiveness analyses, current UK decontamination product

costs, estimated infection-related costs (Table 84 and Table 101) and quality of life data (Table 85)
were presented to the GDG to inform decision making.
Table 120: Ports and hubs decontamination product costs

Decontamination product Average cost (£)
70% Isopropyl alcohol swabs 2.35 (per 100 individual sachets)
2% Chlorhexidine in 70% isopropyl alcohol 4.35 (per 200 individual sachets)
Alcohol free 3.03 (per 200 wipes)
187
Source/Note: NHS Supply Catalogue 2010
Clinical No clinical evidence was identified.
196
88.Decontaminate the injection port or vascular access device

catheter hub before and after accessing the system using
chlorhexidine gluconate in 70% alcohol. Consider using an
aqueous solution of chlorhexidine gluconate if the
manufacturer’s recommendations prohibit the use of alcohol
Recommendations with their catheter. [new 2012]
Relative values of different The GDG considered preventing infection-related mortality, and VAD related
outcomes infections such as septicaemia, bacteraemia and phlebitis as the most
important and relevant outcomes to patients. The frequency of VAD line
removal and clinician time involved is also important. There is a potential delay
to treatment following line removal or reduced venous access and these are
important for patient outcomes.
Trade off between clinical Reduction of infections was considered against the potential for developing
benefits and harms resistance against decontamination solutions, and costs.
Economic considerations The GDG considered the incremental cost of different decontamination
solutions as well as the cost and quality of life associated with VAD related
infections. The group agreed by consensus that the greater incremental cost of
alcoholic chlorhexidine gluconate solution would be justified by a decrease in
vascular catheter related infections.
Quality of evidence There was no direct evidence from RCTs specifically comparing different
methods of decontaminating ports and hubs prior to access found.
Update 2012
The recommendation was developed based on consensus, and information
obtained from studies of decontamination of skin prior to insertion and during
dressing changes reviewed.
Other considerations The GDG took into account the evidence reviewed for skin decontamination
prior to insertion of vascular access devices, and skin decontamination during
dressing changes. Although these studies had important methodological
limitations, there was a trend that chlorhexidine gluconate in alcohol solution
was more effective in skin decontamination prior to insertion and during
dressing changes than other alcoholic or aqueous based disinfectants. The
evidence in these sections was considered relevant by the GDG when drafting
this recommendation. The GDG noted that in practice it is important to
recommend the same type of disinfectant solutions for both decontaminating
the skin and also the ports and hubs. They noted that this could reduce the
chance of confusion around which to solution to use. Using chlorhexidine
gluconate in alcohol was considered important to minimize the number of
alternative preparations that may be used with VAD lines. The residual
antimicrobial effect of chlorhexidine gluconate was also discussed, and had
been documented in the recommendations about decontamination prior to
insertion and during dressing changes (see recommendation 80 and
recommendation 87).
The GDG decided that only chlorhexidine gluconate in alcohol should be
recommended for decontamination of hubs and ports for vascular access
devices. Cleaning with only alcohol was not considered an effective option.
Where the use of alcohol is prohibited in the manufacturer’s instruction,
decontamination of the port or hub using chlorhexidine gluconate in aqueous
was recommended in line with the recommendation about skin
decontamination during dressing changes (recommendation number 87).
Based on the evidence reviewed for that recommendation that showed there
were fewer catheter tips with colonisation when using 2% chlorhexidine
gluconate in aqueous solution rather than 10% povidone iodine in aqueous,
197
88.Decontaminate the injection port or vascular access device

catheter hub before and after accessing the system using
chlorhexidine gluconate in 70% alcohol. Consider using an
Update 2012
aqueous solution of chlorhexidine gluconate if the
manufacturer’s recommendations prohibit the use of alcohol
Recommendations with their catheter. [new 2012]
and also considering the potential disadvantages of staining from iodine
solutions, the GDG considered chlorhexidine gluconate remains the best
option when only aqueous disinfectants could be used.
Considerations about the use of alcohol in infection control was also taken into
account, and discussed at length in the recommendation about hand
decontamination. Please see section 6.4 for more details.
12.8.3 Inline filters do not help prevent infections

Although in-line filters reduce the incidence of infusion-related phlebitis, HICPAC could find no
reliable evidence to support their efficacy in preventing infections associated with intravascular
catheters and infusion systems. Infusate-related BSI is rare and HICPAC concluded that filtration of
medications or infusates in the pharmacy is a more practical and less costly way to remove the
majority of particulates. Furthermore, in-line filters might become blocked, especially with certain
solutions, e.g., dextran, lipids, mannitol, thereby increasing the number of line manipulations and
decreasing the availability of administered drugs.191 In our systematic review we found no additional
good quality evidence to support their use for preventing infusate-related BSI. However, there may
be a role for the use of in-line filtration of parenteral nutrition solutions for reasons other than the
prevention of infection but these are beyond the scope of these guidelines.
89.In-line filters should not be used routinely for infection prevention. [2003]
12.8.4 Antibiotic lock solutions have limited uses in preventing infection

Antibiotic lock prophylaxis, i.e., flushing and then filling the lumen of the CVC with an antibiotic
solution and leaving it to dwell in the lumen of the catheter, is sometimes used in special
circumstances to prevent CRBSI, e.g., in treating a patient with a long-term cuffed or tunnelled
catheter or port who has a history of multiple CRBSI despite optimal maximal adherence to aseptic
technique. Evidence reviewed by HICPAC191 demonstrated the effectiveness of this type of
prophylaxis in neutropenic patients with long-term CVCs. However, they found no evidence that
routinely using this procedure in all patients with CVCs reduced the risk of CRBSI and may lead to
increasing numbers of antimicrobial resistant microorganisms.
90.Antibiotic lock solutions should not be used routinely to prevent catheter-related

bloodstream infections (CRBSI). [2003]
12.8.5 Systemic antibiotic prophylaxis does not reliably prevent CRBSI

No studies appraised by HICPAC demonstrated that oral or parenteral antibacterial or antifungal
drugs might reduce the incidence of CRBSI among adults. However, among low birth weight infants,
two studies reviewed by HICPAC had assessed vancomycin prophylaxis; both demonstrated a
reduction in CRBSI but no reduction in mortality. They noted that because the prophylactic use of
198
vancomycin is an independent risk factor for the acquisition of vancomycin-resistant enterococcus

(VRE), the risk for acquiring VRE probably outweighs the benefit of using prophylactic vancomycin.191
91.Systemic antimicrobial prophylaxis should not be used routinely to prevent catheter

colonisation or CRBSI, either before insertion or during the use of a central venous catheter.
[2003]
12.8.6 A dedicated catheter lumen is needed for parenteral nutrition

HICPAC reviewed evidence from a prospective epidemiologic study examining the risk for CRBSI in
patients receiving Total Parenteral Nutrition (TPN). They concluded that either using a single lumen
CVC or a dedicated port in a multilumen catheter for TPN would reduce the risk for infection.191
92.Preferably, a single-lumen catheter should be used to administer parenteral nutrition. If a

multilumen catheter is used, one port must be exclusively dedicated for total parenteral
nutrition, and all lumens must be handled with the same meticulous attention to aseptic
technique. [2003]
12.8.7 Maintaining catheter patency and preventing catheter thrombosis may help prevent
infections
Indwelling central venous and pulmonary artery catheters are thrombogenic. Thrombus forms on
these catheters in the first few hours following placement122 and may serve as a nidus for microbial
colonization of intravascular catheters.217 Thrombosis of large vessels occurs after long-term
catheterisation in 35 to 65% of patients.14,43,138,255,263 Prophylactic heparin and warfarin have been
widely used to prevent catheter thrombus formation and catheter related complications, such as
deep venous thrombosis (DVT).191,218
Two types of heparin can be used: unfractionated (standard) heparin and low molecular weight
heparins. Although more expensive, low molecular weight heparins have a longer duration of action
than unfractionated heparin and are generally administered by subcutaneous injection once daily.
The standard prophylactic regimen of low molecular weight heparins are at least as effective and as
safe as unfractionated heparin in preventing venous thrombo-embolism and does not require
laboratory monitoring.170
12.8.8 Systemic Anticoagulation

A meta-analysis of randomised controlled trials218 evaluating the benefit of infused prophylactic
heparin through the catheter, given subcutaneously or bonded to the catheter in patients with CVCs
found that prophylactic heparin:
• was associated with a strong trend for reducing catheter thrombus (RR, 0.66; 95% confidence
interval [CI], 0.42,1.05). The test for heterogeneity of variance was not significant (p=0.681);
• significantly decreased central venous catheter-related venous thrombosis by 57% (RR, 0.43; 95%
CI, 0.23,0.78). The test for heterogeneity of variance was not significant (p=0.526). Significant
reduction of deep venous thrombosis was still present after excluding one trial of heparin-bonded
catheters (RR, 0.44; 95% CI, 0.22,0.87);
199
• significantly decreased bacterial colonisation of the catheter (RR, 0.18; 95% CI, 0.06, 0.60). The
test for heterogeneity of variance was not significant (p=0.719). The significant benefit for heparin
remained after excluding one trial of heparin-bonded catheters (RR, 0.19; 95% CI, 0.04, 0.86).
• showed a strong trend for a reduction in CRBSI (RR, 0.26; 95% CI, 0.07,1.03). The test for
heterogeneity of variance was not significant (p=0.859); This trend decreased when one trial of
heparin-bonded catheters was excluded (RR,0.33; 95% CI, 0.07,1.56
The authors of this meta-analysis concluded that heparin administration effectively reduces
thrombus formation and may reduce catheter-related infections in patients who have central venous
and pulmonary artery catheters in place. They suggest that various doses of subcutaneous and
intravenous unfractionated and low molecular weight heparins and new methods of heparin bonding
need further comparison to determine the most cost-effective strategy for reducing catheter-related
thrombus and thrombosis.
There are many different preparations and routes of administration of heparin, and as yet there is no
definite evidence that heparin reduces the incidence of CRBSI, but this may reflect the heterogeneity
of heparin and its administration.
Warfarin has also been evaluated as a means for reducing catheter-related thrombosis. A controlled
trial of 82 patients with solid tumours randomised to receive or not to receive low-dose warfarin (1
mg a day) beginning 3 days prior to catheter insertion and continuing for 90 days, warfarin was
shown to be effective in reducing catheter-related thrombosis.21 The rates of venogram-proved
thrombosis 4 of 42 in the treatment group versus 15 of 40 in the control group with 15 having
symptomatic thromboses. In this study, warfarin was discontinued in 10% of patients due to
prolongation of the prothrombin time.
12.8.9 Heparin versus normal saline intermittent flushes

Although many clinicians use low dose intermittent heparin flushes to fill the lumens of CVCs locked
between use in an attempt to prevent thrombus formation and to prolong the duration of catheter
patency, the efficacy of this practice is unproven. Despite its beneficial antithrombotic effects,
decreasing unnecessary exposure to heparin is important to minimise adverse effects associated with
heparin use, e.g., autoimmune-mediated heparin-induced thrombocytopenia, allergic reactions and
the potential for bleeding complications following multiple, unmonitored heparin flushes.196 The risks
of these adverse effects can be avoided by using 0.9 percent sodium chloride injection instead of
heparin flushes. A systematic review and meta-analysis of randomised controlled trials evaluating the
effect of heparin on duration of catheter patency and on prevention of complications associated with
the use of peripheral venous and arterial catheters concluded that heparin at doses of 10 U/ml for
intermittent flushing is no more beneficial than flushing with normal saline alone.219 This finding was
in agreement with two other meta-analyses.105,201 Manufacturers of implanted ports or opened-
ended catheter lumens may recommend heparin flushes for maintaining catheter patency and many
clinicians feel that heparin flushes are appropriate for flushing CVCs that are infrequently accessed.
HICPAC reviewed all of the evidence14,21,43,105,122,138,196,201,217-219,255,263 for intermittent heparin flushes

and systemic heparin and warfarin prophylaxis and concluded that no data demonstrated that their
use reduces the incidence of CRBSI and did not recommend them.191 Although their use for
preventing CRBSI remains controversial, patients who have CVCs may also have risk factors for DVT
and systemic anticoagulants may be prescribed for DVT prophylaxis.
200
93.Preferably, a sterile 0.9 percent sodium chloride injection should be used to flush and lock
catheter lumens. [2003]
94.When recommended by the manufacturer, implanted ports or opened-ended catheter

lumens should be flushed and locked with heparin sodium flush solutions. [2003]
95.Systemic anticoagulants should not be used routinely to prevent CRBSI. [2003]
12.8.10 Needleless devices require vigilance

Needleless infusion systems have been widely introduced into clinical practice to reduce the
incidence of sharp injuries and the potential for the transmission of blood borne pathogens to
healthcare workers. HICPAC examined evidence that these devices may increase the risk for CRBSI
and concluded that when they are used according to the manufacturers’ recommendations, they do
not substantially affect the incidence of CRBSI.191
96.If needleless devices are used, the manufacturer’s recommendations for changing the
needleless components should be followed. [2003]
97.When needleless devices are used, healthcare workers should ensure that all components of
the system are compatible and secured, to minimise leaks and breaks in the system. [2003]
98.When needleless devices are used, the risk of contamination should be minimised by
decontaminating the access port with either alcohol or an alcoholic solution of chlorhexidine
gluconate before and after using it to access the system. [2003]
See also recommendation 89. (Decontaminate the injection port or catheter hub using chlorhexidine
gluconate in 70% alcohol before and after it has been used to access the system unless
contraindicated by manufacturer).
12.8.11 Change intravenous administration sets appropriately

The optimal interval for the routine replacement of intravenous (IV) administration sets has been
examined in three well-controlled studies reviewed by HICPAC. Data from each of these studies
reveal that replacing administration sets no more frequently than 72 hours after initiation of use is
safe and cost-effective. When a fluid that enhances microbial growth is infused, e.g., lipid emulsions,
blood products, more frequent changes of administration sets are indicated as these products have
been identified as independent risk factors for CRBSI.191
99.In general, administration sets in continuous use need not be replaced more frequently than
at 72 hour intervals unless they become disconnected or if a catheter-related infection is
suspected or documented. [2003]
100. Administration sets for blood and blood components should be changed every 12 hours, or
according to the manufacturer’s recommendations. [2003]
201
101. Administration sets used for total parenteral nutrition infusions should generally be
every 72 hours. [2003]
12.9 Administering infusions or drugs

What is the clinical and cost effectiveness of multi dose vials vs. single-use vials for administrating
infusions or drugs on preventing contamination of the infusate and healthcare-associated infection?
12.9.2 Clinical evidence

No clinical evidence was identified.
This review question was not covered in the previous 2003 guideline.
12.9.3 Cost-effectiveness evidence

This review question was not covered in the previous 2003 guideline.
The co-opted expert advisors were approached about the likely costs of single- compared to
multiple- use vials. They indicated that single-use vials were generally more expensive than multiple-
use, but did not think it would represent a good use of time to evaluate the costs of individual
infusion medications. Similarly, the infections which may arise as a consequence of infusate
Update 2012
contamination are many and varied. It was not considered an effective use of time to calculate the
costs and quality of life associated with all possible infections. Instead, the GDG was encouraged to
use their clinical experience to consider the most likely costs of single versus multiple-use vials and
the likely consequences arising from their contamination.
12.9.4 Evidence statements

Clinical No clinical studies were identified
Economic No economic studies were identified
12.9.5 Recommendations and link to evidence
102. Avoid the use of multidose vials, in order to prevent the

Recommendations contamination of infusates. [new 2012]
Relative values of different The GDG considered that as multi dose vials are accessed more than once the
outcomes most important outcomes as VAD related bacteraemia, septicaemia and
infection related mortality.
Trade off between clinical There is a risk of contamination of the infusate if vials are not used correctly
benefits and harms and incorrect storage may lead to pharmacological instability.
Economic considerations The GDG discussed the trade off between the (assumed) increased cost and
potential infusate wastage associated with single-use vials compared to the
cost and quality of life implications of the potentially severe infections
associated with infusate contamination. The GDG considered the marginally
increased cost of single-use vials to be justified in order to prevent these
infections.
202
102. Avoid the use of multidose vials, in order to prevent the

Recommendations contamination of infusates. [new 2012]
Update 2012
Quality of evidence No clinical evidence was identified. The recommendation was formulated using
the expert opinion of the GDG. Further details about the GDG discussion and
considerations are detailed in “Other considerations” below.
Other considerations The GDG agreed that the correct dose of infusate in a single container should
be used and the vial should then be discarded in order to reduce the risk of
contamination during preparation and administration. Re-accessing multidose
vials can lead to loss of integrity of the vial through puncturing the bung
multiple times.

This is a well researched area and few realistic research needs were identified in developing these
guidelines. The following investigations, along with a health economic assessment, may inform
future clinical practice.
12.10.1 Current issues

The effectiveness of subcutaneous low molecular weight heparins or low dose warfarin to prevent
catheter thrombus, colonisation and CRBSI.
12.10.2 Emerging Technologies

The efficacy of antimicrobial impregnated CVCs and catheters with new forms of heparin bonding to
provide sustained protection against CRBSI in patients with long-term CVCs in the community.
12.11 Research recommendations

6. What is the clinical and cost effectiveness of 2% chlorhexidine in alcohol versus chlorhexidine
0.5% in alcohol versus 2% chlorhexidine aqueous solution versus 0.5% chlorhexidine aqueous
solution for cleansing skin (before insertion of peripheral vascular access devices [VADs] and
during dressing changes of all VADs) on reducing VAD related bacteraemia and VAD site
infections?

Update 2012
The effective management of vascular access devices (VADs) is important for reducing phlebitis and
bacteraemia. In the community, compliance is improved when a single solution is used for all aspects
of VAD related skin care. There is no direct evidence comparing different percentages of
chlorhexidine in aqueous and alcohol solutions, and little evidence on the use of such solutions in the
community. A randomised controlled trial is required to compare the clinical and cost effectiveness
of the different solutions available. The trial should enrol patients in the community with a VAD. The
protocol would need to use the same skin preparation technique regardless of solution, and could
also investigate decontamination technique and drying time. The primary outcome measures should
be rate of VAD related bacteraemia, rate of VAD site infections, mortality, cost and quality of life.
Secondary outcomes measures should include Visual Infusion Phlebitis (VIP) score, insertion times
and skin irritation.
203
Glossary
13 Glossary
Term Definition
Abstract Summary of a study, which may be published alone or as an introduction to a full

scientific paper.
Alcohol- An alcohol-containing preparation designed for application to the hands for
based/Alcoholic reducing the number of viable microorganisms on the hands. In the UK, such
handrub preparations usually contain 60-90% ethanol and isopropanol.
Algorithm (in A flow chart of the clinical decision pathway described in the guideline, where
guidelines) decision points are represented with boxes, linked with arrows.
Allocation The process used to prevent advance knowledge of group assignment in an RCT. The
concealment allocation process should be impervious to any influence by the individual making
the allocation, by being administered by someone who is not responsible for
recruiting participants.
Antiseptic handwash An antiseptic containing preparation designed for frequent use; it reduces the
or soap number of microorganisms on intact skin to an initial baseline level after adequate
washing, rinsing, and drying; it is broad-spectrum and fast-acting.
Applicability The degree to which the results of an observation, study or review are likely to hold
true in a particular clinical practice setting.
Arm (of a clinical Sub-section of individuals within a study who receive one particular intervention, for
study) example placebo arm.
Asepsis Asepsis prevents microbial contamination during procedures where the body’s
natural defences are bypassed.
Asepsis can be defined as medical or surgical. Medical asepsis aims to reduce the
number of organisms and prevent their spread by key principles such as
decontaminating hands, use of PPE and not touching key parts.
Surgical asepsis is a strict process and includes procedures to eliminate
micro-organisms from an area (thus creating a sterile environment) and is practised
in operating theatres and for invasive procedures such as the insertion of a central
venous catheter.
See also ‘aseptic techniques’.
Aseptic non touch A specific type of aseptic technique with a unique theory and practice framework
technique (ANTT™) (www.antt.co.uk).
Aseptic techniques An aseptic technique ensures that only uncontaminated equipment and fluids come
into contact with susceptible body sites. It should be used during any clinical
procedure that bypasses the body’s natural defences. Using the principles of
aspepsis minimises the spread of organisms from one person to another. See
‘asepsis’.
Autonomic Autonomic dysreflexia, also known as hyperreflexia, is where a stimulus, such as
dysreflexia overstretching or irritation of the bladder wall, causes an over-activity of the
sympathetic part of the autonomic nervous system resulting in remarkably high
blood pressure (often ≥200mm/Hg systolic).
Bacteraemia The presence of bacteria in the bloodstream.
Bacteriuria The presence of bacteria in the urine with or without associated symptoms of
infection. In the absence of symptoms this is referred to as asymptomatic
bacteriuria or, in the case of a patient with an indwelling catheter, catheter
colonisation.
Bare below the The GDG defined this as not wearing false nails or nail polish when delivering direct
elbows patient care. Not wearing a wrist-watch or stoned rings. Healthcare workers’
garments should be short sleeved or be able to roll or push up sleeves when
delivering direct patient care and performing hand decontamination.
204
Glossary
Term Definition
Baseline The initial set of measurements at the beginning of a study (after run-in period
where applicable), with which subsequent results are compared.
Bias Systematic (as opposed to random) deviation of the results of a study from the
‘true’ results that is caused by the way the study is designed or conducted.
Bladder instillation Introducing a sterile therapeutic liquid into the bladder and leaving it there for a
variable 'holding' time to dissolve particulates/encrustation, altering pH, or
suppressing bacterial growth.
Bladder irrigation The continuous introduction of a sterile fluid into the bladder via a three way
catheter to allow for the drainage of blood and debris from the bladder.
Bladder washout The introduction into the bladder of a sterile fluid which is allowed to drain more or
less immediately, for the purpose of diluting the bladder contents/unblocking an
obstruction to restore free catheter drainage.
Blinding Keeping the study participants, caregivers, researchers and outcome assessors
unaware about the interventions to which the participants have been allocated in a
study.
Blood borne viruses A virus that is carried in the bloodstream, and transmitted via contact with infected
blood e.g. HBV, HCV and HIV.
Bodily fluid Contamination with any bodily fluid which would include urine, faeces, saliva or
contamination vomit and could result in transmission of infection.
Buried bumper A complication of PEG tubes where the internal disc becomes buried in the stomach
syndrome lining.
C.diff cross infection The transmission of Clostridium difficile from one person to another because of a
breach in a barrier.
C.diff reduction A reduction in the incidence (number of new cases) of Clostridium difficile.
Cannula A peripheral device consisting of a hollow tube made of plastic or metal, used for
accessing the body.
Carer (caregiver) Someone other than a health professional who is involved in caring for a person
with a medical condition.
Catheter blockage Blockage either by deposits and encrustations or by mechanical means, such as
occlusion of catheter due to kinking of the tube, that prevents urine from draining
out of the bladder.
Catheter Deposits of gritty urine crystals on the catheter tube which can increase the risk of
encrustation blockage and infection.
Catheter thrombus Clot adherent to or occluding the catheter or a fibrin sleeve in the vessel around the
catheter.
Catheter tip In clinical studies on the prevention of vascular catheter-related infections,
colonisation catheter-tip colonization (CTC) is frequently used as a surrogate end point for the
most severe form of vascular catheter-related infection, catheter-related BSI. Use of
this end point is based on observations that, in bacteraemic patients who have an
intravascular catheter in place, the catheter is more likely to be the source of
bacteraemia if culture of the catheter tip yields the same bacteria as blood culture.
The higher the load of bacteria found on the catheter, the better the positive
predictive value for catheter-related bacteraemia. More recently, and for practical
reasons—in most studies of catheter-related infection, an absolute cut off value for
catheter culture positivity has been used.
Catheter valve A valve connected to the catheter outlet allowing the bladder to be used to store
urine. Urine is drained by opening the valve at regular intervals.
Catheter-associated The occurrence of local, or distant, clinical symptoms or signs attributable to
Urinary Tract bacteria present either within the urinary tract, or in the bloodstream (with the
205
Glossary
Term Definition
Infection urinary tract as the source).

Infection may arise:
• either at the time of, or immediately following catheter insertion;
• or subsequently, because the colonising flora within the catheterised urinary
tract becomes invasive (this may occur spontaneously, or follow catheter
manipulation).
Cellulitis An infection of the skin and tissues beneath the skin, symptoms include tenderness,
swelling, erythema and may cause pyrexia.
Central venous Catheter inserted into a centrally located vein with the tip residing in the lower third
catheter of the superior vena cava: permits access to the venous system.
Clean procedure Hands are decontaminated before and after the procedure and key parts are not
touched.
Clean technique A technique that is designed to prevent the introduction of microorganisms, but in
recognition that the site is already colonised with bacteria it is not aseptic. Non
sterile gloves may be used.
Clinical effectiveness The extent to which an intervention produces an overall health benefit in routine
clinical practice.
Clinical efficacy The extent to which an intervention is active when studied under controlled
research conditions.
Clinical importance This refers to whether the size of the effect observed between groups are If the MID
is less than the lower limit of the 95% confidence interval, results are likely to be
statistically significant and clinically important. If the MID is greater than the upper
limit of the 95% confidence interval, results are likely to be clinically unimportant. If
the MID lies within the limits of the 95% confidence interval, it is unclear if the
effect is clinically important or not41.
Clinical waste Clinical waste is defined as:
1. “. . . any waste which consists wholly or partly of human or animal tissue,
blood or other body fluids, excretions, drugs or other pharmaceutical products,
swabs or dressings, syringes, needles or other sharp instruments, being waste which
unless rendered safe may prove hazardous to any person coming into contact with
it; and
2. any other waste arising from medical, nursing, dental, veterinary,
pharmaceutical or similar practice, investigation, treatment, care, teaching or
research, or the collection of blood for transfusion, being waste which may cause
infection to any person coming into contact with it.”
Clinical waste can be divided into three broad groups of materials:
1. any healthcare waste which poses a risk of infection (and therefore by
definition possesses the hazardous property H9 Infectious);
2. certain healthcare wastes which pose a chemical hazard (for example one
of H1 to H8, H10 to H15);
3. medicines and medicinally-contaminated waste containing a
pharmaceutically-active agent.
Clinician A healthcare professional providing direct patient care, for example doctor, nurse or
physiotherapist.
Closed System Sterile, pre-filled ready-to-use feeds that do not expose the feed to the air during
(enteral feeding) assembly.
Cohort study A retrospective or prospective follow-up study. Groups of individuals to be followed
up are defined on the basis of presence or absence of exposure to a suspected risk
factor or intervention. A cohort study can be comparative, in which case two or
more groups are selected on the basis of differences in their exposure to the agent
206
Glossary
Term Definition
of interest.
Colony forming units A measure of viable bacteria or fungi numbers per millilitre.
Comparability Similarity of the groups in characteristics likely to affect the study results (such as
health status or age).
Concordance This is a recent term whose meaning has changed. It was initially applied to the
consultation process in which doctor and patient agree therapeutic decisions that
incorporate their respective views, but now includes patient support in medicine
taking as well as prescribing communication. Concordance reflects social values but
does not address medicine-taking and may not lead to improved adherence.
Confidence interval A range of values for an unknown population parameter with a stated ‘confidence’
(CI) (conventionally 95%) that it contains the true value. The interval is calculated from
sample data, and generally straddles the sample estimate. The ‘confidence’ value
means that if the method used to calculate the interval is repeated many times,
then that proportion of intervals will actually contain the true value.
Confounding In a study, confounding occurs when the effect of an intervention on an outcome is
distorted as a result of an association between the population or intervention or
outcome and another factor (the ‘confounding variable’) that can influence the
outcome independently of the intervention under study.
Consensus methods Techniques that aim to reach an agreement on a particular issue. Consensus
methods may be used when there is a lack of strong evidence on a particular topic.
Control group A group of patients recruited into a study that receives no treatment, a treatment of
known effect, or a placebo (dummy treatment) - in order to provide a comparison
for a group receiving an experimental treatment, such as a new drug.
Cost benefit analysis A type of economic evaluation where both costs and benefits of healthcare
treatment are measured in the same monetary units. If benefits exceed costs, the
evaluation would recommend providing the treatment.
Cost-consequence A type of economic evaluation where various health outcomes are reported in
analysis (CCA) addition to cost for each intervention, but there is no overall measure of health
gain.
Cost-effectiveness An economic study design in which consequences of different interventions are
analysis (CEA) measured using a single outcome, usually in ‘natural’ units (for example, life-years
gained, deaths avoided, heart attacks avoided, cases detected). Alternative
interventions are then compared in terms of cost per unit of effectiveness.
Cost-effectiveness An explicit mathematical framework, which is used to represent clinical decision
model problems and incorporate evidence from a variety of sources in order to estimate
the costs and health outcomes.
Cost-utility analysis A form of cost-effectiveness analysis in which the units of effectiveness are quality-
(CUA) adjusted life-years (QALYs).
Catheter-related The patient has one or more recognized pathogens cultured from a single blood
bloodstream culture
infection (CRBSI) OR
If the microorganism is a common skin organism then...
• It must have been cultured from 2 or more blood cultures drawn on separate
occasions, or from one blood culture in a patient in whom antimicrobial therapy has
been started, and
• Patient has one of the following: fever of >38°C, chills, or hypotension
AND
• The presence of one or more central venous catheters at the time of the blood
culture, or up to 48 hrs following removal of the CVC
AND one of the following:
207
Glossary
Term Definition
i. a positive semiquantitative (>15 CFU/catheter segment) or quantitative (>10³ CFU

/ml or >10³ CFU/catheter segment) culture whereby the same organism (species
and antibiogram) is isolated from blood sampled from the CVC or from the catheter
tip, and peripheral blood;
ii. simultaneous quantitative blood cultures with a >5:1 ratio CVC versus peripheral.
Credible Interval The Bayesian equivalent of a confidence interval.
Decision analysis An explicit quantitative approach to decision making under uncertainty, based on
evidence from research. This evidence is translated into probabilities, and then into
diagrams or decision trees which direct the clinician through a succession of
possible scenarios, actions and outcomes.
Dermatitis Inflammation of the skin either due to direct contact with an irritant or due to an
(Standard infection allergic reaction. It maybe eczematous or non eczematous. Non eczematous is
control) usually due to direct contact with an irritant.
Direct patient care Hands-on or face-to-face contact with patients. Any physical aspect of the
healthcare of a patient, including treatments, self-care, and administration of
medication.
Discounting Discounting makes current costs and benefits worth more than those that occur in
the future. This is common practice in health economic evaluation due to the ‘time
preference’ expressed by most people, in which there is a desire to enjoy benefits in
the present while deferring the negative.
Disposable gloves Gloves that are used for single-use only, these may be latex, latex free or vinyl.
Disposable plastic An apron which is for single-use and normally made from a plastic material.
aprons
Dominance An intervention is said to be dominated if there is an alternative intervention that is
both less costly and more effective.
Drop-out A participant who withdraws from a trial before the end.
Economic evaluation Comparative analysis of alternative health strategies (interventions or programmes)
in terms of both their costs and consequences.
Effect (as in effect The observed association between interventions and outcomes or a statistic to
measure, treatment summarise the strength of the observed association.
effect, estimate of
effect, effect size)
Effectiveness See ‘Clinical effectiveness’.
Efficacy See ‘Clinical efficacy’.
Enteral feeding Feeding via a tube that can include any method of providing nutrition via the
gastrointestinal tract.
Epidemiological The study of a disease within a population, defining its incidence and prevalence
study and examining the roles of external influences (for example, infection, diet) and
interventions.
EQ-5D (EuroQol-5D) A standardised instrument used to measure health-related quality of life. It provides
a single utility value for a health state.
Evidence Information on which a decision or guidance is based. Evidence is obtained from a
range of sources including randomised controlled trials, observational studies, and
expert opinion (of clinical professionals and/or patients).
Exclusion criteria Criteria that define who is not eligible to participate in a clinical study.
(clinical study)
Exclusion criteria Explicit standards used to decide which studies should be excluded from
(literature review) consideration as potential sources of evidence.
Expert opinion Opinion derived from seminal works and appraised national and international
208
Glossary
Term Definition
guidelines. This also includes invited clinical experts.

Extended dominance If Option A is both more clinically effective than Option B and has a lower cost per
unit of effect, when both are compared with a do-nothing alternative then Option A
is said to have extended dominance over Option B. Option A is therefore more
efficient and should be preferred, other things remaining equal.
Extrapolation In data analysis, predicting the value of a parameter outside the range of observed
values.
Fill line The manufacturer’s mark on the sharps bin that relates to the bin being ¾ full.
Follow up Observation over a period of time of an individual, group or initially defined
population whose appropriate characteristics have been assessed in order to
observe changes in health status or health related variables.
Full body fluid Full gown that includes full length sleeves that is fluid repellent and should be used
repellent gowns when there is excessive risk of splashing of bodily fluids and secretions.
Fungal Colonisation The presence of fungi on the skin that does not cause disease.
Gastrostomy site An infection of the gastrostomy site often caused by skin flora which includes
infection inflammation around the insertion site. There may be associated pus formation.
Gauze dressings Woven or nonwoven fabric swab.
GDG Consensus GDG Consensus may be used when there is a lack of strong evidence on a particular
topic to reach an agreement for a recommendation.
Gel reservoir A type of intermittent catheter that is lubricated by passing it through a pre-
catheter packaged sterile integral reservoir of lubricating gel. Also known as ‘pre-gelled’.
Generalisability The extent to which the results of a study based on measurement in a particular
patient population and/or a specific context hold true for another population
and/or in a different context. In this instance, this is the degree to which the
guideline recommendation is applicable across both geographical and contextual
settings. For instance, guidelines that suggest substituting one form of labour for
another should acknowledge that these costs might vary across the country.
Gloves porosity The risk of micropuncture within the gloves structure that allows fluids to breach
the glove surface. Defined by the amount of spaces/voids within a solid material
which can absorb fluids.
Gold standard See ‘Reference standard’.
GRADE / GRADE A system developed by the GRADE Working Group to address the shortcomings of
profile present grading systems in healthcare. The GRADE system uses a common, sensible
and transparent approach to grading the quality of evidence. The results of applying
the GRADE system to clinical trial data are displayed in a table known as a GRADE
profile.
Hazard analysis and A system to identify potential hazards in food preparation.
critical control point
(HACCP)
Hand The use of handrub or handwashing to reduce the number of bacteria on the hands.
decontamination In this guideline this term is interchangeable with ‘hand hygiene’.
Hand hygiene See “Hand decontamination”.
Hand A measure of compliance to best practice ideals or policy related to hand

decontamination decontamination.
compliance
Handrub (compliant A preparation applied to the hands to reduce the number of viable microorganisms.
with EN 1500) This guideline refers to handrubs compliant with British standards (BS EN1500;
standard for efficacy of hygienic handrubs using a reference of 60% isopropyl
209
Glossary
Term Definition
alcohol).
Hand washing Washing hands with plain (i.e. nonantimicrobial) soap and water.
Hand to hand The act of passing (a sharp) from one person to another.
Hand /skin wipes Moist towelettes impregnated with various products used for cleansing of skin, or
inactivating pathogenic microorganisms on the skin.
Hang time The total time during which the feed is held in the nutrient container at room
temperature while being administered. This includes periods of time when
administration of the feed is interrupted temporarily.
Harms Adverse effects of an intervention.
Health economics The study of the allocation of scarce resources among alternative healthcare
treatments. Health economists are concerned with both increasing the average level
of health in the population and improving the distribution of health.
Healthcare- Infections that occur as a result of contact with the healthcare system in its widest
associated infection sense – in community and hospital settings. Previously, when most complex
healthcare was hospital based, the term ‘hospital acquired (or nosocomial)
infection’ was used. (See Nosocomial infection)
Healthcare waste Waste from natal care, diagnosis, treatment or prevention of disease in
humans/animals. Examples of healthcare waste include:
• infectious waste;
• laboratory cultures;
• anatomical waste;
• sharps waste;
• medicinal waste;
• offensive/hygiene waste from wards or other healthcare areas.
Healthcare worker Any person employed by the health service, social service, local authority or agency
to provide care for sick, disabled or elderly people.
Health-related A combination of an individual’s physical, mental and social well-being; not merely
quality of life the absence of disease.
(HRQoL)
Heterogeneity (or The term is used in meta-analyses and systematic reviews when the results or
lack of homogeneity) estimates of effects of treatment from separate studies seem to be very different –
in terms of the size of treatment effects or even to the extent that some indicate
beneficial and others suggest adverse treatment effects. Such results may occur as a
result of differences between studies in terms of the patient populations, outcome
measures, definition of variables or duration of follow-up.
Hydrophilic catheter Hydrophilic urinary catheters are coated with a water absorbent polymer. When
exposed to water the coating becomes wet and slippery, reducing friction between
the catheter surface and the urethral mucosa during insertion. Hydrophilic catheters
are sterile and have either packaged with an activated coating (i.e. ready to use) or a
dry coating which requires immersion in water for 30 seconds in order to activate
the coating.
Hypersensitivity A state of altered reactivity in which the body reacts with an exaggerated immune
response to what is perceived as a foreign substance.
Implanted port A VAD catheter surgically placed into a vein and attached to a reservoir located
under the skin (usually in the chest region). The catheter is tunnelled under the skin
and the tip lies in the lower third of the superior vena cava.
Imprecision Results are imprecise when studies include relatively few patients and few events
and thus have wide confidence intervals around the estimate of effect.
Impregnated Dressing permeated with a chemical, usually with antimicrobial properties, to
210
Glossary
Term Definition
dressings reduce the level of bacteria at the wound surface. Examples of active ingredients
include: medical grade honey, iodine, silver and chlorhexidine.
Inclusion criteria Explicit criteria used to decide which studies should be considered as potential
sources of evidence.
Incremental analysis The analysis of additional costs and additional clinical outcomes with different
interventions.
Incremental cost The mean cost per patient associated with an intervention minus the mean cost per
patient associated with a comparator intervention.
Incremental cost The difference in the mean costs in the population of interest divided by the
effectiveness ratio differences in the mean outcomes in the population of interest for one treatment
(ICER) compared with another.
Incremental net The value (usually in monetary terms) of an intervention net of its cost compared
benefit (INB) with a comparator intervention. The INB can be calculated for a given cost-
effectiveness (willingness to pay) threshold. If the threshold is £20,000 per QALY
gained then the INB is calculated as: (£20,000 x QALYs gained) – Incremental cost.
Indirectness The available evidence is different to the review question being addressed, in terms
of PICO (population, intervention, comparison and outcome).
Indwelling (urethral) A catheter that is inserted into the bladder via the urethra and remains in place for a
catheter period of time.
Infusate-related BSI Concordant growth of the same organism from the infusate and blood cultures
(Bloodstream (preferably percutaneously drawn) with no other identifiable source of infection.
Infection)
Injection access site, Resealable cap or other configuration designed to accommodate needles or
such as caps/ ports needleless devices for administration of solutions into the vascular system.
Also includes injection caps, needle free caps, catheter hubs or administration ports
integral to an administration set.
Intention to treat A strategy for analysing data from a randomised controlled trial. All participants are
analysis (ITT) included in the arm to which they were allocated, whether or not they received (or
completed) the intervention given to that arm. Intention-to-treat analysis prevents
bias caused by the loss of participants, which may disrupt the baseline equivalence
established by randomisation and which may reflect non-adherence to the protocol.
Intervention Healthcare action intended to benefit the patient, for example, drug treatment,
surgical procedure, psychological therapy.
Kappa statistic A statistical measure of inter-rater agreement that takes into account the
agreement occurring by chance.
Length of stay The total number of days a participant stays in hospital.
Licence See ‘Product licence’.
Life-years gained Mean average years of life gained per person as a result of the intervention
compared with an alternative intervention.
Likelihood ratio The likelihood ratio combines information about the sensitivity and specificity. It
tells you how much a positive or negative result changes the likelihood that a
patient would have the disease. The likelihood ratio of a positive test result (LR+) is
sensitivity divided by 1- specificity.
Link system An extension attached to the drainage outlet of the day urine collection bag and
connected to a larger capacity night drainage bag.
Localised Catheter Significant growth of a microorganism (> 15 CFU) from the catheter tip,
Colonisation subcutaneous segment of the catheter, or catheter hub in the absence of a positive
blood culture.
Long-term care Residential care in a home that may include skilled nursing care and help with
211
Glossary
Term Definition
everyday activities. This includes nursing homes and residential homes.

Long-term Long-term catheterisation: The use of a catheter (indwelling or intermittent) for a
catheterisation period greater than 28 days.
Loss to follow-up Also known as attrition. The loss of participants during the course of a study.
Participants that are lost during the study are often call dropouts.
Markov model A method for estimating long-term costs and effects for recurrent or chronic
conditions, based on health states and the probability of transition between them
within a given time period (cycle).
Meta-analysis A statistical technique for combining (pooling) the results of a number of studies
that address the same question and report on the same outcomes to produce a
summary result. The aim is to derive more precise and clear information from a
large data pool. It is generally more reliably likely to confirm or refute a hypothesis
than the individual trials.
Midline catheter A peripheral device that permits venous access. The catheter is inserted via the
antecubital veins and advanced into the veins of the upper arm but not extending
past the axilla (usually about 20cm in length). It is used for short-term (up to four
weeks) intravenous access.
MCID (minimal Minimal clinical important difference (MCID) was defined as smallest difference in
clinical important score in the outcome of interest that informed patients or informed proxies
difference) perceive as important, either beneficial or harmful, and that would lead the patient
or clinician to consider a change in the management 129. This is also sometimes
referred as “minimal important change” in clinical papers. See MID, clinical
importance, statistical significance.
MID (minimal The MID is the smallest difference in score in the outcome of interest that informed
important difference) patients or informed proxies perceive as important, either beneficial or harmful, and
that would lead the patient or clinician to consider a change in the management
129,233,234
. This term was adapted from the earlier definition used for MCID (minimal
clinically important difference) with the term "clinical" removed to emphasise on
the importance of patient perspective. The term "MID" has been adopted by
GRADE. In this guideline, we also use the term to refer to the clinically important
thresholds or harms when considering imprecision. See MCID, clinical importance,
statistical significance.
MRSA cross infection The transmission of the disease from one person to another because of a breach in
a barrier.
MRSA reduction A reduction in the incidence (number of new cases) of MRSA.
Multivariate model A statistical model for analysis of the relationship between two or more predictor
(independent) variables and the outcome (dependent) variable.
Needle safety devices Any device that aims to reduce the incidence of sharps’ injuries. This may include
needleless syringes, needle protection devices and needle free devices (see safety
needle devices).
Night drainage bag Bags used for overnight urine collection.
Non-alcohol based Hand washing products that do not contain alcohol, such as plain soap and water, or
decontamination antimicrobial/antiseptic washes.
products
Nosocomial Related to hospital or care, e.g., nosocomial infection is a hospital-acquired
infection.
Number needed to The number of patients that who on average must be treated to prevent a single
treat (NNT) occurrence of the outcome of interest.
Observational study Retrospective or prospective study in which the investigator observes the natural
course of events with or without control groups; for example, cohort studies and
212
Glossary
Term Definition
case–control studies.
Open System Feeds that need to be reconstituted, diluted and/or decanted into a feed container
and/or where the feed is exposed to the atmosphere during assembly of feeding
system.
Opportunity cost The loss of other healthcare programmes displaced by investment in or introduction
of another intervention. This may be best measured by the health benefits that
could have been achieved had the money been spent on the next best alternative
healthcare intervention.
Outcome Measure of the possible results that may stem from exposure to a preventive or
therapeutic intervention. Outcome measures may be intermediate endpoints or
they can be final endpoints. See ‘Intermediate outcome’.
Percutaneous A polyurethane or silicone tube, which has been inserted directly through the
endoscopic abdominal wall into the stomach. An internal retention disc (flange) anchors the
gastrstomy feeding tube in place and prevents the leakage of gastric juices or food. An external fixation
tube plate keeps the PEG in position next to the skin. They are suitable for long-term use.
Peristomal infection Oropharyngeal bacteria can be brought through the abdominal wall during
percutaneous endoscopic gastrostomy (PEG). Peristomal infection is one of the
most frequent complications in patients who undergo the procedure.
Peritonitis Inflammation of the peritoneum (the membrane lining the inner wall of the
abdomen and pelvis). Peritonitis may be primary (ie spontaneous, usually associated
with ascites) or secondary due to: infection by bacteria or parasites; bleeding;
leakage of irritants (such as bile, stomach acid or pancreatic enzymes); or some
systemic diseases (e.g. porphyria). It can result from bacteria tracking
inwards/internally from the gastrostomy site.
Persistent activity or Persistent activity is defined as the prolonged or extended antimicrobial activity that
residual activity prevents or inhibits the proliferation or survival of microorganisms after application
of the product. This activity may be demonstrated by sampling a site several
minutes or hours after application and demonstrating bacterial antimicrobial
effectiveness when compared with a baseline level. This property also has been
referred to as “residual activity.” Both substantive and nonsubstantive active
ingredients can show a persistent effect if they substantially lower the number of
bacteria during the wash period.
Personal Protective All equipment which is intended to be worn or held by a person to protect them
Equipment (PPE) from risks to health and safety whilst at work. Examples of PPE include gloves,
aprons and eye and face protection.
Peripherally inserted Soft flexible central venous catheter inserted into an arm vein and advanced until
central catheter the tip is positioned in the lower third of the superior vena cava. Permits access to
(PICC) the venous system.
Placebo An inactive and physically identical medication or procedure used as a comparator
in controlled clinical trials.
Plain soap Detergents that do not contain antimicrobial agents or contain low concentrations
of antimicrobial agents that are effective solely as preservatives.
Power (statistical) The ability to demonstrate an association when one exists. Power is related to
sample size; the larger the sample size, the greater the power and the lower the risk
that a possible association could be missed.
Primary care Healthcare delivered to patients outside hospitals. Primary care covers a range of
services provided by general practitioners, nurses, dentists, pharmacists, opticians
and other healthcare professionals.
Primary outcome The outcome of greatest importance, usually the one in a study that the power
calculation is based on.
Product licence An authorisation from the MHRA to market a medicinal product.
213
Glossary
Term Definition
Prospective study A study in which people are entered into the research and then followed up over a
period of time with future events recorded as they happen. This contrasts with
studies that are retrospective.
Publication bias Also known as reporting bias. A bias caused by only a subset of all the relevant data
being available. The publication of research can depend on the nature and direction
of the study results. Studies in which an intervention is not found to be effective are
sometimes not published. Because of this, systematic reviews that fail to include
unpublished studies may overestimate the true effect of an intervention. In
addition, a published report might present a biased set of results (e.g. only
outcomes or sub-groups where a statistically significant difference was found).
Pulmonary aspiration Entry of secretions or foreign material, including gastrostomy feed, via the trachea
into the lungs.
P-value The probability that an observed difference could have occurred by chance,
assuming that there is in fact no underlying difference between the means of the
observations. If the probability is less than 1 in 20, the P value is less than 0.05; a
result with a P value of less than 0.05 is conventionally considered to be ‘statistically
significant’.
Quality of life See ‘Health-related quality of life’.
Quality-adjusted life An index of survival that is adjusted to account for the patient’s quality of life during
year (QALY) this time. QALYs have the advantage of incorporating changes in both quantity
(longevity/mortality) and quality (morbidity, psychological, functional, social and
other factors) of life. It is used to measure benefits in cost-utility analysis. The QALYs
gained are the mean QALYs associated with one treatment minus the mean QALYs
associated with an alternative treatment.
Randomisation Allocation of participants in a research study to two or more alternative groups
using a chance procedure, such as computer-generated random numbers. This
approach is used in an attempt to ensure there is an even distribution of
participants with different characteristics between groups and thus reduce sources
of bias.
Randomised A comparative study in which participants are randomly allocated to intervention
controlled trial (RCT) and control groups and followed up to examine differences in outcomes between
the groups.
Ready-to-use Feeds prepared and supplied by the manufacturer, that only require attaching to
the feeding tube.
Relative risk (RR) The number of times more likely or less likely an event is to happen in one group
compared with another (calculated as the risk of the event in group A/the risk of the
event in group B).
Removal of physical The procedure which enables the user to clean all contamination from a specific
contamination surface.
Reporting bias See ‘publication bias’.
Resident (hand) flora Microorganisms that colonise the deeper crevices of the skin and hair follicles as
they have adapted to the hostile environment. Not readily transferred to other
people or objects. Not easily removed by the mechanical action of soap and water,
but can be reduced in number with the use of an antiseptic solution.
Resource implication The likely impact in terms of finance, workforce or other NHS resources.
Retractable needles Built-in safety mechanism is activated by fully depressing plunger while needle is
still in patient. Once activated, needle is automatically retracted from patient,
virtually eliminating exposure.
Retrospective study A retrospective study deals with the present/past and does not involve studying
future events. This contrasts with studies that are prospective.
214
Glossary
Term Definition
Reusable syringe See ‘single patient use’.

Review question In guideline development, this term refers to the questions about treatment and
care that are formulated to guide the development of evidence-based
recommendations.
Risk assessment Making a suitable and sufficient assessment of risks. This will involve identifying the
hazards (something with the potential to do harm), and evaluating the extent of
risks (the likelihood that the harm from a particular hazard is realised); and
identifying measures needed to comply with legal requirements.
Safety cannula A type of cannula that prevents sharps injuries. These can be active (requires
pressing a button to trigger the withdrawal of the needle into a plastic sleeve using
a spring) or passive (with a protective shield that automatically covers the
needlepoint during its withdrawal)
Safety needle devices These include needle free devices, retractable needles and safety resheathing
devices that reduces the risk of sharps injuries.
Secondary outcome An outcome used to evaluate additional effects of the intervention deemed a priori
as being less important than the primary outcomes.
Selection bias A systematic bias in selecting participants for study groups, so that the groups have
differences in prognosis and/or therapeutic sensitivities at baseline. Randomisation
(with concealed allocation) of patients protects against this bias.
Self-catheterisation Intermittent self-catheterisation: urinary catheterisation is undertaken by the
patient to drain the bladder with the immediate removal of the catheter.
Intermittent catheterisation: urinary catheterisation is performed by a carer with
the immediate removal of the catheter.
Sensitivity analysis A means of representing uncertainty in the results of economic evaluations.
Uncertainty may arise from missing data, imprecise estimates or methodological
controversy. Sensitivity analysis also allows for exploring the generalisability of
results to other settings. The analysis is repeated using different assumptions to
examine the effect on the results.
One-way simple sensitivity analysis (univariate analysis): each parameter is varied
individually in order to isolate the consequences of each parameter on the results of
the study.
Multi-way simple sensitivity analysis (scenario analysis): two or more parameters
are varied at the same time and the overall effect on the results is evaluated.
Threshold sensitivity analysis: the critical value of parameters above or below which
the conclusions of the study will change are identified.
Probabilistic sensitivity analysis: probability distributions are assigned to the
uncertain parameters and are incorporated into evaluation models based on
decision analytical techniques (for example, Monte Carlo simulation).
Sepsis A systemic response typically to a serious usually localized infection (as of the
abdomen or lungs) especially of bacterial origin that is usually marked by abnormal
body temperature and white blood cell count, tachycardia, and tachypnoea;
specifically: systemic inflammatory response syndrome induced by a documented
infection.
Septicaemia Invasion of the bloodstream by virulent microorganisms (including bacteria, viruses,
or fungi) from a focus of infection that is accompanied by acute systemic illness.
Also called blood poisoning.
Sharps Sharps are any medical item or device that can cause laceration or puncture
wounds: e.g. needles, cannulae, scalpels and lancets.
Significance A result is deemed statistically significant if the probability of the result occurring by
(statistical) chance is less than 1 in 20 (p <0.05).
215
Glossary
Term Definition
Single-use The medical device/item/equipment is intended to be used on an individual patient

during a single procedure and then discarded. The device is not intended to be
reprocessed or reused.
Single-patient use Items that can be used several times but are reserved for the use of one patient
only.
Skin tunnelled Vascular access device whose proximal end is tunnelled subcutaneously from the
catheter insertion site and brought out through the skin at an exit site. The tip of the catheter
lies in the lower third of the superior vena cava.
Stakeholder Those with an interest in the use of the guideline. Stakeholders include
manufacturers, sponsors, healthcare professionals, and patient and carer groups.
Sterile Free from any living microorganisms, eg, sterile gloves, sterile catheter.
Sterile technique A technique that prevents any possibility for the transmission of microorganisms.
Substantivity Substantivity is an attribute of certain active ingredients that adhere to the stratum
corneum (ie, remain on the skin after rinsing or drying) to provide an inhibitory
effect on the growth of bacteria remaining on the skin.
Suprapubic Suprapubic catheterisation creates a tunnel from the abdominal wall to the bladder.
catheter/catheterisat Urine can then be drained directly from the bladder into a bag through a catheter
ion inserted into this tunnel.
Symptomatic UTI An urinary tract infection causing symptoms which may include: dysuria, loin pain,
supra pubic tenderness, fever, pyuria and confusion.
Systematic review Research that summarises the evidence on a clearly formulated question according
to a pre-defined protocol using systematic and explicit methods to identify, select
and appraise relevant studies, and to extract, collate and report their findings. It
may or may not use statistical meta-analysis.
Time horizon The time span over which costs and health outcomes are considered in a decision
analysis or economic evaluation.
Transient Micro-organisms acquired on the skin through contact with surfaces. The hostile
microorganisms environment of skin means that they can usually only survive for a short time, but
they are readily transferred to other surfaces touched. These can be removed by
washing with soap and water or inactivated by alcohol handrub and antiseptic
agent.
Transparent Adhesive sterile dressing that allows the passage of water vapour and oxygen but is
semipermeable impermeable to water and micro-organsims, usually transparent to allow visual
membrane (TSM) inspection of the skin/site.
dressing
Treatment allocation Assigning a participant to a particular arm of the trial.
Univariate Analysis which separately explores each variable in a data set.
Urethral Relating to the tube that conveys urine from the bladder to the external urethral
orifice.
User preference The preferred technique or product used by the clinician/patient/carer.
Utility A measure of the strength of an individual’s preference for a specific health state in
relation to alternative health states. The utility scale assigns numerical values on a
scale from 0 (death) to 1 (optimal or ‘perfect’ health). Health states can be
considered worse than death and thus have a negative value.
VAD related blood See ‘CRBSI’.
stream infection
VAD related local See ‘VAD related soft tissue infection’.
infection
216
Glossary
Term Definition
VAD related phlebitis Inflammation of the vein, may be accompanied by pain, erythema, oedema, streak
formation and/or palpable cord associated with an indwelling VAD.
VAD related skin See VAD related soft tissue infection.
infection
VAD related soft Presence and growth of a pathogenic micro-organism in the soft tissue around the
tissue infection entry site of a VAD or along the length of a skin tunnelled catheter with signs of
infection/inflammation indicated by pain, redness, immobility (loss of function),
swelling and heat.
VAD related Inflammation of the vein in conjunction with the formation of a blood clot in
thromobophlebitis associated with an indwelling VAD.
Visibly soiled hands Hands showing visible dirt or visibly contaminated with proteinaceous material,
blood, or other body fluids (e.g. fecal material or urine).
Visual Infusion A tool for monitoring intravenous infusion sites and determining when access
Phlebitis (VIP) score should be removed.
Washout(s) See ‘Bladder washout’.
217
Abbreviation
14 Abbreviations
AGREE Appraisal of Guidelines Research and Evaluation
ANS Artificial nutrition support
APIC Association for Professionals in Infection Control
ANTT™ Aseptic non touch technique
BANS British Artificial Nutrition Survey
BBE Bare below elbow
BSI Bloodstream infection
CDC Centers for Disease Control
C.diff Clostridium difficile
CFU Colony forming unit
CI / 95% CI Confidence interval / 95% confidence interval
CRBSI Catheter-related Bloodstream Infection
CVC Central venous catheter
DOH Department of Health
EF Enteral feeding
DVT Deep venous thrombosis
GDG Guideline Development Group
GP General Practitioner
GRADE Grading of Recommendations Assessment, Development and Evaluation
HACCP Hazard analysis and critical control point
HCAI Healthcare-associated infection
HBV/Hep B Hepatitis B Virus
HCV/Hep C Hepatitis C Virus
HCW Healthcare Worker
HETF Home enteral tube feeding
HICPAC Healthcare Infection Control Practices Advisory Committee
HIV Human Immunodeficiency Virus
ICER Incremental cost-effectiveness ratio
ICU Intensive Care Unit
ISC Intermittent self-catheterisation
LTC Long-term urinary catheterisation
MD Mean Difference
MCID Minimal clinical important difference
MHRA Medicines and Healthcare products Regulatory Agency
MID Minimal important difference
MRSA Meticillin-resistant Staphylococcus aureus
N/A Not applicable
NCGC National Clinical Guideline Centre
NHS National Health Service
NICE National Institute for Health and Clinical Excellence
NPSA National Patient Safety Agency
218
Abbreviation
N/R Not reported

NRCT Non-randomised control trial
NRL Natural rubber latex
NST Nutrition support team
PEG Percutaneous endoscopic gastrostomy
PICC Peripherally inserted central catheter
PICO Framework incorporating patients, interventions, comparison and outcome
PPE Personal protective equipment
PTFE Polytetrafluoroethylene
QALY Quality-adjusted life year
RCT Randomised controlled trial
RR Relative risk
TPN Total parenteral nutrition
TSM dressing Transparent semipermeable membrane dressing
UTI Urinary tract infection
VAD Vascular access devices
VIP Score Visual Infusion Phlebitis Score
VRE Vancomycin resistant enterococci
vs. Versus
WHO World Health Organisation
219
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<Click thisprevention
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(partial
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document title / header text>
Scope of partial update
Appendices
Appendix A: Scope of partial update............................................................................................... 2
Appendix B: Declarations of interests ............................................................................................. 7
Appendix C: List of stakeholders ................................................................................................... 21
Appendix D: 2003 guideline appendices ....................................................................................... 30
Appendix E: Review protocols .................................................................................................... 162
Appendix F: Literature search strategies .................................................................................... 184
Appendix G: Clinical evidence tables ........................................................................................... 219
Appendix H: Economic evidence tables ...................................................................................... 323
Appendix I: Forest plots ............................................................................................................. 338
Appendix J: Cost-utility analysis: Intermittent self catheterisation ........................................... 363
Appendix K: Systematic review of health related quality of life for symptomatic UTI ............... 397
Appendix L: Excluded studies ..................................................................................................... 405
Appendix M: High priority research recommendations.......................................................... 415
Appendix N: Bibliography ............................................................................................................ 431
Infection prevention and control (partial update)
Appendix A: Scope of partial update

A.1 Guideline title
Infection: prevention and control of healthcare-associated infections in primary and community care
(update of NICE clinical guideline 2)
A.1.1 Short title

Infection prevention and control (update)
A.2 The remit

NICE has commissioned the National Clinical Guidelines Centre for Acute and Chronic Conditions to
partially update ‘Infection control: prevention of healthcare-associated infection in primary and
community care’ (NICE clinical guideline 2 *2003+).
A.3 Clinical need for the guideline

A.3.1 Epidemiology
a) In 2004, the Department of Health reported that approximately 300,000 healthcare-associated
infections occurred per year in hospital and primary care in the UK. In 2007, infectious diseases
accounted for 70,000 deaths, 150,000 hospital admissions and 40 per cent of GP consultations in the
UK. In the same year, methicillin resistant Staphylococcus aureus (MRSA) bloodstream infections and
Clostridium difficile infections were recorded as the underlying cause of, or a contributory factor to,
approximately 9000 deaths in hospital and primary care.
b) Healthcare-associated infections are estimated to cost the NHS approximately £1 billion a year;
£56 million of this is estimated to be incurred following discharge of patients from hospital.
A.3.2 Current practice

a) Advances in healthcare mean that many more people now survive serious illness. Although
infection is still one of the many risks associated with treatment and/or care, this risk can be
minimised if preventive measures are in place.
b) The risk of patients acquiring a healthcare-associated infection is increased by the rapid turnover
of patients from acute care settings to community care, and by the increasing number of complex
procedures performed in primary and community care. Healthcare-associated infections can
exacerbate existing or underlying conditions, delay recovery and adversely affect quality of life.
c) Healthcare associated infections arise across a wide range of clinical conditions and can affect
patients of all ages. Healthcare workers, families and carers are also at risk of acquiring an infection
as a result of exposure to infections when caring for patients.
d) Healthcare-associated infections are commonly linked with invasive procedures or devices. For
example:
indwelling urinary catheters are the most common cause of urinary tract infections
2
bloodstream infections are often associated with vascular-access devices.
e) Healthcare-associated infections are caused by a wide range of microorganisms. These are often
carried by the patients themselves, but have taken advantage of a route into the body provided by
an invasive device or procedure.
f) In certain circumstances asepsis is very important, particularly when dealing with invasive devices.
Yet the principles of asepsis are poorly understood.
g) This clinical guideline is a partial update of ‘Infection control: prevention of healthcare-associated

infection in primary and community care’, NICE clinical guideline 2 (2003), and will address areas in
which clinical practice for preventing healthcare-associated infections in primary and community
care has changed. The aspects that will be updated are identified in section 4.3.1. Any
recommendations from the previous guideline not mentioned below will be incorporated into this
updated guideline to form an up-to-date guideline on infection prevention and control in primary
and community care. This guideline will not cover aspects of infectious diseases addressed by related
NICE guidance, but will refer to them as appropriate.
A.4 The guideline

The guideline development process is described in detail on the NICE website (see section 6, ‘Further
information’).
This scope defines what the guideline will (and will not) examine, and what the guideline developers
will consider. The scope is based on the referral from the Department of Health.
The areas that will be addressed by the guideline are described in the following sections.
A.4.1 Population
A.4.1.1 Groups that will be covered
a) All adults and children receiving healthcare where standard infection control precautions apply in
primary and community care.
b) Healthcare professionals, family members and carers who provide healthcare in primary and
community settings.
c) Guideline developers will pay particular attention to the needs of different age groups, different
genders, people with disabilities and minority ethnic groups.
A.4.1.2 Groups that will not be covered
a) People receiving healthcare in secondary care settings.
A.4.2 Healthcare setting

a) Primary-care settings, such as general practices, dental clinics, health centres and polyclinics. This
also includes care delivered by the ambulance service.
b) Community-care settings (such as care homes, patient's own home, schools and prisons) where
NHS healthcare is provided or commissioned.
c) This guideline is commissioned for the NHS, but people providing healthcare in other settings, such
as private settings, may find the guidance relevant.
3
A.4.3 Clinical management
A.4.3.1 Key clinical issues that will be covered
a) Standard infection control precautions:

Hand hygiene:
o When to decontaminate hands in relation to patient care in different healthcare settings,
including after the removal of gloves.
o Choice of hand-cleaning preparation (alcohol-based decontamination products, non-alcohol
based decontamination products, antimicrobial/antiseptic hand-washes or agents, or liquid
soap and water).
o What is the most effective hand decontamination technique?
Personal protective equipment:
o Safe disposal of personal protective equipment in line with European Union (EU) legislation.
o Appropriate use of plastic aprons and fluid-repellent gowns.
o Which gloves provide the best protection against infections?
Safe use and disposal of sharps:
o Choice of sharps equipment.
o Safe disposal of sharp instruments and needles in relation to patient care in different
healthcare settings, in line with current EU legislation.
b) Long-term (more than 28 days) urinary catheters:

Use of antibiotics when changing urinary catheters.
Does bladder irrigation, instillation or washout reduce encrustations/blockages?
Does bladder irrigation, instillation or washout reduce symptomatic urinary tract infections?
Which catheters provide the best protection against urinary tract infections (impregnated
catheters, silicon catheters or latex catheters)?
c) Percutaneous gastrostomy feeding:

Use of syringes in enteral feeding systems.
d) Vascular-access devices:
Which dressings provide the best protection against centrally and peripherally inserted catheter-
related bloodstream infection (impregnated dressings, patch, patch plus plain dressings or plain
dressings)?
What is the most clinically- and cost-effective solution for:
o Decontaminating peripheral and centrally inserted catheter ports and hubs before access?
o Decontaminating skin when changing dressings?
What are the most clinically- and cost-effective methods for administering infusions or drugs in
order to prevent contamination?
e) Asepsis:
What are the most clinically- and cost-effective principles of asepsis when handling long-term
urinary catheters and vascular access devices?
f) Information and support for healthcare professionals, patients and carers:

What information do patients, carers and healthcare personnel require to prevent healthcare-
4
A.4.3.2 Clinical issues that will not be covered
a) Advice on the diagnosis, treatment or management of specific infections.
b) Procedures for the insertion of urinary catheters, percutaneous gastrostomies or vascular-access

devices.
c) Infection prevention measures for invasive procedures carried out by paramedic services, such as
at a major trauma, other than in the clinical areas listed in 4.3.1.
d) Decontamination or cleaning of the healthcare environment and equipment, other than the
clinical devices listed in 4.3.1.
A.4.4 Main outcomes

a) All cause mortality.
b) Short- and long-term infection-related mortality.
c) Short- and long-term infection-related morbidity.
d) Rates of patients presenting with a healthcare-associated infection or colonisation, such as MRSA.
e) Length of time to treat infection.
f) Infection related hospital admittance rates.
g) Short-, medium- and long-term quality of life.
h) Rates of needle stick injuries.
i) Costs (prevention costs net of treatment cost savings).
A.4.5 Economic aspects

Developers will take into account both clinical and cost effectiveness when making recommendations
involving a choice between alternative interventions. A review of the economic evidence will be
conducted and analyses will be carried out as appropriate. The preferred unit of effectiveness is the
quality-adjusted life year (QALY), and the costs considered will usually be only from an NHS and
personal social services (PSS) perspective. Further detail on the methods can be found in 'The
guidelines manual' (see ‘Further information’).
A.4.6 Status
A.4.6.1 Scope
This is the final scope.
A.4.6.2 Timing
The development of the guideline recommendations will begin in March 2010.
5
A.5 Related NICE guidance

A.5.1 Published guidance
A.5.1.1 NICE guidance to be updated
This guideline will update and replace the following NICE guidance:
Infection control. NICE clinical guideline 2 (2003). Available from www.nice.org.uk/guidance/CG2
A.5.1.2 Other related NICE guidance

Needle and syringe programmes. NICE public health guidance 18 (2009). Available from
www.nice.org.uk/guidance/PH18
Surgical site infection. NICE clinical guideline 74 (2008). Available from
www.nice.org.uk/gudiance/CG74
Antimicrobial prophylaxis against infective endocarditis in adults and children undergoing
interventional procedures. NICE clinical guideline 64 (2008). Available from
Urinary tract infection in children. NICE clinical guideline 54 (2007). Available from
Urinary incontinence. NICE clinical guideline 40 (2006). Available from
Tuberculosis. NICE clinical guideline 33 (2006). Available from www.nice.org.uk/guidance/CG33
Nutrition support in adults. NICE clinical guideline 32 (2006). Available from
A.6 Further information

Information on the guideline development process is provided in:
‘How NICE clinical guidelines are developed: an overview for stakeholders the public and the
NHS’
‘The guidelines manual’.
These are available from the NICE website (www.nice.org.uk/GuidelinesManual). Information on the
progress of the guideline will also be available from the NICE website (www.nice.org.uk).
6
Declarations of interests
Appendix B: Declarations of interests

B.1 Introduction
All members of the GDG and all members of the NCGC staff were required to make formal
declarations of interest at the outset of each meeting, and these were updated at every subsequent
meeting throughout the development process. No interests were declared that required any actions.
B.2 Declarations of interests of the GDG members

B.2.1 Carol Pellowe
GDG meeting Declaration of Interests
First GDG meeting CP declared she knew of no personal pecuniary interests, personal family
(17th March -18th March interests, non-personal pecuniary interests or personal non-pecuniary
2010) interests in the past 12 months or upcoming months.
Second GDG Meeting No interests to declare

(28th April 2010)
Third GDG Meeting No interests to declare
(10th June 2010)
Fourth GDG Meeting No interests to declare
(16th July 2010)
Fifth GDG Meeting No interests to declare
(6th September 2010)
Sixth GDG Meeting No interests to declare
(19th October 2010)
Seventh GDG Meeting No interests to declare
(17th November 2010)
Eighth GDG Meeting No Interests to declare
(17th December 2010)
Ninth GDG Meeting No Interests to declare
(8th February 2011)
Tenth GDG Meeting No Interests to declare
(18th March 2011)
Eleventh GDG Meeting No Interests to declare
(7th April)
Twelfth GDG Meeting No Interests to declare
(10th May)
Thirteenth GDG Meeting CP declared personal pecuniary interest – members yo the advisory group
(4th October) to Veneacare (pulpable products and maceration) Advisor to Pfizers e
learning antibiotics prescription model.
Fourteenth GDG Meeting No Interests to declare
th
(20 December)
7
B.2.3 Elizabeth Gibbs

First GDG meeting EG declared she knew of no personal pecuniary interests, personal family

(28th April 2010)
(10th June 2010)
(16th July 2010)
Fifth GDG Meeting Did not attend meeting
(19th October 2010)
Eighth GDG Meeting No interests to declare
(8th February 2011)
(18th March 2011)
(7th April)
(10th May)
Thirteenth GDG Meeting No Interests to declare
(4th October )
th
(20 December)
8
B.2.4 Ellie Hayter

First GDG meeting EH did not attend meeting on 17th, no interests to declare on 18th.EH
(17th March - 18th March declared she knew of no personal pecuniary interests, personal family
2010) interests, non-personal pecuniary interests or personal non-pecuniary
interests in the past 12 months or upcoming months.

(28th April 2010)
(10th June 2010)
(16th July 2010)
Sixth GDG Meeting Did not attend meeting
(19th October 2010)
Eighth GDG Meeting Did not attend meeting
(8th February 2011)
(18th March 2011)
Eleventh GDG Meeting Did not attend
(7th April)
(10th May)
(4th October )
th
(20 December)
9
B.2.5 Zara Head

th
First GDG meeting ZH did not attend meeting on 17 and had no interests to declare on the
th
(17th March -18th March 18 . ZH declared she knew of no personal pecuniary interests, personal
2010) family interests, non-personal pecuniary interests or personal non-
pecuniary interests in the past 12 months or upcoming months.

(28th April 2010)
Third GDG Meeting Did not attend meeting
(10th June 2010)
(16th July 2010)
(19th October 2010)
Ninth GDG Meeting No interests to declare
(8th February 2011)
Tenth GDG Meeting Did not attend meeting
(18th March 2011)
Eleventh GDG Meeting Did not attend meeting
(7th April)
Twelfth GDG Meeting Did not attend meeting
(10th May)
(4th October )
th
(20 December)
10
B.2.7 Eugenia Lee

First GDG meeting EL declared she knew of no personal pecuniary interests, personal family

(28th April 2010)
(10th June 2010)
(16th July 2010)
(19th October 2010)
Seventh GDG Meeting Did not attend meeting
Ninth GDG Meeting EL declared a personal non-pecuniary interest in Greenwich commissioning
(8th February 2011)
(18th March 2011)
Eleventh GDG Meeting Did not attend
(7th April)
Twelfth GDG Meeting No interests to declare
(10th May)
(4th October )
th
(20 December)
11
B.2.8 Michael Nevill

First GDG meeting MN declared he knew of no personal pecuniary interests, personal family
(28th April 2010)
(10th June 2010)
(16th July 2010)
(19th October 2010)
(8th February 2011)
Tenth GDG Meeting No interests to declare
(18th March 2011)
Eleventh GDG Meeting No interests to declare
(7th April)
(10th May)
(4th October )
th
(20 December)
12
B.2.9 Brian Pullen

First GDG meeting BP declared he knew of no personal pecuniary interests, personal family

(28th April 2010)
(10th June 2010)
(16th July 2010)
Sixth GDG Meeting Did not attend meeting
(19th October 2010)
(8th February 2011)
Tenth GDG Meeting Did not attend
(18th March 2011)
(7th April)
(10th May)
(4th October )
Fourteenth GDG Meeting Did not attend
th
(20 December)
13
B.2.10 Godfrey Smith

First GDG meeting GS declared he knew of no personal pecuniary interests, personal family

(28th April 2010)
(10th June 2010)
Fourth GDG Meeting Did not attend meeting
(16th July 2010)
(19th October 2010)
14
B.2.11 Julian Spinks

First GDG meeting JS declared he knew of no personal pecuniary interests in the past 12 months. JS
(17th March -18th declared upcoming personal pecuniary interests. He is due to record an
March 2010) educational video on overactive bladder on 1st April 2010 and will receive an
honorarium indirectly from Pfizer UK. On 5th May 2010 he will lecture on
overactive bladder and receive an honorarium from Pfizer UK.
JS declared non-personal pecuniary interests. Since 2008 he has been an ongoing

member of the faculty of Sense of Leadership, a conference supported by Pfizer.
He was an editorial board member of Continence UK (2007 – June 2010), a
journal and conference which received sponsorship and advertising revenue
from a number of pharmaceutical and healthcare product manufacturers.
JS declared personal non-pecuniary interests; since October 2008 he has been a

GP advisor to the Association for Continence Advice; since June 2008 an elected
member of the Kent Local Medical Committee of the BMA; since October 2008 a
press officer of the Dartford, Gravesham and Medway Division of the BMA; and
since August 2009 he has also been a member of ‘Devices 4 Dignity’, an
organisation that promotes development of devices supporting patients with
urinary problems. These personal non-pecuniary interests are all ongoing.
No action for any of the above declarations was deemed necessary, as no

evidence for any clinical area stated in the scope was presented at this two day
meeting.
Second GDG Meeting JS declared no new interests to those declared at the previous meeting.
(28th April 2010)
No action was deemed necessary for the previous declarations, as any payment
received for consultancy work did not relate to the clinical area of types of long
term urinary catheters presented at the meeting.
Third GDG Meeting JS declared a personal pecuniary interest; he received an honorarium from Pfizer
(10th June 2010) and Novartis for speaking at lectures and advisory boards on overactive bladder.
He declared that he knew of no other personal family interest, non-personal
pecuniary interest or personal non-pecuniary interest above those already
declared.
No action for these declarations was deemed necessary, as any payment

received for consultancy work did not relate to the clinical areas for long term
urinary catheters presented at the meeting.
Fourth GDG Meeting Did not attend meeting
(16th July 2010)
Fifth GDG Meeting JS declared a personal pecuniary interest; he received payment from Novartis in
(6th September 2010) September 2010 for consultancy work on an overactive bladder treatment,
which included reviewing documents and offering advice on a clinical pathway.
He declared that he knew of no other personal family interest, non-personal
pecuniary interest or personal non-pecuniary interest above those already
declared.
No action for these declarations was deemed necessary, as any payment
received for consultancy work did not relate to the clinical areas for types of long
term urinary catheters, VADs or PEGs presented at the meeting.
(19th October 2010)
15

(8th February 2011)
(18th March 2011)
(7th April)
(10th May)
(4th October )
Fourteenth GDG Did not attend meeting
Meeting
th
(20 December)
16
B.2.12 Sally Stucke

First GDG meeting SS declared she knew of no personal family interests, personal pecuniary
(17th March -18th March interests, non-personal pecuniary interest or personal non-pecuniary
2010) interest in the past 12 months or upcoming month.

(28th April 2010)
(10th June 2010)
(16th July 2010)
(19th October 2010)
Ninth GDG Meeting Did not attend meeting
(8th February 2011)
(18th March 2011)
Eleventh GDG Meeting Did not attend meeting
(7th April)
(10th May)
(4th October )
Fourteenth GDG Meeting Did not attend meeting
th
(20 December)
17
B.2.13 Graham Tanner

First GDG meeting GT declared he knew of no personal pecuniary interests, personal family

(28th April 2010)
(10th June 2010)
(16th July 2010)
(19th October 2010)
(8th February 2011)
(18th March 2011)
(7th April)
(10th May)
(4th October )
th
(20 December)
18
B.2.14 Sue Wright

First GDG meeting SW declared she knew of no personal pecuniary interests, personal family
(17th March -18th March interest, non-personal pecuniary interest or personal non-pecuniary
2010) interest in the past 12 months or upcoming month.

(28th April 2010)
(10th June 2010)
(16th July 2010)
(19th October 2010)
Seventh GDG Meeting Did not attend meeting
Ninth GDG Meeting Did not attend meeting
(8th February 2011)
(18th March 2011)
(7th April)
(8th May)
(4th October )
th
(20 December)
19
B.3 Declarations of interests of the cooptees

Cooptee Declaration of Interests
Ms Kelly Alexander Personal pecuniary interest: consultancy work for advisory board for
pharmacy management, sponsored by Baxter.
Dr Paul Averley None declared
Ms Daphne Colpman None declared
Mr Andrew Jackson Non-personal pecuniary interest: Manage an IV website and consultancy
company (IVTEAM.com).
Ms Vera Todorvic Personal non-pecuniary interests: I am a member of both the PENG
(Parenteral and Enteral Nutrition Group ) of the British Dietetic Association
and BAPEN ( British Association for Parenteral and Enteral Nutrition
Proffessor Mark Wilcox Personal pecuniary interests: received research support from Actelion,
bioMerieuc, Cerexa, Novacta, Pfizer, Summit and the Medicines company.
Received paid consultancies or lecture honoraria from Actelion, Astellas,
AstraZeneca, Bayer, bioMerieuc, Cerexa, MSD, Nabriva, Novacta, Pfizer,
Photopharmica, the Medicines company and Viropharma.
20
List of stakeholders
Appendix C: List of stakeholders

3M Health Care Limited
Abbott Laboratories Limited
African Health Policy Network
Alder Hey Children's NHS Foundation Trust
Anglian Community Enterprise
Ark Therapeutics Ltd
Aspen Medical Europe Ltd
Association for Continence Advice
Association of British Health-Care Industries
Association of Dance Movement Psychotherapy UK
Association of Paediatric Anaesthetists of Great Britain and Ireland
Astellas Pharma Ltd
Augustine Biomedical International
Barchester Healthcare
Bard Limited
Barnsley Hospital NHS Foundation Trust
Baxter Healthcare Ltd
BD (Beckton, Dickinson and Company)
Berkshire Healthcare NHS Foundation Trust
Birmingham City University
BMJ
Bolton PCT
Brighton and Sussex University Hospitals Trust
British Association of Otolaryngologists Head and Neck Surgeons (ENT UK)
British Association of Social Workers
British Dental Association
British Dietetic Association
British Elbow and Shoulder Society (BESS)
British Healthcare Trades Association
British In Vitro Diagnostics Association
21
British Infection Association (formerly Association of Medical Microbiologists)
British Infection Association (formerly British Infection Society)
British Medical Association (BMA)
British National Formulary (BNF)
British Orthopaedic Association
British Paediatric Allergy, Immunity & Infection Group
British Pain Society
British Psychodrama Association
British Psychological Society, The
British Renal Society
British Society of Immunology
Cambridge Temperature Concepts Ltd
Cambridge University Hospitals NHS Foundation Trust (Addenbrookes)
Camden and Islington Mental Health and Social Care Trust
Cancer Voices
Care Quality Commission (CQC)
Central & North West London NHS Foundation Trust
CJD Support Network
CLIC Sargent
Cochrane Wounds Group
Colchester Hospital University NHS Foundation Trust
College of Optometrists
Coloplast Limted
Connecting for Health
ConvaTec
Cook Medical
Cornwall & Isles of Scilly PCT
County Durham PCT
Covidien UK Commercial
Craegmoor
Danone UK Limited
Dental Practitioners Association

22
Department for Communities and Local Government
Department of Health
Department of Health Advisory Committee on Antimicrobial Resistance and Healthcare Associated

Infection (ARHAI)
Department of Health, Social Services & Public Safety, Northern Ireland (DHSSPSNI)
Derbyshire Mental Health Services NHS Trust
Dermal Laboratories Ltd
DH Advisory Committee on Antimicrobial Resistance and Healthcare Associated Infection
Diving Diseases Research Centre, The
Dorset PCT
Dyson Ltd
Elective Orthopaedic Centre, The
English Community Care Association (ECCA)
Enturia Ltd
Eusapharma (Europe) Ltd
Faculty of Dental Surgery
Faculty of General Dental Practice
Faculty of Intensive Care Medicine
Federation of Ophthalmic & Dispensing Opticians (FODO)
Forest Laboratories UK Limited
Fresenius Medical Care
General Dental Council
George Eilot Hosptal Trust
Gloucestershire Hospitals NHS Trust
Gloucestershire LINk
Great Western Hospitals NHS Foundation Trust
Greater Manchester West Mental Health NHS Foundation Trust
Greater Manchester West Mental Health NHS Foundation Trust
Guy's and St Thomas NHS Foundation Trust
Haag-Streit UK
Hampshire Partnership NHS Foundation Trust
Hayward Medical Communications
23
HCAI SURF(service Users in Research Forum)
Health Protection Agency
Health Protection Scotland
Healthcare Improvement Scotland
Healthcare Quality Improvement Partnership
Herpes Viruses Association
Hertfordshire Partnership NHS Trust
Hospital Infection Society
Hull and East Yorkshire Hospitals NHS Trust
Humber NHS Foundation Trust
ICNet International
Infection Prevention Society
Insitute of Biomedical Science
Interhealth Canada
Janssen
JBOL Ltd
Johnson & Johnson Medical
Karomed Limited
KCI Europe Holding B.V.
KCI Medical Ltd
Kent & Medway NHS and Social Care Partnership Trust
King's College London Dental Institute
Lambeth Community Health
Lancashire Care NHS Foundation Trust
Launch Diagnostics Limited
Leeds PCT
Leicestershire Partnership NHS Trust & Managed Clinical Network for PD
Letterkenny General Hospital
Leukaemia & Lymphoma Research
Liverpool Community Health
Liverpool PCT
Liverpool PCT Provider Services

24
London Ambulance Service NHS Trust
Lothian University Hospitals Trust
Luton & Dunstable Hospital NHS Foundation Trust
Maidstone and Tunbridge Wells NHS Trust
Manchester Community Health
MAST Group
Medicines and Healthcare Products Regulatory Agency (MHRA)
Medihoney (Europe) Ltd
Medway Community Centre
Medway NHS Foundation Trust
Ministry of Defence (MoD)
Monitor - Independent Regulator of NHS Foundation Trusts
Mother and Child Foundation
MRSA Action UK
National Care Forum
National Concern for Healthcare Infections (NCHI)
National Day Nurseries Association
National Electronic Library for Infection
National Infusion & Vascular Access Society
National Patient Safety Agency (NPSA)
National Pharmacy Association
National Treatment Agency for Substance Misuse
Nestor Healthcare Group Ltd
NETSCC, Health Technology Assessment
Newcastle and North Tyneside Community Health
NHS Clinical Knowledge Summaries Service (SCHIN)
NHS Direct
NHS East of England
NHS Forth Valley
NHS Knowsley
NHS Plus
NHS Sefton
25
NHS Sheffield
NHS Western Cheshire
Nordic Surgical Ltd.
North Essex Partnership NHS Foundation Trust
North Somerset PCT
North Staffordshire Combined Healthcare NHS Trust
North West London Perinatal Network
Northampton Primary Care NHS Trust
Nottingham University Hospitals NHS Trust
Nottinghamshire Acute Trust
Nottinghamshire Healthcare NHS Trust
Nutricia Ltd (UK)
Nuture Antenatal
Offender Health - Department of Health
Outer North East London Community Services
Owen Mumford Ltd
Oxford Health NHS Foundation Trust
Paediatric Intensive Care Society
Patient's Association
Patients Council
Pennine Healthcare
PERIGON Healthcare Ltd
Pfizer Limited
Pilgrims Hospices in East Kent
PINNT
Plymouth Local Involvement Network
Poole and Bournemouth PCT
Public Health Medicine Environmental Group (PHMEG)
Public Health Wales
Queen Victoria Hospital NHS Trust
Retreat, The
Reusable Healthcare Textiles Association

26
Richard Wells Research Centre
Robinson Healthcare Ltd
Roche Diagnostics
Rotherham NHS Foundation Trust
Royal Berkshire NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
Royal College of Anaesthetists
Royal College of General Practitioners
Royal College of General Practitioners Wales
Royal College of Midwives
Royal College of Nursing
Royal College of Obstetricians and Gynaecologists
Royal College of Paediatrics and Child Health
Royal College of Pathologists
Royal College of Physicians London
Royal College of Psychiatrists
Royal College of Radiologists
Royal College of Surgeons of England
Royal Free Hospital NHS Trust
Royal Pharmaceutical Society of Great Britain
Royal Society of Medicine
Sanctuary Care
Sandwell PCT
Sanofi-Aventis
Scottish Intercollegiate Guidelines Network (SIGN)
Sheffield Children's NHS Foundation Trust
Sheffield Health and Social Care Foundation Trust
Sheffield PCT
Sheffield Teaching Hospitals NHS Foundation Trust
Sickle Cell Society
Smith & Nephew Healthcare
Social Care Institute for Excellence (SCIE)

27
Social Exclusion Task Force
Society and College of Radiographers
Society for Acute Medicine
Society of British Neurological Surgeons
Society of Chiropodists & Podiatrists
Solent Healthcare
South Asian Health Foundation
South East Coast Ambulance Service
South Essex Partnership NHS Foundation Trust
South Staffordshire & Shropshire NHS Foundation Trust
South Staffordshire PCT
South West Yorkshire Partnership NHS Foundation Trust
South Western Ambulance Service NHS Foundation Trust
Southport & Ormskirk Hospital NHS Trust
Spinal Injuries Association
St Andrew's Healthcare
St Marys Hospital, Manchester
StickSafe
Sue Ryder Care
Surgical Dressing Manufacturers Association (SDMA)
Sussex Partnership NHS Foundation Trust
Synergy Healthcare (UK) Limited
Tees Esk & Wear Valleys NHS Trust
The Association of safe Aseptic practice
The Society and College of Radiographers
The Urology Trade Association
Trafford NHS Provider Services
Turning Point
UK Clinical Pharmacy Association (UKCPA)
UK Ophthalmic Pharmacy Group
UNISON
United Kingdom Clinical Pharmacy Association (UKCPA)

28
United Lincolnshire Hospitals NHS Trust
University Hospitals Birmingham NHS Foundation Trust
University of Southampton
Urgo Medical Ltd
Urology User Group Coalition
Vifor Pharma UK Ltd
Welsh Government
Welsh Scientific Advisory Committee (WSAC)
West Hertfordshire PCT & East and North Hertfordshire PCT
Western Cheshire Primary Care Trust
Western Health and Social Care Trust
Wirral University Teaching Hospital NHS Foundation Trust
Worcestershire Acute Hospitals NHS Trust
Worcestershire PCT
Wound Care Alliance UK
Xpand Medical Ltd
York Teaching Hospital NHS Foundation Trust
29
(partial update)
Infection prevention and control (update)
2003 guideline appendices
Appendix D: 2003 guideline appendices

D.1 Methods and systematic review process (2003) ....................................................................31
D.2 Full scope (2003) ..................................................................................................................38
D.3 Search strategy (2003) .........................................................................................................40
D.4 Key audit criteria (2003) .......................................................................................................46
D.5 AGREE Monitoring Appraisal Forms (2003) ...........................................................................50
D.6 Evidence tables (2003) .........................................................................................................61
D.7 Rejected studies (2003) ...................................................................................................... 120
D.8 Summary of recommendations (2003) ................................................................................ 140
D.9 Text removed from previous guideline (2003) ..................................................................... 148
D.10Deleted and amended recommendations (2003) ................................................................ 159
30
D.1 Methods and systematic review process

D.1.1 Methods
Following critical appraisal, the evidence was tabulated and reports written for each review question.
The evidence was graded using the categories described by Eccles and Mason (2001)116 and
reproduced below:
Catagories of evidence
Ia Evidence form meta-analysis of randomised controlled trials
Ib Evidence from at least one randomised controlled trial
IIa Evidence from at least one controlled trial without randomisation
IIb Evidence from at least one other type of quasi-experimental study
III Evidence from non-experimental descriptive studies, such as comparative studies,

correlation studies and case-control studies
IV Evidence from expert committees reports or opinions and/or clinical experience of respected
authorities
The grading scheme suggested by Eccles and Mason (2001)116 was used to define the strength of
recommendation and is reproduced below.
Recommendation grade Evidence
A Directly based on category 1 evidence
B Directly based on:
Category II evidence, or
Extrapolated recommendation from category 1 evidence
C Directly based on:
Category III evidence, or
Extrapolated recommendation from category I or II
evidence
D Directly based on:
Category IV evidence, or
Extrapolated recommendation from category I,II or III
evidence
External consultation
These guidelines have been subject to extensive external consultation with registered stakeholders
(see NICE website for consultation process and stakeholders). The guidelines will be reviewed in two
years (2005).
D.1.2 Systematic review process
D.1.2.1 Standard principles
Systematic review process
Five sets of guidelines were identified as a result of the search for national and international
guidelines. These were retrieved and appraised using the AGREE instrument466. The appraisal for the
31
epic phase 1 guidelines was undertaken by three external independent appraisers381. These were
regarded as sufficiently robust to be used as a basis for these guidelines with additional searches for
outstanding questions (SP Appendix 1).
After appraisal, search questions were developed from advice received from focus groups,
stakeholders and our specialist advisers (Appendix SP2). The following systematic review questions
were used:
Hand hygiene search questions:

1. What is the evidence that contaminated hands are a cause of healthcare-associated infection?
2. Which hand disinfection agents are the most effective at removing / reducing organisms
responsible for healthcare-associated infection?
3. When must hands be disinfected in relation to patient care activities?
4. What is the most effective hand washing technique for removing / reducing organisms
5. Which hand disinfection agents are least toxic to users?
6. Is there any cost effectiveness evidence relating to the above?
7. What are the training and education implications for staff and patients?
In setting up the search the following MeSH terms were used: infection control; cross infection;
universal precautions, equipment contamination; disease transmission; chlorhexidine; disinfectants;
soaps; anti-infective agents; surface-active agents; handwashing; hand; skin; epidermis; nails. In
addition, the following thesaurus and free text terms were used: antisepsis; sterilisation;
decontamination.
These databases were searched from 1998 onwards: Medline, Cumulated Index of Nursing and Allied
Health Literature (CINAHL), Embase, The Cochrane Library, National Electronic Library for Health, The
NHS Centre for Reviews and Dissemination (CRD), The National Research Register, The Web of
Science, The Institute of Health Technology, Health CD Database, Health Management Information,
Consortium Database.
Search Results: 21219 articles were identified. These articles were initially sifted to determine if they
related to infections associated with hand hygiene, were written in English, were primary research or
were a systematic review or a meta-analysis, and appeared to inform one or more of the review
questions. Following this first sift, 160 full text articles were retrieved. Using the same criteria as in
the first sift, retrieved full-text articles were then re-sifted to select those for critical appraisal. A total
of 24 full text articles were independently critically appraised by two appraisers. Consensus and
grading was achieved through discussion. Following critical appraisal, 23 were accepted into the
study (1 was rejected).
Protective clothing search questions:

1. Which glove materials are least toxic to healthcare workers (HCWs) for general use?
2. What is the evidence that hands need to be disinfected following the use of gloves?
3. What is the evidence that HCWs use gloves appropriately, as a part of Standard Principles?
4. What is the evidence that the uniforms / clothes of HCWs are a source of healthcare-associated
infection?
5. What is the evidence that the use of protective clothing reduces the incidence of healthcare-
associated infection?
32
universal precautions; equipment contamination; disease transmission; protective clothing;
disposable equipment; masks; protective gloves; eye protective devices. In addition the following
thesaurus and free text terms were used: antisepsis; disinfection; sterilisation; decontamination; face
shield; goggles; apron; uniform; gown; clothing; visor; hood.
The databases were searched as described above.
related to infections associated with personal protective equipment, were written in English, were
primary research or were a systematic review or a meta-analysis, and appeared to inform one or
more of the review questions. Following this first sift, 95 full text articles were retrieved. Using the
same criteria as in the first sift, retrieved full-text articles were then re-sifted to select those for
critical appraisal. A total of 7 full text articles were independently critically appraised by two
appraisers. Consensus and grading was achieved through discussion. Following critical appraisal, all
were accepted into the study.
Sharps search questions:

1. What is the evidence that recommended modes of use and disposal of sharps reduce the
incidence of sharps injury in healthcare workers?
2. What is the evidence that education and training interventions improve healthcare workers
adherence to recommended modes of practice?
3. What is the evidence that the use of needle-free devices reduce occupational exposure to
bloodborne pathogens?
universal precautions, equipment contamination; disease transmission; needlestick injuries; needles;
syringes; occupational exposure; occupational accident; medical waste disposal; blood-borne
pathogens. In addition the following thesaurus and free text terms were used: antisepsis;
disinfection; sterilisation; decontamination; blood-borne virus; exposure prone procedure; post
exposure prophylaxis; sharp; puncture; percutaneous injury; epi pen; vacutainer; resheath.
The databases were searched as described above.
related to the safe use and disposal of sharps, were written in English, were primary research or
were a systematic review or a meta-analysis, and appeared to inform one or more of the review
questions. Following this first sift, 84 full text articles were retrieved. Using the same criteria as in the
first sift, retrieved full-text articles were then re-sifted to select those for critical appraisal. A total of
4 full text articles were independently critically appraised by two appraisers. Consensus and grading
was achieved through discussion. Following critical appraisal, all were accepted into the study.
Evidence tables for accepted and rejected studies were generated and used to create summary
reports, including evidence grades (Appendix SP3). The summary reports were used as the basis for
guideline writing.
D.1.2.2 Urinary catheterisation
Two sets of guidelines were identified as a result of the search for national and international
guidelines. These were retrieved and appraised using the AGREE instrument.466 The appraisal for the
epic phase 1 guidelines was undertaken by two external independent appraisers.381 These were
33
regarded as sufficiently robust to be used as a basis for these guidelines with additional searches for
outstanding questions (Appendix UC1).
stakeholders and our specialist advisers (Appendix UC2). The following systematic review questions
were used:
1. If it is necessary to catheterise, which approach – indwelling urethral*/ suprapubic /intermittent
results in the lowest rates of infection?
2. Is the management or type of drainage system a factor in colonisation/infection?
3. Is the frequency or method of changing catheters (indwelling, suprapubic) a factor in
colonisation/infection?
4. Does monitoring urinary pH assist in the prevention of encrustation and blockage of long term
indwelling catheters?
5. Which catheters materials cause least irritation / encrustation / blockage?
6. Does the use of bladder irrigation / instillation* / washout*, prevent / reduce encrustation and
symptomatic urinary tract infection?
7. Does the use of antibiotic prophylaxis at the time of changing catheters reduce symptomatic
infection?
8. Which method of cleaning and storing intermittent catheters result in the lowest rates of
colonisation/infection?
10.What are the training and education implications for staff and patients?
community-acquired infections; disease transmission; urinary tract infections; urinary
catheterization; indwelling catheters; antibiotic prophylaxis; irrigation; biofilms; hydrogen ion
concentration; urease; proteus; proteus infections; providencia; morganella. In addition the
following thesaurus and free text terms were used: intermittent catheterisation; uretheral
catheterisation; suprapubic catheterisation; bacteriuria*; pyuria; encrustation; blockage; non
blocker; bladder irrigation; washout; bladder instillation.
These databases were searched from 1985 onwards: Medline, Cumulated Index of Nursing and Allied
Health Literature (CINAHL), Embase, The Cochrane Library, National Electronic Library for Health, The
NHS Centre for Reviews and Dissemination (CRD), The National Research Register, The Web of
Science, The Institute of Health Technology, Health CD Database, Health Management Information,
related to infections associated with long term urinary catheters, were written in English, were
primary research or were a systematic review or a meta-analysis, and appeared to inform one or
more of the review questions. Following this first sift, 978 full text articles were retrieved. Using the
same criteria as in the first sift, retrieved full-text articles were then re-sifted to select those for
critical appraisal. A total of 75 full text articles were independently critically appraised by two
appraisers. Consensus and grading was achieved through discussion. Following critical appraisal, 34
were accepted into the study (41 were rejected).
reports, including evidence grades (Appendix UC3). The summary reports were used as the basis for
guideline writing.
Following our reviews, guidelines were drafted which described 28 recommendations within the
below 5 intervention categories:
34
1. Education of patients, their carers and healthcare personnel;

2. Assessing the need for catheterisation;
3. Selection of catheter drainage system;
4. Catheter insertion;
5. Catheter maintenance.
D.1.2.3 Enteral feeding
Three sets of guidelines were identified as a result of the search for national and international
guidelines. These were retrieved and appraised using the AGREE instrument.466 As all were written
prior to 1995, they did not score highly in some areas and their contribution has been used as expert
opinion only. (See Appendix EF1)
stakeholders and our specialist advisers (See Appendix EF2). The following systematic review
questions were used:
1. Was one type of feeding system superior to others in terms of infection rates?
2. Did the administration of the feed contribute to infection?
3. Was it safe to reuse equipment used in the administration of feeds?
4. Were there any storage issues that contribute to infection?
5. Was the stoma site a source of infection?
6. Was there any cost effectiveness evidence relating to the above?
7. What were the training and education implications for staff and patients?
In setting up the search the following MeSH terms were used: cross infection; community acquired
infection; infection control; food contamination; equipment contamination; enteral nutrition,
nutritional support, gastrostomy, gastroenterostomy, jejunostomy. In addition the following
thesaurus and free text terms were used: home nutrition; home artificial nutrition; PEG feed; tube
feed; tube nutrition; gastric feed; gastric nutrition; enteral feed; enteric feed; nasoenteric;
intragastric; post-pyloric; percutaneous; transpyloric; gastrojejunostomy; gastroduodenostomy;
duodenostomy.
These databases were searched from 1990: Medline, Cumulated Index of Nursing and Allied Health
Literature (CINAHL), Embase, The Cochrane Library, National Electronic Library for Health, The NHS
Centre for Reviews and Dissemination (CRD), The National Research Register, The Web of Science,
The Institute of Health Technology, Health CD Database, Health Management Information,
related to infections associated with enteral feeding, were written in English, were primary research
or were a systematic review or a meta-analysis, and appeared to inform one or more of the review
study (12 were rejected).
reports, including evidence grades (Appendix EF3). The summary reports were used as the basis for
guideline writing.
35
Guidelines were then drafted which described 15 recommendations within the below 4 intervention
categories:
1. Education of patients, their carers and healthcare personnel;
2. Preparation and storage of feeds;
3. Administration of feeds;
4. Care of insertion site and enteral feeding tube.
D.1.2.4 Central venous catheters
After this appraisal, we systematically searched, retrieved and appraised additional supporting
evidence published since the HICPAC guidelines were developed (CVC Appendix 2). This search was
confined to elements of infection prevention where expert members of the Guideline Development
Group indicated new developments or changes in technology had occurred, or where pertinent new
experimental trials or systematic reviews had been published.
The following systematic review questions were used:

1. Should the catheter insertion site be protected by a dressing and, if so, which type of dressing
should be used and how frequently should it be changed?
2. Which antiseptic/disinfectant was best for: preparation of the skin site (cutaneous antisepsis)
prior to central venous catheter insertion; cleansing of the entry site once the catheter was in
place (if any such evidence exists that routine cleansing prevents infections); cleaning the catheter
hub and/or injection ports prior to accessing the system?
3. Should the catheter be routinely flushed before or after accessing. If so, which solution, e.g.,
heparin or normal saline, should be used?
4. Would low-dose systemic anticoagulation reduce the risk of bloodstream infections?
5. Was the maintenance of a closed system, e.g., Vygon Bionector 2 Connection Accessory,
practicable, effective in reducing infection complications, and cost-effective?
6. Did stopcocks and three-way taps increase the risk of catheter colonisation* and/or bloodstream
infections?
7. Did the use of inline filters (in-line filtration of microbes/endotoxins) prevent bloodstream
infections?
8. How frequently should the intravenous catheter administration set be changed?
In setting up the search the following MeSH terms were used: Infection control; cross infection;
universal precautions; equipment contamination; disease transmission; bacteremia; chlorhexidine;
povidone-iodine; anticoagulants; sepsis; central venous catheterisation; indwelling catheters;
parenteral nutrition. In addition the following free text terms were used: PICC; TPN; catheter hub;
catheter port; dressings; flushing solutions.
These databases were searched from 1998: Medline, Cumulated Index of Nursing and Allied Health
Literature (CINAHL), Embase, The Cochrane Library, National Electronic Library for Health, The NHS
Centre for Reviews and Dissemination (CRD), The National Research Register, The Web of Science,
The Institute of Health Technology, Health CD Database, Health Management Information,
Search Results: 4650 articles were located. They were initially sifted to determine if they related to
infections associated with central venous catheters, were written in English, were primary research
or were a systematic review or a meta-analysis, and appeared to inform one or more of the review
36
study (7 were rejected).
Evidence tables for accepted and rejected studies were generated and used to create evidence
summary reports (see CVC Appendix 3). The summary reports along with the primary evidence from
the Expert Review of the HICPAC Guidelines, were used as the basis for guideline writing.
Previously, a similar process had informed the development of national guidelines for preventing
CRBSI in hospitals associated with the insertion and maintenance of CVCs commissioned by the
Department of Health (England) and published in 2001.381 It is expected that patients in primary and
community care settings would have a CVC inserted or replaced in hospital where these guidelines
apply. Consequently, recommendations for the selection of the best type of catheter and insertion
site and the optimum aseptic technique required during CVC placement are not included in guidance
for community and primary healthcare personnel* as these issues are addressed in the above
guidelines for acute care facilities. However, it is good practice for hospital and relevant community
nursing staff to discuss in advance the selection of the most appropriate type of catheter in relation
to the available skills and resources in the community to care for patients with different types of
central vascular access devices.
Education of patients, their carers and healthcare personnel;

1. General asepsis;
2. Catheter site care;
3. Standard principles for catheter management.
These guidelines apply to caring for all adults and children in the community with CVCs which are
being used for the administration of fluids, medications, blood components and/or total parenteral
nutrition (TPN). They should be used in conjunction with the recommendations on Standard
Principles for preventing healthcare-associated infections (HAI).
Although these recommendations describe general principles of best practice that apply to all
patients in the community using long-term central vascular access devices, they do not specifically
address the more technical aspects of the care of patients receiving haemodialysis, who will
generally have their CVCs managed in dialysis centres.
Because these recommendations describe broad general statements of best practice, they need to
be adapted and incorporated into local practice guidelines.
37
D.2 Full scope (2003)

D.2.1 Objective
The National Institute for Clinical Excellence has commissioned a clinical guideline for patients, carers
and clinicians on the prevention of healthcare associated infection (HCAI) in primary and community
care. The guideline will provide advice on effective and cost-effective care using the best available
evidence.
The commission received from the Department of Health and the National Assembly for Wales
We would like NICE to produce a guideline on infection control in primary and community care.
This guideline will be expected to address a standard approach to preventing and controlling
healthcare associated infections in primary and community care and additional guidance for selected
healthcare interventions with a potential risk for infection.
D.2.2 Title
Clinical guideline for the prevention and control of healthcare associated infection in primary and
community care.
D.2.3 Clinical Need and Practice

As complex care is increasingly performed in primary and community care settings, the risk of
infections associated with healthcare interventions increases. This can result in increased morbidity
and mortality, greater costs and use of resources and profound consumer dissatisfaction.
This guideline will assist clients and all healthcare providers involved in direct patient care to
minimise the risk of infection.
Guideline developers will work closely with service users and carers to ensure that the guidelines are
understandable to clients and their carers.
D.2.4 Population
This guideline will apply to patients of all ages receiving healthcare interventions in primary and
community care.
D.2.5 Health care setting

The guideline will cover the care received from primary and community health care professionals
who have direct contact with and make decisions concerning the care of patients and will offer 'best
practice' advice on preventing healthcare-associated infections. It will describe a standard set of
infection prevention measures that anyone giving or receiving care in primary and community care
can follow.
The guideline will also be compatible with guidelines for the prevention of hospital-acquired
infections, and will influence discharge planning.
This is an NHS guideline. Although it will address the interface with other services, such as those
provided by social services, secure settings and the voluntary sector, it will not include services
exclusive to these sectors.
38
D.2.6 Interventions and treatment

In addition to standard principles for preventing healthcare associated infections, the guideline will
describe measures for preventing infections associated with the use of long-term urinary catheters,
central venous catheters and enteral feeding systems.
This guideline will be appropriate for use in preventing infections associated with all direct care
activities. It will also assist clients to prevent infections when managing aspects of their own care.
This guideline will focus on using a 'standard approach' for preventing infections and will include
issues associated with:
hand hygiene;
use of personal protective equipment;
use and disposal of needles and sharp instruments.
This guideline will not include advice on the diagnosis, treatment and management of specific
infections.
This guideline will not include advice on the insertion of central venous catheters or enteral feeding
systems as these activities are carried out in acute care facilities.
D.2.7 Presentation
The guideline will be available in three forms:
4. The full guideline containing the evidence base used by the developers.
5. A short form version, using a standard template, which will form the Institute's guidance to the
NHS including a clinical practice algorithm.
6. The guideline will be accompanied by a version prepared specifically for patients and their carers.
This patient/carer version will interpret the recommendations made in the Institute's short form
version and will be designed to help patients to make informed choices about their care.
D.2.8 Status
This scoping statement has been the subject of a four week period of consultation with stakeholders.
The scope has been re-drafted and submitted to the Guidelines Advisory Committee and
subsequently the Institute's Guidance Executive, for approval. The development of the guideline will
begin in the autumn of 2001.
Information on the guidelines development process, stakeholder involvement and the progress of
this guideline is available on the website http://www.nice.org.uk/.
39
D.3 Search strategy (2003)

D.3.1 Hand Hygiene - Systematic Review Process
D.3.1.1 Systematic Review Questions
Search questions:
1. What is the evidence that contaminated hands are a cause of healthcare-associated infection?
2. Which hand disinfection agents are the most effective at removing / reducing organisms
3. When must hands be disinfected in relation to patient care activities?
4. What is the most effective hand washing technique for removing / reducing organisms
5. Which hand disinfection agents are least toxic to users?
D.3.1.2 Databases and Search Terms Used
DATABASES
MEDLINE, CUMULATED INDEX OF NURSING AND ALLIED HEALTH LITERATURE (CINAHL), EMBASE, THE
COCHRANE LIBRARY, THE NATIONAL ELECTRONIC LIBRARY FOR HEALTH, THE NHS CENTRE FOR
REVIEWS AND DISSEMINATION (CRD), THE NATIONAL RESEARCH REGISTER, THE WEB OF SCIENCE,
THE INSTITUTE OF HEALTH TECHNOLOGY, HEALTH CD DATABASE , HEALTH MANAGEMENT
INFORMATION CONSORTIUM DATABASE.
MESH TERMS
infection control; cross infection; universal precautions, equipment contamination; disease

transmission; chlorhexidine; disinfectants; soaps; anti-infective agents; surface-active agents;
handwashing; hand; skin; epidermis; nails.
THESAURUS AND FREE TEXT TERMS
antisepsis; sterilisation; decontamination
D.3.1.3 Search Results
Total number of articles located = 21219
Sift 1 Criteria
Abstract indicates that the article: relates to infections associated with hand hygiene, is written in
English, is primary research or a systematic review or a meta-analysis, and appears to inform one or
more of the review questions.
Articles Retrieved
Total number of articles retrieved from sift 1 = 160
40
Sift 2 Criteria
Full Text confirms that the article relates to infections associated with hand hygiene is written in
English, is primary research or a systematic review or a meta-analysis, and informs one or more of
the review questions.
Articles Selected for Appraisal
Total number of articles selected for appraisal during sift 2 = 24
D.3.1.4 Critical Appraisal
All articles which described primary research, a systematic review or, a meta-analysis and met the sift
2 criteria were independently critically appraised by two appraisers. Consensus and grading was
achieved through discussion.
Accepted and Rejected Evidence
Total number of articles accepted after critical appraisal = 23
Total number of articles rejected after critical appraisal = 1
D.3.1.5 Evidence Tables
summary reports. The summary reports were, in turn, used as the basis for guideline writing.
D.3.2 Protective Clothing - Systematic Review Process
Search questions:
1. Which glove materials are least toxic to health care workers (HCWs) for general use?
2. What is the evidence that hands need to be disinfected following the use of gloves?
3. What is the evidence that HCWs use gloves appropriately, as a part of Standard Principles?
4. What is the evidence that the uniforms / clothes of HCWs are a source of healthcare-associated
infection?
5. What is the evidence that the use of protective clothing reduces the incidence of healthcare-
associated infection?
DATABASES
41
MESH TERMS
infection control; cross infection; universal precautions; equipment contamination; disease

transmission; protective clothing; disposable equipment; masks; protective gloves; eye protective
devices.
antisepsis; disinfection; sterilisation; decontamination; face shield; goggles; apron; uniform; gown;
clothing; visor; hood.
Sift 1 Criteria
Abstract indicates that the article: relates to infections associated with protective clothing, is written
in English, is primary research or a systematic review or a meta-analysis, and appears to inform one
or more of the review questions.
Articles Retrieved
Sift 2 Criteria
Full Text confirms that the article relates to infections associated with protective clothing is written in
42
D.3.3 Sharps - Systematic Review Process
D.3.3.2 Search questions:

1. What is the evidence that recommended modes of use and disposal of sharps reduce the
incidence of sharps injury in health care workers?
2. What is the evidence that education and training interventions improve health care workers
adherence to recommended modes of practice?
3. What is the evidence that the use of needle-free devices reduce occupational exposure to
bloodborne pathogens?
DATABASES
MESH TERMS
infection control; cross infection; universal precautions, equipment contamination; disease

transmission; needlestick injuries; needles; syringes; occupational exposure; occupational accident;
medical waste disposal; blood-borne pathogens.
antisepsis; disinfection; sterilisation; decontamination; blood-borne virus; exposure prone

procedure; post exposure prophylaxis; sharp; puncture; percutaneous injury; epi pen; vacutainer;
resheath.
Sift 1 Criteria
Abstract indicates that the article: relates to infections associated with sharps, is written in English, is
primary research or a systematic review or a meta-analysis, and appears to inform one or more of
Articles Retrieved
43
Sift 2 Criteria
Full Text confirms that the article relates to infections associated with protective clothing is written in
D.3.4 Long-term Indwelling Urinary Catheters - Systematic Review Process
DATABASES
MESH TERMS
infection control; cross infection; community-acquired infections; disease transmission; urinary tract
infections; urinary catheterization; indwelling catheters; antibiotic prophylaxis; irrigation; biofilms;
hydrogen ion concentration; urease; proteus; proteus infections; providencia; morganella.
intermittent catheterisation; uretheral catheterisation; suprapubic catheterisation; bacteriuria;

pyuria; encrustation; blockage; non blocker; bladder irrigation; bladder washout; bladder instillation.
44
D.3.5 Enteral Feeding - Systematic Review Process
DATABASES
Databases to be searched are determined together with search strategy,
i.e., relevant medical subject headings (MESH), free text and thesaurus terms.
MESH TERMS
infection control; cross infection; community-acquired infections; food contamination; equipment

contamination; enteral nutrition, nutritional support, gastrostomy, gastroenterostomy, jejunostomy.
THESAURUS & FREE TEXT TERMS
PEG feed; tube feed; tube nutrition; gastric feed; gastric nutrition; enteral feed; enteric feed; naso
enteric feed or nutrition; intra gastric feed or nutrition; post pyloric feed or nutrition; percutaneous
feed or nutrition; transpyloric feed or nutrition; gastrojejunostomy; gastroduodenostomy;
duodenostomy. Exclusions: letters
D.3.5.2 Search results
D.3.6 Central Venous Catheters - Systematic Review Process
DATABASES
MESH TERMS
Infection control; cross infection; universal precautions; equipment contamination; disease

transmission; bacteremia; chlorhexidine; povidone-iodine; anticoagulants; sepsis; central venous
catheterisation; indwelling catheters; parenteral nutrition.
PICC; TPN; catheter hub; catheter port; dressings; flushing solutions.
Total number of articles located = 4,650
45
D.4 Key audit criteria (2003)

D.4.1 Standard principles
Aim Criteria
To ensure all healthcare personnel have access to All healthcare personnel should have an appropriate
appropriate hand decontamination equipment and supply of hand decontamination equipment, gloves,
protective clothing wherever they deliver care aprons and protective clothing in their care setting.
Standard 100%
Data collection: self audit

Ensure that all healthcare personnel are trained and All healthcare personnel involved in care are trained
competent in hand decontamination and risk and updated.
assessment.
Standard 100%
Data collection: review of staff education records

To ensure that all healthcare personnel respond All healthcare personnel should be aware of their
appropriately to any sharps injury local sharps injury policy and how to access
appropriate help should they sustain a sharps injury.
Standard 100%
Data collection: direct questioning

To ensure patients and carers are informed and All patients and carers are aware of the need to:
educated about standard principles. Decontaminate their hands;
Use protective clothing;
Dispose of sharps safely.
Standard 100%
Data collection: direct questioning of patients and

carers.
D.4.2 Urinary catheterisation

Aim Criteria
Identify all patients with LTC, their clinical need for All patients should have a patient record that
catheterisation, assessed and documented. documents the reason for catheterisation, type of
catheter, catheter insertion, changes and care.
Standard 100%
Data collection: review of patient notes

Ensure that all healthcare personnel are trained and Healthcare personnel receive training and updates in
competent in urinary catheterisation. the management of urinary catheters.
Standard 100%
Data collection: review of staff education records
46
Aim Criteria
To prevent catheter-related urinary tract infections All healthcare personnel decontaminate their hands
(CR-UTI) associated with LTC and wear a new pair of non-sterile gloves before
manipulating the system.
Standard 100%
Data collection: observation/ self audit

To reduce the incidence of CR-UTI by maintaining a All long-term catheters must be connected to a
closed system. sterile closed drainage system or valve
Standard 100%
Data collection: observation

To reduce the incidence of CR-UTI caused by All newly catheterised patients should have a patient
blocking. record that documents the integrity of the catheter
at first change and adjustments made to their change
schedule accordingly.
Standard 100%
Data collection: review of patient notes

educated about catheter management Decontaminate their hands;
Keep the system closed.
Standard 100%
Data collection: direct patient questioning of patients

and carers.
D.4.3 Enteral feeding

Aim Criteria
Identify all patients undergoing HETF are linked to a All patients should have a patient record that
Nutrition Support Team or community specialist for documents their contact person for ongoing support.
ongoing support.
Standard 100%
Data collection: Review of patient notes

Ensure that all healthcare personnel are trained and All healthcare personnel involved in the care of
competent in administration of HETF. people receiving enteral feeding are trained and
updated
Standard 100%
Data collection: Review of staff education records

To prevent infections associated with the All healthcare personnel decontaminate their hands
administration of HETF. before starting feed preparation and manipulating
the system.
47
Aim Criteria
Standard 100%
Data collection: Observation/ self audit, incidence of

HETF related infection.
To prevent infections associated with the Ready–to-hang feeds are used wherever possible,
administration of HETF by maintaining a closed and hung for no longer than the maximum
system. recommended time.
Standard 100%
Data collection: Observation/ patient records,

incidence of HETF related infection.
To prevent infections associated with the All patients should have a patient record that
administration of HETF caused by blocking. documents the care of their enteral tube, including
flushing regimen
Standard 100%
Data collection: Review of patient notes, incidence of

HETF related infection.
educated about HETF. Decontaminate their hands;
Keep the system closed.
Standard 100%
and carers.
D.4.4 Central venous catheters

Aim Criteria
Identify all patients with central venous catheters. All patients should have a patient record that
documents the reason for CVC placement, type of
catheter, catheter insertion site, catheter
replacements and care.
Standard 100%
Ensure that all healthcare personnel are trained to All healthcare personnel involved in the care of
implement these guidelines and assessed as people with CVCs receive training and updates in the
competent. management of CVCs.
Standard 100%
Support healthcare personnel to consistently
adhere to guideline recommendations. Data collection: Review of staff education
records/direct observation/self-audit
Assess the need for continuing venous access on a Evidence of regular and frequent assessment of the
regular basis and remove a CVC as soon as clinically need for CVC and catheter discontinuation rates
possible in order to reduce the risk for infection. when the catheter is no longer essential for medical
management.
48
Aim Criteria
Standard 100%
Ensure that patients and carers are informed and All patients and carers are aware of the need to:
educated about the management of their CVC. Decontaminate their hands when manipulating the
system;
Use aseptic technique when manipulating or
accessing the system.
Standard 100%

and carers.
49
D.5 AGREE Monitoring Appraisal Forms (2003)

D.5.1 Standard precautions
Table 1: Guideline for Hand Hygiene in Health-Care Settings Recommendations of the Healthcare Infection Control Practices Advisory Committee and
the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force
Domain 1 total 2 total 3 total 4 total 5 total 6 total
Item 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
Appraise 3 3 2 8 2 1 2 1 6 4 3 3 4 3 3 1 21 4 3 3 3 13 3 3 4 10 4 1 5
r1
Appraise 4 4 4 12 3 1 1 1 6 4 4 4 4 4 2 1 23 4 4 4 4 16 4 3 3 10 1 1 2
r2
Appraise 4 4 3 11 4 1 2 1 8 3 3 3 4 4 4 1 22 4 4 4 4 16 4 3 3 10 3 2 5
r3
Appraise 4 4 4 12 3 1 3 1 8 2 2 1 4 4 1 1 15 4 4 4 1 13 4 4 4 12 3 1 4
r4
Total 1 1 1 43 1 4 8 4 28 13 1 11 16 15 10 4 81 16 15 15 12 58 15 13 14 42 11 5 16
5 5 3 2 2 (268)
Table 2: Domain scores

Domain Score
Domain 1 Maximum possible score = 4 x 3 x 4 = 48
Standardised domain score is: (43/48) x 100 = 90%
50
Domain Score
Table 3: The epic Project. National Evidence-based guidelines for preventing healthcare-associated infections. Jan 2001
Item 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1 1 1 2 21 22 23
7 8 9 0
Appraise 4 4 4 12 4 3 3 1 11 4 4 4 4 4 4 3 27 3 4 4 2 13 2 3 2 7 4 2 6 (76)
r1
Appraise 4 4 4 12 4 3 3 1 11 4 4 4 4 4 4 3 27 3 4 4 2 13 2 3 2 7 4 2 6 (76)
r2
Appraise 4 4 4 12 4 4 4 2 14 4 4 4 4 4 4 4 28 4 4 4 2 14 3 4 3 10 3 2 5(83)
r3
Total 8 8 8 36 8 6 6 2 36 8 8 8 8 8 8 6 82 6 8 8 4 40 4 6 4 24 8 4 17

Domain Score
51
Domain Score
Table 5: Health Canada - Hands

tota tot tota tota tota
Domain 1 l 2 al 3 l 4 l 5 l 6 total
Item 1 2 3 4 5 6 7 8 9 10 1 1 1 1 1 1 1 1 1 2 21 22 23
1 2 3 4 5 6 7 8 9 0
Appraise 4 4 2 10 4 1 4 1 10 4 4 1 3 3 1 1 17 4 3 4 2 13 3 3 3 9 4 1 5 (64)
r1
Appraise 4 3 3 10 1 1 2 1 5 1 3 1 2 1 1 1 10 2 2 3 2 9 2 1 2 5 1 1 2 (41)
r2
Appraise 4 4 2 10 4 1 4 1 10 1 3 2 3 4 2 1 16 4 3 4 3 14 4 2 3 9 4 2 6 (65)
r3
Appraise 1 2 2 5 4 1 2 1 8 1 1 1 1 2 1 1 8 3 2 3 1 9 1 1 1 3 3 1 4 (37)
r4
Total 13 13 9 35 13 4 12 4 33 7 11 5 9 1 5 4 51 1 1 1 8 45 1 7 9 26 12 5 17 (207)
0 3 0 4 0

Domain Score
52
Domain Score
Table 7: ICNA Protective Clothing

tota tot
Domain 1 l 2 al 3 total 4 total 5 total 6 total
Item 1 2 3 4 5 6 7 8 9 10 1 1 1 1 1 1 1 1 1 2 21 22 23
1 2 3 4 5 6 7 8 9 0
Appraise 4 3 4 11 2 1 4 1 8 1 3 1 3 2 1 1 12 3 3 4 1 11 2 1 1 4 2 2 4 (50)
r1
Appraise 3 4 3 10 1 1 4 1 7 1 1 1 1 1 1 1 7 3 1 3 1 8 1 1 1 3 1 1 2 (37)
r2
Appraise 3 2 2 7 2 1 4 1 8 1 1 1 3 1 1 1 9 4 1 4 3 12 1 1 1 3 1 1 2 (41)
r3
Appraise 3 3 4 10 1 1 4 1 7 1 1 1 2 1 1 1 8 3 1 3 2 8 2 1 3 6 2 1 3 (43)
r4
Total 13 13 13 38 6 4 16 4 30 4 6 4 9 5 4 4 36 1 6 1 7 39 6 4 6 16 6 5 11
3 4 (171)

Domain Score
53
Domain Score
Table 9: ICNA Hand Contamination Guidelines

tota
Domain 1 total 2 l 3 total 4 total 5 total 6 total
Item 1 2 3 4 5 6 7 8 9 10 1 1 1 1 1 1 1 1 1 2 21 22 23
1 2 3 4 5 6 7 8 9 0
Appraiser 1 2 3 6 2 1 2 1 6 1 1 1 2 1 1 1 8 3 4 4 2 13 2 1 1 4 3 3 6 (43)
1
Appraiser 3 3 3 9 1 1 3 1 6 1 1 1 1 1 1 1 7 3 1 2 1 7 1 1 1 3 1 1 2 (34)
2
Total 4 5 6 15 3 2 5 2 12 2 2 2 3 2 2 2 15 6 5 6 3 20 3 2 2 7 4 4 8 (77)

Domain Score
54
Table 11: PHLS Ward Urinary Catheters Guidelines

tot tot tot
Domain 1 total 2 al 3 al 4 al 5 total 6 total
Item 1 2 3 4 5 6 7 8 9 10 1 1 1 1 15 1 1 1 1 2 2 2 23
1 2 3 4 6 7 8 9 0 1 2
Appraiser 1 3 2 3 8 4 1 4 1 10 1 1 1 1 1 1 1 7 3 3 4 1 11 1 1 1 3 3 2 5 (44)
Appraiser 2 2 1 2 5 3 1 1 1 6 1 1 1 1 1 1 1 7 3 3 4 1 11 1 1 3 5 2 1 3 (37)
Appraiser 3 3 3 3 9 3 1 3 1 8 1 1 2 1 1 1 1 8 3 1 2 1 7 1 1 1 3 3 1 4 (39)
Total 8 6 8 22 10 3 8 3 24 3 3 4 3 3 3 3 22 9 7 1 3 29 3 3 5 11 8 4 12
0 (120)

Domain Score
55
Table 13: The epic Project. National Evidence-based guidelines for preventing healthcare associated infections. Jan 2001
tot
Domain 1 total 2 al 3 total 4 total 5 total 6 total
Item 1 2 3 4 5 6 7 8 9 10 1 1 1 1 1 1 1 1 1 2 21 22 23
1 2 3 4 5 6 7 8 9 0
Appraiser 1 4 4 4 12 4 3 3 1 11 4 4 4 4 4 4 3 27 3 4 4 2 13 2 3 2 7 4 2 6 (76)
Appraiser 2 4 4 4 12 4 3 3 1 11 4 4 4 4 4 4 3 27 3 4 4 2 13 2 3 2 7 4 2 6 (76)
Appraiser 3 4 4 4 12 4 4 4 2 14 4 4 4 4 4 4 4 28 4 4 4 2 14 3 4 3 10 3 2 5(83)
Total 8 8 8 36 8 6 6 2 36 8 8 8 8 8 8 6 82 6 8 8 4 40 4 6 4 24 8 4 17

Domain Score
56
Table 15: Enteral and Parenteral Nutrition in the Community – British Association for Parenteral and Enteral Nutrition. Nov 1994
tot
Item 1 2 3 4 5 6 7 8 9 10 1 1 1 1 1 1 1 1 1 2 21 22 23
1 2 3 4 5 6 7 8 9 0
Appraise 4 4 4 12 4 1 2 1 8 1 1 1 4 1 1 1 10 2 2 4 2 10 4 1 1 6 4 1 5 (50)
r1
Appraise 3 3 4 10 4 2 3 1 10 1 1 1 2 1 1 1 8 4 2 3 2 11 3 2 1 6 2 1 3 (48)
r2
Total 7 7 8 22 8 3 5 2 18 2 2 2 6 2 2 2 18 6 4 7 4 21 7 3 2 12 6 2 8

Domain Score
57
Table 17: Guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients. ASPEN 1993
tot
Item 1 2 3 4 5 6 7 8 9 10 1 1 1 1 1 1 1 1 1 2 21 22 23
1 2 3 4 5 6 7 8 9 0
Appraiser 1 3 3 4 10 3 1 3 1 8 1 1 1 1 3 3 4 14 4 3 4 1 12 1 1 1 3 2 1 3 (50)
Total 3 3 4 10 3 1 3 1 8 1 1 1 1 3 3 4 14 4 3 4 1 12 1 1 1 3 2 1 3

Domain Score
58
Table 19: American Gastroenterological Association – Guidelines for the use of enteral nutrition. Nov 1994)
tot
Item 1 2 3 4 5 6 7 8 9 10 1 1 1 1 1 1 1 1 1 2 21 22 23
1 2 3 4 5 6 7 8 9 0
Appraise 1 2 2 5 1 1 2 1 5 1 1 1 2 2 1 1 9 1 3 3 2 9 1 1 1 3 1 1 2 (33)
r1
Appraise 3 1 2 6 1 1 1 1 4 1 1 1 2 1 1 1 8 3 3 3 2 11 1 1 1 3 1 1 2 (34)
r2
Total 4 3 4 11 2 2 3 2 9 2 2 2 4 3 2 2 17 4 6 6 4 20 2 2 2 6 2 2 4

Domain Score
59
D.5.4 Central venous catheterisation
Table 21: Centres for Disease Control & Prevention. Guidelines for the Prevention of Intravascular Catheter Related Infections. 2002
Item 1 2 3 4 5 6 7 8 9 10 1 1 1 1 1 1 1 1 1 2 21 22 23
1 2 3 4 5 6 7 8 9 0
Appraiser 1 4 4 4 12 4 1 4 3 12 1 1 2 3 4 3 2 16 4 4 4 4 16 3 3 4 10 1 4 5 (71)
Appraiser 2 4 3 4 11 4 1 3 1 9 1 1 4 4 4 1 1 16 4 3 4 4 15 3 3 4 10 4 1 5 (66)
Appraiser 3 4 4 4 12 4 3 4 2 13 4 4 4 4 4 4 4 28 4 4 4 3 15 4 4 4 12 4 4 8 (88)
Total 12 1 1 35 12 5 1 6 34 6 6 10 1 1 8 8 60 1 1 1 1 46 1 1 12 32 9 9 18
1 2 1 1 2 2 1 2 1 0 0 (225)

Domain Score
60
D.6 Evidence tables (2003)

D.6.1 Hands accepted studies
Author, Date,
Country of Origin and
Quest. Objective Design, Setting, Sample Size and
ID Number Population Outcomes Strengths and Limitations
H3 2&4 Lucet JC, Riguad F, Mentre F, Design: Randomised Q2. Bacterial reduction after hand Authors state that the subjects
Kassis N, Deblangy C, Controlled Trial washing with antiseptic soap or hand performed the 6 hygiene
Andremont A, Bouvet E. 2002. rubbing with alcohol-based disinfectant techniques in a random order
274
France. Hospital was significantly greater than that immediately after a health care
Setting:
obtained after hand washing with the procedure but fail to say how
To compare the bacterial un-medicated soap. There was no allocation occurred.
Sample: 516 specimens, 258 significant difference between hand
efficiency of various hand beforehand
hygiene techniques, including washing with the antiseptic soap and Presumably depended on where
hygiene and 258 hand rubbing with the alcohol based
hand rubbing with an alcohol after. the health care worker worked.
based compound and disinfectatnt.
handwashing with antiseptic Popn: Standard times for length of the
agents and with unmedicated 33 Healthcare Q4. No statistically significant difference
Workers (HCWs) procedure, the volume of product
soap to assess the factors was found between hand washing with used, method of drying hands
associated with hand and Intensive Care un-medicated soap for 10 or 30 seconds
decontamination after care. Units (ICUs) and 10 although there was a trend towards
from medical wards greater reduction after hand washing
(14M, 29F) with un-medicated soap for 10’s
compared with hand washing with un-
medicated soap for 30 seconds, 388
specimens cultured positive 241 before
and 147 after hand hygiene. There was
no significant difference between hand
washing with the antiseptic soap (either
10, 30 or 60 seconds) and hand rubbing
with the alcohol based disinfectant.
H11 2 Herruzo-Cabrera R, Garcia- Design: 1.Randomised 1.The alcoholic solution of NPD was In vivo component demonstrated
Cabballero J, Martin- Moreno Control Trial highly germicidal in vivo, destroying effect of NDP intervention in non-
JM, Graciani-Perez-Regadera organisms better than classic hand clinical setting
61
Author, Date,
MA, Perez-Rodriguez J. 2001. 2.DescriptiveStudy washing on the hands of 69 health care
190
Spain. – before and after staff in PICU and NICU. Hand washing Similar results were obtained for
follow up study alone led to a 63% reduction in the different study periods
To study the effectiveness of colonisation. NDP alone led to a 95%
Colonisation prevalence was tallied
an alcohol solution of N- reduction in colonisation. Difference
Setting: Neonatal Intensive twice.
duopropenide (NDP) in vivo p<0.01 average colony forming units
Care Unit (NICU) The practice of surveillance and
and its effect on the control of and Paediatric after hand washing and NDP use.
measurement could have led the
a multi-resistant Klebsiella Intensive Care Unit HCW to modify their practice
pneumoniae outbreak in NICU Sample: (PICU) 2. Before NDP use the cumulative
The results of plate cultures
that had persisted for 13 incidence of infection of Klebsiella
obtained were shown to staff to
months. pneumonae infection 25%. After NDP
45 health care motivate them to wash their hands.
introduction reduced to 6.5% and then
workers in NICU
and 24 HCW in 0% after 5 months (p<0.0000001)
Popn: PICU (gender not

stated)
Health care
workers.
H12 2 Herruzo-Cabrera R, Garcia- Design: 1.Laboratory Laboratory component established that: Laboratory study, and an in use
Caballero J, Fernandez Acenero Experiment Ethylsulphate and NPD-alcohol component.
189
MJ. 2001. Spain. 2.Quasi-experiment produced a 0.9-1.2 log10 reduction in
Setting: 1.Laboratory colony forming units.
Is fast disinfection with an 2.Hospital 60 alcohol/phenol alcohol 0.4 – 0.6
alcohol solution better than log10 reduction in colony forming units.
hand washing and can it Classic hand washing resulted in 0.1-0.3
Sample: 52 healthy
improve compliance? log10 reduction in colony forming units.
volunteers
102 healthcare In use component demonstrated:
personnel from NPD alcohol 95% mean reduction in
burn ICU and 4 colony forming units (>2log10)
other ICU compared to 50% ) 0.1 log10) in classic
Popn: hand wash. P<0.00001 reduction for
62
Author, Date,
both NPD and hand washing, but always
Healthy volunteers greater with NPD alcohol.
health care
personnel
367
H13 5 Pietsch H. 2001. Germany. Design: Laboratory Alcohol rub was found to cause Volunteers not healthcare workers.
experiment significantly less skin irritation than a Author works for a chemical
To compare the dermal chlorhexidine based antiseptic. company therefore possible bias.
tolerance and antimicrobial Setting: Laboratory
efficacy of a chlorhexidine
antiseptic (Hibiscrub) and a 60 (gender not
Sample:
alcohol hand rub (Sterillium). stated)
Popn: Volunteers, no
other details.
H14 2 Kramer A, Rudolf P, Kampf G, Design: Laboratory Most alcohol based hand rinses meet Non-clinical study that may not
235
Pittet D. 2002. Switzerland. experiment EN1500 requirements within 30s. 30s replicate in use conditions.
hand rubs with gel containing a total
To investigate antimicrobial Laboratory amount of up to 70% alcohol is
Setting:
efficacy of 10 gels and 4 rinses (Industry) significantly less effective than hand rub
according to European with 2 propanol 60%.
Sample:
standards. 15 volunteers
Ethanol content of up to 70% is not as
Popn: effective as 2 propanol 60%.
Volunteers, details
In terms of bacterial efficacy, 1-
unknown
propanol can be regarded as the most
effective alcohol, followed by 2 propanol
and ethanol. Comparison of 2 propanol
with ethanol showed that the efficacy of
63
Author, Date,
2 propanol 60% is almost equivalent to
ethanol 80%.
Therefore ethanol based hand
formulations should contain at least 80%
ethanol.
H15 2 Moadab A, Rupely KF, Design: Laboratory HandClens (alcohol free product) Non-clinical study that may not
300
Wadhams P. 2001. USA. experiment outperformed Purell ( alcohol based replicate in use conditions.
product) and met regulatory
To evaluate the efficacy of a College of podiatric requirements for a hand sanitizer. Purell
Setting:
novel surfactant, allantoin and medicine failed as an antimicrobial wash and was
benzalkonium chloride hand less effective than a control soap used in
40 (gender not
sanitiser using the US Food and the study
stated)
Drug Administration’s method Sample: Both groups met the minimum
for testing antiseptic requirement for the first hand wash,
Volunteer Students with an average reduction factor of 2.6
handwashes used by health Popn:
care personnel. for HandClens and 2.6 for Purell. An
overall trend of sustained disinfecting
power was seen for HandClens as
demonstrated by the reduction factor
values. This surpassed the minimum
persistence values. In contrast Purell’s
performance diminished over time and
values plummeted after only 3 washes.
The antimicrobial activity of the alcohol
based hand sanitzer was significantly
less (wash1, p<0.001, washes 3,7, and
10, p<.001) than that of the alcohol free
Han Clens product and hand washes.
H16 2&5 Winnefeld M, Richard MA, Design: Randomised Q2. Alcohol based rinse significantly Study conducted under clinical use
Darncourt, Grob JJ. 2000. Controlled Trial more effective than liquid soap at conditions.
64
Author, Date,
507
France. removing transient microorganisms
Setting: Hospital p=0.016.
To assess skin tolerance and 20/50 hand washes with antiseptic soap
antimicrobial effects of two resulted in residual bacterial
Sample: 52 (2M, 49F)
widely accepted hand hygiene contamination of hands.
measures under in use At the end of the study factors
Popn: Volunteer nurses in
conditions. influencing the total bacterial count
12 medical and 4
increased with the increasing number of
surgical
hand washes in the soap group p=0.003
departments
and with the degree of skin damage
p=0.005 in the antiseptic group.
The rate of successful hand

decontamination was low, 20% in hand
wash group and 31% in handrub group.
Skin assessment on 1st and last day

Q5. Self assessment of skin condition of study using 3 scores 2
and grade of skin damage worsened determined by the same observer
significantly more using soap than in the
group using alcoholic disinfectant
p=0.004 p=0.01 respectively.
H17 1&2 Gould D, Gammon J, Donnelly Design: Descriptive Study Q1. Poor conditions in patients’ homes Complex but comprehensive
M, Batiste L, Ball E, De Melo compromise nurse’s ability to perform research in that it uses 3 methods
AMSC, Alidad V, Miles R, Setting: Community. adequate hand hygiene effectively and to assess the risk of cross infection.
162
Halablab M. 2000. UK. Clients’ homes and thereby increase risks of cross infection.
clinic settings. Unclear how many nurses the data
To establish whether the Q2. Application of an antiseptic cream relates to.
potential for cross infection 17 (chlorhexidine based) exhibited residual
during home visits could be Sample: effectiveness in reducing bacteria
reduced by supplying nurses
Nurses working in
65
Author, Date,
with an antiseptic cream to be Popn: the community
used in addition to their delivering various
routine hand hygiene procedures and
precautions care.
H18 1 Pittet D, Dharan S, Touveneau Design: Descriptive Study Bacterial contamination increased Standard definitions of patient care
S, Sylvie RN, Sauvan V, linearly with time on gloved hands (av activities were used. There may
Perneger TV. 1999. Setting: Hospital 16 colony forming units (CFUs) per have been some observational bias.
371
Switzerland. minute). Patient care activities
significantly associated (p<0.05) with a Maximal bacterial colony counts
Sample: 266 hospital staff, high contamination level were direct
To study the process of 417 episodes of were truncated at 300CFU – longer
bacterial contamination of patient contact p<0.001, respiratory observational periods would have
care care p<0.001, handling body fluids
health care worker’s hands resulted in a higher proportion of
during routine patient care in a Popn: p<0.02. maximal colony counts at later
large teaching hospital. Health care Contamination levels varied with times. Threshold of bacterial
workers hospital location, Medical rehabilitation contamination associated with an
ward had higher levels (49 CFU p=0.03). increased risk for sub infection
Simple hand washing before patient care Findings may not be generalisable
without hand antisepsis is associated to non-dominant hand.
with a higher colony count 52 CFU
p=0.03
H20 2 Guilhermetti M, Evandro S, Design: Laboratory Results suggest that 10% povidine iodine Non-clinical study that may not
Hernandes D, Fukushigue Y, experiment and 70% ethyl alcohol may be the most replicate in use conditions.
Garcia LB, Cardoso CL. 2001. effective hand cleansing agents for
169
Brazil Laboratory removing MRSA from either lightly or
Setting:
(University) heavily contaminated hands. Plain liquid
To investigate the effectiveness soap was more effective than
Sample: 5 (2M, 3F)
of hand cleansing agents in chlorhexidine 4% detergent
removing a hospital strain of
66
Author, Date,
Methicillin Resistant Staph. Popn: Volunteers
Aureus (MRSA) from artificially
contaminated hands of five
volunteers.
H21 2 Faoagali J, Narelle G, Fong J, Design: Longitudinal / The use of 1% triclosan formulation for Clinically based study.
Davy J, Dowser M. 1999. comparative study a 30 s hand wash effectively removed
128
Australia. MRSA from staff hands (p<0.05, in
contrast 4% hibiclens was unable to
Setting: Specialist surgical
To determine the effect of 4% produce or sustain this result p<0.05
ward
chlorhexidine gluconate and although it showed an effective
1% triclosan on the immediate and residual overall anti
Sample: 41 doctors and bacterial effect. Hand colonisation rate
composition of the hand
nurses (gender not with GNB increased pre and post-
bacterial flora.
stated) washing when 1% Triclosan was used.
Popn:
Clinical staff
H42 5 Boyce JM, Kelliher S, Vallande Design: Prospective Self assessment scores of skin irritation Small sample size.
43
N. 2000. USA. Randomised Trial and dryness decreased slightly during The cross over nature of the design
with cross over the 2 weeks when nurses used the with a 2 week washout period
To compare the frequency of design alcoholic – hand-gel regimen (mean reduced the likelihood of pre-
skin irritation and dryness baseline score 2, mean final score 2.0 existing skin problems influencing
Setting: p=0.08) but increased substantially
associated with using an Teaching Hospital results.
alcohol – hand gel regimen for during the 2 weeks when nurses used
hand antisepis versus using Sample: soap and water (mean baseline score
32 nurses on 3 Mean number of hand washes for
soap and water for hand 2.0, mean final score 4.8 p<0.0001).
wards, 2 ICUs and 1 both groups were the same over
washing. Visual assessment scores by the study the study period. Self-assessment
standard ward.
nurses did not change significantly when by the study nurses may have been
the alcoholic hand gel regimen was used biased as they knew what regimen
Popn: Nurses but scores increased substantially when they were using.
nurses used soap and water (baseline
score .59, mean final score 1.21 p=0.05).
3 methods of assessing skin
67
Author, Date,
Epidermal water content of dorsal condition reduced opportunity for
surface of the nurses’ hands changed bias.
little when the alcoholic hand gel
regimen was used but increased
significantly with soap and water hand
washing (mean baseline 25.9+/-7.5,
mean final reading, 20.5+/- 5.4,
p=0.0003.
H50 4 Gustavson DR, Vetter EA and Design: Laboratory No statistically significant differences Non-clinical study that may not
Larson DR, Ilstrup DM, Maker experiment were noted in the numbers of colony replicate in use conditions.
MD, Thompson RL, Cockerill forming units for each drying method Glove juice method permits
170
FR. 2000. USA. Laboratory p=0.72 sampling of inter-digital areas and
Setting:
(Healthcare) is a more comprehensive measure
To evaluate the effects of 4 of sampling skin bacteria
different drying methods to 100 (gender not
remove bacteria from washed Sample:
stated)
hands
Volunteers (no
Popn:
break down)
H51 2 Paulson DS, Fendler EJ, Dolan Design: Experimental All product configurations were Laboratory setting rather than in
352
MJ, Williams RA. 1999. USA. effective in reducing transient microbial use.
Setting: Laboratory levels on hands. The mean log
To evaluate the antimicrobial (industry) reductions from baseline were greatest Glove juice sampling procedure
efficacy and irritation potential for the lotion soaps with alcohol gel was used, the specified method for
Sample: 25 adults between
of 5 handwash product sanitizer, less for the alcohol and the testing products for use in a health
18-70 years (both
regimens: a nonantimicrobial antimicrobial soap when used alone, care setting and is known to be
sexes, though
lotion soap, an antimicrobial and least for the bland soap. All the accurate and precise.
gender specifics not
lotion soap, an alcohol gel products showed a low potential for
stated)
santizer, a nonantimicrobial skin irritation.
The authors reported that the
lotion soap with an alcohol gel Popn: study was based on small sample
Adults
sanitizer and an antimicrobial sizes and therefore precision may
lotion soap with an alcohol gel have been compromised.
68
Author, Date,
sanitizer.
H52 2&5 Larson E, Siberger M, Jakob K, Design: Prospective quasi Q2. The use of mild soap for cleaning
Whittier S, Lena L, Latta PD, experimental and an alcohol-based waterless product
249
Saiman L. 2000. USA. provided antimicrobial effectiveness
Hospital neonatal comparable to traditional antiseptic
Setting:
To compare 2 hand care intensive care unit hand washing.
regimens (traditional antiseptic
hand wash with chlorhexidine- 16 nurses (gender Q5. The use of mild soap for cleaning
containing detergent versus Sample: and an alcohol-based waterless product
not stated)
mild soap wash with significantly improved skin condition
subsequent alcohol-based rinse p<0.005.
for degerming as necessary) in Nurses
Popn:
a neonatal intensive care unit
(NICU).
H53 2&5 Larson E, Aiello A, Bastyr J, Lyle Design: Randomised Under in-use conditions in two adult This is a replication of the small
C, Stahl J, Cronquist A, Lai L, controlled trial critical care units, an alcohol-based study done a year previously (H52)
250
Della-Latta P. 2001. USA. hand hygiene product was comparable referred to in this study as ‘the
with a CHG-containing antiseptic pilot’ (p8). This study uses two sites
To compare skin condition and detergent in terms of antimicrobial and a larger study population
Setting: 2 critical care units
skin microbiology among effectiveness, was associated with across a number of professional
intensive care unit personnel improved skin condition and took groups (physicians, nurses,
Sample: 50 (before significantly less time to use. housekeepers and respiratory
using one of two randomly
dropouts, 7 therapists).
assigned hand hygiene
physicians, 36
regimens: a 2% chlorhexidine
nurses, 7 other
gluconate (CHG) containing
staff) (11M, 39F)
traditional antiseptic wash and
a waterless hand scrub
Popn: Health care workers
containing 61% ethanol with
emollients.
69
Author, Date,
H54 2 Girou E, Loyeau S, Legrand P, Design: Randomised The median percentage reduction in In use study designed not to
Oppein F, Brun-Buisson C. Controlled Trial bacterial contamination for hand interfere with regular clinical
154
2002. France. rubbing was significantly higher than activities.
94 bedded with hand washing (83% vs. 58% p= The difference in the hand wash
Setting:
To compare the efficacy of university hospital 0.012) with a median difference of 26%. group may have been due to the
hand rubbing with an alcoholic The median duration of hand hygiene fact that they were less likely to
based solution versus for each group was 30 seconds. adhere to the duration of 30
Sample: 23
conventional handwashing seconds recommended, i.e. in only
with antiseptic soap in 35% of opportunities did this
reducing hand contamination Popn: Health care happen alternatively less than 30s
during routine patient care. workers. may be enough for the hand
rubbing.
Bacterial contamination was
assessed by agar fingerprints and
not the glove juice test which may
be more effective in estimating the
true burden of bacteria present
and therefore underestimating the
true estimate of contamination,
H55 2 Zaragoza M, Salles M, Gomez J, Design: Randomised Control 49.6% average reduction for soap and Larger sample needed.
Bayas JM, Trilla A. 1999. Trial water vs. 88.2% with alcoholic solution
528
Spain. p<0.001. alcoholic solution well One observer monitored
Clinic wards and ICU tolerated by overall acceptance rate healthcare worker activity and may
Setting:
To compare the effectiveness in 1 hospital. classified by 72% of HCW after 2 wk use. have been some observer bias.
(reduction of bacterial There was no difference between
microflora on hands) of an medical wards and surgical vs. ICU.
Sample: 50
alcoholic solution compared
with the standard hygienic
handwashing procedure during Popn: Hospital health care
regular work in clinical wards workers
and intensive care.
70
Author, Date,
H56 1 Fendler EJ, Ali Y, Hammond BS, Design: Controlled Ttudy One of the primary infection types In use study in normal clinical
Lyons MK Kelley MB, Vowell found was in people with UTI with a conditions over an extended period
130
NA. 2002. USA. Hospital Foley catheter. Other primary infections of time.
were respiratory tract and wound
Setting:
To determine the effect of the infections. Standardised protocol used for
265 employees
use of alcohol gel hand Comparison of the infection types and hand hygiene.
Sample: rates for the units where hand sanitizers
sanitizer by caregivers on
infection types and rates in an Employees in a 275 was used compared with those control
bed extended care The study was carried out over 34
extended care facility. Popn: units where hand sanitizers were not
facility specialising months and there may have been
used showed a 30.4% decrease in
in rehabilitation and differences in infection rates over
infection rates for the 34month period
subacute care. the time period
in the units where the sanitizer was
used. No measure of compliance with the
protocol.
H65 1 Ryan MAK, Christian RS, Design: Controlled Trial Overall rate of respiratory illness in post A well designed controlled
415
Wohlrabe J. 2001, USA. intervention period was 45% lower than experiment.
Setting: Navy Training in the year prior to intervention.
To implement and evaluate a Centre
hand washing program at a Sample: 1,089,800 person-
large Navy training centre in weeks reviewed.
terms of the programmes
effect on the incidence of
Popn: Navy Trainees. 80%
respiratory disease.
men average age 20
years.
H66 2 Cardoso CL, Pereira HH, Design: Laboratory Results suggest 70% ethyl alcohol and A well controlled laboratory
Zequim JC, Guilhermetti M. experiment 10% povidone iodine may be the most experiment.
60
1999. Brazil. Setting: Laboratory effective agents for removing A.
(University) baumenii strain from heavily
To explore the effectiveness of contaminated hands.
hand-cleansing agents (plain 5 (2M, 3F)
Sample:
71
Author, Date,
liquid soap, 70% ethyl alcohol,
10% povidone-iodine, 4% Popn: 5 healthy adults
chlorhexidine gluconate) for with no skin
removing a hospital strain problems aged 10-
Acinetobacter baumanii from 47 years.
artificially contaminated hands
of 5 volunteers.
H67 2 Kampf G, Jarosch R, Ruden H. Design: Laboratory Hibisol was significantly more effective A well controlled laboratory
214
1998. Germany. experimental p=<0.05against MRSA than Hibiscrub. experiment.
To determine the bactericidal Setting: Laboratory

efficacy of Chlorhexidine, (University)
Hibiscrub (Chlorhexidine and
water) and Hibisol 612 tests
(Chlorhexidine and Alcohol) Sample:
against MRSA and MSSA.
Popn: N/A
H68 5 Forrester BG, Roth VS. 1998. Design: Descriptive Study There was a strong relationship Sample is predominantly female
134
USA. between frequency of hand washing and no comparative analysis
Setting: Regional Neonatal and dermatitis. between the two sites used. High
To investigate the prevalence Intensive Care and Subjects washing hands > 35 times prevalence of occupational hand
of hand dermatitis in ICU Surgical Intensive p0.005 more likely to have occupational dermatitis may be due to reporting
personnel. Care Unit hand dermatitis, than those washing bias. The lack of association of
hands < 35 times per shift. atopy and prevalence of dermatitis
Authors conclude that most cases were may have been due to the phrasing
126 (18M, 108F) in the questionnaire.
Sample: likely to be as a result of hand washing.
The solution in use in the study setting
All (203) employees was Chlorhexidine.
Popn:
in study setting.
H69 2 Dyer DL, Gerenraich KB, Design: Laboratory All 3 hand products were equally The company producing one of the
114
Wadhams PS. 1998. USA. experiment effective after a single application. After products carried out the research
repeated use the alcohol containing study which may have biased the
72
Author, Date,
To evaluate the immediate and Setting: Laboratory sanitizers did not meet government results
persistent effectiveness of two (Industry) approved performance standards and Subjective assessment of hand
alcohol- containing hand 56% male and 44% the alcohol free sanitizer did. The condition after completion of tests
Sample:
sanitizers to supplement women aged benzalkonium chloride hand sanitizer Carried out under controlled
normal hand washing. between 18-47. was the most favorable of the rinse free conditions in a laboratory and
formulas for normal hand washing pathogens artificially introduced
Same results obtained when the rinse The interval between washes was
Volunteers.
Popn: was omitted 10 minutes, chosen to model the
frequency that may occur in a
clinical environment i.e. 10/12
patient contacts per hour, it would
be interesting to see whether the
agents are effective with 10 –15 sec
wash as opposed to the 2 minutes
given in this study
H193 ALL Pratt RJ, Pellowe C, Loveday HP Design: Systematic Review There is a comprehensive description of There may have been a degree of
382
et al. 2001. UK. the methodology used for the review. publication bias and the
Setting: Laboratory and heterogeneity of retrieved studies
Systematic review of hand hospital settings Search included major databases, meant that studies could not be
hygiene practice and the Medline, Embase, CINAHL, Cochrane pooled.
reduction of HAI. Study Designs: RCT, and DARE, references from retrieved
Sample:
CCT, Experimental studies and existing national and
laboratory studies international guidelines.
were a major
component of All studies were assessed for clinical
retrieved studies utility and study quality.
Popn: N/A
73
D.6.2 Hands rejected studies

Quest. Author, Date and Design, Setting, Sample Size & Population
ID Number Country of Origin Objective Reasons for Rejection
H19 2 Chudleigh J and To determine whether Design: Observational Number of nurses participating
Buckingham C. 1999. or not nurses were unclear.
73
UK. adhering to existing Setting: Hospital – special care baby unit. No quantitative results and p values
infection control given
policies and guidelines. 3 variables compared – soap, gloves
Sample: 12 nurses (3 unqualified)
To determine the most and alcohol but no documentation as
appropriate product to to who used what or how many used
use for hand Popn: Nurses which technique or in what
decontamination combination
74
D.6.3 Personal protective equipment accepted studies

Author, Date,
Ques Country of Origin and Objective Design, Setting, Sample Size and
ID t Population Outcomes Strengths and Limitations
57
G4 4 Callaghan I. 1998. UK. Design: Descriptive Study Uniforms were found to be equally and Variable not well controlled. Data
heavily contaminated at all sites and statistical analysis missing.
To examine the levels of Setting: 2 urban hospitals sampled and at all times.
contamination on nurses’ Plastic aprons were also heavily
uniforms and the role if any of contaminated and their use was not
Sample: 88 (48 in pilot, 40 in
plastic aprons. associated with significantly less
comparative study)
contamination on uniforms.
60 staff (30.6%) did not wear a fresh
Popn: Nurses’ uniforms. uniform daily.
G5 4 Perry C, Marshall R, Jones E. 2001. Design: Descriptive Study 22 (39%) uniforms contaminated prior Study over one day only
360
UK. to shift. Three had not put on clean No link made with infection
Setting: City hospital uniforms and these had MRSA. prevalence on ward,
To assess whether MRSA, By the end of the shift 31 (54%) were
Clostridium difficile and positive for one or more organism, VRE
Sample: 57 (gender not
Vancomycin Resistant on 22.
stated)
Enterococcus (VRE) were present Levels of contamination varied between
on healthcare worker’s uniforms Popn: ward areas, highest medical 92% lowest
at the beginning and end of a span Staff from five surgical 7.7%
of unitform. different ward
No difference between trained and
areas in one
untrained staff.
hospital
Uniforms do become contaminated with
organisms when carrying out clinical
duties. Recommendation that uniforms
are supplied on the basis of the number
of days rather than hours worked and
guidance given on home laundering
G6 3 Godin G, Naccache H, Fortin C. Design: Descriptive Study Those who supported and considered Poor response to survey
157
1998. Canada. glove use a norm had 14.61 times Responses do not necessarily
Setting: Hospital physicians greater odds of wearing them compared match practice.
75
Author, Date,
To identify factors explaining the throughout Canada. with those with a moderate or negative
intention of physicians to wear perception p<0.001.
gloves when contact with blood or Sample: 667 (504M, 163F)
body fluids was possible.
Popn: Physicians
G34 2 Tenorino AR, Badri SM, Sahgal NB, Design: Descriptive Study. 16 HCW had VRE on hands prior to care Study limited by the number of
Hotta B, Matushek M, Hayden MK, Of the 44 who didn’t 17 (39%) acquired patients infected and no control
Trenholme GM, Weinstein RA. Setting: Urban Hospital VRE on gloves and after removal 5 (29%) group, otherwise a thorough study.
463
2001. USA. also had the same strain on their hands
Sample: 60 (50 healthcare VRE acquisition associated with duration
To assess the effectiveness of workers and the 10 of contact, contact with body fluids,
routine gloving in the prevention patients with VRE diarrhoea, mean VRE colony count on
of hand carriage of VRE by health infection in the patient’s skin.
care workers during patient care hospital)
activities.
HCW hands and

Popn: gloves before and
after contact with a
patient with VRE
G35 4 Huntley DE, Campbell J. 1998. Design: Descriptive Study Aerosol contamination is produced Contamination established but not
200
USA. during dental procedures, supporting risk to patient.
Setting: Dental Clinic OSHA’s standard that long sleeves be
To assess bacterial contamination worn to protect exposed skin during
of uniforms by aerosols during exposure prone procedures.
dental procedures.
Bacterial filters applied to arms and
Popn: Senior students chest before patient appointment and
treating 145 removed after.
patients.
Control filters 2.67 when clinic in session

CFU on dominant arm 31.13, median 29
76
Author, Date,
(p =0.13)
Non dominant arm 31.16, median 28 (p
= 0.03)
Chest 22.43, median 20.5
Ultra sonic scalers and air polishers
created most contamination.
G37 3 Kearns HPO, Burke FJT, Cheung Design: Descriptive Study 92% (n = 162) used gloves routinely for Reported use may not reflect
217
SW. 2001. Eire. all patients and procedures practice.
Setting: National Survey 4% ( n =7) for selected patients and 5% High rate of compliance to glove
To examine the infection control (n = 8) for selected procedures wearing but reported practice does
procedures used in general dental 80% of routine glove users changed not necessarily reflect actual
Sample: 177 (145M, 32F)
practice in the Republic of Ireland. gloves between patients (n =130) and practice.
93% decontaminated hands before
Popn: Data collected on donning gloves (n = 151)
demographics,
14% of non changes felt new gloves not
glove and mask
necessary (n = 23)
use, sterilising and
cleaning 40% (n =70) had had a needlestick
procedures and injury and 38% ( n=67) reported glove
needlestick injuries. puncture
G39 5 Murray CA, Burke FJT, Mc Hugh S. Design: Controlled Trial Following clinical use 1.9% of the latex Small number of dentists involved
312
2001. UK. gloves and 5.3% nitrile (p<0.0001) had in study though extensive use of
Setting: Suggests 5 sites punctures, but punctures also found in the gloves
Pilot study to compare the number 2.5% (n=5) latex and 5.5% (n= 11) nitrile
of glove punctures occurring in unused gloves. No statistical difference
Sample: 200 used and 200 between incidence following procedure
latex and nitrile gloves. unused gloves. compared with unused glove.
Popn: 5 right handed This could be considered to indicate

dentists in general good puncture resistance of the gloves
practices used 200 tested in clinical use.
of each kind of
glove
77
Author, Date,
200 unused gloves
of each type also
tested.
G193 ALL Pratt RJ, Pellowe C, Loveday HP et Design: Systematic Review There is a comprehensive description of There may have been a degree of
382
al. 2001. UK. the methodology used for the review. publication bias and the
Setting: Hospital acute heterogeneity of retrieved studies
Systematic review of the selection settings. Search included Medline, Embase, meant that studies could not be
and use of personal protective CINAHL, Cochrane and DARE, references pooled.
clothing and the reduction of HAI. Study Designs: RCT, from retrieved literature and existing
Sample:
NRCT, Experimental national and international guidelines.
Laboratory studies
(Gloves), All studies were assessed for clinical
Descriptive Before utility and study quality.
and After Studies.
Popn: N/A
78
D.6.4 Sharps accepted studies

Author, Date,
Quest. Country of Origin and Objective Design, Setting, Sample Size and
S8 2&3 Reddy SG, Emery RJ. 2001. Design: Descriptive Study Reduction in rate of NSI over 6 year Not conducted in primary care/
394
USA. period community setting, but controls
Setting: Hospital Drop from 10.6/10.3% in 1994/1995 to could be applied in setting.
Evaluation of the effect of 6.45 in 1996 (education programme
engineering controls ( safety introduced) The introduction of needle safety
Sample: 550
syringes and needleless IV Smaller reductions over next 3 years devices should logically reduce the
systems) in reducing rates of falling 2% between 1997/99. incidence of NSI.
nosocomial sharps injury (NSI). Popn: Staff reporting NSI
P=<0.0001
x2 63.1 df =5 The introduction of an education
programme and the OSHA
standard may have had some
impact on rates.
S9 2&3 Gershon RRM, Pearse L, Grimes Design: Descriptive Study Significant reduction in NSI over 9 yr Longitudinal study that identifies
M, Flanagan PA, Vlahov D. 1999. period. sustainability, other factors such as
145
USA. Setting: Community All NSI 2/3 reduction. changes in staffing levels, shift
Hospital All NSI p<.0.0001 from 82 to 24 patterns not clear.
To determine the impact of a /1000WFTE (working full time Multi-interventional study does
Sample:
multifocused interventional equivalent) not look at the relative impact of
693
programme on sharps injury Hollow bore NSI p< 0.05 from 196/1000 the individual interventions.
rates. Popn: Under-reporting of NSI in general
WTE (6.5 per WFTE) to 53 (1.6 per 1000
Staff reporting may be a factor.
WFTE)
sharps injuries.
Only relevant to acute care, not
certain that the same trend would
occur in Community settings.
356
S42 2,3,4 Peate WF. 2001. USA. Design: Descriptive Study Reduction in injuries from 16 per 954 USA based with OSHA standard in
work years to 2 per 477 work years. place. Lancets are relatively low
Evaluation of the introduction of Setting: Urban fire service risk devices as they are not hollow
a safety lancet for use with Significant at 0.05 level bore.
glucometers. Sample: 477 (Age range z test of proportions
from 20 to 61 z=2.071787
79
Author, Date,
Quest. Country of Origin and Objective Design, Setting, Sample Size and
years; 81% male,
9% female)
Popn: Active-duty EMS
workers.
S43 2,3,4 Zakrzewska JM, Greenwood I, Design: Descriptive Study Reduction in avoidable NSI in Dental Institutional setting not general
527
Jackson J. 2001. UK. School. dental practice. Comparison
Setting: Dental Pre change average frequency of between school using safety
Change programme to introduce hospital/school avoidable NSI 11.8 per 1000,000 hours syringe and a clinical unit
the use of disposable safety worked to 0 per 1000 000 hours continuing to use metal non-
Sample: disposable syringes may reflect
syringes into dental practice. worked.
Incidence per 100 employees fell from general dental practice. Costs of
Popn: Qualified clinical use may be greater in general
20.5 pre intervention to 0 post-
staff and students. practice.
intervention
Similar changes were not observed in No statistical measure of certainty
the clinical unit. given. Small numbers and
statistical significance not
demonstrated.
S193 ALL Pratt RJ, Pellowe C, Loveday HP Design: Systematic Review There is a comprehensive description of There may have been a degree of
382
et al. 2001. UK. the methodology used for the review. publication bias and the
Setting: Acute care settings heterogeneity of retrieved studies
Systematic review of the safe Search included major databases, meant that studies could not be
use and disposal of sharps and Medline, Embase, CINAHL, Cochrane pooled.
Sample: Study Designs:
the reduction of HAI and Before and after and DARE, references from retrieved
occupational exposure. studies without literature and existing national and
control groups and international guidelines.
descriptive studies
were major All studies were assessed for clinical
components of utility and study quality.
retrieved studies.
Popn: N/A
80
D.6.5 Urinary catheter accepted tables

Author, Date,
Objective Design, Setting, Sample Size and
ID Quest. Population Outcomes Strengths and Limitations
UC6 1 Bakke A, Vollset SE. 1993. Design: Descriptive Study – 1 Bacteriuria equal amongst men and Complicated descriptive study
27
Norway. year follow-up study women. The incidence of clinical UTI possibly compromised by the fact
over twofold higher in women during that infection rates and severity
To study factors that may Not stated the 1 year observational period. 25% of relied on self reporting. Large
Setting:
predict the occurrence of patients had no infection at all, while sample size.
bacteriuria and clinical urinary only 1 or 2 lower urinary infections
Sample: 302 (149M, 153F) episodes were noted in 23%.
tract infection in patients Many of the patients were using
using clean intermittent prophylactic antibiotics and anti-
catheterisation. Popn: Residents in Norway More serious infection problems, infective agents which may have
carrying out CIC including upper urinary tract infection, had a direct effect on the results.
were noted in 17%. Same cohort as UC35.
In the total male population

determinants of high urinary tract
infection were: Age of 45 years or less;
diseases or injuries of the spinal cord
above the conus; affection of the conus
and peripheral nerves; high frequency of
cleansing the meatus; and
catheterisation not performed by
patient himself.
Determinants of high urinary tract

infection in the women were, age and
mean catheterisation volume p<0.05.
Younger women more at risk than older
women.
UC14 6 Getliffe KA, Hughes SC, Le Design: Experimental Under controlled laboratory conditions, Has not been tried in clinical
149
Claire M. 2000. UK smaller (50 ml) volumes of acidic practice but clinical implications
Setting: Laboratory bladder washout solution are as considered.
81
Author, Date,
To identify the optimum effective as the 100 ml commonly used, A well conducted study, each
volume of acidic bladder Sample: 24 but two sequential washouts with 50 ml experiment repeated 5 times.
washout solution (Suby G) to are more effective than a single Washout followed standard
dissolve catheter encrustation washout. procedure.
Popn: Pooled urine from 4
and to compare the Optiflow as effective as the other
volunteers.
effectiveness of different devices.
bladder washout delivery
devices.
UC32 1 Horgan AF, Prasad B, Waldron Design: Descriptive Study – 30 urethral catheter – mean period 3 A well conducted study.
196
DJ et al. 1992. Eire. Prospective Follow- weeks.
up 56 suprapubic – mean period 5 weeks. Mean duration of catheterisation is
Three year follow-up of Setting: 12 (40%) urethral group had infections. misleading due to large range.
patients who presented to the Urban Hospital 10 (18%) suprapubic p<0.05.
accident and emergency Accident and 5 (17%) urethral catheters developed
department with acute Emergency Unit and urethral stricture compared with none
urinary retention due to Sample: Home in suprapubic p<0.001.
prostatomegaly required
13 (23%) suprapubic catheters became
catheterisation and were Popn: 86 (Males) dislodged.
managed either by suprapubic
catheters or catheterised
urethrally. Men with acute Prostatic symptoms – mean duration 10
retention due to months
prostatomegaly.
Makes recommendation that suprapubic
catheters be used rather than urethral
for the treatment of acute urinary
retention.
UC34 6 Kennedy AP, Brocklehurst JC, Design: Randomised Administration of bladder irrigation The study addresses an appropriate
Robinson JM. et al. 1992. Controlled Trial using: 100 mls sodium chloride 0.9%, and clearly focused question.
220
UK. Suby G or Solution R for 20-30 minutes, Small study but the fact that it
3 urban hospitals twice weekly over a 3 week period, includes total population and
Setting:
To compare the use of acidic followed by a rest week with saline. crossover trial strengthens its
82
Author, Date,
washout solutions with validity.
neutral saline in a group of Sample: 25 (Females) Catheters changed at the end of each Only 14 completed full trial.
elderly catheterized females. period.
Popn: All female patients
with long-term More crystals observed during saline
catheters. washouts (p<0.0001). Struvite appeared
significant in saline and rarely seen in
Suby G and Solution R (p<0.001).
Uric acid identified in Suby G and

Solution R. Overall Solution R produced
the best results and Suby G the worst.
Suggests catheterised patients are

potential blockers as they tend to
become crystal formers. Acidic washouts
do not appear to reduce crystals and
may actually damage endothelium.
Acidic washouts may be contra-

indicated for patients with dehydration
or low urine output.
UC35 1 Bakke A; Vollset SE; Hoisarter Design: Descriptive Women had higher infection scores than Lack of comparison group makes it
28
PA et al. 1993. Norway. prospective study men 2.5 Vs 1.8 (p<0.01) over 3 month difficult to judge if there are any
period. Tendency for lower infection differences in complications with
To characterize and quantify Out-patients scores in men with increasing age similar groups using other forms of
Setting:
the complications related to (p<0.01). Lower infection score for urinary drainage.
clean intermittent patients using low friction catheters
Sample: 302 (149M, 153F) compared to those using PVC catheters
catheterisation (CIC). Same cohort as UC6.
2.1 vs 3.7 (p<0.05).
Popn: Residents in Norway
83
Author, Date,
carrying out CIC. Results indicate that rates of
symptomatic UT infection is lower in
those using only low friction catheters
compared to those using plain PVC
catheters, however only 41 of the
patients used plain PVC catheters.
UC36 5 Roberts J, Kaak B, Fussell E. Design: Descriptive Study No bacteria adhered to the inside or No details of origin of specimen.
402
1993. USA outside of the hydrophilic catheter
Setting: Laboratory surfaces regardless of preparation.
To evaluate bacterial Infrequent adherence to the outside of
adherence of 8 catheters except silicone.
Sample: 120 samples
microorganisms to 5 urethral Adherence variable to the inside of
catheters: red rubber Teflon and elastomer catheters but less
polytetrafluoroethylene- Popn: Urine specimen taken than silicone.
coated latex (Teflon), silicone from patient with
elastomer-coated latex, and catheter in situ.
hydrophilic-coated latex
(Lubricath).
UC38 4 Kunin CM, Chin QF, Chambers Design: Descriptive Study Blockers tended to tolerate catheter for The study addresses an appropriate
240
S. 1987. USA. 7-10 days and excreted more alkaline and clearly focused question. All
Setting: Urban 250-bed skilled urine, containing more calcium, protein relevant outcomes are measured in
To describe the factors nursing home and mucin than non-blockers. standard,
associated with the formation valid and reliable way.
of encrustations and blockage 50 (9M, 41F) There were significant differences in the
Sample:
of flow of urine, and the composition of 24 hour urine samples
microbial flora in the catheter between blocked and non-blocked
and bladder urine of 50 Popn: Nursing home catheters.
patients aged 60+years who patients
required a long term catheter.
148
UC41 6 Getliffe K. 1994 (a). UK. Design: Experimental Saline washout has no effect. Laboratory study – well controlled
and thorough.
84
Author, Date,
To examine the effectiveness Setting: Laboratory Suggests both Suby G and mandelic acid
of bladder washouts of Suby make it difficult for P mirabilis to adhere
G, mandelic acid 1% and Sample: 15 samples to sides and therefore reduce
saline 0.9% in reducing encrustation
catheter encrustation, in a
model bladder. Popn: Not relevant as
synthetic urine.
UC43 1 Webb RJ, Lawson AL, Neal DE. Design: Descriptive study – 145 patient were successfully using CISC General study of CIC that
495
1990. UK. Retrospective Follow- at time of writing/ Seven patients were contributes to the evidence.
up either "unable or unwilling to master the
Follow up of 172 patients techniques"
Setting:
using Clean Intermittent Self- Hospital out-patients
Catheterisation (CISC). at one urban hospital Symptomatic infection rates were
available in 153 patients; 70 (48%) had
Sample: never had a symptomatic infection (1
170 (gender not
stated) total of 1187 infection free patient
Popn: months) and 22 (14%).
Reported only 1 infection (mean time on
Out-patients using
treatment = 32 months); 32 patients
CIC.
(21%) reported infection rates of less
than 1 per year, 9(6%) recorded 2
infections per year, 12 (8%) had 4
infections per year and 8 (5%)
complained of 6 or more infections per
year. The mean infection rate was 1 per
87 patient months.
UC52 1,2,6,7 Saint S and Lipsky BS. 1999. Design: Systematic synthesis Catheterisation should be avoided when Only 1 database (Medline used).
419
USA. of literature not required, and when needed
terminated as soon as possible. Use of Other references identified by
To provide ‘an evidence based Various (mainly suprapubics and condom catheters may expert consideration and review of
Setting:
synthesis of the literature on hospital) be associated with a lower risk of UTI. references in retrieved articles.
Aseptic catheter insertion and a
85
Author, Date,
preventing catheter- properly maintained closed drainage
associated urinary tract Sample: N/A system are critical to reducing risk of Preference given to RCT, data on
infections to develop bacteriuria. prevention summarised
recommendations for Instillation of antimicrobial agents into qualitatively. Therefore no formal
Popn: Adults
clinicians’. the bladder and urinary drainage bags metanalysis.
are crucial to reducing the risk of
bacteriuria. Instillation of antimicrobial
agents into the bladder or urinary
drainage bag and rigorous meatal
cleaning seem to be of little benefit.
Systemic antibiotic drug therapy seems

to prevent UTIs but primarily in patients
catheterised for 3-14 days.
UC55 3 Bregenzer T, Frei R, Widmer A Design: Descriptive Minimal increase in bacteraemia Study carried out within routine
50
et al. 1997. Switzerland. (27/480, 5.6%) and bacteriuria (5/120, clinical practice. All subjects
Setting: 2 Long-term care 4.2%). 0/120 had clinical symptoms or included underwent the same
To determine the incidence hospital facilities signs of infection. treatment.
and clinical relevance of Criteria for inclusion and exclusion
bacteraemia induced by Catheter replacement does not clearly stated.
Sample: 39 (26M, 13F). 120
urinary catheter routine catheter necessarily increase the chance of Study was restricted to elderly
replacements. replacements. colonisation. (over 65yrs).
Geriatric patients in However there was no comparison

Popn: group to test this.
long-term care
facilities.
UC61 1 Bakke A Digranes A. Design: Descriptive Study- 1413 urine samples cultured. Bacteriuria 1 year follow-up of a total CIC
26
1991,.Norway. Prospective. in 51% of samples, no difference population.
between male and female. Frequency of Epidemiological study.
To assess the occurrence of Hospital Out Patients bacteriuria significantly lower in patients
Setting:
bacteriuria in all patients using antibiotics and methenamine
86
Author, Date,
using CIC in a defined hippurate cpw those not using anti-
population over a period of Sample: 407 (206M, 201F) infectives (p<0.05). Gram –ve species
one year. higher (p<0.001) among patients using
antibiotics or methenamine hippurate
Popn: Adult out-patients
compared with those not using anti-
using CIC Feb-Aug
infectives.
1988.
Majority of patients with bacteriuria
were asymptomatic.
UC66 2 Hardyck C, Petrinovich L. Design: Descriptive Study UTI rate in the DB group was 1395 with Selection of sample unclear.
175
1998. USA. 27 admissions. Data collection based on
Setting: Patient’s Homes The NDB rate was 71 with 2 admissions. retrospective reports from multiple
To compare the effectiveness The reduction in UTIs resulted in cost informants.
of two drainage systems in Sample: 82 (36M, 27F) savings that outweighed the higher cost
controlling urinary tract of the NDB units.
infections and the total costs
of drainable bags (DB) versus Popn: Home care patients
non-drainable bags (NDB).
UC72 6 Stickler DJ, Clayton CL, Chawla Design: Experimental With the exception of phenoxyethanol A well reported laboratory study.
450
JC, 1987, UK. against Pv Stuartii and possibly Ps
Setting: Laboratory aeruginosa, all washouts only
To test the efficacy of temporarily reduced bacterial growth.
povidone iodine 2%w/v, Sample: 48 samples
phenoxyethanol 2.4v/v, Phenoxyethanol is the only effective
chlorhexidine 200ug/ml +/- antiseptic against Pv Stuartii and, if
Tris and EDTA against E. coli, Popn: Sterile pooled urine. given twice against Ps aeruginosa, daily
Pv starti, Pr mirabili, K washouts of other antiseptics merely
pneumoniae, Ps aeruginosa reduce microorganisms that recover
and S. faecalis within 24 hours. It is the cells in the
biofilm that are the most difficult to
treat.
87
Author, Date,
147
UC74 4&5 Getliffe KA. 1994 (b). UK. Design: Descriptive Study Q4: Blocker status was significantly The study addresses an appropriate
associated with high urinary pH and high and clearly focused question. All
A prospective long-term study Setting: Community urinary ammonia. relevant outcomes are measured in
of 47 community patients standard, valid and reliable way.
with long-term catheters, Sample: 42 (18M, 24F). Q5: At least 76% of all patients
identifying them as blockers experienced one or more recurrent
and non-blockers. problems associated with
Popn: Community patients catheterisation, with almost half (47%)
living at home or in complaining of urinary leakage, and
warden controlled nearly a third (37%) suffering from
community settings retention. A prevailing tendency
across three health towards ‘crisis care’ existed for patients
authorities. classed as blockers. Blockers had a
significantly shorter time between
recatheterisations than non blockers.
P<0.0001.
Blocker status associated with females,
poor mobility and with high urinary pH
and ammonium, and catheters needed
replacing <6 weeks.
Q5: Blockers were significantly less

mobile than non-blockers.
Q5: There was no relationship between

blocking and fluid intake.
UC75 5 Roe BH, Brocklehurst J. 1987. Design: Qualitative Study Patients with a catheter of at least 18 Data collected from
405
UK. Charriere were more likely to experience medical/nursing records and carers
Setting: A community study in pain as well as patients though results
A preliminary investigation of one health authority 32 (89%) experienced leakage at least not clearly linked to source.
patients’ understanding and once a week
88
Author, Date,
knowledge of their catheter’s Sample: 36 (20M, 16F) 23 (64%) blocked with a median
location and function, its occurrence of between 1 and 3 months.
acceptance, problems
Popn: Patients over 50
associated with its use, social years with long-term
implications and its
catheter.
subsequent management.
UC87 1 Duffy LM, Cleary J, Ahern SA Design: Randomised No significant differences found Randomised by research site.
110
et al. 1995. USA. Controlled Trial between clean and sterile groups with Previous history of UTI identified by
regard to: treatment episodes, time to authors as possible confounding
To compare the safety and 3 long term facilities first infection, types of organism factor.
Setting:
cost of clean versus sterile cultured or cost of antibiotic treatment.
intermittent bladder 80 (Males)
Sample:
catheterization in male
nursing home patients.
Popn: Veterans aged 36-96
years.
UC88 7 Romanelli G, Guistina A, Design: Randomised A single dose 2g im. of aztreonam is Not double blind.
407
Cravarrezza P. 1990. Italy. controlled trial effective in preventing UTI in elderly Well matched experimental group
patients needing indwelling urethral and controls.
To evaluate the Hospital medical catheters. Prophylactic use of antibiotic was
Setting:
bacteriological and clinical ward 89% of the aztreonam group had before first catheterisation.
efficacy of aztreonam in the negative urine cultures compared with
Sample: 46% of the placebo p<0.001. For the
prevention of UTI in elderly 162 (96M, 66F)
hospitalised patients who diabetics, 29 received aztreonam and 30
needed indwelling urethral Popn: placebo 14% and 63% respectively had
catheterisation. Elderly hospitalised UTI p<0.001.
patients needing
urethral
All patients were followed up for 7 days.
catheterisation. Age
range: 60-91 years.
146
UC91 5 Getliffe K. 1990. UK. Design: Descriptive Study Despite all catheters being susceptible All relevant outcomes are
to encrustation and blockage, the length measured in a standard, valid and
89
Author, Date,
To examine a number of Setting: Community settings of time a catheter remains functional reliable way. However it relies on
issues related to catheter (patients homes in can vary and requires individual care the nurses completing the
blockage in patients at home. one district regimens. questionnaire accurately and fully.
authority).
Over 50% of patients suffer from
Sample:
81 (47M, 34F) recurrent encrustation and blockage.
Popn:
Patients with
indwelling urinary
catheters for more
than four weeks.
UC96 2 Wilson C, Sandhu SS, Kaisary Design: Randomised 17 involved in crossover study, all Lacking detail as to underlying
505
AV. 1997. UK Controlled Trial preferred valve system. conditions or how patient
No significance in UTI rate between preference collected.
To compare the use of a Setting: Hospital (one follow groups.
catheter-valve with the up at home) Patient satisfaction significantly higher
standard drainage system in in valve group, 92% compared with
terms of morbidity and 100 (84M, 16F) those in the standard drainage group.
patient preference. Sample:
Use of valve was more cost effective.
Popn: Patients undergoing

long term
catheterisation.
UC99 4 Burr RG, Nuseibeh I. 1995. Design: Descriptive Study Catheter blockage was significantly Convenience sample.
55
UK. related to the duration of cord lesion,
Setting: Spinal Injuries Unit patient age, urinary pH and calcium
To relate blockage of the concentration.
urinary catheter to urine The only significant prediction of
Sample: 44 (46M, 18F)
chemistry. catheter blockage were urine pH and
calcium concentration.
Popn: Patients with spinal
cord lesions with
90
Author, Date,
indwelling urinary Patients troubled by frequent blockage
catheters. (n=21) and those who experienced no
blockage (n=23) were compared.
Maximum pH and calcium
concentrations correctly discriminated
between 91% of the patients (95% CI 78-
97%).
Urinary pH and calcium levels were

higher in patients who had a more
recent spinal injury.
UC100 1 Charbonneau-Smith R. 1993. Design: Descriptive Study The use of the O’Neil catheter (UK No discussion of other changes that
70
Canada. equivalent Instant Cath Protect) results may have taken place in the unit
Setting: Long-term care in a reduction in number of infections between the control-experimental
To assess the effectiveness of facility (from 3 to 1 per person – medians) and times that could potentially reduce
the O’Neil Sterile FieldTM reduction in length of infection (from number and length of infections
Sample: 39.5 to 12.5 days – medians). was recorded.
urinary catheter in reducing 110 (gender not
number and length of Comparison was between retrospective
Popn: stated)
infections in a group of spinal control data and prospective
cord injured patients experimental data.
(requiring intermittent Traumatic spinal cord
catheterisation). injuries.
UC113 1 Terpenning MS; Bradley SF; Design: Descriptive Study – Catheterisation is a significant risk Catheterisation only one of many
465
Wan JY et al. 1994. USA. Prospective Before factor. Infection rates tend to be lower risk factors studied.
and After with intermittent catheterisation that No details given regarding the
To assess colonization and with indwelling. number of patients within this
infection with methicillin- Nursing home care Statistically significant catherisation sample who were catheterised.
Setting:
resistant Staphylococcus unit associated with recurrent UTI (p=0.007)
aureus (MRSA), high-level indwelling catheters (p=0.001).
gentamicin-resistant Sample:
551 (542M, 9F)
enterococci (R-ENT) and
91
Author, Date,
gentamicin and/or Popn: Patients admitted to
ceftriaxone-resistant Gram- unit June 1989 – May
negative bacilli (R-GNB) and 1991.
the factors that are associated
with colonization and
infection with these
organisms.
304
UC116 8 Moore KN. 1990. Canada. Design: Cross over study 60 catheters examined from each group. Plastic catheters were used only
No difference between the two groups once, when normally they are re-
To compare the effectiveness Setting: Home in terms of the contaminated catheters used for 1-3 weeks. Therefore
of 2 solutions for cleaning or type of organisms cultured 4/8 hours limited generalisability.
plastic urethral catheters used after cleaning.
Sample: 30 (16M, 14F)
for clear intermittent Very low colony count on contaminated
catheterisation: sunlight liquid catheters.
detergent and cetrimide 1:30 Popn: Patients aged 1-18
(Savlon). years with
neurogenic bladder
using CIC for 2
months.
UC122 8 Griffith D, Nacey J, Robinson Design: Experimental Colony count reducing with increased Proteus sp bacteria were used and
167
R, et al. 1993. New Zealand. duration of microwaving. After 6 mins, the authors report that their
Setting: Laboratory complete sterilisation was achieved. sensitivity to microwaves is similar
To determine whether Suggests that this is a reliable cost- to other species eg. E coli,
microwaves were an effective effective method for sterilising Klebsiella, Pseudomonas and
Sample: 2 groups of catheters Enterobacter but these were not
means of sterilising polyethylene catheters for ISC that could
in batches of 6 tested tested in this study.
polyethylene catheters and to be carried out easily by patients.
at 5 different times
provide a simple sterilisation periodically. Total Suggests infection may be as low as 1 in
protocol which patients using number not specified. 8 patient months using this technique.
this technique could follow.
Not stated.
Popn:
92
Author, Date,
238
UC124 4 Kunin C. 1989. USA. Design: Descriptive Study Urine of blockers was significantly more No comment on the advisability of
alkaline and contained less Mg PO4 and monitoring urinary pH.
To study the blocker/non Setting: 260 bed nursing urea than non blockers.
blocker ‘phenomenon’: home.
How consistently do patients Sample:
remain as blockers or non 65 (Females)
blockers?
Popn:
Do blockers have more febrile Nursing home
episodes? patients with
Is there a relationship indwelling catheters.
between formation of
encrustations and: urinary
microbial sp.; production of
urease; pH and constituents
of urine?
Do some organisms protect
against encrustations?
5 Does antimicrobial
therapy alter
formation of
encrustations?
UC125 7 Firestein M, Mendelson D, Design: Randomised Treatment group 1gm of IV meropenem Patients recruited had no
132
Gronich E et al. 2001. Israel. Controlled Trial 30 minutes before catheterisation. antibiotics for previous 2 weeks.
Random allocation to treatment.
To investigate whether Setting: Geriatric Centre Use of prophylactic antibiotic did not Treatment and control groups
prophylactic antibiotics given prevent or delay development of similar.
during catheter replacement 70 (21M, 49F) bacteriuria after long term urinary Regular follow-up over 28 days.
Sample:
can prevent or delay the catheter replacement.
development of subsequent
bacteriuria Popn: Residents with long-
term urinary No significant difference in urine
cultures between treatment and control
93
Author, Date,
catheters. groups at 3, 7, 14 or 28 days.
UC128 4 Choong S, Wood S, Fry C et al. Design: Descriptive Study Non-blockers had a significantly more No patient details included. Not
72
2001. UK. acidic voided urine pH (6.26) with a wide clear how many specimens taken
Setting: Setting not stated safety margin between voided and or over what time frame.
To determine the relationship crystallization pH (7.66) and no
between urinary pH, UTI and infection.
encrustation in patients with stated)
long term catheters.
Popn:
Patients with long-
term indwelling
urinary catheters.
UC137 1 Perrouin-Verbe B, Labat JJ, Design: Retrospective period Aim 1: 60% had asymptomatic Non-random sample from total
Richard I et al. 1995. prevalence survey cytobacteriological infection (39.7% population.
359
France. females; 66% males) ; 28% symptomatic Outcomes well defined.
Rehabilitation infection (17.3 females; 32.7% males) Authors suggest a comparative
Setting:
To evaluate the overall rate of hospital P<0.05 in both groups. study should be undertaken.
complications of CIC.
Sample:
To record reasons for Aim 1: 159 (113M, Aim 2: Symptomatic infections <1 every
acceptance of CIC, frequency 46F) 2 yrs in 11pts; <1 a year in 1 pt; 1-2
of UTI and rates of urethral episodes in 5; 2-4 times a year in 4pts.
Aim 2: 21
strictures. Popn: Asymptomatic cytobacteriological
infections: <1 infection every 2 yrs in 15;
Spinal cord injury <1 per year in 2; 1-2 times per yr in 2; 2
patients. pts had permanent antimicrobial
prophylaxis.
UC138 1&8 Moore KN, Kelm M, Sinclair O Design: Crossover Study Q1: 6 months crossover using sterile Crossover design adds to internal
306
et al. 1993. Canada. (Randomised single-use catheters or clean reused. A validity.
Controlled Trial) comparable group used sterile catheters
To test the hypothesis that only. Only conducted amongst subjects
94
Author, Date,
bacteriuria would be reduced Setting: Clinic at children’s 38% +ve cultures in crossover groups with spinabifida and therefore
in subjects who used single- hospital regardless of whether sterile single use generalisability may be limited.
use rather than clean reused or clean reused catheters were
catheters for intermittent self employed. Compared with 36% +ve
Sample: 2 samples. 30 in
catheterisation. crossover (15M, 15F). cultures in the group using only sterile
23 comparisons. catheters.
No differences between males and
females, those performing self or
Spina bifida children
Popn: parental catheterisation.
age range: 3-16 years.
Q8: Soapy water and rinsing can be used

as method of cleaning a catheter for re-
use.
UC140 1 Sheriff MK, Foley S, Mc Design: Descriptive Study 9 (6%) developed recurrent UTI. Well designed study conducted in a
434
Farlane J et al. 1998. UK. 28 (18%) experienced blockages. standard, valid and reliable way.
Setting: Neurological unit 12 (8%) leakage.
To identify the current place
of long-term suprapubic Sample: 157 (80M, 77F) Overall 30% of patients had catheter
catheterisation in the related complaints.
management of neuropathic
bladder, how should these be Popn: Patients referred to
best managed and what do neurological unit. Suggests suprapubic catheterisation is
patients think about this form an effective and well tolerated method
of bladder management. for patients with neuropathic bladder
for whom surgery is the only option.
UC143 3 White MC, Ragland KE. 1995. Design: Historical Cohort Only patients who were free of infection Limitations: retrospective chart
499
USA. Study at the start of home care period were review; data on other risk factors
Setting: included in analysis: n=81. Incidence = for infection e.g. co-morbidities not
To determine in home care Patient’s Home 20.9 infections/10,000 catheter days. collected/not available.
patients on long term urinary Of those whose catheters were changed
Sample:
catheterisation: at intervals of 2 weeks or less – 15.4%
106 (gender not
remained free of infection after 4
95
Author, Date,
the urinary catheter infection Popn: stated) weeks. Those whose catheters were
rate, changed at 4 to 6 week intervals – 80%
the characteristics of patients Home care patients remained free of infection after 6
who get UTI’s compared with weeks. The number of different nurses
those who do not, changing the catheter was also
significant, with a relative hazard of 1.38
the influence of catheter
change interval on the length (CI 1.22 – 1.55).
of time patients remain Relative hazard rate for infection = 11.94
infection free. (CI 5.46-26.22) for catheter change </= 4
weeks versus catheter change >4 weeks.
This analysis controlled for age, sex,
severity of illness and number of nurses
changing catheter.
UC145 4 Burr RG, Nuseibeh IM. 1997. Design: Descriptive Study Mean and maximum circadian pH and Included newly injured patients
56
UK Ca was higher in blockers than non- whose calcium levels may have
Setting: Spinal Injuries Centre blockers. been higher than normal.
To study the relationship pH and calcium urine measurement in No information on patient
between urine pH and laboratory correctly diagnosed 56-58 selection.
Sample: 60 (42M, 18F)
calcium to catheter blockage (96.6%) as blockers or non-blockers.
and suggest how to reduce
encrustation. Popn: Spinal injuries
patients
UC149 1 Shekelle PG, Morton SC, Clark Design: Systematic Review Eight studies were reviewed using Well-conducted systematic review
KA, Pathak M, Vickrey BG. different populations and were but the many of studies are quite
432
1999. USA. Setting: Not reported consistent in their findings: persons old.
using intermittent catheterisation had
To identify controlled clinical fewer infections than those with Databases searched and selection
Sample: Multiple studies indwelling catheters and those voiding
trials, cohort and cross criteria clearly stated.
sectional studies that without catheters.
assessed risk factors for UTI Popn: Adults and
and included bacteriuria or adolescents over the
UTI as an outcome. age of 13 years with
96
Author, Date,
neurogenic bladder
due to spinal cord
dysfunction.
UC193 All Pratt RJ, Pellowe C, Loveday Design: Systematic Review Comprehensive description included in For some areas only low grade
381 382
HP et al. 2001. UK. technical report . evidence available
Setting: Acute care settings
To develop national evidence- All databases included, 7 in total. No
based guidelines for Sample: Study Designs: Mainly hand searching.
preventing hospital acquired controlled trials,
infections associated with the some experimental All articles subjected to clinical review
use of short–term indwelling and descriptive. and critical appraisal.
urethral catheters.
N/A
Popn:
97
D.6.6 Enteral feeding accepted studies

Quest. Author, Date,
Numbe Country of Origin and Objective Design, Setting, Sample Size and
ID r Population Outcomes Strengths and Limitations
P1 1 Dentinger B, Faucher KJ, Ostrom Design: Experimental Of the 211 samples, 18 had one cfu and Patients were not actually fed; the
98
SM et al. 1995. USA. Laboratory Study one had 137 colony forming unit (CFU). level of contamination is extremely
That is 19 (9%) had some likely to be an underestimate of
Assess the contamination in a Care Centre contamination. the level observed when patients
Setting:
closed system of enteral feeding No feeding bottles had separation or are fed.
over 36 hours. coagulation (not defined) immediately
Sample: 211 containers
or one week after the study indicating A higher protocol standard than
were used to
they had no contamination. normal regarding handling was
simulate
continuous enteral used.
feeding for 36 It appears from the data presented here
hours. that microbiological contamination does Study supported by industry.
Popn: In-patients of care not enter from the formula, closed
facility. system or administration set.
P2 1 Beattie TK and Anderton A. 1998. Design: Experimental Results indicate sterilisation of a sealed Lack of standardisation between
36
UK. system (steriflo), prior to assembly or the 7 protocols in terms of
Setting: Laboratory during further manipulation, reduces interventions and numbers of
To compare the risks of microbiological contamination. samples makes comparison
introducing microbial difficult.
Sample: 7 experimental
contamination when assembling Disinfection of a non-sealed system of No details of control.
protocols reported
and running two commonly used, 5 times per nutrition glass bottles does not prevent
ready-to-hang, enteral feeding protocol. NB contamination when faulty handling
systems with a newly introduced sampling variable occurs.
feeding system. for each protocol.
Nutrition glass bottles and steriflo Total samples=90
vs nutrition pack. (5x11) + baseline:-
7x5.
Popn: Laboratory Study
P6 1 Weenk GH, Kemen M and Werner Design: Experimental NB “>” indicates the system(s) on the The main issue in the
497
HP. 1993. Germany. left of the sign had higher levels of interpretation of this paper is
Setting: 2 hospital intensive counts – which is worse - than the whether total absence of cfus is
98

To compare four enteral feeding care units (ICUs) system(s) to the right of the sign. important (in which case Steriflo is
systems in terms of their ability to and 2 simulated the best) or whether the BDA
limit the chance of introducing ward conditions 1: samples with cfus just after setting up standard should be used, in which
microbial contamination during 48 cultures time (0 hrs), no significant diff between case, there is no significant
Sample:
the set up of the systems: nutriset systems (although there were difference between systems.
bag, nutriset container, nutriset difference observed in cfus: Bag>all Patients do not appear to have
Not stated
crown cork bottle and nutriset Popn: been involved.
other methods)
steriflo.
2: a) samples with different levels of
counts after 6 hrs (crown cork) 12 hrs
(all other systems): no significant
differences between systems at
100cfu/ml level
b) looking at the systems with ANY cfus
(vs. NO cfus): Bag> crown cork,
container>Steriflo significant at 5%
3: number of bags with no counts after

incubation for 72hrs: Bag>Crown cork,
container, Steriflo significant at 5%
Steriflo system emerged as safest in this

study.
BUT NOTE:
1: no feed samples reached 100cfu/ml
during the times they were
recommended for ward use (6hr for
crown cork; 12 hrs for all others)
2: the significant differences between
systems were measuring absence of
counts, NOT the British Dietetic
Standards of 100cfu/ml
99

P7 1 Wagner DR, Elmore MF, Knoll DM. Design: Random Controlled 1: initial contamination: No The BDA standard of 100 cfu/ml is
485
1994. USA. Trial contamination in any CS, compared with not used or reported so it is not
22 (30%) of OS-Can and (60) 100% of OS possible to compare the results
To quantify: factors associated Two critical care powder, with ANY growth (differences with other similar studies.
Setting:
with the use of three different units in a between OS-Can and OS-Powder Inadequate information given
feeding-delivery systems for community hospital significant) p<0.001. about potentially confounding
peptide-based diets, sterile 2: initial contamination: No high factors.
closed, open system-can, open contamination (defined as
Samples: 87 closed
system powder: Sample: >10,000cfu/ml) in any CS, compared
system (CS), 72
preparation time with 4(5%) in OS-Can and 24(40%) in OS
open system can
Powder (differences between OS-Can
total formula waste (OS-Can), 60 open
and OS-Powder significant) p<0.001.
bacterial contamination system powder
(OS-powder). 3: final contamination: 5 (6%) of CS, 58
Popn:
(80%) of OS-Can and 60 (100%) of OS
powder had any growth at the end of
Critical care delivery (difference between CS and
patients requiring other two systems significant) p<0.001.
enteral feeding
4: final contamination (high) 2 (2%) CS
had high contamination compared with
(60%) OS-Can and 50 (83%) OS Powder
(all differences significant) 43 (p<0.001).
P8 1 Herlick SJ, Vogt C, Pangman et al. Design: Randomised Bacterial contamination: It would appear that differences
188
2000. Canada. Crossover Overall, with the 72 samples: between sites can be larger than
Experiment no growth at all in 20 (56%) of closed differences between systems.
Compare open and closed systems Setting: systems compared with only 1 (3%) of Several study measures were
in two long-term care facilities 4 chronic care units open systems no significant level affected by different prescribing
(each with two units) on the in two long-term reported). practices. Also, some of the nurses
following: care facilities High contamination (greater than at A had previous experience of a
a) Bacterial contamination 10,000 cfu/ml) found in 78% open closed system, whereas none at B
Sample: samples compared with 39% from had this. Finally, the system at B
b) Diarrhoea 36. Facility A-13, B-
closed system (p<0.05) required a more difficult
23
connection to a foley catheter.
Coliform found in 5.6% of closed
The study is, perhaps, a little small
100

Popn: People with brain system compared with 28% open in size, but appears well-conducted
injury system (significant at p<0.05) with major sources of confounding
BUT: there were no significant identified or removed.
differences in facility A compared with
very highly significant differences in
facility B between the two systems.
479
P9 1 Vanek VW. 2000. USA. Design: Descriptive 67% compliance for open delivery Many different sites within the
system. hospital but all patients included.
To review the compliance rate Setting: One hospital site 10 closed systems hung for 20.8 – 45.8
with maximum enteral feeding many different hours sterile. 8 open systems hung for
hang-time policy for open vs. units 6.8 – 26.6 hours. Compliance with hang
closed systems and to determine times 67% open 88% closed. 2
Sample: contaminated. Recommend closed
the incidence of tube feeding 138 (69M, 69F)
contamination. systems whenever possible.
Popn:
In-patients
requiring enteral
feeding
P12 1&2 Lee CH, Hodgkiss IJ. 1999. Hong Design: Experimental Suggests a complete ready assembled No details of control.
259
Kong. system is best to reduce risk of
Setting: Laboratory contamination and wearing of gloves.
To compare two commercially No bacterial contamination with sterile
available enteral feeding systems gloves even when manipulation faulty
Sample: 2 experimental
IsoSource Closed system protocol repeated Bare hand contamination noted at 4
(Novartis), and Compat Pumpset 3 times per hours and rising
(Novartis) and the effect on the protocol. Total Contaminated hands contamination
level of contamination when sample = 24 (3x6) + noted at 4 hours at a higher level than
subjected to different handling (baseline x 6) bare hands
procedures. No differences between the 2 systems
Popn: Laboratory Study “to resist bacterial challenge”.
No contamination was detected when
clean non-sterile gloves were used but
101

study showed it was possible to deliver
a sterile feed even when using bare
hands. Conclusion is that the level of
contamination is related to the degree
of manipulation of the system.
P13 2 Graham S, McIntyre M, Chicoine J Design: Randomised Trial No significant differences in morbidity A range of feeding access was
163
et al. 1993. Canada. when 24 hour tube changes compared used, including nasogastric which
Setting: 417 bed long-term with 72 hours. may have had some bearing on the
To determine whether more care facility result.
prolonged intervals between bag The results indicate that it may not be
and tubing changes adversely 11 patients for the necessary to change tubing and bags 2 study periods, data collection
Sample:
affected patient health. first study period every 24 hours and that they could be and definition. Consistent
and 12 for the left for 72 hours without increased sampling frame known.
second. infection. Randomisation method
satisfactory and explicit.
Popn:
Elderly, clinically
stable and suffering
neurological
disease.
P15 2 McKinlay J, Anderton A, Wood W Design: Randomised Number of days feeds contaminated: No information on patients'
289
et al. 1995. UK. Controlled Trials 3/30 (10%) 500ml underlying conditions.
To compare the levels and types 2/30 (7%) 1000ml
of micro-organisms present in Setting: Urban hospital Most frequently and heavily
residual feed in nutritional contaminated from distal end.
containers and giving sets when
either 500mls or 1000 mls pre-
stated) The results indicate that the more
filled, ready-to-hang nutritional
containers were used to Popn: frequently the bags are changed the
administer 1-2 litre quantities of In-patients more likely it is that the feed will
feed to patients on hospital wards requiring enteral become infected.
over 24 hours using a single giving feeds.
set over this period.
102

P16 2 Patchell CJ, Anderton A, Holden C Design: Descriptive Study In patients: using the new protocol only No patient details given.
349
et al. 1998. UK. 3/77 (4 %) of samples were Small sample.
Setting: Urban contaminated at the end of the Cannot identify which changes to
To examine the effects of Hospital/Some administration period as compared with the protocol are the most
improvements in the enteral patients’ homes 28 (45% ) using the old protocol. important.
feeding protocol, coupled with an p<0.001
Sample:
intensive staff training 21 children (gender
programme on bacterial not stated) Home patients: 2/36 (6%) samples
contamination. contaminated compared with 8 (28%) at
Popn: the start and 18 (62% ) at the end under
All patients previous protocol. p<0.001.
receiving Nutrison
paediatric standard
as an enteral feed. New protocol involved priming the
feeding on an alcohol treated metal
tray, spraying the bottle opener and top
with 70% alcohol wearing sterile non-
disposable gloves and filling the feeding
reservoir with feed for up to 24 hours
use rather than 4 hours.
P17 2 Rupp MM, Weseman R, Nedra M Design: Descriptive study 5 patients had 8 nosocomial infections, The patients were particularly ill in
412
et al. 1999. USA. none associated with feeds. this study and sample small.
Setting: Urban hospital Mean infusion time 22.7 hours. None Met power calculation.
To determine whether prolonged contaminated.
infusion of a sterile, closed Sample: 15(7M, 8F) Concludes that when properly handled,
system, non-air dependent non-air dependent, sterile, closed
enteral feeding solution was system enteral feeds can be safely
associated with bacterial Popn: Patients who administered with hang times of 24
contamination or nosocomial underwent liver hours.
infection. transplantation
P19 2 Patchell CJ, Anderton A, Design: Randomised Trial Inpatients: Although no contamination Research on home patients using
MacDonald A, George I et al. of the modular feeds was detected PEGs however, no information is
350
1994. UK. Setting: One Urban Hospital immediately after mixing 14% had given about the diseases the
103

in-patients evidence of contamination by the start children are suffering from.
To define further the mechanisms compared with of administration, which had increased
producing feed contamination and home patients to nearly 50% by the end (p<0.001).
the setting in which it occurs’ Despite less contamination at the start
Sample:
comparing the contamination of a 35 children (21M, (2%) the ready-to-use feeds were
modified feed with a ready-to-use 14F) equally contaminated as the modular
feed in hospital and at home. feed at the end of the administration.
Popn:
Children 1-5 years
or weighing 8-20 Kg Home patients: As in hospital the
receiving at least modular feeds were significantly more
50% energy needs contaminated at the start of
via enteral feeding. administration with over 75% of feeds
contaminated compared with 28% of
ready to use feeds. This significant
difference was maintained by the end of
administration when all modular feeds
were contaminated compared with
nearly two thirds of ready-to-use feeds
(p<0.01).
The study highlights the importance of

hygiene training for parents and the
desirability of a ready-to-use formula.
P20 2 Anderton A and Aidoo KE. 1991. Design: Experimental No feed contamination from subjects Needs to be repeated in a clinical
18
UK. wearing sterile gloves, and only <1 cfu setting.
Setting: Laboratory per plate when the volunteers wore
The effect of handling procedures non-sterile gloves, compared with 54
on microbial contamination of cfu/ml when no gloves used.
enteral feeds – a comparison of stated)
the use of sterile vs non-sterile
gloves. Popn:
Volunteers with
uninfected and
104

undamaged skin.
P22 2 Beattie TK, Anderton A. 1999. Design: Experimental Contamination. 87% Osmolite. 27% Experimental study.
37
UK. Dripac. 80% Steriflo. 13% Easybag
Setting: Laboratory (p<0.05). 13% had >104 cfu/ml.
To investigate the levels of
contamination in four currently Sample: 65 samples (5x4x3) ‘Closed’ systems do become
used 1000mL, ‘ready –to-hang’ + 5 catheters. contaminated, especially when
enteral feeding systems Osmolite manufacturers instructions are not
(Ross Ready-to-Hang), Steriflo, followed.
Dripac-flex and Easybag when Popn: Laboratory Study
faulty procedures were used
during assembly of the systems.
P23 3 Anderton A, Nwoghu CE. Design: Experimental The only effective cleaning method was Not explicitly stated whether all 3
19 a complicated procedure involving types of catheter were subjected
1991. UK.
Setting: Laboratory hypochlorite, unlikely to be followed to all 5 cleaning regimens.
completely in practice. Reuse is not
To evaluate the effectiveness of a
advised.
representative range of currently Sample: In vitro study (3
used cleaning procedures in systems, 5 cleaning
removing bacteria from the methods, each
lumina of the tubes. duplicated)
Popn:
Laboratory Study
P24 3 Smarszcz RM, Proicu GC, Dugle JE. Design: Experimental At 18 days:- Lab study, use of sanitizer needs to
443
2000. USA. Water alone ineffective in eliminating be demonstrated in clinical
Setting: Laboratory organisms. practice.
To assess the microbiological Soap and water did not prevent
colonization of the Ross Hide-A- Sample: 132 tubes adherence of bacteria and yeast though
Port extension tubes challenged better than water alone and reduced
with 4 separate organisms S. Candida to <105.
epiudermis, Entereobacter Popn: Laboratory Study
Use of ammonia sanitizer significantly
aerogenes, Candida Albicans and reduced organisms.
105

Acinetobacter.
230
P25 2 Kohn CL. 1991. USA. Design: Descriptive study Of 21 delivery sets 23.8% unacceptably No universal definition of
contaminated at 24 hours and by 48 unacceptable contamination.
To determine whether formula Setting: Urban hospital and hours 42.9% unacceptable. This study used 105 cfu/ml.
contamination increased when Laboratory
delivery sets were used for 24 Suggests if use 105cfu/ml, giving sets
hours in the clinical settings and 21 (10M, 11F) should not be used for more than 24
Sample:
for an additional 48 hours in the hours, due to the amount of
laboratory. contamination. Therefore the cost
Popn: Patients requiring effective advantage of prolonged use is
continuous, full not met.
strength Osmolite
feeds in a pump.
P30 5 Sturgis TM. Yancy W, Cole JC et al. Design: Randomised Wound infections:- Wound evaluation on patients
454
1996. USA. Controlled Trials 4/30 (13%) cefazolin discharged were by telephone
Placebo 6/31 (19%) though seen by an investigator if
To determine whether Hospital and an infection was thought to be
Setting: 2/54 (3%) on antibiotics
prophylactic antibiotic treatment follow-up nursing developing.
with Cefazolin reduces the home
58% infections occurred 72 hours after
incidence of peristomal infection
Sample: insertion.
after percutaneous gastrostomy. 115patients, 30
Cefazolin, 31
A single dose of Cefazolin does not
placebo and 54
reduce the overall peristomal wound
already on
infection in percutaneous endoscopic
antibiotics.
infection. Patients receiving prior
Popn: extended antibiotic therapy have fewer
Patients referred peristomal wound infections.
for PEG.
P32 5 Kozarek RA, Payne M, Barkin J et Design: Descriptive Study Peristomal infection before 1 week: 7, Study largely about insertion but
234
al. 1995. USA. after 4 weeks: 4. contains important infection data.
106

Setting: 5 urban hospitals
A prospective multicentre trial to Suggests the theoretical advantages on
establish the use, ease of insertion Sample: 86 (gender not one-step gastrostomies are outweighed
and short and long term safety stated) by placement problems and subsequent
profile of the One-step button complications and suggests further
Popn:
gastrostomy work is needed
Patients with CVA,
neurological
problems, Cancer, Follow up longer than usually reported,
including head and mean 1.5 months range 2-180 days
neck
P74 1 Duncan HD, Bray MJ, Kapadia SA Design: Randomised No significant differences in the number 21 deaths during follow-up though
112
et al. 1996. UK. Uncontrolled Trial of PEG site infections between the 12 no significant difference between
and 20 FG groups, suggesting that the tubes.
To determine if UK size is Urban district larger 20 FG offers no advantage over
Setting:
important in affecting the general hospital the 12 FG tube apart from its ease of
complications of percutaneous insertion.
endoscopic gastrostomy (PEGs), 12 FG–Minor peristomal infection 5,
Sample: 52 (18M, 34F)
i.e infection and leakage. serious 3.
20 FG–Minor peristomal infection 6,
Popn: Patients referred serious 6.
for PEGs.
P75 1 Van den Hazel S, Mulder C and Design: Randomised Trial During the first four weeks of follow-up,
Den Hartog G et al. 2000. major complications occurred twice No analysis is done about whether
477
Netherlands. Setting: Hospital with both polyurethane and silicone the different surgeons have
PEGs (relative risk 3.8. 95% confidence different rates of infection.
A randomized controlled trial to interval: 1.37-10.5). Long-term follow-
Sample: 106 (gender not up was available in 96 patients. Seven
compare two PEG catheters which stated) The mean period for PEG
were similar in design, but one polyurethane PEGs and 10 silicone PEGs
placement was considerably less
was made of polyurethane and were removed because of PEG
for the polyurethane PEG than for
the other of silicone. These Popn: All patients malfunctioning, the remainder
the silicone PEG.
catheters were compared with requiring PEG functioned well until death or the
regard to PEG-related catheters. reinstitution of oral feeding. The
107

complications and PEG survival. median complication-free survival was
916 days for the polyurethane PEG and
354 days for the silicone PEG (Log rank
test: P=0.24).
P77 2 Anderton A and Aidoo KE. 1990. Design: Experimental When using non-disinfected containers An experimental setting.
17
UK. and the feed decanted wearing sterile
Setting: Laboratory gloves and using disinfected bottle
To examine the procedures used openers or scissors no contamination
in the opening and decanting of a was detected in samples from crown
Sample: 160 (80 feed cap or screw cap bottles, but the feed
range of different types of pre- containers
packed liquid feeds and to from the cans (3/12 – 4 hours, 12/20 – 2
disinfected, 80 not hours) and the tetrapaks (6/20 – 24
determine the resultant levels of disinfected)
contamination hours) were contaminated by organisms
Popn: from their surfaces. More samples from
Laboratory Study cans were contaminated.
The main source of contamination

seemed to come from the
experimenter’s hands and counts up to
10 2 cfu/ml were recorded for feeds
that had been decanted from screw-cap
bottles, tetrapaks and cans by
experimenters with either unprotected
bare hands or experimentally
contaminated hands.
127
P78 2&4 Fagerman KE. 1992. USA. Design: Descriptive Study ENS samples were either contamination This is really 2 studies reported in
free or within acceptable limits after one paper.
To describe the effect of enteral Setting: Hospital A – 500 modifications to protocols in both
quality control (QC) programs on bed tertiary care hospitals. Improved sanitation in
bacterial levels within the enteral facility. preparation has greatest improvement
nutrition service in two in reducing bacterial levels.
Hospital B – 100
institutional settings primary care
referring hospital. Q4: Use of Potassium Sorbate as a
108

preservative was effective in
Sample: Incomplete maintaining feeds sterile at 12 hours in
information. Hosp room temperature.
A – 6000 feeds.
Popn: No details given.
P80 1 McKinlay J, Wildgoose A, Wood W Design: Randomised Trial Contamination found in 14/120 (12%) A useful clinical study
290
et al.. 2001. UK. Nutrison packs compared with 25/120 Randomisation not blinded
Setting: Urban Hospital (21%) Ross (p<0.05).
To investigate the effect that On 19 occasions similar organisms were
recent changes in system design isolated from both the feed and patient
may have in reducing the risk of specimens.
stated)
contamination when Most frequently and heavily
administering Nutricia, Ross and Popn: contaminated specimens were collected
Abbott feeds In-patients from the distal end of giving set.
requiring enteral
Retrograde spread of the patient’s own
feeds.
flora is a source of contamination and
samples from a distal end may reflect
endogenous rather than exogenous
contamination.
System design is important re
contamination.
P82 1&2 Bott L, Husson MO, Guimber D et Design: Descriptive Study 45% distal giving sets showed All observations and samples taken
41
al. 2001. France. overgrowth and 30% were by one person during a normal
Setting: Homes contaminated. procedure.
To evaluate the risk of Manipulation error observed in 40% Defined overgrowth as 104 cfu/ml.
contamination of enteral feeding cases though this was not associated Observation by study operator may
Sample: 20 children (12M,
systems in children fed at home with contamination of feeds. have influenced outcome.
8F)
via gastrostomy No difference in contamination Small sample but a limited
Popn: between gastrostomy button or tube. population.
Children with a
Gastric bacterial over growth was not
gastrostomy and
109

fed at home associated with retrograde colonization.
Demonstrates that to avoid /minimise
contamination, closed systems should
be used in preference to open systems
for feeding at home.
P86 3 Grunow JE, Christenson JC, Doris Design: Laboratory Clean enteral nutrition systems can be Well conducted laboratory study.
168
Moutous D. 1989. USA. Experiment reused after short infusion periods and
used up to 7 days in vitro without
To determine the incidence of ‘Vacant room’ in a significant contamination. Bacteria
Setting:
contamination in a delivery children’s hospital cannot be eradicated from heavily
system reused in vitro simulating contaminated bags by rinsing.
nocturnal supplemental enteral Flexiflo Top Fill
feeding. Sample:
Enteral Nutrition
Systems (Ross
Laboratories)
Popn: Not Applicable
P89 2 Freedland CP, Roller RD, Wolfe Design: Descriptive Study Contaminated enteral feeds may Well conducted study.
136
BM et al. 1989. USA. constitute reservoirs for contamination
Setting: Urban hospital of other body sites. Contamination of
Evaluation of an open, continuous feeds with Serratia marcescens
enteral tude feeding system in correlated with cultures for the same
Sample: 33 patients (gender organisms in patient’s other body sites
clinical use, i.e., Biosearch Top Fill not specified) 82
500cc enteral feeding bag, (p<0.01).
enteral feeding
extension tubing and a Dobhoff cultures.
enteral pump or an Imed Undiluted canned feeds were
Volumetric Infusion pump. significantly less contaminated at 24hrs
All hospital patients than those requiring mixing of powder
Popn:
(except neonates) (p<0.0001).
undergoing
110

continuous enteral
pump feeding for a
minimum of 3 days
without
interruption >24
hours.
P92 2 Skiest DJ, Khan N, Feld R et al. Design: Randomised IEF resulted in lower gastric pH and This is a hospital based critical care
441
1996. USA. Controlled Trial gastric colonisation. Mean am gastric pH study and it is difficult to
in IEF significantly lower than CEF extrapolate to community setting
To determine whether 2 urban hospitals (p=0.0008). No significant difference in Very small sample size to
Setting:
administering enteral feeding pm pH – (p>0.05). generalise (Pilot Study)
intermittently (IEF) as opposed to 16 CEF (4M, 3F), IEF
Sample:
continuously (CEF) results in (5M, 4F)]
decreased rates of gastric
colonisation in mechanically
ventilated patients. Popn: ICU patients about
to begin enteral
feeding
P94 2 Schroeder P, Fisher D, Volz M et Design: Descriptive Study Enteral feeding systems can support Effect of enteral contamination on
425
al. 1983. USA. considerable microbial contamination patients not measured
Setting: Community that varies in type and amount. Samples small
To estimate the type and amount hospital Awareness of study and education did
of contamination that occur in not reduce contamination.
Sample:
nutrient feeding solutions in a 9 in study 5. The Study 1 looked at the sterility of
community hospital using normal others were unrefrigerated NFS using 5 cans and
procedures. Laboratory and samples taken at 4 hr intervals
simulated clinical (laboratory)
studies. Study 2 contamination due to
decanting(laboratory)
Popn: Not reported Study 3 contamination due to decanting
and nurses unaware they were being
monitored (simulated clinical)
Study 4 duplicated study 3(different
111

systems)
Study 5 contamination in gavage
feeding bags without nurses being
aware of the study (clinical)
Study 6 contamination in gavage
feeding bags with nurses aware of the
study (clinical)
Study 7 contamination as a result of
organisms travelling from a colonoised
nasogastric tube into gavage tubing
(laboratory).
Study 1 Ensure did not reveal growth
over 24 hours.
Study 2 No bacterial growth over 48
hours regardless of delivery systems.
Study 3 Contamination in all systems by
24 hours
Study 4 Less growth than study 3 even
at 36 hours.
Study 5 All but one system
contaminated at 24 hours
Study 6 Considerable growth at 24
hours
Study 7 No bacterial growth in any tube
samples
P97 2 Elston-Hurdle BJ, Grey C, Roy I et Design: Experimental Suggests feeds may be hung for 24 Several details missing, numbers
121
al. 1989. USA. hours without reservoir bag change small.
Setting: Acute setting, with no major risk of reservoir
To evaluate the extent of possibly ICU contamination.
bacteriological contamination
following low-level contamination 58 infusion sets, Little risk to patient and reduction in
Sample:
of enteral feed preparation with costs if reservoir bags and connection
112

Pseudomonas aeruginosa, patient details tubes are hung with good technique.
Klebsiella pneumoniae missing
orEnterobacter clocae. In vivo: No growth at 12 hours in bag or
Popn:
Not stated reservoir end of tubing. At 24 hours
2/58 had growth
In vivo: no growth in bag or reservoir
end tubing at 24 hours. Patient end of
tubing all contaminated with challenge
bacteria
D.6.7 Central venous catheter studies

Quest. Author, Date, Country of Design, Setting, Sample Size
ID. Number Origin and Objective and Population Outcomes Strengths and Limitations
CVC2 2 Chaiyakunapruk N, Veenstra Design: Meta-analysis The use of CHXG rather than PI can Well conducted MA except the
67
D, Lipsky A et al. 2002. USA. reduce the risk for CR-BSI by 49% (risk means by which the quality of
Setting: Hospital in-patients ratio, 0.51 [CI, 0.27 to 0.97]) in accepted studies not explicitly
To evaluate the efficacy of both on general ward hospitalised patients who require addressed but general quality
skin disinfection for vascular and ICU short-term central venous remarks were included for all
catheter-site care using catheterisation. Authors estimate that studies (authors being contacted
Sample: for every 1000 vascular catheter sites for further information).
chlorhexidine gluconate 8 studies involving a
(CHXG) compared with disinfected with CHXG rather than PI, Confounders, e.g., publication
total of 4143 71 episodes of CR-BSI would be bias, heterogeneity of study
povodine-iodine (PI) in vascular catheters
preventing catheter related prevented. Although this MA included participants, catheter type,
were accepted into studies using all vascular catheter sites outcome definitions well covered.
blood stream infection (CR- the MA (from 302
BSI). (central venous, peripheral venous, Declared limitations: (1) disparate
initially retrieved and peripheral arterial, pulmonary arterial, design of individual trials accepted
assessed). peripherally inserted central venous, into the analysis; (2) different
Popn: introducer sheaths and haemodialysis), types of CHXG sol. used in
Trials used 4143 the magnitude of the reduction in risk different trials; (3) different ways
vascular catheters of CR-BSI attributed to CHXG use in the some studies defined CR-BSI; (4)
(1493 CVC & 75 subgroup analyses were similar to none of the 8 included studies
peripherally inserted those in the main analysis. reported strategies to distinguish
113

central catheters) true bacteraemia from blood
inserted into patients culture contamination.
whose average age Several types of CHXG solution
was 50-65 years for were used in individual trials, incl.
duration 1.6-10 days 0.5% or 1% CHXG alcohol sol, &
using either PI or 0.5% or 2% CHXG aqueous sol. All
CHXG for site of these solutions provided a
disinfection and concentration of CHXG that is
subsequent catheter higher than the MIC for most
care. nosocomial bacterial & yeast.
Subset analyses of aqueous & non-
aqueous sol. Showed similar effect
sizes, but only the subset analysis
of the 5 studies that used alcoholic
sol. Produced a statistically
significant reduction in CR-BSI.
Because few studies used CHXG
aqueous sol, the lack of a
significant difference seen for this
solution compared with PI sol.
May be a result of inadequate
statistical power.
CVC3 9 Newall F, Ranson K, Robertson Design: Descriptive Study Results indicate that children with The reliability of data for period of
322
J. 1998. Australia. filters were at greater risk of infection. filter possible compromised as it
Setting: Paediatric oncology was collected retrospectively.
To determine whether the unit The difference between positive blood
removal of in-line filters from Sample: cultures associated with and without
central venous infusion lines 88 patients (Gender the use of filters was not statistically
changes the incidence of not specified) significant,
septicaemia associated with p = 0.8992.
the presence of central Popn:
venous access devices. Patients with cancer
between the ages of
3 months and 18
years.
114

268
CVC4 1 Little K, Palmer D. 1998. UK. Design: Randomised No statistical difference between two Unclear whether baseline
Controlled Trial dressing regimes. measurements were taken.
To conpare OpSite IV 3000 Statistical measure of uncertainty not Variable frequency of dressing
with a standard dressing Setting: Combined gastro- given. changes but dressing changes
(sterile dry dressing with enterology unit and recorded.
Betadine ointment) for central intensive care unit Patients were from 2 different
venous catheter access sites. units - no account taken of this
73 patients (Gender during allocation to groups.
Sample:
not specified)
Patients requiring
Popn: CVC
CVC5 9 Seymour VM, Dhallu TS, Moss Design: Controlled Trial Comparison of contamination of three- Subjects appear not to be
430
HA et al. 2000. UK. way taps between the 2 groups = randomised to study groups.
Setting: Probably Intensive p>0.1. Variable number of three-way
To evaluate the microbial Care Unit but setting taps, and therefore connectors,
contamination of the not explicitly does not seem to have affected
Connecta Clave compared to identified. the outcomes.
conventional three-way taps No baseline measurements seem
in clinical practice. Sample: to have been taken.
77 patients (no
details of gender
given)
Popn:
Patients admitted for
coronary artery
bypass graft or heart
valve replacement
and who required
CVC for
management.
115

CVC7 8 Raad I, Hanna HA, Awad A et Design: Randomised Study indicates that it may not be safe Authors acknowledge underpower
390
al. 2001. USA. Controlled Trial to extend use of IV administration sets in study.
beyond 72 hours for patients receiving
To determine the safety and A tertiary university total parenteral nutrition, blood
Setting:
cost-effectiveness of replacing cancer centre. transfusions or interleukin-2.
intravenous (IV) tubing sets in
hospitalised patients at 4- to 512 patients
7-day intervals instead of Sample:
(276 M, 236 F)
every 3 days.
Popn: Cancer patients

requiring IV therapy
CVC10 1 Nikoletti S, Leslie G, Gandossi Design: Randomised The study indicates that there is an Authors acknowledge that a) the
330
S et al. 1999. Australia. Controlled Trial increased risk of catheter colonization number of dressing changes varied
associated with the use of hydrocolloid between patients and, b) the
To evaluate the risk of Intensive care unit dressings. dressing changes were not
Setting:
infection associated with a recorded.
thin, transparent hydrocolloid 204 patients (92 M,
Sample:
dressing (Comfeel) compared 112F) Sample weakened through high
with conventional transparent attrition rate.
polyurethane dressing Popn:
(Tegaderm). Patients older than
18 years who
required insertion of
a multi-lumen
central venous
catheter.
CVC177 3 Randolph AG, Cook DJ, Design: Meta-analysis Heparin administration effectively The aim and inclusion criteria
Gonzales CA et al. 1998. reduces thrombus formation and may were clearly stated. A number of
392
USA. Setting: N/A reduce catheter-related infections in sources were searched for
patients who have central venous and relevant studies. Outcomes were
To evaluate the effect of pulmonary artery catheters in place. defined. Details of methods used
Sample: 12 RCTs of CVCs and Cost-effectiveness comparisons of to assess validity and extract data
heparin on thrombus 2 RCTs of pulmonary
formation and infection unfractionated heparin, low molecular were given. Heterogeneity was
artery catheters
116

associated with the use of were included. Both weight heparin and warfarin are assessed statistically. In the
central venous and pulmonary used bonded needed. absence of significant statistical
artery catheters. heparin. heterogeneity a meta-analysis was
appropriate. Results were clearly
Participants were displayed. The discussion included
Popn: consideration of the following
adults or paediatric
patients whose limitations of the review: methods
treatment included used to diagnose thrombosis in
the insertion of the studies (line-o-grams and
central venous ultrasound) are less sensitive than
catheters and venography and may have
pulmonary artery underestimated the diagnosis of
catheters. large vessel thrombosis; and
studies used variable definitions of
catheter-related infections.
It is not stated if any language
restrictions were applied to
include studies. Fuller details of
included studies such as sample
size would have been welcome. It
is not clear if the analysis was
undertaken by intention-to-treat.
The 95% confidence limits are
wide for some outcomes,
presumably reflecting small
sample size, and do not exclude a
result of no effect of heparin used
with central venous catheters on
catheter thrombus and catheter-
related bacteraemia and sepsis.
CVC179 9 Cookson ST, Ihrig M, O’Mara Design: Retrospective follow- The CVC associated BSI rate was Reliance on retrospective medical
EM, Denny M, Volk H, up and prospective significantly higher in the needleless records
Banerjee SN, Hartstein AI, survey device period than in the needle device
81
Jarvis WR. 1998. USA. period.
Setting:
Surgical and medical
117

To determine if an apparent intensive care and Increase in BSI rate was associated with
increase in bloodstream transplant units in a nurses’ unfamiliarity with the device,
infections in patients with 350 bed urban acute and needleless device use and care
CVCs was associated with the tertiary care hospital. practices different from the
implementation of a manufacturer’s instructions.
needleless access device. (Retrospective study)
Sample:
Total = 53
(Gender not stated).
(Survey) 99
respondents
Popn: Intensive care and

transplant patients.
CVC183 1 Garland JS, Alex CP, Mueller Design: Randomised The two dressing regimes where A generally well controlled study
CD, Otten D, Shivpuri C, Harris Controlled Trial equally effective in preventing CRBSI but may be underpowered as
MC, Naples M, Pellegrini J, and BSI without a source. Some recruitment was stopped short
Buck RK, McAuliffe TL, 6 neonatal intensive adverse reactions were associated with (705 neonates) of the intended
Setting:
Goldman DA, Maki DG. 2001. care units. the chlorhexidine dressing, e.g., severe 980 due to “funding constraints
141
USA. localised dermatitis in 7 of the first 118 and low rate of CRBSI” in both
recruited and pressure necrosis in 2 groups.
Sample: Total = 705 (400 M, subjects.
To ascertain the efficacy of a 305 F)
chlorhexidine impregnated
Intervention Group =
dressing on the CVC sites of Although the neonates randomized to
335
neonates for the prevention of the intervention group were less likely
catheter tip colonization. Control Group = 370 to have colonized CVC tips than those
in the control group15% vs 24% relative
Neonates requiring a risk: 6.95% confidence interval:0.5-0.9.
Popn: CVC for a least 48hrs.
Rates of CRBSI (3.8% vs 3.2% RR: 1.2, CI
0.5-2.7) and BSI without a source
(15.2% vs 14.3%, RR:1.1, CI: 0.8-1-5) did
not differ between the 2 groups.
CVC210 2 Humar A, Ostromecki A, Design: Randomised No significant difference between Data from three sites. No details
118

Direnfeld J, Marshall JC, Lazar Controlled Trial povidone iodine and chlorhexidine in of sub analysis of data from each
N, Houston PC, Boiteau P, terms of catheter related bacteraemia. site / clinical area.
199
Conly JM. 2000. Canada. ICU’s in three
Setting:
teaching hospitals
To determine which of two Including:
solutions, 10% Povidone- 2 medical surgical
Iodine or 0.5% Tincture of ICU’s
Chlorhexidine was the most
1 medical ICU’s
effective solution for
preventing CVC exit site 1 neurosurgical ICU’s
colonization.
242 150M, 92 F
Sample:
Povidone Group =
117
Chlorhexidine Group
= 125
Popn:
All patients over 18
years of age who had
CVC’s inserted for
any purpose.
CVC238 9 Do AN, Ray BJ, Banerjee SN, Design: Case-control study Results suggest that the risk for BSI was There are potential confounding
Illian AF, Barnett BJ, Pham related to the frequency of changing factors arising from the fact that
MH, Hendricks KA, Jarvis WR. Setting: Home health care the device end caps. patients are un-supervised at
104
1999. USA. (community) home. Authors discuss the
patients possible effects of showering
To evaluate the influences of routines. Patients also responsible
Sample: for their own dressings.
infection-control practices on 124 (93M, 31F)
BSI associated with the use of
Case Patients = 53
needleless devices in the HHC
setting. Case Controls = 71
Popn:
Case patients
defined as those
119

“with a central
venous catheter or
midline catheter who
acquired a primary
BSI during the study
period.
D.7 Rejected studies (2003)

D.7.1 Hand hygiene
H19 2 Chudleigh J and To determine whether Design: Observational Number of nurses participating
Buckingham C. 1999. or not nurses were unclear.
73
UK. adhering to existing Setting: Hospital – special care baby unit. No quantitative results and p values
infection control given
policies and guidelines. 3 variables compared – soap, gloves
Sample: 12 nurses (3 unqualified)
To determine the most and alcohol but no documentation as
appropriate product to to who used what or how many used
use for hand Popn: Nurses which technique or in what
decontamination combination
D.7.2 Urinary catheter

Quest. Author, Date and Design, Setting, Sample Size and Population
UC5 6 Pearman JW, Bailey To compare the efficacy Design: Randomised Controlled Trial The sample size is not appropriate.
M, Harper WE. 1988. of Trisdine and
354
Australia. Kanamycin-colistin in Setting: Spinal Injuries Unit
reducing bacteriuria in
new spinal injuries
patients. Sample: 18 (15M, 3F)
120
Popn: Spinal cord injury patients.
UC9 1 Eika B, Frokiaer J. The aim of this study Design: Descriptive Study - Retrospective Unreliable data source.
118
1989. Denmark. was to analyse a group Review
of women using CISC. Setting:
Not reported
Sample:
80 (Females)
Popn:
Women with neurogenic and non
neurogenic voiding problems.
UC10 6 King JB, Stickler DJ, To examine the activity Design: Experimental Laboratory study using bladder model.
223
1992. UK. of repeated
installations of Setting: Laboratory
chlorhexidine
0.02%w/v,
chlorhexidine/EDTA/TRI Sample: Not available.
S and mandelic acid
1.0%w/v against Popn: Not available.
established infections
of Pseudomonas
aeruginosa, Proteus
mirabilis, Providencia
stuartii and Escherica
coli.
UC12 4 Mobley HLT, Warren To observe the Design: Descriptive Study Study question unclear.
301
JW. 1987. USA. incidence of urease No details of recruitment or sample.
production and Setting: Setting not stated
blockage in women ≥ 65
years with silicone-
latex coated catheters Sample: 32F > 65 years
121
in place for ≥100 days.
Popn: Long-term catheterised
UC23 6 Robertson MH, To test the effect of 1% Design: Experimental Study Too many items missing, e.g., setting,
Norton MS, 1990, mandelic acid bladder characteristics of study population.
403
UK. washouts on 40 Setting: Hospital In-Patients (assumed as no
patients with indwelling detail).
urethral catheters.
Sample: 40
Popn: Patients with indwelling catheters

harbouring Proteus or Pseudomonas
sp. but asymptomatic.
UC24 6 Muncie HL, Hoopes To ascertain whether Design: Randomised Controlled Trial High dropout rate (21/41).
JM, Damron DJ et al. once daily irrigations of
311
1989. USA. long-term catheters Setting: Urban hospital
with normal saline has
an effect on the
formation of Sample: 44 (gender not stated)
encrustation and
blockage and the Popn: Patients with long-term indwelling
development of catheters.
infection.
UC27 6 Maizels M, Schaeffer To determine whether Design: Randomised Controlled Trial Sample too small for study design.
280
(now AJ. 1980. USA. the incidence of
UC147) bacteriuria can be Setting: Spinal cord injury unit.
reduced in catheterised
patients by instilling
hydrogen peroxide into Sample: 31 (24M, 7F)
the drainage bag.
Popn: Acute spinal injuries.
122
UC28 4 Hedelin H, Larsson L, To observe which Design: Descriptive Study Sample underpowered.
Eddeland A et al. factors affected the
184
1985. Sweden. frequency of catheter Setting: Department of long-term care and
blockage and change rehabilitation
within a 6-week
schedule.
Popn: No information
UC30 1 Mitsui T, Minami K, Long-term outcome of Design: Descriptive Study - Long term Follow- Method and criteria for determining
Furuno T et al. 2000. spinal cord injury (SCI) up infection and other complications not
299
Japan. patients was compared Setting: stated.
between those Outpatients Methodology not clear.
managed by suprapubic Follow-up time different.
cystomy (SPC) and clean Sample:
61 (57M, 4F) Groups comparable in terms of age,
intermittent
sex and sample number but Group A
catheterisation (CIC). Popn:
were high cervical lesions and Group B
Spinal cord injury patients.
low cervical lesions preventing
meaningful comparison.
UC44 1 Hellstrom P, Tammela, To investigate the Design: Descriptive Study Sample too small given variables such
T, Lukkarinen O et al. efficacy, safety and as:
186
1991. Finland. complications of clean Setting: Hospital Outpatients age range, the wide range of
intermittent underlying / pre-existing aetiologies,
catheterisation different frequency of CIC, and no
Sample: 41 (26M, 15F)
monitoring of catheterisation
techniques, e.g., hand washing.
Popn: Patients attending urology department No stats given.
UC45 4 Hedelin H, Bratt CG, To correlate urinary pH Design: Descriptive Study Sample underpowered.
Eckerdal G et al., with the precipitation of No baseline measures.
183
1991, Sweden. catheter encrustation Setting: Hospital with 500 beds for long-term
and detect any unusual care and rehabilitation
123
urea-splitting bacteria
in catheter urine Sample: 11 (8M, 3F)
samples with a raised
pH but without growth
Popn: No information
of urease-producing
bacteria.
UC47 6 Elliott TSJ, Reid L, To test the effect of Design: Randomised Controlled Trial Small study – only females in
Gopal Rao G et al. bladder washouts on intervention group.
119
1989. UK. the urothelium. Setting: Not stated
Sample: 50 (30M, 20F)
Popn: Control – normal adult men. Women

had long-term indwelling urinary
catheters.
UC54 4 Kohler-Ockmore J. To identify factors Design: Descriptive Study No information on gender,
229 which may cause confounding conditions or catheter
1991. UK.
catheter blockage and Setting: Community; own home and nursing types.
how they may be homes Analysis poor and incomplete.
overcome.
Sample: 54
Popn: 3 health districts residents with

catheters for >3 months.
UC58 7 Wiseman O. 1997. To determine the Design: Descriptive Study (Retrospective) Audit though described as research.
508
UK. management of long- Flawed urine collection method.
term urinary catheter in Setting: Accident and Emergency department
asymptomatic patient
in the Accident and
Emergency department. Sample: 40 patients with 80 presentations
(68M, 12F)
124
Popn: A&E
UC71 8 Kurtz MJ, Van Zandt K, To identify a single Design: Experimental Small sample.
241
Burns JL. 1995. USA. effective and
inexpensive cleaning Setting: Laboratory
method that could be
recommended to
clients using Sample: 16
intermittent
catheterisation. Popn: Children re-using non-latex catheters
for IC.
404
UC73 2 Roe BH. 1990. UK. To test the effects of an Design: Randomised Controlled Trial Small sample inadequate for statistical
education programme tests. Method of randomisation not
(including an Setting: Community (Home and Home Care) stated. Drop out rate unacceptable.
information booklet
and demonstration) on
the management of Sample: 45 (gender not stated)
urine drainage systems
by patients and carers. Popn: 2 district health authority, patients >18
years of age.
UC78 8 Mervine J, Temple R. To determine the effect Design: Experimental No detail on sample size or patient
297
1997. USA. on: details.
the concentration of Setting: Laboratory No statistical analysis.
bacteria of washing
(with soap and water)
Sample: Urine from patients was used but it is
red rubber and clear
not stated how many specimens were
plastic intermittent-use
obtained.
catheters,
Popn: Patients in urban hospital giving urine

the amount of time in a
for routine culture or on CIC.
microwave oven
required to eliminate
stock bacteria from red
rubber and clear plastic
125
catheters,
the effect of repeated

use of a microwave
oven on the patency
and pliability of red
rubber and clear plastic
catheters.
UC79 1&7 Prieto-Fingerhut T, To determined the Design: Randomised Controlled Trial Numbers are small. Method of
Banovac K, Lynne CM. effect of sterile and randomisation not stated.
383
1997. USA. nonsterile intermittent Setting: Medical Rehabilitation Centre No details of reliability of
catheterisation on the catheterisation techniques.
incidence of urinary No baseline measurements.
tract infection (UTI) in Sample: 29 (16M, 13F)
patients after spinal
cord injury. Popn: Spinal cord injury patients
UC80 1 Terpenning MS, Allada A prospective study of Design: Descriptive Study (Prospective Follow- Total population not given and no idea
R, Kauffman CA. 1989. elderly patients up study) of refusals/drop outs.
464
USA. receiving IC for Sample size too small given two sites.
development of Veteran Administration Hospital and No standardisation of catheter used.
Setting:
bacteriuria and/or nursing home Descriptive statistics only.
urinary tract infection.
Popn: Patients aged 60 years and over with

long-term catheter.
UC81 1 Ouslander JG, To examine the relative Design: Descriptive Study – Comparative Comparison group preferentially
Greengold B, Chen S. frequency of urinary Follow-up included patients with a past history of
344
1987. USA. tract infection (UTI) and a GU diagnosis.
bacteriuria among male Nursing Home Significant differences among the
Setting:
nursing home patients groups that could have affected their
managed with and susceptibility to infection.
Sample: 92 (Males)
126
without catheters. Observation uncontrolled but long
Popn: Male nursing home residents. follow up period.
No baseline measurements of UTI.
Many confounding variables.
Small sample, two groups which do
not meet power requirements.
UC83 1 Johnson DE, Muncie To assess the safety and Design: Descriptive Study - Observational Insufficient description of
HL, O’Reilly JL et al. efficacy of a new methodology.
208
1990. USA. external urine collection Setting: Hospital and a medical centre
system for women.
Sample: 26 (Females)
Popn: All women over 65 years old not

receiving antibiotics.
UC86 1 Quigley PA, Riggin OZ. To determine whether Design: Randomised Controlled Trial Small sample - 14 in the control group
389
1993. USA. there was a difference and 16 experimental groups.
in the incidence of Setting: Hospital rehabilitation Groups not treated equally.
urinary tract infection No stats.
that occurred following
Sample: 30 (gender not stated) Multiple factors affecting reliability of
use of two types of
data collection.
catheterization
(intermittent) Popn: Rehabilitation patients, spinal cord
techniques: open injuries and stroke patients.
catheterization and
closed catheterisation.
UC89 1&6 Pearman JW, Bailey To compare the Design: Uncontrolled randomised trial The sample size is not appropriate.
M, Riley LP. 1991. incidence of "significant Groups not homogenous.
355
Australia. bacteriuria" following Setting: Urban hospital spinal department No baseline measurements.
two different methods
Unreliable in terms of standardisation
of intermittent
Sample: 37 (30M, 7F) and monitoring of catheterisation
catheterisation, a)
technique.
nelaton catheter with
Trisidine instillation and Popn: Patients with acute spinal cord No identification of confounding
127
b) O'Neal catheter trauma. variable.
(Nelaton with
introducer) in patients
with acute spinal chord
trauma.
UC92 1 Wyndaele JJ, Maes D. To study the long term Design: Descriptive Study - Retrospective Method used to select patients or
518
1990. Belgium. effects and Follow-up source of patients unclear.
complications resulting Insufficient information on
in patients using demographics of sample
Setting: Hospital Outpatients/rehabilitation
intermittent self No baseline measures.
catheterisation.
Sample: 75 (33M, 42F) Patients monitored over varying
lengths of time.
Popn: Patients using CISC.

UC94 8 Silbar EC, Cicmanec JF, To see whether Design: Experimental No details are given about the
Burke BM et al. 1989. microwaving would population and sample.
437
USA. make aseptic Setting: Laboratory
intermittent self- Greater concentration of bacteriuria
catheterisation a used than would have been found on a
practical possibility. Sample: No details given about patients.
patient.
Popn: Patients with UTI

UC95 1 Taylor CED, Hunt GM, A comparison was Design: Descriptive Study Small sample.
Matthews IG. 1986. made between two No attempt to control acknowledged
461
UK. groups of children using Setting: Assume hospital outpatients at extraneous variables.
CIC. Addenbrookes, Cambridge No baseline measurements.
Popn: Myelomeningocele and spina bifida

patients.
UC97 2 Bennett CJ; Young To determine whether Design: Descriptive Study Small sample.
MN; Razi SS et al. an introducer tip Variability in number of
128
38
1997. USA. catheter reduces Setting: Hospital catheterisations was high. Sampling
urinary tract infection in method unclear.
spinal cord injured
Sample: 19 (gender not stated)
patients on intermittent
catheterisation.
Popn: Spinal cord injuries unit.
UC98 1 Perkash I, Giroux J. To evaluate long-term Design: Descriptive Study – Small sample. 66% discontinued.
358
1993. USA. clean intermittent Observational/follow-up
catheterisation for
genito-urinary Community setting/Outpatients
Setting:
complications ‘ in non-
hospitalised spinal cord
injury patients and to ‘ Sample: 50 (Males)
institute and evaluate
prompt management. Popn: Spinal cord injuries.
UC109 2 Joseph C, Jacobsen C, A pilot study of Design: Randomised Controlled Trial Pilot study which states sample
Strausbaugh L et al. intermittent urinary inadequate.
210
1991. USA. catheterisation in Setting: Elderly Nursing Home Care Unit. Study protocol not adhered to.
elderly nursing home
patients utilizing a new
modification of clean Sample: 14 (Males)
technique and
conventional sterile Popn: Residents >50 years of age.
technique.
UC114 1&2 Oie S, Kamiya A, Seto To evaluate the Design: Descriptive Study This system is not used in the UK.
339
T et al. 2000. Japan. microbial Potential sample bias.
contamination of a Setting: Out patients department
widely used in-use
lubricant for non-touch
urethral catheters. Sample: 46
Popn: Attendees at hospital outpatient

department.
UC117 1 Maynard FM and To report on 5 year Design: Descriptive Study – Observational Self reports of estimated frequency
129
287
Glass J. 1987. USA. urological outcomes in over the last year of UTI, not
a population of new Setting: Outpatients necessarily confirmed by lab reports
spinal cord injury and lab reports not available to
patients who were all researcher. Relies on long term
managed initially by memory.
clean technique of Unclear when follow up occurred and
intermittent Popn: Out-patients this may have been variable between
catheterisation. patients.
No stats available, may have been that
sample size was too small.
UC118 7 Orrett FA & Presumed objective to Design: Descriptive Study States this is a RCT but methodology
Permanand N. 1993. identify the prevalence unclear, no control group.
341
Trinidad. and incidence of Setting: Hospital outpatient clinic No statistics provided.
bacteriuria developing Timing of microbiological assessment
in chronically unclear.
catheterised out- Sample: 120 (119M, 1F)
Also unclear whether the results of
patients who have been
this study are directly applicable to the
prescribed Popn: Urology out-patients
patient group targeted by the study.
prophylactically
systematic antibiotic
therapy at each out-
patients clinic visit.
UC121 6 Nesbit SA, Katz LE, To compare the efficacy Design: Randomised Controlled Trial Small study that failed to recruit
McClain BW et al. of amphotericin B 10mg adequate numbers.
319
1999. USA. vs. 50mg per litre of Setting: Urban hospital, medical floor or
sterile water as a intensive care
continuous irrigation for
72 hours to eradicate
funguria. Sample: 28 (8M, 20F)
Popn: All hospitalised patients whose

physicians ordered amphotericin B
continuous bladder irrigation.
UC127 6 Linsenmeyer TA, Jain To determine the Design: Descriptive study Small study, two people had two sets
130
A, Thompson BW. effectiveness of of irrigation.
267
1999. USA. neomycin/polymyxin Setting: Rehabilitation Unit Use of statistics inappropriate in this
bladder irrigations in sample.
asymptomatic spinal
Sample: 10 (7M, 3F)
cord injury patients
with resistant
organisms. Popn: Spinal cord injury patients who had
undergone bladder irrigation.
UC130 8 Sims L, Ballard N. To review the records Design: Descriptive Study (Retrospective) The findings may have been influenced
439
1993. USA. of spinal cord injured by the between group differences in
subjects and compare Setting: Neurological rehabilitation unit length of time of catheterisation
two CIC catheter intervals.
cleaning and storage
procedures (wet and Sample: 48 (37M, 11F)
Potential lack of sensitivity in detecting
dry). a type 2 error.
Popn: Spinal cord injury patients.
Generalisability limited due to

convenience sampling.
Sampling bias due to unequal

distribution of subjects and small sub
groups.
Limited reliability of retrospective data

collection.
UC131 3&7 Polastri F, To quantify the micro- Design: Descriptive Study Lack of clarity on sampling technique,
Auckenthaler R, Loew organisms present in e.g. 33 patients specified – 46 cases in
F et al. 1990. blood at urinary Setting: Geriatric Medical Centre group 2.
378
Switzerland. catheter removal and
reinsertion.
Sample: 33 (15M, 18F)
To identify whether:
Popn: Patient’s chronic indwelling catheter

Q3: there was an
131
increased risk of positive urine cultures.
bacteriuria during UC
removal and insertion,
Q7: prophylactic
antibiotics would be
useful before this
manipulation.
UC133 1 Kuhn W, Rist M, Zaech Presumed aim is to Design: Descriptive Study The study does not address an
G. 1991. record long term appropriate and clearly focused
237
Switzerland. outcomes Setting: Paraplegic centre question.
(bacteriological The selection of subjects to the study
‘evolution’, acceptance, may have induced bias.
continence and Sample: 46 (27M, 19F)
complications) of IUSC.
Popn: Patients using ISC.
UC134 1 Wyndaele JJ, de Taeye To evaluate Design: Descriptive Study Outcomes difficult to measure given
517
N. 1990. Belgium. intermittent self that some patients (unspecified) had
catheterisation with Setting: Spinal injury unit pre-existing UTI.
intermittent Unspecified number of patients
catheterisation received antibiotics during the study.
performed by a Sample: 25 (22M, 3F)
catheter team.
Popn: Paraplegics
UC135 1 Yadav A, Presumed aim was to Design: Descriptive Study The study does not address an
Vaidyanaathan S, record the frequency of appropriate and clearly focused
Panigrahi D. 1993. infective episodes’ in Setting: Spinal injury unit question.
520
India. two groups of patients The selection of subjects to the study
with neuropathic has induced bias.
bladders who used Sample: 48 (gender not stated)
Measurements not standardised.
clean intermittent
catheterisation. Popn: Patients with neuropathic bladders.
UC139 1 Sadowski A, Duffy L, To investigate the Design: Descriptive Study (Survey) Questionnaire study with poor
416
1988, USA. current usage, response (48%) and reporting bias.
132
procedural differences,
incidence of Setting: Long term care facilities
documented urinary
tract infections and
Sample: 103 facilities
staff satisfaction with
CIC in a long term care
setting. Popn: Patients in long term care using
urinary catheters.
UC141 2 Giannantoni A, Du To compare patients’ Design: Randomised Controlled Trial Sample too small for RCT.
Stasi SM. Scivoletto G acceptance and safety
150
et al. 2001. Italy. related to the use of the Setting: Hospital in-patients
conventional Nelaton
catheter and the
prelubricatd Sample: 18 (16M, 2F)
nonhydrophilic catheter
in spinal cord injured Popn: Spinal cord injury patients.
patients on intermittent
catheterization.

P3 1 Iber, FI, Livak AL and To describe 111 PEG Design: Descriptive study Lack of control of possible
202
Patel M. 1996. USA. tubes with a view to confounders.
learning more about Setting: Hospital Department of
the reasons for PEG Gastroenterology
failure
Sample:
111 PEGs removed, replaced or
dislodged at the hospital during an 11
month period
Popn:
In-patients receiving PEG feedings.
133
P4 1 Payne-James, J; Rana To compare Design: Descriptive study Small sample in each phase.
SK, Bray MJ et al. contamination of
353
1992. UK. enteral diet containers Setting: Urban DGH
using three different
giving sets.
Sample: 55 (gender not specified)
Popn: In patients receiving continuous 24

hour infusion.
Phase I (18 patients)
Phase II (17 patients)
Phase III (18 patients)
P11 1 Gottlieb K, Leya J, To investigate the Design: Descriptive Study The sample size is not appropriate
Kruss D et al. 1993. prevalence of fungal
160
USA. colonization in a variety Setting: Veterans Administration Hospital
of PEG types.
Sample: 10 (Males)
Popn: Patients from 2 wards with functioning

PEGs in-situ.
P21 2 Thurn J, Crossley K, A prospective study to Design: Descriptive Study The sample size is not appropriate
Gerdts A et al. 1990. determine the
470
USA. relationship between Setting: One hospital but 3 different intensive
contamination of care areas
enteral feeds and
nosocomial infection.
Sample: 24 patients (20M, 4F)
Popn: Patients requiring enteral feeds

between Sept 1986 - April 1987.
P27 2&3 Donius MA. 1993. To compare Design: Descriptive study Very small study, underpowered,
106
USA. contamination of though it confirms findings in another
formula collected from
134
the distal end of the Setting: Long-term care facility study
tubing set of a refillable
bag with contamination
Sample: 4 patients (gender not stated)
of a commercially
prepared 1000ml pre-
filled ready-to-hang Popn: Stable patients requiring enteral feeds.
enteral feeding system.
P31 5 Nunley D, Berk SL. A retrospective study to Design: Descriptive Study A retrospective study of notes 1985-
332
1992. USA. evaluate the 1987 but reported in 1992, therefore
gastrostomy site as Setting: Urban hospital old data and dependant on accurate
source of MRSA record keeping.
colonization.
Sample: 26 reports of Gastrostomy site
cultures.
Popn:
Patients with gastrostomy
P76 2 Weenk G, van Unen E, To assess the risks of Design: Descriptive Study The sample size is not appropriate
van Ess I et al. 1995. using a ready-to-use 1
496
Netherlands. litre enteral feeding Setting: Burns unit
system in a centre for
burns patients.
Sample: 5 patients (gender not specified)
Popn: Patients with severe burns requiring

enteral feeding.
P81 2 Anderton A, Nwogh To investigate and Design: Descriptive Study Patients and parents collected home
CE, McKune I et al. compare the levels and samples which may have altered
20
1993. UK. types of bacterial Setting: Patients’ homes and hospital contamination levels.
contamination in
enteral feeds prepared Parents and patients were responsible
and administered in Sample: 95 feeds sampled from 6 children
(gender not stated) for collection and storage of home
hospital and the home samples.
Children received multiple doses of
Popn: Children being fed at home and in
antibiotics for their cystic fibrosis
135
hospital over a 3 month period.
P83 2 Perez SK, Brandt K. To explore the Design: Quasi experimental Small study no controls.
357
1989. USA. differences in bacterial Findings inconclusive.
growth in continuous Setting: Hospital No data on patients.
enteral feeding when
using tap water versus
sterile water over 24 Sample: Unclear – 32 surgical bedded but data
and 48 hours. only given for 10 people
Popn:
P87 3 Oie S, Kamiya A, To examine the Design: Controlled Experiment Sample inadequate.
Hironaga K, Koshiro A. contamination of
338
1993. Japan. enteral feeding solution Setting: One hospital and two unspecified
immediately after ‘affiliated institutions’
administration, after 30
mins and 2hrs and the
effectiveness of Sample: 22 samples from 22 patients
decontaminating
administration Popn: No patient details given
containers for reuse.
P90 1 Heyland DK. 1998. Examine the Design: Systematic Review and Meta-analysis This review offers little evidence of use
191
Canada. relationship between for the guideline development.
nutritional support and Setting:
infectious morbidity
and mortality in the
critically ill patient Sample:
Popn: Adult patients undergoing major

surgery, suffering major trauma.
P91 1 Eddy VA, Snell JE, Determine short and Design: Descriptive Study NEJ relevant but conduct of study
Morris JA. 1996. long term complications means results are unreliable.
117
USA. associated with needle Setting: University medical centre
catheter jejunostomy
Sample: 122 (95M, 27F)
136
Popn: Patients who had received needle

catheter jejunostomies included in
study over 6 year period.

CVC1 1,2,4,5,6 Mermel L. 2000. To review the literature Design: Systematic Review Does not meet SIGN criteria or NICE
296
USA. on prevention of criteria to be accepted as a well-
intravascular catheter Setting: Not reported conducted systematic review, i.e., only
. related infections one electronic database (MEDLINE)
searched (Cochrane & EMBASE not
Sample: Number of studies reviewed not searched). Although the characteristics
reported (but 133 references cited) of those studies accepted into the
review were discussed, there was no
Popn: Not reported. description of how the quality of these
studies were assessed. Finally,
important search data missing, e.g.,
how many studies retrieved, rejected
(& why) and accepted (& why).
CVC6 8 DeMoissac D, Jensen To examine the effects Design: Randomised Controlled Trial Authors acknowledge that results may
97
L. 1998. Canada of changing IV have been affected by lack of a
administration sets at Setting: Urban cancer setting standardised procedure for making
48 hrs versus 24 hrs on and breaking connections in IV
the incidence of administration sets.
infusion-related Sample: 50 patients (14M, 36F)
Small sample.
septicaemia in
nutropenic patients Popn:
with cancer.
CVC8 8 Matlow AG, Kitai I, To compare the Design: Randomised Controlled Trial There are numerous potential
Kirpalani H et al. 1999. microbial confounding variables, e.g.,
137
285
Canada. contamination rate of Setting: 35 bed Neonatal Intensive Care Authors identify differences between
infusate in the groups which "should be considered as
intravenous tubing of potential confounders of the tubing
Sample: 1189 babies (709 M, 480 F)
newborns receiving change effect", e.g., birth weight.
lipid therapy, replacing Sampling was not undertaken at
the intravenous delivery Popn: Neonates for whom IV lipid was
weekends resulting in a imbalance of
system at 72-hour ordered
samples between the two groups.
versus 24-hour
intervals.
CVC9 1 Madeo M, Martin CR, To establish whether Design: Randomised Controlled Trial Study is underpowered. The
Turner C et al. 1998. there is a difference in researchers conducted a post hoc
278
UK. the rate of skin Setting: Intensive care unit. power analysis (0.8) and concluded
colonization when using 530 subjects would be needed for a
Arglaes compared to future replication of the study.
Tegaderm; to establish Sample: 31 (16 M, 15 F)
whether there is a
difference in Popn: Patients admitted to an intensive care
adhesiveness, unit who required arterial and/or
application and central venous catheterisation.
durability in the two
dressings; and to
determine if there is a
difference in
colonization of the
catheter tips between
the two groups.
CVC180 6 Lucet J-C, Hayon J, To compare the Design: Randomised Controlled Trial Report lacks detail regarding
Bruneel F, Dumoulin J- colonization of hubs homogeneity of groups at the start of
L, Joly-Guillou M-L. with hub protection Setting: Three medical or surgical ICUs study and subsequent treatment of
273
2000. France. boxes and hubs with subjects, e.g., frequency of
needleless closed measurement. (1.6)
connectors. Sample: 77 patients (Gender not stated)
(Cultures obtained from 137 CVCs)
No details given.
138
Popn:
CVC181 8 Donaldson I. 1999. To determine whether Design: Systematic Review No details of methodology, e.g., search
105
UK. the frequency of strategy, appraisal or grading systems.
changing intravenous Setting:
administration sets in
critically ill adults with
central venous Sample:
catheters (CVCs) affects
the incidence of CVC- Popn:
related sepsis /
systemic inflammatory
response syndrome
(SIRS) / bacteraemia.
CVC182 3 Henrickson KJ, Axtell To determine whether Design: Randomised Controlled Trial Sample size is small when viewed in
RA, Hoover SM, Kuhn an antibiotic flush relation to risk sub groups.
SM, Pritchett J, Kehl solution containing Setting: 2 “Medical Centres” Wide age range may affect results
SC, Klein JP. 2000. Vancomycin, Heparin despite fairly even distribution
187
USA. and Ciprofloxacin (VHC) between groups given that authors
can prevent the Sample: Total 126 Gender only specified in
acknowledge previous work which
majority of line terms of number of lines rather than
suggests infection rate is directly
infections. subjects.
linked to infection rate. Again age
Popn: banding produces very small numbers.
Paediatric oncology patients under 20
years of age.
139
D.8 Summary of recommendations (2003)

The following guidance is evidence based and the grading for each recommendation is shown.
This guideline makes recommendations on both the standard principles for preventing healthcare-
associated infections and measures for preventing infections associated with three specific aspects of
care – the use of long-term urinary catheters, enteral feeding systems and central venous catheters.
D.8.1 Standard principles

The recommendations on standard principles provide guidance on infection control precautions that
should be applied by all healthcare personnel to the care of patients in community and primary care
settings.
The recommendations are divided into four distinct interventions:

hand hygiene
the use of personal protective equipment
the safe use and disposal of sharps
education of patients, their carers and healthcare personnel.
D.8.1.1 Hand hygiene
SP1. Hands must be decontaminated immediately before each and every episode of direct patient
contact or care and after any activity or contact that could potentially result in hands
becoming contaminated. [B]
SP2. Hands that are visibly soiled, or potentially grossly contaminated with dirt or organic material,
must be washed with liquid soap and water. [A]
SP3. Hands must be decontaminated, preferably with an alcohol-based hand rub unless hands are
visibly soiled, between caring for different patients or between different care activities for the
same patient. [A]
SP4. Before regular hand decontamination begins, all wrist and ideally hand jewellery should be
removed. Cuts and abrasions must be covered with waterproof dressings. Fingernails should
be kept short, clean and free from nail polish. [D]
SP5. An effective handwashing technique involves three stages: preparation, washing and rinsing,
and drying. Preparation requires wetting hands under tepid running water before applying
liquid soap or an antimicrobial preparation. The handwash solution must come into contact
with all of the surfaces of the hand. The hands must be rubbed together vigorously for a
minimum of 10-15 seconds, paying particular attention to the tips of the fingers, the thumbs
and the areas between the fingers. Hands should be rinsed thoroughly before drying with
good quality paper towels. [D]
SP6. When decontaminating hands using an alcohol handrub, hands should be free from dirt and
fingers, the thumbs and the areas between the fingers, until the solution has evaporated and
the hands are dry. [D]
SP7. An emollient hand cream should be applied regularly to protect skin from the drying effects of
regular hand decontamination. If a particular soap, antimicrobial hand wash or alcohol
140
product causes skin irritation an occupational health team should be consulted. [D]
D.8.1.2 Use of personal protective equipment
SP8. Selection of protective equipment must be based on an assessment of the risk of transmission
of microorganisms to the patient, and the risk of contamination of the healthcare
practitioners’ clothing and skin by patients’ blood, body fluids, secretions or excretions. [D,
H&S]
SP9. Gloves must be worn for invasive procedures, contact with sterile sites and non-intact skin or
mucous membranes, and all activities that have been assessed as carrying a risk of exposure
to blood, body fluids, secretions or excretions, or sharp or contaminated instruments. [D,
H&S]
SP10. Gloves must be worn as single-use items. They must be put on immediately before an
Gloves must be changed between caring for different patients, and between different care or
treatment activities for the same patient. [D, H&S]
SP11. Gloves must be disposed of as clinical waste and hands decontaminated after the gloves
have been removed. [D, H&S]
SP12. Gloves that are acceptable to healthcare personnel and that conform to European
Community (CE) standards must be available. [H&S]
SP13. Sensitivity to natural rubber latex in patients, carers and healthcare personnel must be
documented, and alternatives to natural rubber latex gloves must be available. [H&S]
SP14. Neither powdered gloves nor polythene gloves should be used in healthcare activities. [D,
H&S]
SP15. Disposable plastic aprons should be worn when there is a risk that clothing may become
exposed to blood, body fluids, secretions or excretions, with the exception of sweat. [D, H&S]
SP16. Full-body fluid-repellent gowns must be worn where there is a risk of extensive splashing of
blood, body fluids, secretions or excretions, with the exception of sweat, onto the skin or
clothing of healthcare personnel (for example when assisting with childbirth). [D, H&S]
SP17. Plastic aprons should be worn as single-use items, for one procedure or episode of patient
care, and then discarded and disposed of as clinical waste. [D, H&S]
SP18. Face masks and eye protection must be worn where there is a risk of blood, body fluids,
secretions or excretions splashing into the face and eyes. [D, H&S]
SP19. Respiratory protective equipment, for example a particulate filter mask, must be used when
clinically indicated. [D, H&S]
D.8.1.3 Safe use and disposal of sharps
SP20. Sharps must not be passed directly from hand to hand, and handling should be kept to a
minimum. [D, H&S]
SP21. Needles must not be recapped, bent, broken or disassembled before use or disposal. [D,
H&S]
141
SP22. Used sharps must be discarded into a sharps container (conforming to UN3291 and BS 7320
standards) at the point of use by the user. These must not be filled above the mark that
indicates that they are full. [D, H&S]
SP23. Containers in public areas must be located in a safe position, and must not be placed on the
floor. They must be disposed of by the licensed route in accordance with local policy. [D,
H&S]
SP24. Needle safety devices must be used where there are clear indications that they will provide
safer systems of working for healthcare personnel. [D, H&S]
SP25. Everyone involved in providing care in the community should be educated about standard
principles and trained in hand decontamination, the use of protective clothing and the safe
disposal of sharps. [D]
SP26. Adequate supplies of liquid soap, handrub, towels and sharps containers should be made
available wherever care is delivered. [D]
D.8.2 Care of patients with long-term urinary catheters

Standard Principles. These guidelines focus on preventing infection. However, because infection has
a complex inter-relationship with encrustation and blockage, these aspects of catheter management
are also addressed.
The recommendations are divided into five distinct interventions:

education of patients, their carers and healthcare personnel
assessing the need for catheterisation
selection of catheter drainage options
catheter insertion
catheter maintenance.
D.8.2.1 Education of patients, their carers and healthcare personnel
UC1. Patients and carers should be educated about and trained in techniques of hand
management before discharge from hospital. [D]
UC2. Community and primary healthcare personnel must be trained in catheter insertion, including
suprapubic catheter replacement and catheter maintenance. [D]
UC3. Follow-up training and ongoing support of patients and carers should be available for the
duration of long-term catheterisation. [D]
D.8.2.2 Assessing the need for catheterisation
UC4. Indwelling urinary catheters should be used only after alternative methods of management
have been considered. [D]
UC5. The patient’s clinical need for catheterisation should be reviewed regularly and the urinary
catheter removed as soon as possible. [D]
UC6. Catheter insertion, changes and care should be documented. [D]
142
D.8.2.3 Catheter drainage options
UC7. Following assessment, the best approach to catheterisation that takes account of clinical
be selected. [C]
UC8. Intermittent catheterisation should be used in preference to an indwelling catheter if it is

clinically appropriate and a practical option for the patient. [A]
UC9. For urethral and suprapubic catheters, the choice of catheter material and gauge will depend
on an assessment of the patient’s individual characteristics and predisposition to blockage.
[D]
UC10. In general, the catheter balloon should be inflated with 10ml of sterile water in adults and 3-
5ml in children. [D]
UC11. In patients for whom it is appropriate, a catheter valve can be used as an alternative to a
drainage bag. [A]
D.8.2.4 Catheter insertion
UC12. All catheterisations carried out by healthcare personnel should be aseptic procedures. After
training, healthcare personnel should be assessed for their competence to carry out these
types of procedures. [D]
UC13. Intermittent self-catheterisation is a clean procedure. A lubricant for single-patient use is

required for non-lubricated catheters. [A]
UC14. For urethral catheterisation, the meatus should be cleaned before insertion of the catheter,
in accordance with local guidelines/policy. [D]
UC15. An appropriate lubricant from a single-use container should be used during catheter
insertion to minimise urethral trauma and infection. [D]
D.8.2.5 Catheter maintenance
UC16. Indwelling catheters should be connected to a sterile closed urinary drainage system or
catheter valve. [D]
UC17. Healthcare personnel should ensure that the connection between the catheter and the
urinary drainage system is not broken except for good clinical reasons, (for example
changing the bag in line with manufacturer’s recommendations). *D+
UC18. Healthcare personnel must decontaminate their hands and wear a new pair of clean, non-
after removing gloves. [D]
UC19. Carers and patients managing their own catheters must wash their hands before and after
manipulation of the catheter, in accordance with the recommendations in the Standard
Principles Section (Section 2). [A]
UC20. Urine samples must be obtained from a sampling port using an aseptic technique. [D]
UC21. Urinary drainage bags should be positioned below the level of the bladder, and should not
be in contact with the floor. [D]
UC22. A link system should be used to facilitate overnight drainage, to keep the original system
intact. [D]
143
UC23. The urinary drainage bag should be emptied frequently enough to maintain urine flow and
prevent reflux, and should be changed when clinically indicated. [D]
UC24. The meatus should be washed daily with soap and water. [A]
UC25. Each patient should have an individual care regimen designed to minimise the problems of
blockage and encrustation. The tendency for catheter blockage should be documented in
each newly catheterised patient. [D]
UC26. Bladder instillations or washouts must not be used to prevent catheter-associated infection.
[A]
UC27. Catheters should be changed only when clinically necessary, or according to the
manufacturer’s current recommendations. *D+
UC28. Antibiotic prophylaxis when changing catheters should only be used for patients with a
history of catheter-associated urinary tract infection following catheter change, or for
patients who have a heart valve lesion, septal defect, patent ductus or prosthetic valve. [B]
UC29. Reusable intermittent catheters should be cleaned with water and stored dry in accordance
with the manufacturer’s instructions. *A+
D.8.3 Care during enteral feeding

Standard Principles.

preparation and storage of feeds
administration of feeds
care of insertion site and enteral feeding tube.
EF1. Patients and carers should be educated about, and trained in the techniques of hand
being discharged from hospital. [D]
EF2. Community staff should be trained in enteral feeding and management of the administration
system. [D]
EF3. Follow-up training and ongoing support of patients and carers should be available for the
duration of home enteral tube feeding. [D]
D.8.3.2 Preparation and storage of feeds
EF4. Wherever possible pre-packaged, ready-to-use feeds should be used in preference to feeds
requiring decanting, reconstitution or dilution. [A]
EF5. The system selected should require minimal handling to assemble, and be compatible with the
patient’s enteral feeding tube. *B+
EF6. Effective hand decontamination must be carried out before starting feed preparation. [A]
144
EF7. When decanting, reconstituting or diluting feeds, a clean working area should be prepared
and equipment dedicated for enteral feed use only should be used. [D]
EF8. Feeds should be mixed using cooled boiled water or freshly opened sterile water and a no-
touch technique. [D]
EF9. Feeds should be stored according to manufacturer’s instructions and, where applicable, food
hygiene legislation. [D]
EF10. Where ready-to-use feeds are not available, feeds may be prepared in advance, stored in a
refrigerator, and used within 24 hours. [D]
D.8.3.3 Administration of feeds
EF11. Minimal handling and an aseptic no-touch technique should be used to connect the
administration system to the enteral feeding tube. [C]
EF12. Ready-to-use feeds may be given for a whole administration session, up to a maximum of 24
hours. Reconstituted feeds should be administered over a maximum 4-hour period. [C]
EF13. Administration sets and feed containers are for single use and must be discarded after each
feeding session. [B]
D.8.3.4 Care of insertion site and enteral feeding tube
EF14. The stoma should be washed daily with water and dried thoroughly. [D]
EF15. To prevent blockage, the enteral feeding tube should be flushed with fresh tap water before
and after feeding or administrating medications. Enteral feeding tubes for patients who are
immunosuppressed should be flushed with either cooled freshly boiled water or sterile
water from a freshly opened container. [D]
D.8.4 Care of patients with central venous catheters

These recommendations apply to the care in the community of all adults and children with central
venous catheters (CVCs) that are being used for the administration of fluids, medications, blood
components and/or total parenteral nutrition (TPN). They should be used in conjunction with the
recommendations on Standard Principles.
These recommendations do not specifically address the more technical aspects of the care of
patients receiving haemodialysis, who will generally have their CVCs managed in dialysis centres.
The recommendations are divided into four intervention categories:

general asepsis
catheter site care
standard principles for catheter management.
CVC1. Before discharge from hospital, patients and their carers should be taught any techniques
they may need to use to prevent infection and safely manage a central venous catheter. [D]
145
CVC2. Community healthcare personnel caring for a patient with a central venous catheter should
be trained, and assessed as competent, in using and consistently adhering to the infection
prevention practices described in this guideline. [D]
CVC3. Follow-up training and support should be available to patients with central venous catheters
and their carers. [D]
D.8.4.2 General asepsis
CVC4. An aseptic technique must be used for catheter site care and for accessing the system. [B]
CVC5. Before accessing or dressing central vascular catheters, hands must be decontaminated
either by washing with an antimicrobial liquid soap and water, or by using an alcohol
handrub. [A]
CVC6. Hands that are visibly soiled or contaminated with dirt or organic material must be washed
with soap and water before using an alcohol handrub. [A]
CVC7. Following hand antisepsis, clean gloves and a no-touch technique or sterile gloves should be
used when changing the insertion site dressing. [D]
D.8.4.3 Catheter site care
CVC8. Preferably, a sterile, transparent, semipermeable polyurethane dressing should be used to

cover the catheter site. [A]
CVC9. If a patient has profuse perspiration, or if the insertion site is bleeding or oozing, a sterile
gauze dressing is preferable to a transparent, semi-permeable dressing. [D]
CVC10. Gauze dressings should be changed when they become damp, loosened or soiled, and the
need for a gauze dressing should be assessed daily. A gauze dressing should be replaced by a
transparent dressing as soon as possible. [D]
CVC11. Transparent dressings should be changed every 7 days, or sooner if they are no longer
intact or moisture collects under the dressing. [A]
CVC12. Dressings used on tunnelled or implanted CVC sites should be replaced every 7 days until
the insertion site has healed, unless there is an indication to change them sooner. [A]
CVC13. An alcoholic chlorhexidine gluconate solution should be used to clean the catheter site
during dressing changes, and allowed to air dry. An aqueous solution of chlorhexidine
gluconate should be used if the manufacturer’s recommendations prohibit the use of alcohol
with their product. [A]
CVC14. Individual sachets of antiseptic solution or individual packages of antiseptic-impregnated

swabs or wipes should be used to disinfect the dressing site. [D]
CVC15. Healthcare personnel should ensure that catheter-site care is compatible with catheter
materials (tubing, hubs, injection ports, luer connectors and extensions) and carefully check
compatibility with the manufacturer’s recommendations. *D+
D.8.4.4 General principles for catheter management
CVC16. The injection port or catheter hub should be decontaminated using either alcohol or an
alcoholic solution of chlorhexidine gluconate before and after it has been used to access
the system. [C]
146
CVC17. In-line filters should not be used routinely for infection prevention. [D]
CVC18. Antibiotic lock solutions should not be used routinely to prevent catheter-related
bloodstream infections (CRBSI). [A]
CVC19. Systemic antimicrobial prophylaxis should not be used routinely to prevent catheter
colonisation or CRBSI, either before insertion or during the use of a central venous
catheter. [A]
CVC20. Preferably, a single lumen catheter should be used to administer parenteral nutrition. If a
multilumen catheter is used, one port must be exclusively dedicated for TPN, and all
lumens must be handled with the same meticulous attention to aseptic technique. [D]
CVC21. Preferably, sterile 0.9 percent sodium chloride injection should be used to flush and lock
catheter lumens. [D]
CVC22. When recommended by the manufacturer, implanted ports or opened-ended catheter

lumens should be flushed and locked with heparin sodium flush solutions. [D]
CVC23. Systemic anticoagulants should not be used routinely to prevent CRBSI. [D]
CVC24. If needleless devices are used, the manufacturer’s recommendations for changing the
needleless components should be followed. [D]
CVC25. When needleless devices are used, healthcare personnel should ensure that all
components of the system are compatible and secured, to minimise leaks and breaks in the
system. [D]
CVC26. When needleless devices are used, the risk of contamination should be minimised by
decontaminating the access port with either alcohol or an alcoholic solution of
chlorhexidine gluconate before and after using it to access the system. [D]
CVC27. In general, administration sets in continuous use need not be replaced more frequently
than at 72 hour intervals unless they become disconnected or a catheter-related infection
is suspected or documented. [A]
CVC28. Administration sets for blood and blood components should be changed every 12 hours, or
according to the manufacturer’s recommendations. *D+
CVC29. Administration sets used for total parenteral nutrition (TPN) infusions should generally be
every 72 hours. [D]
147
D.9 Text removed from previous guideline (2003)

D.9.1 Scope and Purpose of the Guidelines
Each set of guidelines follows an identical format, which consists of:
a glossary;
the intervention heading;
a headline statement describing the key issues being addressed;
a synthesis of the related evidence and corresponding evidence grade;
an economic opinion, where appropriate;
guideline recommendation(s) with the corresponding recommendation grade(s);
a bibliography listing the cited evidence.
Finally, at the end of each section there is a description of areas for further research, suggested audit
criteria, and a bibliography of all evidence reviewed.
D.9.2 Methodology
Following critical appraisal, the evidence was tabulated and reports written for each
review question. The evidence was graded using the categories described by Eccles
and Mason (2001)116 and reproduced below:
Categories of evidence
Ia Evidence from meta-analysis of randomised controlled trials
Ib Evidence from at least one randomised controlled trial
IIa Evidence from at least one controlled trial without randomisation
IIb Evidence from at least one other type of quasi-experimental study
III Evidence from non-experimental descriptive studies, such as comparative studies, correlation
studies and case-control studies
IV Evidence from expert committees reports or opinions and/or clinical experience of respected
authorities
The grading scheme suggested by Eccles and Mason (2001)116 was used to define the strength of
recommendation and is reproduced below.
Recommendation grade Evidence
A Directly based on category 1 evidence
B Directly based on:
Category II evidence, or
Extrapolated recommendation from category 1 evidence
C Directly based on:
Category III evidence, or
Extrapolated recommendation from category I or II
evidence
D Directly based on:
Category IV evidence, or
Extrapolated recommendation from category I,II or III
evidence
148
D.9.2.1 External consultation
These guidelines have been subject to extensive external consultation with registered
stakeholders (see NICE website for consultation process and stakeholders). The
guidelines will be reviewed in two years (2005).
D.9.3 Standard Precautions

1. Hand hygiene;
2. The use of personal protective equipment;
3. The use and disposal of sharps;
4. Education of patients, their carers and healthcare personnel.
The systematic review process is detailed in appendix D.1.2.
1. Standard Principles for Hand Hygiene;
2. Standard Principles for the Use of Personal Protective Clothing;
3. Standard Principles for the Safe Use and Disposal of Sharps;
4. Education of patients, carers and their healthcare personnel
D.9.3.1 Areas for Further Research
Given the poor data available on community healthcare personnel practice, qualitative and
quantitative studies are required to map the current situation. This should include:
the availability of hand decontamination equipment;
gloves and protective equipment in community and primary care settings and;
their use by different healthcare personnel and compliance with current guidance.
D.9.4 Hand hygiene
D.9.4.1 When must you decontaminate your hands in relation to patient care?
Decontamination refers to the process for the physical removal of blood, body fluids, and transient
microorganisms from the hands, i.e., handwashing, and/or the destruction of microorganisms, i.e.,
hand antisepsis44.
Guidance suggests that, in deciding when it is necessary to decontaminate hands, four key factors
need to be considered380:
the level of the anticipated contact with patients or objects;
the extent of the contamination that may occur with that contact;
the patient care activities being performed;
the susceptibility of the patient.
149
Patients are put at potential risk of developing a healthcare-associated infection when informal
carers or healthcare personnel caring for them have contaminated hands. Hands must be
decontaminated before every episode of care that involves direct contact with patients’ skin, their
food, invasive devices or dressings. Current expert opinion consistently recommends that hands
need to be decontaminated after completing an episode of patient care and following the removal of
gloves to minimise cross contamination of the environment44,203,242.
Recommendation
Hands must be decontaminated immediately before each and every episode of direct patient
contact or care and after any activity or contact that could potentially result in hands becoming
contaminated.
D.9.4.2 Is any one hand cleaning preparation better than another?
Our previous systematic review 380 identified no compelling evidence to favour the general use of
antimicrobial handwashing agents over soap, or one antimicrobial agent over another. The current
review has identified no new evidence that alters this analysis.
Our systematic review identified seventeen acceptable studies that compared hand hygiene
preparations including alcohol based hand rubs and gels, antimicrobial handwashes and liquid soap.
Five of the studies were randomised controlled trials (RCT) conducted in clinical settings comparing
the use of alcohol-based preparations with other agents154,250,274,507,528. Four RCTs demonstrated
alcohol to be a more effective hand hygiene agent than non-medicated soap and antimicrobial
handwash,154,250,274,507 while a fifth study found no statistical difference between the use of alcohol
and antiseptic soap528. These studies underpin a growing trend to adopt the use of alcohol-based
hand rinses and gels in clinical practice. Three clinically based, quasi-experimental studies189,190,249
and seven controlled laboratory experiments60,114,169,214,235,300,352 also demonstrated an association
between reductions in microbiological flora and the use of alcohol-based preparations. One
clinically-based quasi-experimental study compared the use of two antimicrobial handwash
preparations in reducing MRSA128. One descriptive study of the use of an antiseptic hand cream by
community nurses showed sustained residual effect in reducing microbiological flora162.
When deciding which hand decontamination preparation to use, the practitioner must consider the
need to remove transient and/or resident hand flora*. Preparations with a residual effect contain
antimicrobial agents and are not normally necessary for everyday clinical practice but may be used
for some invasive procedures and in outbreak situations. What is important is that healthcare
practitioners use an appropriate preparation to decontaminate their hands. National and
international guidelines44,380 suggest that the acceptability of agents and techniques is an essential
criterion for the selection of preparations for hand hygiene. Acceptability of preparations is
dependent upon the ease with which the preparation can be used in terms of time and access
together with their dermatological effects44,380.
Economic analysis of cost effectiveness is based on the assumption that the rate of infection in
primary and community care is 4 percent, i.e., half that in hospital,377,380 and that alcohol gel reduces
infection rate by 30%130 or 25%154 i.e. to 2.8% or 3.0% compared to not washing. For every 1000
patients, between 10 and 12 infections would be avoided. If each infection resulted in a nurse visit
(estimated cost £25320) then between £250 and £300 would be saved in avoided costs. This is
without the possibility of Accident and Emergency Department attendances and/or inpatient stays.
Therefore, if the cost of an alcoholic handrub* is within 25 pence of the cost of conventional
handwashing, it will be cost saving. If one were to include patient outcomes (i.e. of avoiding
infection with the associated morbidity and mortality) and hospital attendance, the cost
effectiveness of hand hygiene with alcohol rubs would increase.
150
The cost of a single hospital acquired infection is estimated to be over £3000 453. The author
concludes that even a very low reduction in infections through the use of alcohol handrubs, would be
cost saving. It is felt that although the above analysis is in a different setting, it represents a
conservative analysis.
Choice of decontamination: is it always necessary to wash hands to achieve decontamination?
In the community and home setting, choosing a method of hand decontamination will be heavily
influenced by the assessment of what is practically possible, the available resources in the care
setting (particularly patients’ own homes), what is appropriate for the episode of care, and, to some
degree, personal preferences based on the acceptability of preparations or materials.
In general, effective handwashing with a non-medicated liquid soap will remove transient
microorganisms and render the hands socially clean. This level of decontamination is sufficient
for general social contact and most clinical care activities380.
Using an antimicrobial liquid soap preparation will reduce transient microorganisms and resident
flora, and result in hand antisepsis44,380.
Although alcohol does not remove dirt and organic material, the effective use of alcohol-based
handrubs on contaminated hands will result in substantial reductions of transient
microorganisms44, Alcohol handrubs offer a practical and highly acceptable alternative to
handwashing when the hands are not grossly soiled and are recommended for routine
use44,154,250,274,507,528.
Recommendations
Hands that are visibly soiled, or potentially grossly contaminated with dirt or organic material,
must be washed with liquid soap and water.
Hands must be decontaminated, preferably with an alcohol-based hand rub unless hands are
visibly soiled, between caring for different patients or between different care activities for the
same patient.
D.9.5 Personal protective equipment
D.9.5.1 Do gloves leak?
Gloves must be disposed of as clinical waste and hands decontaminated after the gloves have been
removed.
D.9.5.2 Making choices
Expert opinion is quite clear about when gloves must be used by healthcare practitioners in general
clinical practice2,76,414. Having decided that gloves should be used for a healthcare activity, the
practitioner must make a choice between the use of:
sterile or non-sterile gloves, based on contact with susceptible sites or clinical devices;
surgical or examination gloves, based on the aspect of care or treatment to be undertaken.
NHS Trusts need to provide gloves that conform to European Community Standard (CE), and which
are acceptable to healthcare practitioners76,381. Gloves are available in a variety of materials, the
most common being natural rubber latex (NRL) and synthetic materials. NRL remains the material of
choice due to its efficacy in protecting against bloodborne viruses and properties that enable the
wearer to maintain dexterity76,381. A pilot study of dentists using nitrile gloves in place of NRL found
that they compared favourably in terms of puncture resistance312. The problem of patient or
151
healthcare practitioner sensitivity to NRL proteins must be considered when deciding on glove
materials. As a consequence, expert opinion strongly advises that powdered gloves should not be
used in healthcare2,76,381,414.
Synthetic materials are generally more expensive than NRL and due to certain properties may not be
suitable for all purposes76. Nitrile gloves have the same chemical range as NRL and may also lead to
sensitivity problems. Vinyl gloves made to European Community standards provide the same level of
protection as NRL381. Polythene gloves are not suitable for clinical use due to their permeability and
tendency to damage easily76,381.
The following table highlights the cost comparison of the various gloves materials. Healthcare
personnel should be aware of the cost differential in gloves and should select the most appropriate
for the activity.
Pack Size (largest where

Product more than one pack size) Cost per pack Cost per individual glove
Lightly powdered 1000 £19.97 £0.02
protector latex
examination gloves
Lightly powdered vinyl 1000 £19.95 £0.02
seamless examination
gloves
Nitrile gloves 1000 £54.95 £0.05
Powder free latex 1000 £24.97 £0.02

examination gloves
(non-sterile)
Powder free sterile 100 £13.99 £0.14
latex gloves
Web address: http://www.medisave.co.uk/acatalog/
Recommendations
Gloves that are acceptable to healthcare personnel and that conform to European Community (CE)
standards must be available.
Sensitivity to natural rubber latex in patients, carers and healthcare personnel must be
documented, and alternatives to natural rubber latex gloves must be available.
Neither powdered gloves nor polythene gloves should be used in healthcare activities.
D.9.5.3 Aprons or gowns?
In our systematic review, three studies were identified that highlighted the potential for uniforms to
become contaminated57,200,360. These studies considered the uniforms of nurses and healthcare
assistants in hospital and dentists in an out patient department. All found evidence of contamination
of clothing during the shift, though no link was made to any adverse clinical outcome. However, two
studies commented on the need for a clean uniform to be worn for each shift and recommended
that they should be supplied on the basis of the number of days worked per week rather than
hours57,360.
152
Our previous systematic review identified a variety of studies, none of which supported the routine
use of gowns in general or specialist clinical settings380. However, expert opinion suggests that
protective clothing should be worn by all healthcare practitioners when contamination with blood,
body fluids, secretions, or excretions (with the exception of sweat), or when close contact with the
patient, materials or equipment may lead to contamination of the clothing with microorganisms76,381.
Plastic aprons are recommended for general use, 76,381 but unused aprons need to be stored carefully,
i.e., away from potential contamination57,381. Full body gowns need only be used where there is the
possibility of extensive splashing of blood, body fluids, secretions or excretions and should be fluid
repellent76,381.
D.9.5.4 Recommendations
Disposable plastic aprons should be worn when there is a risk that clothing may become exposed
to blood, body fluids, secretions or excretions, with the exception of sweat. Full-body fluid-
repellent gowns must be worn where there is a risk of extensive splashing of blood, body fluids,
secretions or excretions, with the exception of sweat, onto the skin or clothing of healthcare
personnel (for example when assisting with childbirth).
Plastic aprons should be worn as single-use items, for one procedure or episode of patient care,
and then discarded and disposed of as clinical waste.
D.9.6 Sharps
D.9.6.1 Sharps injuries – what’s the problem?
National and international guidelines, are consistent in their recommendations for the safe use and
disposal of sharp instruments and needles65,126,336. As with many infection prevention and control
policies, the assessment and management of the risks associated with the use of sharps is paramount
and safe systems of work and engineering controls must be in place to minimise any identified risks,
e.g., positioning the sharps bin as close as possible to the site of the intended clinical procedure.178
Any healthcare worker experiencing an occupational exposure to blood or body fluids needs to be
assessed for the potential risk of infection by a specialist practitioner, e.g., physician, occupational
health nurse and offered before testing, immunisation and post-exposure prophylaxis if
appropriate125.
D.9.6.2 Do needle safety devices reduce avoidable injuries?
Expert advice encourages healthcare providers and their employees to pursue safer methods of
working through considering the benefits of new safety devices126. The incidence of injuries related
to needle devices has led to the development of prevention devices in eleven different product
groups179. They are designed to minimise the risk of operator injury during venepuncture,
intravenous therapy and injections, and so-called “downstream” injuries occurring following the
disposal of sharps and often involving housekeeping or portering staff responsible for the collection
of sharps disposal units. People with insulin dependent diabetes frequently use needle clipping
devices.
It would seem to be logical that where needle safety or other protective devices are used, there
should be a resulting reduction in sharps injuries. Our systematic review identified four studies that
involved the introduction of needle safety devices to reduce reported needlestick injuries.145,356,394,527
All of the studies were descriptive and involved the implementation of other interventions at the
same time as the introduction of the needle safety devices. Only two of these studies produced
statistically significant reductions in needlestick injuries.145,356
153
A comprehensive report and product review conducted in the US provides background information
and guidance on the need for and use of needlestick prevention devices in four clinical
applications:179
delivering intravenous (IV) medications;
delivering intramuscular and subcutaneous medications;
introducing IV catheters;
collecting blood.
The report identifies that none of the devices evaluated is without limitations in relation to cost,
applicability and effectiveness. Some of the devices available are more expensive, may not be
compatible with existing equipment, and paradoxically, may be associated with an increase in
bloodstream infection rates.66
National Guidelines and the National Health Service Purchasing and Supply Agency identify that
meaningful evaluations are paramount in assessing user acceptability and clinical applicability of
needle safety devices.324,381 The evaluation should ensure that the safety feature works effectively
and reliably, that the device is acceptable to healthcare practitioners and that it does not adversely
affect patient care.
Recommendations
Needle safety devices must be used where there are clear indications that they will provide safer
systems of working for healthcare personnel.
D.9.7.1 Is one catheter better than another?
A systematic review identified three experimental studies that compared the use of coated latex with
silicone catheters.381 No significant difference in the incidence of bacteriuria was found. Our
systematic review identified one laboratory study which indicated that bacteria were less likely to
adhere to hydrophilic coated catheters than silicone coated catheters.402 However, many
practitioners have strong preferences for one type of catheter over another. This preference is often
based on clinical experience, patient assessment and which materials induce the least allergic
response.
D.9.7.2 Instillation and washouts do not prevent infection
Our systematic review suggests that more than 50% of patients with long-term catheters will
experience catheter encrustation and blockage.146,405 A tendency to encrustation is multifactorial
and includes patient factors, catheter materials and bacterial organisms. Several studies identified an
association between high urinary pH (alkaline) and encrustation and blocking but there is no
evidence that monitoring urinary pH can be used to predict blocking.55,56,72,147,238,239
Systematic review381 evidence and further evidence from one controlled trial220 failed to demonstrate
any beneficial effect of bladder instillation or washout with a variety of antiseptic or antimicrobial
agents in preventing catheter-associated infection. A laboratory study demonstrated that any effect
was only temporary.450 Study investigators commented that these agents may prove detrimental to
patients with dehydration or low urine output. A study using a model bladder identified that whilst
saline had no effect on encrustation. Suby G and mandelic acid washouts both made it more difficult
for P.Mirabilis to adhere to catheters.148
154
Evidence from best practice supports the above and indicates that the introduction of such agents
may have local toxic effects and contribute to the development of resistant microorganisms.240
Recommendations
Each patient should have an individual care regimen designed to minimise the problems of
blockage and encrustation. The tendency for catheter blockage should be documented in each
newly catheterised patient.
Bladder instillations or washouts must not be used to prevent catheter-associated infection.
D.9.7.3 Changing catheters
Our systematic review suggests that antibiotic prophylaxis to prevent bacteraemia* at primary
catheter insertion for acute retention is of proven value.407 In the community setting however, a
prospective survey of 120 catheter changes without chemoprophylaxsis found zero incidence of
clinical complications, despite a 5.6 percent incidence of sub clinical bacteraemia detected by blood
culture.50 This descriptive finding is matched by the result of an experimental study of residents in a
geriatric care centre.132 Antibiotic prophylaxis was of no benefit in preventing or delaying bacteriuria
following long-term catheter placement. A systematic review419 and expert opinion92,293 suggest
antibiotic prophylaxis at catheter change should be reserved for those with a history of symptomatic
UTI following catheter change, for patients catheterised between 3-14 days or to prevent
endocarditis in patients with heart valve lesion, septal defect, patent ductus or prosthetic valve.
Recommendations
Antibiotic prophylaxis when changing catheters should only be used for patients with a history of
catheter-associated urinary tract infection following catheter change, or for patients who have a
heart valve lesion, septal defect, patent ductus or prosthetic valve.
D.9.7.4 Re-use of intermittent catheters
Many people use disposable single-use catheters for intermittent catheterisation. Reusable single
patient use catheters need to be cleaned after use. Our systematic review identified two crossover
studies of young people with neurogenic bladders which indicated that cleaning catheters with soap
and water results in acceptably low rates of bacteriuria when compared with the use of sterile
catheters304,306 However, manufacturer’s recommendations advise against using soap as soap
residues may cause urethral irritation. Catheters should be stored in a clean and dry condition, which
is least likely to promote the growth of contaminating microorganisms.
155
Recommendation
Reusable intermittent catheters should be cleaned with water and stored dry in accordance with
the manufacturer’s instructions.
D.9.8 Enteral Feeding
D.9.8.1 Care of insertion site and enteral feeding tube
Keep the tube clear
To help minimise the potential risk of microbial colonisation of the internal and external surfaces of
enteral feeding tubes, expert opinion suggests that the tube should be flushed with either cooled
boiled water or freshly opened sterile water before and after each change of feed, aspiration or drug
administration.16,137 However, expert advice from specialist members of the Guideline Development
Group suggests that fresh tap water may be safely used for flushing enteral feeding tubes in
immuncompetent patients.4,457
Recommendations
The stoma should be washed daily with water and dried thoroughly.
To prevent blockage, the enteral feeding tube should be flushed with fresh tap water before and
after feeding or administrating medications. Enteral feeding tubes for patients who are
immunosuppressed should be flushed with either cooled freshly boiled water or sterile water from
a freshly opened container.
D.9.9.1 General Asepsis
Good standards of hand hygiene and antiseptic technique can reduce the risk of infection
Because the potential consequences of CRBSI are so serious, enhanced efforts are needed to reduce
the risk of infection to the absolute minimum. For this reason, hand antisepsis and proper aseptic
technique are required for changing catheter dressings and for accessing the system.44,334
Hand antisepsis can be achieved by washing hands with an antimicrobial liquid soap and water or by
using an alcohol-based hand rub. When hands are visibly dirty or contaminated with organic
material, such as blood and other body fluids or excretions, they must first be washed with soap and
water if alcohol-based hand rubs are going to be used to achieve hand antisepsis. In community and
primary care settings, alcohol-based hand rubs are the most consistently accessible and appropriate
agent to use for hand antisepsis.
Appropriate aseptic technique does not necessarily require sterile gloves; a new pair of disposable
nonsterile gloves can be used in conjunction with a ‘no-touch’ technique, for example, in changing
catheter site dressings.334 The ‘Standard Principles for Preventing HAI’ previously described in these
guidelines gives additional advice on hand decontamination and the use of gloves and other
protective equipment.
156
Following hand antisepsis, clean gloves and a no-touch technique or sterile gloves should be used
when changing the insertion site dressing.
D.9.9.2 Use the right dressing regimen to protect the catheter site
Following CVC placement, one of two types of dressings is used to protect the catheter site; sterile
gauze and tape or sterile transparent semipermeable polyurethane dressings.
HICPAC reviewed the evidence up to the end of 1999 related to which type of dressing provided the
greatest protection against infection and found little difference.334 They concluded that the choice of
dressing can be a matter of preference. If blood is oozing from the catheter insertion site, a gauze
dressing might be preferred. Our systematic review did not identify any additional evidence which
conflicted with HICPAC’s conclusions.
Gauze dressings are not waterproof and require frequent changing in order to inspect the catheter
site. They are rarely useful in patients with long-term CVC. Sterile transparent, semipermeable
polyurethane dressings have become a popular means of dressing catheter insertion sites. These
reliably anchor the CVC, permit continuous visual inspection of the catheter site, allow patients to
bathe and shower without saturating the dressing, and require less frequent changes than do
standard gauze and tape dressings, saving healthcare personnel time.
Recommendations
Preferably, a sterile, transparent, semipermeable polyurethane dressing should be used to cover

the catheter site.
If a patient has profuse perspiration, or if the insertion site is bleeding or oozing, a sterile gauze
dressing is preferable to a transparent, semi-permeable dressing.
Gauze dressings should be changed when they become damp, loosened or soiled, and the need for
a gauze dressing should be assessed daily. A gauze dressing should be replaced by a transparent
dressing as soon as possible.
Transparent dressings should be changed every 7 days, or when they are no longer intact or
moisture collects under the dressing.
D.9.9.3 Use an appropriate antiseptic agent for disinfecting the catheter insertion site during dressing
changes
HICPAC described compelling evidence that aqueous chlorhexidine 2 percent was superior to either
10% povidone iodine or 70% alcohol in lowering CRBSI rates when used for skin antisepsis prior to
CVC insertion. They made no recommendation for the use of any disinfectant agent for cleaning the
insertion site during dressing changes.334
A recent meta-analysis assessed studies that compared the risk for CRBSI following insertion-site skin
care with either any type of chlorhexidine gluconate (CHG) solution vs. povodine iodine (PI)
solution.67 This analysis indicated that the use of CHG rather than PI can reduce the risk for CRBSI by
approximately 49% (risk ratio, 0.51 [CI, 0.27 to 0.97]) in hospitalised patients who require short-term
catheterisation, i.e., for every 1000 catheter sites disinfected with CHG rather than PI, 71 episodes of
catheter colonization and 11 episodes of CRBSI would be prevented. In this analysis, several types of
CHG solutions were used in the individual trials, including 0.5 percent or 1 percent CHG alcohol
solution and 0.5 percent or 2 percent CHG aqueous solution. All of these solutions provided a
concentration of CHG that is higher than the minimal inhibitory concentration (MIC) for most
157
nosocomial bacteria and yeasts. Subset analysis of aqueous and non-aqueous solutions showed
similar effect sizes, but only the subset analysis of the five studies that used alcoholic CHG solution
produced a statistically significant reduction in CRBSI. Because few studies used CHG aqueous
solution, the lack of a significant difference seen for this solution compared with PI solution may be a
result of inadequate statistical power.
Alcohol and other organic solvents and oil-based ointments and creams may damage some types of
polyurethane and silicon CVC tubing. The manufacturer’s recommendations for only using
disinfectants that are compatible with specific catheter materials must be followed.
Recommendations
An alcoholic chlorhexidine gluconate solution should be used to clean the catheter site during
dressing changes, and allowed to air dry. An aqueous solution of chlorhexidine gluconate should
be used if the manufacturer’s recommendations prohibit the use of alcohol with their product.
D.9.9.4 Aseptic technique is important when accessing the system
Following their review of the evidence, HICPAC stressed the importance of minimising the risk of
introducing infection by using an appropriate antiseptic to decontaminate the access port before
accessing the system with sterile devices. As most modern catheter hubs, luer connectors and other
access ports are made from alcohol-resistant materials, the use of alcohol wipes, chlorhexidine
gluconate or an iodophor for this purpose are recommended by HICPAC. However, they stress the
importance of ensuring that any antiseptic agent used is chemically compatible with catheter hubs,
ports and connectors.334
Recommendation
The injection port or catheter hub should be decontaminated with either alcohol or an alcoholic
solution of chlorhexidine gluconate before and after it has been used to access the system.
158
D.10 Deleted and amended recommendations (2003)

D.10.1 Deleted recommendations from from NICE clinical guideline 2
Recommendation in 2003 guideline Comment
Hands that are visibly soiled, or potentially Replaced by:
grossly contaminated with dirt or organic 1.1.2.2 Decontaminate hands preferably with a
material, must be washed with liquid soap and handrub (conforming to current British
water a
standards ), except in the following
(Recommendation 1.1.2.2 in 2003 guideline) circumstances, when liquid soap and water must
be used:
• when hands are visibly soiled or potentially
contaminated with body fluids or
• in clinical situations where there is potential for
the spread of alcohol-resistant organisms (such
as norovirus, Clostridium difficile, or organisms
that cause diarrhoeal illness).
Hands must be decontaminated, preferably with Replaced by:
an alcohol-based handrub unless hands are 1.1.2.2 Decontaminate hands preferably with a
visibly soiled, between caring for different handrub (conforming to current British
patients and between different care activities for a
the same patient circumstances, when liquid soap and water must
(Recommendation 1.1.2.3 in 2003 guideline) be used:
as norovirus, Clostridium difficile, or organisms
that cause diarrhoeal illness).
Reusable intermittent catheters should be Removed to avoid confusion as single-use
cleaned with water and stored dry in accordance intermittent urinary catheters have been
with the manufacturer’s instructions. recommended:
(Recommendation 1.2.5.14 in 2003 guideline) 1.2.3.3 Offer a choice of either single-use
hydrophilic or gel reservoir catheters for
intermittent urinary self catheterisation.
Hands that are visibly soiled or contaminated Replaced by:
with dirt or organic material must be washed 1.1.2.2 Decontaminate hands preferably with a
with soap and water before using an alcohol handrub (conforming to current British
handrub a
(Recommendation 1.4.2.3 in 2003 guideline) circumstances, when liquid soap and water must
be used:
as Clostridium difficile, or organisms that cause
diarrhoeal illness).
The GDG did not consider it necessary to repeat

this hand decontamination recommendation in
the vascular access device chapter.
Following hand antisepsis, clean gloves and a no- Replaced by:
a
At the time of publication of the guideline (March 2012): BS EN 1500: 1997
159
Recommendation in 2003 guideline Comment

touch technique or sterile gloves should be used 1.4.2.1 Hands must be decontaminated (see
when changing the insertion site dressing section 1.1.2) before accessing or dressing a
(Recommendation 1.4.2.4 in 2003 guideline) vascular access device.
1.4.2.2 An aseptic technique, such as Aseptic Non
Touch Technique (ANTT), must be used for
vascular access device catheter site care and
when accessing the system.
D.10.2 Amended recommendations (change to meaning)

Recommendations have been labelled [2003, amended 2012] if the evidence has not been reviewed
but changes have been made that change the meaning of the recommendation.
Recommendation in current
Recommendation in 2003 guideline guideline Comment
1.1.4.1 Sharps must not be passed 1.1.4.1 Sharps should not be passed The updated
directly from hand to hand, and directly from hand to hand, and recommendation contains
handling should be kept to a handling should be kept to a 'should' rather than ‘must’
minimum. minimum. because the GDG
considered that the use of
‘must’ in the 2003 version is
not covered by legislation
(in accordance with the
NICE guidelines manual,
2009).
1.2.5.4 Carers and patients managing 1.2.5.4 Patients managing their own This recommendation has
their own catheters must catheters, and their carers, must be been amended to reflect
wash their hands before and after educated about the need for hand input from the NICE Patient
manipulation of the catheter, in decontamination before and after and Public Involvement
accordance with the manipulation of the catheter, in Programme:
recommendations in the standard accordance with the recommendations cannot
principles section (Section 1.1). recommendations in the standard be made directly about
principles section (section 1.1.). what patients and carers
must do.
1.4.1.1 Before discharge from 1.4.1.1 Before discharge from The updated
hospital, patients and their carers hospital, patients and their carers recommendations contain
should be taught any techniques they should be taught any techniques they 'vascular access device'
may need to use to prevent infection may need to use to prevent infection rather than 'central venous
and safely manage a central venous and safely manage a vascular access catheter'. This change has
catheter. device. been made because
1.4.1.2 Community healthcare 1.4.1.2 Healthcare workers caring peripherally inserted
personnel caring for a patient with a for a patient with a vascular access catheters were included in
central venous catheter should be device should be trained, and the scope of the guideline
trained, and assessed as competent, assessed as competent, in using and update.
in using and consistently adhering to consistently adhering to the infection
the infection prevention practices prevention practices described in this
described in this guideline. guideline.
1.4.1.3 Follow-up training and 1.4.1.3 Follow-up training and
support should be available to support should be available to
patients with central venous patients with a vascular access device
catheters and their carers. and their carers.
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D.10.3 Amended recommendations (no change to meaning)

Recommendation in current guideline Comment
1.1.3.1 Selection of protective equipment musta be All instances of ‘healthcare personnel’ have been
based on an assessment of the risk of transmission changed to ‘healthcare worker’. This is for
of microorganisms to the patient, and the risk of consistency with other NICE clinical guidelines and is
contamination of the healthcare worker’s clothing considered a more modern term. The GDG
and skin by patients’ blood, body fluids, secretions considered the term ‘healthcare workers’ to include
or excretions. a wider group of people than healthcare
1.2.1.2 Community and primary healthcare workers professionals, which they considered to be only
must be trained in catheter insertion, including those staff with professional qualifications.
suprapubic catheter replacement and catheter In recommendation 1.3.1.2, ‘community staff’ has
maintenance. been changed to ‘healthcare workers’, for
1.2.4.1 All catheterisations carried out by consistency with this terminology.
healthcare workers should be aseptic procedures. In recommendation 1.4.1.2, ‘community healthcare
After training, healthcare workers should be personnel’ has been changed to ‘healthcare
assessed for their competence to carry out these workers’, for consistency with this terminology.
types of procedures.
1.2.5.2 Healthcare workers should ensure that the
connection between the catheter and the urinary
drainage system is not broken except for good
clinical reasons, (for example changing the bag in
line with the manufacturer’s recommendations).
1.2.5.3 Healthcare workers must decontaminate
their hands and wear a new pair of clean, non-sterile
gloves before manipulating a patient’s catheter, and
must decontaminate their hands after removing
gloves.
1.3.1.2 Healthcare workers should be trained in
enteral feeding and management of the
administration system.
1.4.1.2 Healthcare workers caring for a patient with
a vascular access device should be trained, and
assessed as competent, in using and consistently
adhering to the infection prevention practices
described in this guideline.
1.4.3.7 Healthcare workers should ensure that
catheter-site care is compatible with catheter
materials (tubing, hubs, injection ports, luer
connectors and extensions) and carefully check
compatibility with the manufacturer’s
recommendations.
1.4.4.10 When needleless devices are used,
healthcare workers should ensure that all
components of the system are compatible and
secured, to minimise leaks and breaks in the system.
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Appendix E: Review protocols

E.1 Standard principles - Education of patients, carers and their
healthcare workers
Component Description
Review question What information do healthcare professionals, patients and carers require to
prevent healthcare associated infections in primary and community care
settings?
Objectives The objective of this review is to obtain information and evidence that can
help to inform the guideline development group (GDG) about what
information should routinely be provided to patients to prevent health care
associated infections. Recommendations can be then made to address
important gaps in knowledge or behaviour.
The GDG had decided to focus on patients and the lay people for this review
question. Patients play an important role in reducing healthcare infection
and hand hygiene was identified as an area that is of importance and
applicable to all patients.
Setting ( or situation) Primary-care settings, such as general practices, dental clinics, health centres
and polyclinics. This also includes care delivered by the ambulance service.
Community-care settings (such as care homes, patient's own home, schools
and prisons) where NHS healthcare is provided or commissioned.
Exclusions: patients in the intensive care units
Population “Patients” who are being cared in the primary care and community care
(perspective) setting. This may involve people who are relatively well but receive
occasional care in through the general practice and dental services.
Exclusion: Health care professionals
Intervention Hand hygiene practice
Comparison None
Evaluation Patient experiences; preferences; perceptions, including factors which
encourage or prevent effective hand hygiene
Qualitative studies (Interviews, focus groups, observations) and surveys
about patient perception, experiences and preferences of hand hygiene
practice, including factors which encourage or prevent hand hygience
Search strategy The databases to be searched are Medline, Embase, The Cochrane Library,
CINAHL and PsychInfo.
Studies will be restricted to English language only.
No date restriction will be applied. Databases will be searched from their
date of origin.
Studies were evaluated to assess their relevance to the question asked. The
The review strategy
most relevant studies are those conducted in the UK, in the NHS settings, in
the population of interest for the purpose of finding of what information is
required to reduce health care associated infections through hand hygiene.
Analysis began with studies that are most relevant to the review question in
terms of population, setting (situation), context and objectives.
Thematic analysis were conducted, common themes across studies were
extracted and reported.
Quality of studies was evaluated on three key components – methodological
quality (study limitations), transferability (indirectness) and other
considerations. The consistency of themes between various studies was also
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evaluated.
E.2 Hand Decontamination
Review question What is the clinical and cost effectiveness of when to decontaminate hands,
including after the removal of gloves, on hand decontamination compliance,
MRSA and C diff reduction or cross infection, colony forming units and
removal of physical contamination?
Objectives To determine when hands should be decontaminated and to look at the
implementation of hand decontamination guidance including the WHO 5
moments of hand hygiene to determine if infection have been reduced.
Population Healthcare professionals
Settings – primary care or community
Intervention Implementation of a published hand decontamination guideline or policy e.g.
CDC/WHO guidance.
Exclusion criteria: Local policy not based on published guidance e.g. locally
developed hand decontamination guidance.
Comparison Implementation of a published hand decontamination guideline or policy
No policy or guideline
Outcomes Colony forming units (CFUs)
Hand decontamination compliance
MRSA reduction
MRSA cross infection
C. diff reduction
C. diff cross infection
Removal of physical contamination
Search strategy The databases to be searched are Medline, Embase, The Cochrane Library
and CINAHL.
Randomised controlled trials (RCTs) will be considered. If no RCTs are found,
well conducted cohort studies and observational studies may also be
considered.
Studies will be restricted to English language only
Databases will be searched from 2002.
The review strategy Meta-analyses will be conducted where possible.
Only include hospital settings if no evidence is available from community
settings. Only include intensive care settings if no other evidence is available
from other hospital settings.
If there is heterogeneity the following subgroups will be analysed separately:
Age (adults, children)
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Review question What is the clinical and cost effectiveness of cleaning preparations (soap and
water, alcohol based rubs, non-alcohol products and wipes) for healthcare
worker hand decontamination, on hand decontamination compliance, MRSA
and C. diff reduction or cross infection, colony forming units and removal of
physical contamination?
Objectives To determine which product should be used to decontaminated hands.
Intervention Alcohol based hand rubs
Non-alcohol hand sanitizers
Antimicrobial/ antiseptic hand washes or agents
Liquid soap and water
Skin wipes, hand wipes or wet wipes
Exclusion criteria: surgical scrubs
Comparison As above
No hand cleaning products/ placebo
MRSA reduction
MRSA cross infection
C. diff reduction
C. diff cross infection
Removal of physical contamination
and CINAHL.
considered.
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Review question What is the clinical and cost effectiveness of healthcare workers
decontaminating wrists vs. not decontaminating wrists or usual practice on
MRSA and C. diff reduction or cross infection, colony forming units and
removal of physical contamination and transient organisms?
Objectives To determine the effectiveness of washing wrists on reduction of healthcare
associated infection.
Intervention Decontaminating wrists
Instructions/protocol to include decontaminating wrists
Comparison Not decontaminating wrists
Usual practice/ technique
Cross infection of MRSA
Cross infection of C. Diff
Removal of physical contamination (bodily fluids and dirt)
Removal of transient organisms
and CINAHL.
Randomised controlled trials (RCTs) will be considered. If no RCTs are found
conducted cohort studies and observational studies may also be considered.
Review question What is the clinical and cost effectiveness of healthcare workers following
bare below the elbow policies (short sleeves or rolled up sleeves) vs. no bare
below the elbow policy (long sleeves, not rolled up or no specific restrictions)
on MRSA and C. diff reduction or cross infection, colony forming units and
removal of physical contamination and transient organisms?
Objectives To determine the effectiveness of following a bare below the elbow policy on
reduction of healthcare associated infection.
Settings – primary care or community, acute care settings
Intervention Short sleeves
Rolling up sleeves
‘Bare below elbow’ policies
Comparison Not rolling up sleeves
Long sleeves
No specific restrictions/ standard practice
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Cross infection of MRSA
Cross infection of C. Diff
Removal of physical contamination (bodily fluids and dirt)
Removal of transient organisms
and CINAHL.
considered.
E.3 Personal protective equipment
Review question What is the clinical and cost effectiveness of healthcare workers wearing
vinyl, latex or nitrile gloves on user preference and reduction of
hypersensitivity, blood borne infections, glove porosity and tears?
Objectives To determine which glove material is the most appropriate for protecting
healthcare workers and patients from infection.
Population Healthcare workers
Subgroup:
Healthcare workers who work in high risk units – HIV, Hepatitis
Healthcare workers who undertake procedures with a risk of bodily
contamination
Intervention Synthetic gloves:
Vinyl gloves
Nitrile gloves
Latex gloves
Comparison As above
Outcomes Ability to perform task
Blood borne infections
Bodily fluid contamination
Glove porosity
Holes or tears in gloves
Hypersensitivity
User preference
and CINAHL.
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considered.
Review question What is the clinical and cost effectiveness of healthcare workers wearing
plastic aprons or fluid repellent gowns vs. no aprons or gowns, gloves only or
standard uniform on the reduction of blood and bodily fluid and pathogenic
microorganism contamination?
Objectives To determine which type of personal protective equipment (gowns or
aprons) provides the best protection from infection.
Subgroup:
Healthcare workers who work in high risk units – HIV, Hepatitis
Healthcare workers who undertake procedures with a risk of bodily
contamination
Intervention Disposable plastic apron
Full body fluid repellent gown
Disposable plastic apron plus gloves
Full body fluid repellent gown plus gloves
Comparison No protection
Wearing disposable gloves only
Standard uniform
Outcomes Blood borne viruses
Bodily fluid contamination
and CINAHL.
considered.
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E.4 Safe use and disposal of sharps
Review question What is the clinical and cost effectiveness of healthcare workers using safety
needle cannulae vs. standard cannulae on compliance and user preference,
infection related mortality and morbidity and sharps injuries?
Objectives To determine whether safety cannulae prevent sharps injuries and
associated infections.
Intervention Safety Cannulae
Comparison Standard Cannulae
Compliance
Infection related mortality
Infection related morbidity
Sharps injuries
User preference
and CINAHL.
considered.
Review question What is the clinical and cost effectiveness of healthcare workers using safety
needle devices (needle-free, retractable needles, safety re-sheathing
devices) vs. standard needles on compliance and user preference, infection
related mortality and morbidity and sharps injuries?
Objectives To determine whether safety devices prevent sharps injuries and associated
infections.
Intervention Needle safety devices
Needle removal devices
Needleless/ needle-free devices
Retractable needles
Covered needles/ capped needles
Safety lancets
Safety re-sheathing devices
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Comparison Standard Needles/ fixed needles/ capped needles
Compliance
Infection related morbidity
Sharps injuries
User preference
and CINAHL.
considered.
E.5 Waste disposal

Review question Are there any changes in the legislations which affect the disposal of
personal protective equipments in relation to patient care in the primary and
community care settings?
Objectives To review and update the current recommendations about the safe disposal
of personal protective equipment so that it is in line with the European
Union (EU) and national legislations.
Population Settings – primary care or community
Intervention Disposal of PPE equipments
Comparison N/A
Outcomes N/A
Search strategy Guidance documents from the Department of Health will be reviewed.
The review strategy This question will be answered in accordance with EU legislation and
therefore does not require a PICO.
Guidance documents from the Department of Health will be reviewed.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publication
sPolicyAndGuidance/DH_063274
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Review question Are there any changes in the legislations which affect the disposal of sharp
instruments and needles in relation to patient care in the primary and
Objectives To review and update recommendations about safe disposal of sharp
instruments and needles in relation to patient care in primary and
community care, in line with current EU legislations.
Population Settings – primary care or community
Healthcare workers.
Intervention Disposal of sharp instruments and needles.
Comparison N/A
Outcomes N/A
Search strategy Guidance documents from the Department of Health will be reviewed.
The review strategy This question will be answered in accordance with EU legislation and
therefore does not require a PICO.
Guidance documents from the Department of Health will be reviewed.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publication
sPolicyAndGuidance/DH_063274
E.6 Long-term urinary catheters
Review question What is the clinical and cost effectiveness of different types of long term
indwelling urinary catheters (non-coated silicone, hydrophilic coated, or
silver or antimicrobial coated/impregnated) on urinary tract infections,
bacteraemia, frequency of catheter change, encrustations and blockages,
mortality, and patient preference?
Objectives To determine the most effective long term indwelling urinary catheter type
to prevent infection.
Population All patients with long term (>28days) urinary catheters
Catheter subgroups include suprapubic and urethral
At risk groups may include immunocompromised patients
Patients with previous history of UTI
Patients undergoing/had orthopaedic surgery
Intervention 100% silicone catheter
Hydrogel coated latex
Hydrogel coated silicone
Silicone coated latex catheter
Impregnated silicone catheters
Impregnated hydrogel coated latex catheter
Comparison As above
Outcomes Symptomatic UTI
Number (or average number) of symptomatic recurrent UTIs (within 3
months, 6 months or 1 year)
Bacteraemia
Catheter replacement / frequency of catheter change
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Encrustations and blockages
Mortality
Patient preference/ comfort
(secondary outcomes – blood in urine and pH changes)
and CINAHL.
considered.
Review question What is the clinical and cost effectiveness of different types of long-term
intermittent urinary catheters (non-coated, hydrophilic or gel reservoir) on
symptomatic urinary tract infections, bacteraemia, mortality, and patient
preference?
Objectives To determine the most effective long term urinary intermittent catheter type
to prevent infection.
Intervention Uncoated catheters (note: reusable up to 7 days)
Hydrophilic catheters (note: not reusable)
Catheters with gel reservoirs
Comparison As above
Bacteraemia
Number of catheters used per day/week
Mortality
and CINAHL.
considered.
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Review question In patients performing intermittent catheterisation, what is the clinical and
cost effectiveness of non-coated catheters reused multiple times compared
to single use on urinary tract infections, bacteraemia, mortality, and patient
preference?
Objectives To determine the most effective long term urinary intermittent catheter type
(noncoated reused multiple times vs single use) to prevent infection.
Intervention Uncoated catheters – single use, disposable
Comparison Uncoated catheters – reusable (multi-use).
Bacteraemia
Mortality
and CINAHL.
considered.
date of origin.
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Review question What is the clinical and cost effectiveness of bladder instillations or washouts
on reduction of catheter associated symptomatic urinary tract infections and
encrustations and blockages?
Objectives To determine whether bladder instillations or washouts reduce catheter
associated symptomatic urinary tract infections.
At risk groups may include Immunocompromised patients
Intervention Saline
Chlorhexidine
CBG or CBR (citric acid based formulas)
Sodium chloride
Other solutions without active medications
Comparison No instillations or washouts or placebo
Outcomes Number (or average number) of symptomatic recurrent UTIs (within 3
Bacteraemia
Catheter replacement / frequency of catheter change
Encrustations and blockages
Mortality
Symptomatic UTI
and CINAHL.
well conducted cohort studies may also be considered.
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Review question In patients with long term urinary catheters (more than 28 days), what is the
clinical and cost effectiveness of prophylactic antibiotics (single dose or short
course) use during catheter change on reduction of urinary tract infections?
Objectives To determine whether prophylactic antibiotics should be administered for
patients with long term urinary catheters during catheter change.
At risk groups may include Immunocompromised patients

Intervention Single dose
Short course (24-72 hours, no longer than 3 days)
(Inc. antibiotics administered on insertion and removal)
Comparison Single dose
Short course (24-72 hours, no longer than 3 days)
No treatment
(Inc. antibiotics administered on insertion and removal)
Outcomes Antibiotic resistance
Bacteraemia (< 1 week)
Mortality
Patient preference
Symptomatic UTIs (< 1 week)
Upper UTIs (< 1 week)
and CINAHL.
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E.7 Enteral feeding
Review question What is the clinical and cost effectiveness of single vs. reusable syringes used
to flush percutaneous endoscopic gastrostomy tubes on reduction of tube
blockages, diarrhoea, fungal colonisation, gastrostomy site infection,
peritonitis and vomiting?
Objectives To determine the effectiveness of single vs. reusable syringes syringes used
to flush percutaneous endoscopic gastrostomy tubes on prevention of
infection.
Population All patients with PEGs.
At risk groups may include: immunocompromised patients
Intervention Single use syringes
(Subgroup: fresh tap water, cooled boiled water or freshly opened sterile
water)
Comparison Reusable syringes
(Subgroup: fresh tap water, cooled boiled water or freshly opened sterile
water)
Outcomes Blockages/ tube occlusion
Diarrhoea
Fungal Colonisation
Gastrostomy site infection
Peritonitis
Vomiting
and CINAHL.
considered.
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E.8 Vascular access devices
Review question What is the most clinical and cost effective product or solution for
decontamination of the skin prior to insertion of peripherally inserted VAD
on catheter tip colonisation, infection related mortality, frequency of line
Objectives To determine which solution is the most effective for decontamination of the
skin prior to insertion of peripherally inserted VAD.
Population All patients with peripherally inserted VADs
VAD subgroups: Peripheral cannula (IV)/ PICC/Mid-line
At risk groups may include: patients receiving chemotherapy or
immunocompromised patients
Intervention Decontamination solutions:
Iodine
2% Alcoholic chlorhexidine
Alcohol swabs/sponges/wipes
Comparison As above
Outcomes Catheter tip colonisation
Infection-related mortality
Septicaemia
VAD line removal or frequency of line removal
VAD related blood stream infection/Bacteraemia
VAD related phlebitis
VAD related soft tissue infection/local infection/skin infection
and CINAHL.
for certain outcomes such as adverse events, well conducted cohort studies
and observational studies may also be considered.
date of origin.
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Review question What is the clinical and cost effectiveness of dressings (transparent semi-
permeable, impregnated or gauze and tape) covering peripherally or
centrally inserted vascular access device insertion site, including those that
are bleeding or oozing, on catheter tip colonisation, frequency of dressing
change, infection related mortality, septicaemia, bacteraemia and phlebitis?
Objectives To determine the effectiveness of types of dressings on prevention of
infection.
Population All patients with peripherally and centrally inserted VADs
Insertion site subgroup: where insertion sites are bleeding or oozing
Exclusion criteria: Intensive care or high dependency units if more relevant
studies are found.
Intervention VAD dressings/IV dressings
Cannula dressings
Impregnated dressings
Antimicrobial dressings
Semi permeable dressings
Transparent dressings
Gauze dressings
Comparison All of the above
Dressing change or frequency of dressing change
Septicaemia
VAD related blood stream infection/bacteraemia
and CINAHL.
considered.
No date restriction will be applied for peripheral catheters. Databases will be
searched from their date of origin. Databases will be searched from 2002 for
central catheters.
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Review question What is the clinical and cost effectiveness of frequency of dressing change
(from daily up to 7 days) on catheter tip colonisation, infection related
Objectives To determine the effectiveness of frequency of dressing change on
prevention of infection.
Intervention Transparent dressings changed at daily intervals up to 7 days
Comparison Standard frequency of change – every 7 days
Dressing change or frequency of dressing change
Septicaemia
VAD related blood stream infection/ Bacteraemia
and CINAHL.
considered.
central catheters.
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Review question What is the most clinical and cost effective product or solution for skin
decontamination when changing VAD dressings on catheter tip colonisation,
infection related mortality, frequency of line removal, septicaemia,
bacteraemia and phlebitis?
Objectives To determine the most effective solution for skin decontamination when
changing VAD dressings.
Intervention Iodine
Alcohol swabs/sponges/wipes
Comparison As above
Septicaemia
and CINAHL.
date of origin.
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Review question What is the most clinical and cost effective duration of application of
decontamination product/solution to the skin prior to insertion of
peripherally inserted VAD on catheter tip colonisation, infection related
mortality, frequency of line removal, septicaemia, bacteraemia and
phlebitis?
Objectives To determine the most effective duration of application of decontamination
product/solution to the skin prior to insertion of peripherally inserted VAD.
VAD subgroups: Peripheral cannula (IV)/PICC/Mid-line
Intervention 30 seconds for peripherally inserted VADs
Comparison <30 seconds
>30 seconds
Standard or usual practice
Septicaemia
and CINAHL.
date of origin.
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Review question What is the most clinical and cost effective product or solution for
decontaminating VAD ports and hubs prior to access on catheter tip
colonisation, infection related mortality, septicaemia, bacteraemia and
frequency of line removal?
Objectives To determine the most effective product or solution for decontaminating
VAD ports and hubs prior to access.
Settings – primary care or community , or acute care
Intervention Decontamination solutions:
2% Chlorhexidine
0.5% Chlorhexidine
70% Alcohol
Isopropyl alcohol
Providone iodine
2% Chlorhexidine -alcohol mix
2% Chlorhexidine -aqueous mix
Comparison As above
Septicaemia
and CINAHL.
central catheters.
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Review question What is the clinical and cost effectiveness of multi dose vials vs. single use
vials for administrating infusions or drugs on preventing contamination of
the infusate and healthcare associated infection?
Objectives To determine the effectiveness of multi dose vials vs. single use vials for
administrating infusions or drugs to prevent infection.
Intervention Multi-dose vials
Comparison Single use vials
Septicaemia
and CINAHL.
date of origin.
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E.9 Asepsis
Review question What is the most clinically and cost effective technique (such as aseptic
technique, non-touch technique, aseptic non-touch technique or a clean
technique) when handling long-term urinary catheters to reduce colony
forming units, urinary tract infections, compliance, MRSA or C. diff reduction
and mortality?
What is the most clinically and cost effective technique (such as aseptic
technique) when handling vascular access devices to reduce infection related
bacteraemia, phlebitis, compliance, MRSA or C. diff reduction and mortality?
What is the most clinically and cost effective technique (such as aseptic
technique) when handling PEGs to reduce healthcare associated infections?
Objectives To determine the most effective aseptic technique to prevent infection.
Setting subgroup:
Primary care settings
Community settings
Intervention Aseptic non touch technique or procedure or program
Aseptic no touch procedure
Aseptic technique
Comparison Sterile technique
Clean technique
Standard techniques
Outcomes Infection related bacteraemia
Colony forming units (CFUs)
UTI (for LTUC)
Phlebitis/ soft tissue infection/ local infection (for VAD)
Compliance
MRSA or C diff reduction
and CINAHL.
Databases will be searched from 2002
183
Literature search strategies
Appendix F: Literature search strategies

Search strategies used for the Infection Prevention and Control guideline are outlined below and
were run as per the NICE Guidelines Manual 2009
http://www.nice.org.uk/media/5F2/44/The_guidelines_manual_2009_-_All_chapters.pdf .
Searches for the clinical reviews were run in Medline (OVID), Embase (OVID), the Cochrane Library
and Cinahl (EBSCO).
Usually, searches were constructed in the following way:

A PICO format was used for intervention searches where population (P) terms were
combined with Intervention (I) and sometimes Comparison (C) terms. An intervention can be
a drug, a procedure or a diagnostic test. Outcomes (O) are rarely used in search strategies for
interventions. Search Filters were also added to the search where appropriate.
A PEO format was used for prognosis searches where population (P) terms were combined
with exposure (E) terms and sometimes outcomes (O). Search filters were added to the
search where appropriate.
Searches for patient views were run in Medline (Ovid), Embase (Ovid), PsychINFO (Ovid), Cinahl
(EBSCO) and the Cochrane Library. Searches were constructed by adding a patient views search filter
to the population terms.
Searches for the health economic reviews were run in Medline (Ovid), Embase (Ovid), the NHS
Economic Evaluations Database (NHS EED), the Health Technology Assessment (HTA) database and
the Health Economic Evaluation Database (HEED). NHS EED and HTA were searched via the Centre
for Reviews and Dissemination (CRD) interface. Searches in NHS EED, HTA and HEED were
constructed using only population terms. For Medline and Embase an economic filter (instead of a
study type filter) was added to the same clinical search strategy.
All searches were run up to 18th April 2011 unless otherwise stated. Any studies added to the
databases after this date were not included unless specifically stated in the text.
The search strategies are presented below in the following order:
Section F.1 Population terms by database for each key area. The same searches were used for all
questions within that topic area and for both clinical and health economic searches. Order as
presented in guideline.
F.1.1 Hand hygiene population
F.1.2 Long term urinary catheters population
F.1.3 Percutaneous endoscopic gastrostomy population
F.1.4 Vascular access devices population
F.1.5 Asepsis population
Section F.2 Study filter terms by database. These include filters for epidemiological study designs, health
economic and quality of life studies and patient views.
Section F.3 Searches run for specific questions with the intervention or exposure terms by database.
Order as presented in guideline
F.3.1 Standard principles (patient information)
F.3.2 Hand hygiene – when to decontaminate
F.3.3 Hand hygiene – cleaning preparations
F.3.4 Hand hygiene – wrist decontamination
F.3.5 Hand hygiene – bare below the elbows
184
F.3.6 Personal protective equipment – legislation

F.3.7 Personal protective equipment – gloves
F.3.8 Personal protective equipment – aprons
F.3.9 Sharps – legislation
F.3.10 Sharps – safety devices
F.3.11 Long term urinary catheters – catheter type
F.3.12 Long term urinary catheters – single versus multi use
F.3.13 Long term urinary catheters – bladder washout
F.3.14 Long term urinary catheters – antibiotic prophylaxis
F.3.15 Percutaneous endoscopic gastrostomy – syringes
F.3.16 Vascular access devices – dressings
F.3.17 Vascular access devices – decontamination
F.3.18 Vascular access devices – vials
F.3.19 Asepsis
Section F.4 Economic searches
F.1 Population search strategies

F.1.1 Hand hygiene population
Medline search terms
1. Handwashing/
2. (handwash$ or hand wash$ or hand hygiene).ti,ab.
3. infection control/ or cross infection/ or universal precautions/ or disease transmission,
infectious/ or equipment contamination/
4. hand/
5. 4 and 3
6. (hand$1 adj3 (clean$ or disinfect$ or decontaminat$ or antisepsis or wash$)).ti,ab.
7. or/1-2,5-6
Embase search terms

3. hand washing/
4. infection control/
5. cross infection/
6. exp disease transmission/
7. hand/
8. 7 and (4 or 5 or 6)
9. or/1-3,8
Cinahl search terms

S1 mh Handwashing or handwash* or hand wash* or hand hygiene
S2 (MH "Hand+")
S3 (MH "Equipment Contamination") or (MH "Infection Control") or (MH "Microbial
Contamination+") or (MH "Cross Infection") or (MH "Universal Precautions") or (MH "Disease
Transmission+")
185
S4 S2 and S3
S5 hand* n3 clean* or hand* n3 disinfect* or hand* n3 decontaminat* or hand* n3 antisepsis or
hand* n3 wash*
S6 S1 or S4 or S5
Cochrane search terms

#1 MeSH descriptor Handwashing explode all trees
#2 (handwash* or hand wash* or hand hygiene):ti,ab,kw
#3 MeSH descriptor Hand, this term only
#4 MeSH descriptor Infection Control, this term only
#5 MeSH descriptor Cross Infection, this term only
#6 MeSH descriptor Universal Precautions, this term only
#7 MeSH descriptor Disease Transmission, Infectious, this term only
#8 MeSH descriptor Equipment Contamination, this term only
#9 (#4 OR #5 OR #6 OR #7 OR #8)
#10 (#3 AND #9)
#11 (hand* NEAR/3 (clean* or disinfect* or decontaminat* or antisepsis or wash*)):ti,ab,kw
#12 (#1 OR #2 OR #10 OR #11)
PsychInfo search terms

1. hygiene/
4. or/1-3
F.1.2 Long term urinary catheters population

1. Urinary Catheterization/
2. (((urinary or urethr$ or indwelling or suprapubic or bladder) adj catheter$) or (intermittent
adj2 catheter$)).ti,ab.
3. or/1-2
Embase search terms

1. exp ureter catheter/ or exp urinary catheter/
2. exp bladder catheterization/ or exp ureter catheterization/
3. (((urinary or urethr$ or indwelling or suprapubic or bladder) adj catheter$) or (intermittent
adj2 catheter$)).ti,ab.
4. or/1-3
Cinahl search terms

S1 mh Urinary Catheterization
S2 urinary n1 catheter* or urethr* n1 catheter* or indwelling n1 catheter* or suprapubic n1
catheter* or bladder n1 catheter* or intermittent n2 catheter*
S3 S1 or S2

#1 MeSH descriptor Urinary Catheterization, this term only
#2 (((urinary or urethr* or indwelling or suprapubic or bladder) NEAR catheter*) or (intermittent
186
NEAR/2 catheter*)):ti,ab,kw
#3 (#1 OR #2)
F.1.3 Percutaneous endoscopic gastrostomy population

1. Enteral Nutrition/
2. ((PEG or tube or gastric or enteral or naso enteric or nasoenteric or intra gastric or intragastric
or post pyloric or postpyloric or percutaneous or transpyloric or gastrointestin*) adj1 (feed* or
nutrition* or intubat*)).ti,ab.
3. Intubation, Gastrointestinal/
4. or/1-3
Embase search terms

1. enteric feeding/
2. exp digestive tract intubation/
3. ((PEG or tube or gastric or enteral or naso enteric or nasoenteric or intra gastric or intragastric
or post pyloric or postpyloric or percutaneous or transpyloric or gastrointestin*) adj1 (feed* or
nutrition* or intubat*)).ti,ab.
4. or/1-3
Cinahl search terms

S1 mh Enteral Nutrition or mh Intubation, Gastrointestinal
S2 PEG n1 feed* or PEG n1 nutrition* or PEG n1 intubat* or tube n1 feed* or tube n1 nutrition*
or tube n1 intubat* or gastric n1 feed* or gastric n1 nutrition* or gastric n1 intubat* or enteral
n1 feed* or enteral n1 nutrition* or enteral n1 intubat*
S3 naso enteric n1 feed* or naso enteric n1 nutrition* or naso enteric n1 intubat* or nasoenteric
n1 feed* or nasoenteric n1 nutrition* or nasoenteric n1 intubat* or intra gastric n1 feed* or
intra gastric n1 nutrition* or intra gastric n1 intubat* or intragastric n1 feed* or intragastric n1
nutrition* or intragastric n1 intubat*
S4 post pyloric n1 feed* or post pyloric n1 nutrition* or post pyloric n1 intubat* or postpyloric n1
feed* or postpyloric n1 nutrition* or postpyloric n1 intubat* or percutaneous n1 feed* or
percutaneous n1 nutrition* or percutaneous n1 intubat* or transpyloric n1 feed* or
transpyloric n1 nutrition* or transpyloric n1 intubat*
S5 gastrointestin* n1 feed* or gastrointestin* n1 nutrition* or gastrointestin* n1 intubat*
S6 S1 or S2 or S3 or S4 or S5

#1 MeSH descriptor Enteral Nutrition, this term only
#2 MeSH descriptor Intubation, Gastrointestinal, this term only
#3 ((PEG or tube or gastric or enteral or naso enteric or nasoenteric or intra gastric or intragastric
or post pyloric or postpyloric or percutaneous or transpyloric or gastrointestin*) NEAR/1
(feed* or nutrition* or intubat*)):ti,ab,kw
#4 (#1 OR #2 OR #3)
F.1.4 Vascular access devices population

1. Catheters, Indwelling/
2. (PICC or PIC or TPN).ti,ab.
3. (((venous or intravenous or vascular or intravascular) adj (access or device$ or catheter$ or
187
line$)) or venous-access or intravenous-access or vascular-access).ti,ab.

4. catheterization, central venous/ or catheterization/
5. (central$ adj2 (catheter$ or line$)).ti,ab.
6. (catheter adj2 (hub$ or port$ or site$)).ti,ab.
7. ((tunnel?ed or non-tunnel?ed or non tunnel?ed or implanted) adj (catheter$ or line$)).ti,ab.
8. (peripheral$ adj2 (catheter$ or line$)).ti,ab.
9. exp catheterization, peripheral/
10. or/1-7
11. limit 10 to yr="2002 -Current"
12. or/8-9
13. 11 or 12
Embase search terms

1. artery catheter/ or central venous catheter/ or indwelling catheter/ or intravascular catheter/
or intravenous catheter/ or lung artery catheter/ or pulmonary artery catheter/ or subclavian
vein catheter/
2. exp blood vessel catheterization/ or vascular access device/
3. (central$ adj2 (catheter$ or line$)).ti,ab.
4. (catheter adj2 (hub$ or port$ or site$)).ti,ab.
5. (((venous or intravenous or vascular or intravascular) adj (access or device$ or catheter$ or
line$)) or venous-access or intravenous-access or vascular-access).ti,ab.
6. (PICC or PIC or TPN or midline or mid-line).ti,ab.
7. ((tunnel?ed or non-tunnel?ed or non tunnel?ed or implanted) adj (catheter$ or line$)).ti,ab.
8. or/1-7
9. limit 8 to yr="2002 -Current"
10. (peripheral$ adj2 (catheter$ or line$ or cannula$)).ti,ab.
11. or/9-10
Cinahl search terms

S1 (MH "Catheterization, Central Venous+") or (MH "Catheters, Vascular+") or mh catheters or
mh catheterization
S2 PICC or PIC or TPN or midline or mid-line or venous-access or intravenous-access or vascular-
access or venous n access or venous n device* or venous n catheter* or venous n line*
S3 intravenous n1 access or intravenous n1 device* or intravenous n1 catheter* or intravenous
n1 line* or vascular n1 access or vascular n1 device* or vascular n1 catheter* or vascular n1
line* or intravascular n1 access or intravascular n1 device* or intravascular n1 catheter* or
intravascular n1 line*
S4 central* n2 catheter* or central* n2 line* or catheter n2 hub* or catheter n2 port* or catheter
n2 site* or catheter* n1 tunnel#ed or catheter* n1 non-tunnel#ed or catheter* n1 non
tunnel#ed or catheter* n1 implanted or line* n1 tunnel#ed or line* n1 non-tunnel#ed or line*
n1 non tunnel#ed
S5 line* n1 implanted
S7 S1 or S2 or S3 or S4 or S5 Limiters - Published Date from: 20020101-20110418
S8 mh catheterization, peripheral+ or peripheral* n2 catheter* or peripheral* n2 line* or
peripheral* n2 cannula*
S9 S7 or S8
188
#1 MeSH descriptor Catheterization, Central Venous, this term only

#2 MeSH descriptor Catheters, Indwelling, this term only
#3 MeSH descriptor Catheterization, this term only
#4 (PICC or PIC or TPN or midline or mid-line):ti,ab,kw
#5 (((venous or intravenous or vascular or intravascular) NEAR (access or device* or catheter* or
line*)) or venous-access or intravenous-access or vascular-access):ti,ab,kw
#6 (central* NEAR/2 (catheter* or line*)):ti,ab,kw
#7 (catheter NEAR/2 (hub* or port* or site*)):ti,ab,kw
#8 ((tunnel?ed or non-tunnel?ed or non tunnel?ed or implanted) NEAR (catheter* or
line*)):ti,ab,kw
#9 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8)
#10 (#9), from 2002 to 2011
#11 MeSH descriptor Catheterization, Peripheral explode all trees
#12 (peripheral* NEAR/2 (catheter* or line* or cannula*)):ti,ab,kw
#13 (#10 OR #11 OR #12)
F.1.5 Asepsis population

1. (antt or no touch or non touch or non-touch).ti,ab.
2. ((aseptic$ or aseps$ or sterile or clean) adj2 (technique$ or procedure$ or program$)).ti,ab.
3. Asepsis/
4. or/1-3
Embase search terms

1. (antt or no touch or non touch or non-touch).ti,ab.
2. ((aseptic$ or aseps$ or sterile or clean) adj2 (technique$ or procedure$ or program$)).ti,ab.
3. asepsis/
4. or/1-3
Cinahl search terms

S1 (MH "Asepsis")
S2 antt or no touch or non touch or non-touch
S3 aseptic* n2 technique* or aseptic* n2 procedure* or aseptic* n2 program* or aseps* n2
technique* or aseps* n2 procedure* or aseps* n2 program* or sterile n2 technique* or sterile
n2 procedure* or sterile n2 program* or clean n2 technique* or clean n2 procedure* or clean
n2 program*
S4 S1 or S2 or S3

#1 (antt or no touch or non touch or non-touch):ti,ab,kw
#2 ((aseptic* or aseps* or sterile or clean) NEAR/2 (technique* or procedure* or
program*)):ti,ab,kw
#3 MeSH descriptor Asepsis, this term only
#4 (#1 OR #2 OR #3)
189
F.2 Study filter search terms

F.2.1 Systematic review search terms
1. meta-analysis/
2. (metaanalys$ or meta-analys$ or meta analys$).tw.
3. exp "review literature"/
4. (systematic$ adj3 (review$ or overview$)).tw.
5. (selection criteria or data extraction).ab. and review.pt.
6. (cochrane or embase or psychlit or psyclit or psychinfo or psycinfo or cinahl or cinhal or
science citation index or bids or cancerlit).ab.
7. (reference list$ or bibliograph$ or hand search$ or hand-search$ or manual search$ or
relevant journals).ab.
8. or/1-7
9. (comment or letter or editorial).pt.
10. exp animal/ not human/
11. or/9-10
12. 8 not 11
Embase search terms

1. meta analysis/
2. (metaanalys$ or meta-analys$ or meta analys$).tw.
3. systematic review/
4. (systematic$ adj3 (review$ or overview$)).tw.
5. (selection criteria or data extraction).ab. and Review.pt.
6. (cochrane or embase or psychlit or psyclit or psychinfo or psycinfo or cinahl or cinhal or
science citation index or bids or cancerlit).ab.
7. (reference list$ or bibliograph$ or hand search$ or manual search$ or relevant journals).ab.
8. or/1-7
9. (letter or editorial or conference abstract).pt.
10. (exp animal/ or nonhuman/ or exp animal-experiment/) not exp human/
11. or/9-10
12. 8 not 11
F.2.2 Randomised controlled studies (RCTs) search terms

1. Randomized-Controlled-Trials/ or Random-Allocation/ or Double-Blind-Method/ or Single-
Blind-Method/ or exp Clinical-Trials as topic/ or Cross-Over-Studies/ or Prospective-Studies/ or
Placebos/
2. (Randomized-Controlled-Trial or Clinical-Trial or Controlled-Clinical-Trial).pt.
3. (((clinical or control or controlled) adj (study or trial)) or ((single or double or triple) adj
(blind$3 or mask$3)) or (random$ adj (assign$ or allocat$ or group or grouped or patients or
study or trial or distribut$)) or (crossover adj (design or study or trial)) or placebo or
placebos).ti,ab.
4. ((Case-Reports not Randomized-Controlled-Trial) or Letter or Historical-Article or Review-Of-
Reported-Cases).pt.
5. exp Animal/ not Human/
190
6. or/17-19
7. or/20-21
8. 22 not 23
Embase search terms

1. Clinical-Trial/ or Randomized-Controlled-Trial/ or Randomization/ or Single-Blind-Procedure/
or Double-Blind-Procedure/ or Crossover-Procedure/ or Prospective-Study/ or Placebo/
2. (((clinical or control or controlled) adj (study or trial)) or ((single or double or triple) adj
(blind$3 or mask$3)) or (random$ adj (assign$ or allocat$ or group or grouped or patients or
study or trial or distribut$)) or (crossover adj (design or study or trial)) or placebo or
placebos).ti,ab.
3. Case-Study/ or Abstract-Report/ or Letter/ or (case adj report).tw. or conference abstract.pt.
4. (exp Animal/ or Nonhuman/ or exp Animal-Experiment/) not exp Human/
5. 30 or 31
6. 32 or 33
7. 34 not 35
F.2.3 Observational studies search terms

1. Epidemiologic studies/
2. exp case control studies/
3. exp cohort studies/
4. Case control.tw.
5. (cohort adj (study or studies)).tw.
6. Cohort analy$.tw.
7. (Follow up adj (study or studies)).tw.
8. (observational adj (study or studies)).tw.
9. Longitudinal.tw.
10. Retrospective.tw.
11. Cross sectional.tw.
12. Cross-sectional studies/
13. or/1-12
Embase search terms

1. Clinical study/
2. Case control study/
3. Family study/
4. Longitudinal study/
5. Retrospective study/
6. Prospective study/
7. Randomized controlled trials/
8. 6 not 7
9. Cohort analysis/
10. (Cohort adj (study or studies)).mp.
11. (Case control adj (study or studies)).tw.
191
12. (follow up adj (study or studies)).tw.

13. (observational adj (study or studies)).tw.
14. (epidemiologic$ adj (study or studies)).tw.
15. (cross sectional adj (study or studies)).tw.
16. or/1-5,8-15
F.2.4 Health economic, quality of life and model search terms

1. exp "costs and cost analysis"/
2. economics/ or exp economics, hospital/ or exp economics, medical/ or economics, nursing/ or
economics, pharmaceutical/
3. exp "fees and charges"/ or exp budgets/
4. budget$.tw.
5. cost$.ti.
6. (cost$ adj2 (effective$ or utilit$ or benefit$ or minimi$)).ab.
7. (economic$ or pharmacoeconomic$ or pharmaco-economic$).ti.
8. (price$ or pricing$).tw.
9. (financial or finance or finances or financed).tw.
10. (fee or fees).tw.
11. (value adj2 (money or monetary)).tw.
12. value of life/ or quality adjusted life year/
13. quality adjusted life.tw.
14. (qaly$ or qald$ or qale$ or qtime$).tw.
15. disability adjusted life.tw.
16. daly$.tw.
17. Health Status Indicators/
18. (sf36 or sf 36 or short form 36 or shortform 36 or sf thirtysix or sf thirty six or shortform
thirtysix or shortform thirty six or short form thirtysix or short form thirty six).tw.
19. (sf6 or sf 6 or short form 6 or shortform 6 or sf six or sfsix or shortform six or short form
six).tw.
20. (sf12 or sf 12 or short form 12 or shortform 12 or sf twelve or sftwelve or shortform twelve or
short form twelve).tw.
21. (sf16 or sf 16 or short form 16 or shortform 16 or sf sixteen or sfsixteen or shortform sixteen
or short form sixteen).tw.
22. (sf20 or sf 20 or short form 20 or shortform 20 or sf twenty or sftwenty or shortform twenty or
short form twenty).tw.
23. (euroqol or euro qol or eq5d or eq 5d).tw.
24. (hql or hqol or h qol or hrqol or hr qol).tw.
25. (hye or hyes).tw.
26. health$ year$ equivalent$.tw.
27. health utilit$.tw.
28. (hui or hui1 or hui2 or hui3).tw.
29. disutilit$.tw.
30. rosser.tw.
192
31. (quality of wellbeing or quality of well being or qwb).tw.

32. willingness to pay.tw.
33. standard gamble$.tw.
34. time trade off.tw.
35. time tradeoff.tw.
36. tto.tw.
37. exp models, economic/ or *models, theoretical/ or *models, organizational/
38. economic model$.tw.
39. markov chains/
40. markov$.tw.
41. monte carlo method/
42. monte carlo.tw.
43. exp decision theory/
44. (decision$ adj2 (tree$ or analy$ or model$)).tw.
45. or/1-44
46. (letter or editorial or comment).pt.
47. 45 not 46
Embase search terms

1. exp economic aspect/
2. cost$.ti.
3. (cost$ adj2 (effective$ or utilit$ or benefit$ or minimi$)).ab.
4. (economic$ or pharmacoeconomic$ or pharmaco-economic$).ti.
5. (price$ or pricing$).tw.
6. (financial or finance or finances or financed).tw.
7. (fee or fees).tw.
8. (value adj2 (money or monetary)).tw.
9. quality adjusted life year/
10. quality adjusted life.tw.
11. (qaly$ or qald$ or qale$ or qtime$).tw.
12. disability adjusted life.tw.
13. daly$.tw.
14. (sf36 or sf 36 or short form 36 or shortform 36 or sf thirtysix or sf thirty six or shortform
thirtysix or shortform thirty six or short form thirtysix or short form thirty six).tw.
15. (sf6 or sf 6 or short form 6 or shortform 6 or sf six or sfsix or shortform six or short form
six).tw.
16. (sf12 or sf 12 or short form 12 or shortform 12 or sf twelve or sftwelve or shortform twelve or
short form twelve).tw.
17. (sf16 or sf 16 or short form 16 or shortform 16 or sf sixteen or sfsixteen or shortform sixteen
or short form sixteen).tw.
18. (sf20 or sf 20 or short form 20 or shortform 20 or sf twenty or sftwenty or shortform twenty or
short form twenty).tw.
19. (euroqol or euro qol or eq5d or eq 5d).tw.
20. (hql or hqol or h qol or hrqol or hr qol).tw.
21. (hye or hyes).tw.
22. health$ year$ equivalent$.tw.
23. health utilit$.tw.
193
24. (hui or hui1 or hui2 or hui3).tw.

25. disutilit$.tw.
26. rosser.tw.
27. (quality of wellbeing or quality of well being or qwb).tw.
28. willingness to pay.tw.
29. standard gamble$.tw.
30. (time trade off or time tradeoff or tto).tw.
31. exp mathematical model/
32. economic model$.tw.
33. markov$.tw.
34. monte carlo method/
35. monte carlo.tw.
36. decision theory/
37. (decision$ adj2 (tree$ or analy$ or model$)).tw.
38. or/1-37
39. (comment or letter or editorial).pt.
40. 38 not 39
F.3 Searches by specific questions

F.3.1 Standard principles (patient information)
What information do healthcare professionals, patients and carers require to prevent healthcare
Search constructed by combining the columns in the following table using the AND Boolean operator
Intervention /
Population exposure Comparison Study filter used Date parameters
Hand hygiene Patient views, 2002 to
motivation 18/04/2011
Patient views, motivation search terms

1. Patients/ or Inpatients/ or Outpatients/
2. Caregivers/ or exp Family/ or exp Parents/ or exp Legal-Guardians/
3. (patients or carer$ or famil$).tw.
4. or/1-3
5. Popular-Works-Publication-Type/ or exp Information-Services/ or Publications/ or Books/ or
Pamphlets/ or Counseling/ or Directive-Counseling/
6. 4 and 5
7. ((patient or patients) adj3 (education or educate or educating or information or literature or
leaflet$ or booklet$ or pamphlet$)).ti,ab.
8. Patient-Education/ or Patient-Education-Handout-Publication-Type/
9. or/6-8
10. exp Consumer-Satisfaction/ or Personal-Satisfaction/ or exp Patient-Acceptance-Of-Health-
Care/ or exp Consumer-Participation/ or exp Patient-Rights/ or Health Care Surveys/ or
Questionnaires/ or Interview/ or Focus groups/
194
11. (patient$ adj3 (view$ or opinion$ or awareness or tolerance or perception or persistenc$ or

attitude$ or compliance or satisfaction or concern$ or belief$ or feeling$ or position or idea$
or preference$ or choice$)).tw.
12. (Discomfort or comfort or inconvenience or bother$4 or trouble or fear$ or anxiety or anxious
or worr$3).tw.
13. or/10-12
14. or/9,13
15. Motivation/
16. Health Knowledge, Attitudes, Practice/
17. behavior/ or health behavior/
18. Health Promotion/
19. "Practice (Psychology)"/
20. (motivat$ or barrier$ or behavio?r or incentive$ or disincentive$).ti,ab.
21. or/15-20
22. or/14,21
Embase search terms

1. Consumer attitude/ or patient satisfaction/ or patient compliance/ or patient right/ or health
survey/ or questionnaire/ or interview/
or preference$ or choice$)).tw.
or embarrass$4).tw.
4. or/1-3
5. Patient/ or Hospital patient/ or Outpatient/
6. Caregiver/ or exp Family/ or exp Parent/
8. or/5-7
9. Information Service/ or Information center/ or Publication/ or Book/ or Counseling/ or
Directive counseling/
10. 8 and 9
12. Patient information/ or Patient education/
13. or/10-12
14. or/4, 13
15. behavior/ or motivation/
16. health behavior/ or attitude to health/
18. "theory of planned behavior"/
19. or/15-18
20. or/14,19
21. conference abstract.pt.
22. 20 not 21
Cinahl search terms

S1 mh Patients or mh Inpatients or mh Outpatients or mh Caregivers or mh Family+ or mh
195
Parents+ or mh Guardianship, Legal or patients or carer* or famil*

S2 mh Information Services+ or mh Books+ or mh Pamphlets or mh Counseling
S3 S1 and S2
S4 patient n3 education or patient n3 educate or patient n3 educating or patient n3 information
or patient n3 literature or patient n3 leaflet* or patient n3 booklet* or patient n3 pamphlet*
S5 patients n3 education or patients n3 educate or patients n3 educating or patients n3
information or patients n3 literature or patients n3 leaflet* or patients n3 booklet* or patients
n3 pamphlet* or mh Patient Education+
S6 S3 or S4 or S5
S7 mh Consumer Satisfaction+ or mh Consumer Attitudes or mh Personal Satisfaction or mh
Consumer Participation or mh Patient Rights+ or mh Questionnaires+ or mh Interviews+ or mh
Focus groups or mh surveys
S8 patient* n3 view* or patient* n3 opinion* or patient* n3 awareness or patient* n3 tolerance
or patient* n3 perception or patient* n3 persistenc* or patient* n3 attitude* or patient* n3
compliance or patient* n3 satisfaction or patient* n3 concern* or patient* n3 belief* or
patient* n3 feeling*
S9 patient* n3 position or patient* n3 idea* or patient* n3 preference* or patient* n3 choice* or
discomfort or comfort or inconvenience or bother* or trouble or fear* or anxiety or anxious
S10 embarrass*
S11 S7 or S8 or S9 or S10
S12 S6 or S11
S13 (MH "Case Studies") or PT case study or PT commentary or PT anecdote or PT editorial or PT
letter
S14 S12 not S13
S15 (MH "Health Behavior") OR (MH "Behavior") OR (MH "Motivation")
S16 (MH "Health Knowledge")
S17 (MH "Health Promotion")
S18 (MH "Ajzen's Theory of Planned Behavior")
S19 motivat* or barrier* or behavior or behaviour or incentive* or disincentive*
S21 S14 or S20

#1 MeSH descriptor Consumer Satisfaction explode all trees
#2 MeSH descriptor Personal Satisfaction, this term only
#3 MeSH descriptor Patient Acceptance of Health Care explode all trees
#4 MeSH descriptor Consumer Participation explode all trees
#5 MeSH descriptor Patient Rights explode all trees
#6 MeSH descriptor Health Care Surveys, this term only
#7 MeSH descriptor Questionnaires, this term only
#8 MeSH descriptor Focus Groups, this term only
#9 (patient* NEAR/3 (view* or opinion* or awareness or tolerance or perception or persistenc*
or attitude* or compliance or satisfaction or concern* or belief* or feeling* or position or
idea* or preference* or choice*)):ti,ab,kw
#10 (Discomfort or comfort or inconvenience or bother*4 or trouble or fear* or anxiety or anxious
or worr*3):ti,ab,kw
#11 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10)
#12 MeSH descriptor Patients, this term only
196
#13 MeSH descriptor Inpatients, this term only

#14 MeSH descriptor Outpatients, this term only
#15 MeSH descriptor Caregivers, this term only
#16 MeSH descriptor Family explode all trees
#17 MeSH descriptor Parents explode all trees
#18 MeSH descriptor Legal Guardians explode all trees
#19 (patients or carer* or famil*):ti,ab,kw
#20 (#12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19)
#21 MeSH descriptor Information Services explode all trees
#22 MeSH descriptor Publications, this term only
#23 MeSH descriptor Books, this term only
#24 MeSH descriptor Pamphlets, this term only
#25 MeSH descriptor Counseling, this term only
#26 MeSH descriptor Directive Counseling, this term only
#27 (#21 OR #22 OR #23 OR #24 OR #25 OR #26)
#28 (#20 AND #27)
#29 ((patient or patients) NEAR/3 (education or educate or educating or information or literature
or leaflet* or booklet* or pamphlet*)):ti,ab,kw
#30 MeSH descriptor Patient Education as Topic, this term only
#31 (#28 OR #29 OR #30)
#32 (#11 OR #31)
#33 MeSH descriptor Motivation, this term only
#34 MeSH descriptor Health Knowledge, Attitudes, Practice, this term only
#35 MeSH descriptor Behavior, this term only
#36 MeSH descriptor Health Behavior, this term only
#37 MeSH descriptor Health Promotion, this term only
#38 MeSH descriptor Practice (Psychology), this term only
#39 (motivat* or barrier* or behavio*r or incentive* or disincentive*):ti,ab,kw
#40 (#33 OR #34 OR #35 OR #36 OR #37 OR #38 OR #39)
#41 (#32 OR #40)
PsychInfo search terms

1. exp consumer satisfaction/ or exp client attitudes/ or client participation/ or exp client rights/
or treatment compliance/ or consumer surveys/ or exp questionnaires/ or interviews/ or
expectations/
or preference$ or choice$ or expect$)).tw.
or embarrass$4).tw.
4. or/1-3
5. exp patients/
6. caregivers/ or exp family/ or exp parents/ or exp guardianship/
8. or/5-7
9. exp information services/ or exp printed communications media/ or reading materials/ or exp
counseling/
197
10. 8 and 9
12. client education/
13. or/10-12
14. or/4,13
15. motivation/ or planned behavior/
16. behavioral assessment/ or behavior/
17. health behavior/
19. or/14-18
20. or/14,19
F.3.2 Hand decontamination – when to decontaminate

What is the clinical and cost effectiveness of when to decontaminate hands, including after the
removal of gloves, on hand decontamination compliance, MRSA and C diff reduction or cross
infection, colony forming units and removal of physical contamination?
Intervention /
Hand hygiene Guidelines, policies Systematic 2002 to
reviews, RCTs, 18/04/2011
implementation
terms (Medline
and Embase only)
Guidelines, policies search terms

1. (world health organi?ation or five moments or 5 moments or IPS or infection prevention
society or CDC or ((center$1 or centre$1) adj2 disease control) or Ayliffe).ti,ab.
2. world health organization/
3. (guideline$ or policy or policies).ti,ab.
4. exp guideline/
5. guidelines as topic/ or practice guidelines as topic/ or guideline adherence/
6. or/1-5
Embase search terms

1. (world health organi?ation or five moments or 5 moments or IPS or infection prevention
society or CDC or ((center$1 or centre$1) adj2 disease control) or Ayliffe).ti,ab.
2. world health organization/
3. (guideline$ or policy or policies).ti,ab.
4. practice guideline/
5. or/1-4
Cinahl search terms

S1 (MH "World Health Organization")
S2 world health organi?ation or five moments or 5 moments or IPS or infection prevention
198
society or CDC or center* n2 disease control or centre* n2 disease control or Ayliffe

S3 guideline* or policy or policies
S4 (MH "Guideline Adherence") OR (MH "Practice Guidelines")
S5 S1 or S2 or S3 or S4

#1 (world health organi?ation or five moments or 5 moments or IPS or infection prevention
society or CDC or ((center* or centre*) NEAR/2 disease control) or Ayliffe):ti,ab,kw
#2 MeSH descriptor World Health Organization, this term only
#3 (guideline* or policy or policies):ti,ab,kw
#4 MeSH descriptor Guidelines as Topic, this term only
#5 MeSH descriptor Practice Guidelines as Topic, this term only
#6 MeSH descriptor Guideline Adherence, this term only
#7 #1 or #2 or #3 or #4 or #5 or #6
Implementation search terms

1. Program Evaluation/
2. (implement$ or validat$ or evaluat$ or impact$ or effect$).ti.
3. or/1-2
Embase search terms

1. (implement$ or validat$ or evaluat$ or impact$ or effect$).ti.
F.3.3 Hand decontamination – cleaning preparations

What is the clinical and cost effectiveness of cleaning preparations (soap and water, alcohol based
rubs, non-alcohol products and wipes) for healthcare worker hand decontamination, on hand
decontamination compliance, MRSA and C. diff reduction or cross infection, colony forming units
and removal of physical contamination?
Intervention /
Hand hygiene Cleaning preparations Systematic 2002 to
observational
studies (Medline
and Embase only)
Cleaning preparation search terms

1. disinfectants/ or soaps/ or anti-infective agents, local/ or surface-active agents/
2. ((alcohol$ or alcohol-based or non-alcohol$ or non alcohol$ or antimicrob$ or antiseptic or
antibacterial or detergent$ or sporicid$ or disinfect$) adj3 (wash$ or rub$ or gel$ or agent$ or
sanitiz$ or sanitis$ or wipe$)).ti,ab.
3. (soap$ or skin wipe$ or hand wipe$ or wet wipe$).ti,ab.
4. or/1-3
199
Embase search terms

1. topical antiinfective agent/
2. soap/
3. surfactant/
4. ((alcohol$ or alcohol-based or non-alcohol$ or non alcohol$ or antimicrob$ or antiseptic or
antibacterial or detergent$ or sporicid$ or disinfect$) adj3 (wash$ or rub$ or gel$ or agent$ or
sanitiz$ or sanitis$ or wipe$)).ti,ab.
5. (soap$ or skin wipe$ or hand wipe$ or wet wipe$).ti,ab.
6. or/1-5
Cinahl search terms

S1 (MH "Disinfectants") OR (MH "Antiinfective Agents, Local")
S2 (MH "Soaps")
S3 (MH "Surface-Active Agents")
S4 soap* or skin wipe* or hand wipe* or wet wipe*
S5 alcohol* n3 wash* or alcohol-based n3 wash* or non-alcohol* n3 wash* or non alcohol* n3
wash* or antimicrob* n3 wash* or antiseptic n3 wash* or antibacterial n3 wash* or
detergent* n3 wash* or sporicid* n3 wash* or disinfect* n3 wash*
S6 alcohol* n3 rub* or alcohol-based n3 rub* or non-alcohol* n3 rub* or non alcohol* n3 rub* or
antimicrob* n3 rub* or antiseptic n3 rub* or antibacterial n3 rub* or detergent* n3 rub* or
sporicid* n3 rub* or disinfect* n3 rub*
S7 alcohol* n3 gel* or alcohol-based n3 gel* or non-alcohol* n3 gel* or non alcohol* n3 gel* or
antimicrob* n3 gel* or antiseptic n3 gel* or antibacterial n3 gel* or detergent* n3 gel* or
sporicid* n3 gel* or disinfect* n3 gel*
S8 alcohol* n3 agent* or alcohol-based n3 agent* or non-alcohol* n3 agent* or non alcohol* n3
agent* or antimicrob* n3 agent* or antiseptic n3 agent* or antibacterial n3 agent* or
detergent* n3 agent* or sporicid* n3 agent* or disinfect* n3 agent*
S9 alcohol* n3 sanitiz* or alcohol-based n3 sanitiz* or non-alcohol* n3 sanitiz* or non alcohol*
n3 sanitiz* or antimicrob* n3 sanitiz* or antiseptic n3 sanitiz* or antibacterial n3 sanitiz* or
detergent* n3 sanitiz* or sporicid* n3 sanitiz* or disinfect* n3 sanitiz*
S10 alcohol* n3 sanitis* or alcohol-based n3 sanitis* or non-alcohol* n3 sanitis* or non alcohol*
n3 sanitis* or antimicrob* n3 sanitis* or antiseptic n3 sanitis* or antibacterial n3 sanitis* or
detergent* n3 sanitis* or sporicid* n3 sanitis* or disinfect* n3 sanitis*
S11 alcohol* n3 wipe* or alcohol-based n3 wipe* or non-alcohol* n3 wipe* or non alcohol* n3
wipe* or antimicrob* n3 wipe* or antiseptic n3 wipe* or antibacterial n3 wipe* or detergent*
n3 wipe* or sporicid* n3 wipe* or disinfect* n3 wipe*
S12 S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9 or S10 or S11

#1 MeSH descriptor Disinfectants, this term only
#2 MeSH descriptor Soaps, this term only
#3 MeSH descriptor Anti-Infective Agents, Local, this term only
#4 MeSH descriptor Surface-Active Agents, this term only
#5 (soap* or skin wipe* or hand wipe* or wet wipe*):ti,ab,kw
#6 ((alcohol* or alcohol-based or non-alcohol* or non alcohol* or antimicrob* or antiseptic or
antibacterial or detergent* or sporicid* or disinfect*) NEAR/3 (wash* or rub* or gel* or agent*
or sanitiz* or sanitis* or wipe*)):ti,ab,kw
#7 (#1 OR #2 OR #3 OR #4 OR #5 OR #6)
200
F.3.4 Hand decontamination – wrist decontamination

What is the clinical and cost effectiveness of healthcare workers decontaminating wrists vs. not
decontaminating wrists or usual practice on MRSA and C. diff reduction or cross infection, colony
Intervention /
Hand hygiene Wrists 2002 to
18/04/2011
Wrist search terms

1. Wrist/
2. (wrist$ or forearm$).ti,ab.
3. 1 or 2
Embase search terms

1. wrist/
2. (wrist$ or forearm$).ti,ab.
3. or/1-2
Cinahl search terms

S1 (MH "Wrist")
S2 wrist* or forearm*
S3 S1 or S2

#1 MeSH descriptor Wrist, this term only
#2 (wrist* or forearm*):ti,ab,kw
#3 (#1 OR #2)
F.3.5 Hand decontamination – bare below the elbows

What is the clinical and cost effectiveness of healthcare workers following bare below the elbow
policies (short sleeves or rolled up sleeves) vs. no bare below the elbow policy (long sleeves, not
rolled up or no specific restrictions) on MRSA and C. diff reduction or cross infection, colony
Intervention /
Infection terms Bare below the elbows 2002 to
18/04/2011

2. (infect$ or contaminat$ or decontaminat$ or disinfect$ or colonis$ or coloniz$).ti,ab.
3. 1 or 2
201
4. (sleeve$ adj3 (short$ or long$ or roll$)).ti,ab.

5. 3 and 4
6. (bare below adj2 elbow$).ti,ab.
7. 5 or 6
Embase search terms

1. infection control/
2. cross infection/
3. exp disease transmission/
4. (infect$ or contaminat$ or decontaminat$ or disinfect$ or colonis$ or coloniz$).ti,ab.
5. or/1-4
6. (sleeve$ adj3 (short$ or long$ or roll$)).ti,ab.
7. 5 and 6
8. (bare below adj2 elbow$).ti,ab.
9. 7 or 8
Cinahl search terms

S1 (MH "Infection Control") OR (MH "Universal Precautions")
S2 (MH "Cross Infection") OR (MH "Microbial Contamination+")
S3 (MH "Disease Transmission+")
S4 (MH "Equipment Contamination")
S5 infect* or contaminat* or decontaminat* or disinfect* or colonis* or coloniz*
S7 sleeve* n3 short* or sleeve* n3 long* or sleeve* n3 roll*
S8 S6 and S7
S9 bare below n2 elbow*
S10 S8 or S9

#1 (sleeve* NEAR/3 (short* or long* or roll*)):ti,ab,kw
#2 (bare below NEAR/2 elbow*):ti,ab,kw
#3 (#1 OR #2)
F.3.6 Personal protective equipment – legislation

Are there any changes in the legislations which affect the disposal of personal protective
equipments in relation to patient care in the primary and community care settings?
No search was conducted for this question as it related to changes in legislation only.
F.3.7 Personal protective equipment - gloves

What is the clinical and cost effectiveness of healthcare workers wearing vinyl, latex or nitrile
gloves on user preference and hypersensitivity, blood borne infections, glove porosity and tears?
Intervention /
Infection terms Gloves Systematic 2002 to
202
Intervention /
observational
studies (Medline
and Embase only)

2. (infect$ or colonis$ or coloniz$ or contaminat$).ti,ab.
3. or/1-2
4. exp Gloves, Protective/
5. (glov$ adj3 (plastic or latex or vinyl or synthetic or nitrile or material$)).ti,ab.
6. or/4-5
7. 3 and 6
Embase search terms

1. infection control/ or cross infection/ or exp disease transmission/
3. or/1-2
4. glove/
5. surgical glove/
6. (glov$ adj3 (plastic or latex or vinyl or synthetic or nitrile or material$)).ti,ab.
7. or/4-6
8. 3 and 7
Cinahl search terms

S1 mh infection control or mh cross infection or mh universal precautions or mh equipment
contamination or mh disease transmission+ or mh Microbial Contamination+ or infect* or
colonis* or coloniz* or contaminat*
S2 (MH "Gloves")
S3 glov* n3 plastic or glov* n3 latex or glov* n3 vinyl or glov* n3 synthetic or glov* n3 nitrile or
glov* n3 material* or glov* n3 polythene or glov* n3 powder*
S4 S2 or S3
S5 S1 and S4

#6 (infect* or colonis* or coloniz* or contaminat*):ti,ab,kw
#7 (#1 OR #2 OR #3 OR #4 OR #5 OR #6)
#8 MeSH descriptor Gloves, Protective explode all trees
#9 (glov* NEAR/3 (plastic or latex or vinyl or synthetic or nitrile or material* or polythene or
powder*)):ti,ab,kw
#10 (#8 OR #9)
#11 (#10 AND #7)
203
F.3.8 Personal protective equipment – aprons

What is the clinical and cost effectiveness of healthcare workers wearing plastic aprons or fluid
repellent gowns vs. no aprons or gown, gloves only or standard uniform on blood borne viruses
and bodily fluid decontamination?
Intervention /
Infection terms Aprons, gowns Systematic 2002 to
observational
studies (Medline
and Embase only)

1. infection control/ or cross infection/ or universal precautions/ or equipment contamination/
or disease transmission, infectious/
3. or/1-2
4. (gown$ or apron$ or overgown$ or covergown$ or coverall$).ti,ab.
5. Protective Clothing/
6. or/4-5
7. 3 and 6
Embase search terms

3. or/1-2
4. (gown$ or apron$ or overgown$ or covergown$ or coverall$).ti,ab.
5. protective clothing/
6. or/4-5
7. 3 and 6
Cinahl search terms

contamination or mh disease transmission+ or mh Microbial Contamination+ or infect* or
colonis* or coloniz* or contaminat*
S2 gown* or apron* or overgown* or covergown* or mh Protective Clothing
S3 S1 and S2

#6 (infect* or colonis* or coloniz* or contaminat*):ti,ab,kw
#7 (#1 OR #2 OR #3 OR #4 OR #5 OR #6)
#8 (gown* or apron* or overgown* or covergown* or coverall*):ti,ab,kw
204
#9 MeSH descriptor Protective Clothing

#10 #8 or #9
#11 #7 and #10
F.3.9 Sharps – legislation

Are there any changes in the legislations which affect the disposal of sharp instruments and
needles in relation to patient care in the primary and community care settings?
No search was conducted for this question as it related to changes in legislation only.
F.3.10 Sharps – safety devices

Searches for the following two clinical questions were run as one search.
What is the clinical and cost effectiveness of healthcare workers using safety needle devices
(needle-free, retractable needles, safety re-sheathing devices) vs. standard needles on compliance
and user preference, infection related mortality and morbidity and sharps injuries?
What is the clinical and cost effectiveness of healthcare workers using safety needle cannulae vs.
standard cannulae on compliance and user preference, infection related mortality and morbidity
and sharps injuries?
Intervention /
Infection/ Safety devices Systematic 2002 to
needlestick terms reviews, RCTs, 18/04/2011
observational
studies (Medline
and Embase only)

1. infection control/ or cross infection/ or universal precautions/ or equipment contamination/
or disease transmission, infectious/
2. ((needlestick or needle-stick or needle stick or accidental innoculation$) adj2 injur$).ti,ab.
3. (infection$ adj2 (control or prevent$)).ti,ab.
4. Needlestick Injuries/
5. or/1-4
6. (needle$ adj1 (retract$ or covered or capped or fixed or uncapped or guard$ or protect$ or
removal)).ti,ab.
7. (safe$ adj1 (needle$ or sharp$ or lancet$ or cannula$ or re-sheath$ or resheat$)).ti,ab.
8. (needleless or needlefree or needle-free or ((needle stick or needle-stick or needlestick) adj
prevent$)).ti,ab.
9. or/6-8
10. 5 and 9
Embase search terms

2. ((needlestick or needle-stick or needle stick or accidental innoculation$) adj2 injur$).ti,ab.
3. (infection$ adj2 (control or prevent$)).ti,ab.
4. needlestick injury/
205
5. or/1-4
6. (needle$ adj1 (retract$ or covered or capped or fixed or uncapped or guard$ or protect$ or
removal)).ti,ab.
7. (safe$ adj1 (needle$ or sharp$ or lancet$ or cannula$ or re-sheath$ or resheat$)).ti,ab.
8. (needleless or needlefree or needle-free or ((needle stick or needle-stick or needlestick) adj
prevent$)).ti,ab.
9. or/6-8
10. 5 and 9
Cinahl search terms

contamination or mh disease transmission, infectious or infection n2 control or infection n2
prevent* or mh Needlestick Injuries or needlestick n2 injur* or needle-stick n2 injur* or needle
stick n2 injur* or accidental innoculation* n2 injur*
S2 needleless or needlefree or needle-free or needle stick n prevent* or needle-stick n prevent*
or needlestick n prevent*
S3 safe* n1 needle* or safe* n1 sharp* or safe* n1 lancet* or safe* n1 cannula* or safe* n1 re-
sheath* or safe* n1 resheat*
S4 needle* n1 retract* or needle* n1 covered or needle* n1 capped or needle* n1 fixed or
needle* n1 uncapped or needle* n1 guard* or needle* n1 protect* or needle* n1 removal
S5 S2 or S3 or S4
S6 S1 and S5

#7 (infection* NEAR/2 (control or prevent*)):ti,ab,kw
#8 MeSH descriptor Needlestick Injuries, this term only
#9 ((needlestick or needle-stick or needle stick or accidental innoculation*) NEAR/2
injur*):ti,ab,kw
#10 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9)
#11 (needleless or needlefree or needle-free or ((needle stick or needle-stick or needlestick) NEAR
prevent*)):ti,ab,kw
#12 (safe* NEAR (needle* or sharp* or lancet* or cannula* or re-sheath* or resheat*)):ti,ab,kw
#13 (needle8 NEAR (retract* or covered or capped or fixed or uncapped or guard* or protect* or
removal)):ti,ab,kw
#14 (#11 OR #12 OR #13)
#15 (#10 AND #14)
F.3.11 Long term urinary catheters – catheter type

What is the clinical and cost effectiveness of different types of long term indwelling urinary
catheters (silicone, hydrogel coated or impregnated) on urinary tract infections, bacteraemia,
frequency of catheter change, encrustations and blockages, mortality, and patient preference?
206
What is the clinical and cost effectiveness of different types of long term urinary intermittent self
catheters (uncoated, hydrophilic or gel reservoir) on urinary tract infections, bacteraemia,
frequency of catheter change, encrustations and blockages, mortality, and patient preference?
Intervention /
Long term urinary Catheter types Systematic 2002 to
catheters reviews and RCTs 18/04/2011
(Medline and
Embase only)
Catheter type search terms

1. (impregnat$ or silicon$ or latex or coat$ or silver or hydrogel or hydrophilic or uncoat$ or non
coat$ or gel reservoir$).ti,ab.
Embase search terms

1. (impregnat$ or silicon$ or latex or coat$ or silver or hydrogel or hydrophilic or uncoat$ or non
coat$ or gel reservoir$).ti,ab.
Cinahl search terms

S1 impregnat* or silicon* or latex or coat* or silver or hydrogel or hydrophilic or uncoat* or
noncoat* or gel reservoir*

#1 (impregnat* or silicon* or latex or coat* or silver or hydrogel or hydrophilic or uncoat* or
noncoat* or gel reservoir*):ti,ab,kw
F.3.12 Long term urinary catheters – single versus multi use

In patients performing intermittent catheterisation, what is the clinical and cost effectiveness of
noncoated catheters reused multiple times compared to single use on urinary tract infections,
bacteraemia, frequency of catheter change, encrustations and blockages, mortality, and patient
preference?
Intervention / Study filter
Population exposure Comparison used Date parameters
Intermittent Single use catheters Multiple use No date restrictions,
catheterisation catheters search run up to
18/04/2011

1. Urinary Catheterization/
2. (intermittent adj2 catheter$).ti,ab.
3. or/1-2
4. (sterile or "single use" or single-use).ti,ab.
5. (clean or "multi use" or multi-use or "multiple use$" or reuse$).ti,ab.
6. (("multi use" or multi-use or "multiple use$" or reuse$) adj2 catheter$).ti,ab.
7. 6 or (4 and 5)
8. 3 and 7
207
Embase search terms

1. intermittent catheterization/
2. (intermittent adj2 catheter$).ti,ab.
3. (sterile or "single use" or single-use).ti,ab.
4. (clean or "multi use" or multi-use or "multiple use$" or reuse$).ti,ab.
5. (("multi use" or multi-use or "multiple use$" or reuse$) adj2 catheter$).ti,ab.
6. 5 or (3 and 4)
7. or/1-2
8. 6 and 7
Cinahl search terms

S1 (MH "Urinary Catheterization, Intermittent")
S2 intermittent n2 catheter*
S3 S1 or S2
S4 sterile or single use or single-use
S5 clean or multi use or multi-use or multiple use* or reuse*
S6 reuse* n2 catheter* or multi use n2 catheter* or multi-use n2 catheter* or multiple use* n2
catheter*
S7 S4 and S5
S8 S6 or S7
S9 S3 and S8

#1 MeSH descriptor Urinary Catheterization, this term only
#2 (intermittent NEAR/2 catheter*):ti,ab,kw
#3 (#1 OR #2)
#4 (sterile or "single use" or single-use):ti,ab,kw
#5 (clean or "multi use" or multi-use or "multiple use*" or reuse*):ti,ab,kw
#6 (#4 AND #5)
#7 (("multi use" or multi-use or "multiple use*" or reuse*) NEAR/2 catheter*):ti,ab,kw
#8 (#6 OR #7)
#9 (#3 AND #8)
F.3.13 Long term urinary catheters – bladder washout

What is the clinical and cost effectiveness of bladder instillations or washouts on reduction of
catheter associated symptomatic urinary tract infections and encrustations and blockages?
Intervention /
Long term urinary Bladder Systematic 2002 to
catheters washout/irrigation/ reviews and RCTs 18/04/2011
instillation (Medline and
Embase only)
208
Bladder washout/irrigation/instillation search terms

1. therapeutic irrigation/
2. ((bladder adj2 wash$) or bath$ or irrigat$ or instillat$ or washout$ or lavage$ or bwo).ti,ab.
3. or/1-2
Embase search terms

1. bladder irrigation/ or bladder irrigator/
2. ((bladder adj2 wash$) or bath$ or irrigat$ or instillat$ or washout$ or lavage$ or bwo).ti,ab.
3. or/1-2
Cinahl search terms

S1 bladder n2 wash* or bladder n2 bath* or irrigat* or instillat* or washout* or lavage* or bwo
S2 (MH "Irrigation") OR (MH "Urinary Bladder Irrigation")
S3 S1 or S2

#1 MeSH descriptor Irrigation, this term only
#2 ((bladder NEAR/2 (wash* or bath*)) or irrigat* or instillat* or washout* or lavage* or
bwo):ti,ab,kw
#3 (#1 OR #2)
F.3.14 Long term urinary catheters – antibiotic prophylaxis

In patients with long term urinary catheters (>28 days), what is the clinical and cost effectiveness
of prophylactic antibiotics (single dose or short course) use during catheter change on reduction of
urinary tract infections?
Intervention /
Long term urinary Antibiotics Systematic 2002 to
catheters reviews and RCTs 18/04/2011
(Medline and
Embase only)
Antibiotic search terms

1. exp Anti-Bacterial Agents/
2. (antibiotic$ or antimicrobial$ or antibacterial$ or anti-bacterial$ or anti-microbial$).ti,ab.
3. (penicillin$ or benzylpenicillin or phenoxymethylpenicillin or temocillin or flucloxacillin or
ampicillin or amox?cillin or co-amoxiclav or co-fluampicil or ticarcillin or piperacillin or
pivmecillinam or mecillinam$).ti,ab
4. (cephalosporin$ or cefradine or cephradine or cefuroxime or cefotaxime or ceftazidime or
ceftriaxone or ceftazidime or ceftriaxone or cefalexin or cephalexin or cefradine or cefadroxil
or cefaclor or cefixime or cefpodoxime).ti,ab
5. (carbapenem$ or imipenem or meropenem or doripenem or ertapenem or cilastatin or
aztreonam).ti,ab
6. (tetracycline$ or minocycline or oxytetracycline or doxycycline or demeclocycline or
lymecycline or tigecycline).ti,ab
209
7. (aminoglycoside$ or amikacin or gentamicin or neomycin or streptomycin or tobramycin).ti,ab

8. (macrolide$ or erythromycin or azithromycin or clarithromycin or spiramycin or telithromycin
or clindamycin).ti.ab
9. (trimethoprim or metronidazole or tinidazole or methenamine or nitrofurantoin).ti,ab
10. (quinolone$ or nalidixic acid or norfloxacin or ciprofloxacin or ofloxacin or levofloxacin or
moxifloxacin).ti,ab
11. or/1-10
Embase search terms

1. exp antibiotic agent/
2. (antibiotic$ or antimicrobial$ or antibacterial$ or anti-bacterial$ or anti-microbial$).ti,ab.
3. (penicillin$ or benzylpenicillin or phenoxymethylpenicillin or temocillin or flucloxacillin or
pivmecillinam or mecillinam$).ti,ab.
4. (cephalosporin$ or cefradine or cephradine or cefuroxime or cefotaxime or ceftazidime or
or cefaclor or cefixime or cefpodoxime).ti,ab.
5. (carbapenem$ or imipenem or meropenem or doripenem or ertapenem or cilastatin or
aztreonam).ti,ab.
6. (tetracycline$ or minocycline or oxytetracycline or doxycycline or demeclocycline or
lymecycline or tigecycline).ti,ab.
7. (aminoglycoside$ or amikacin or gentamicin or neomycin or streptomycin or tobramycin).ti,ab.
8. (macrolide$ or erythromycin or azithromycin or clarithromycin or spiramycin or telithromycin
or clindamycin).ti,ab.
9. (trimethoprim or metronidazole or tinidazole or methenamine or nitrofurantoin).ti,ab.
10. (quinolone$ or nalidixic acid or norfloxacin or ciprofloxacin or ofloxacin or levofloxacin or
moxifloxacin).ti,ab.
11. or/1-10
Cinahl search terms

S1 mh anti-bacterial agents+ or antibiotic* or antimicrobial* or antibacterial* or anti-bacterial* or
anti-microbial*
S2 penicillin* or benzylpenicillin or phenoxymethylpenicillin or temocillin or flucloxacillin or
ampicillin or amoxicillin or amoxycillin or co-amoxiclav or co-fluampicil or ticarcillin or
piperacillin
S3 pivmecillinam or mecillinam* or cephalosporin* or cefradine or cephradine or cefuroxime or
cefotaxime or ceftazidime or ceftriaxone or ceftazidime or ceftriaxone or cefalexin
S4 cephalexin or cefradine or cefadroxil or cefaclor or cefixime or cefpodoxime or carbapenem*
or imipenem or meropenem or doripenem or ertapenem or cilastatin
S5 aztreonam or tetracycline* or minocycline or oxytetracycline or doxycycline or demeclocycline
or lymecycline or tigecycline or aminoglycoside* or amikacin or gentamicin or neomycin
S6 streptomycin or tobramycin or macrolide* or erythromycin or azithromycin or clarithromycin
or spiramycin or telithromycin or clindamycin or trimethoprim or metronidazole or tinidazole
S7 methenamine or nitrofurantoin or quinolone* or nalidixic acid or norfloxacin or ciprofloxacin
or ofloxacin or levofloxacin or moxifloxacin
S8 S1 or S2 or S3 or S4 or S5 or S6 or S7

#1 MeSH descriptor Anti-Bacterial Agents explode all trees
#2 (antibiotic* or antimicrobial* or antibacterial* or anti-bacterial* or anti-microbial*):ti,ab,kw
#3 (penicillin* or benzylpenicillin or phenoxymethylpenicillin or temocillin or flucloxacillin or
210

pivmecillinam or mecillinam*):ti,ab,kw
#4 (cephalosporin* or cefradine or cephradine or cefuroxime or cefotaxime or ceftazidime or
or cefaclor or cefixime or cefpodoxime):ti,ab,kw
#5 (carbapenem* or imipenem or meropenem or doripenem or ertapenem or cilastatin or
aztreonam):ti,ab,kw
#6 (tetracycline* or minocycline or oxytetracycline or doxycycline or demeclocycline or
lymecycline or tigecycline):ti,ab,kw
#7 (aminoglycoside* or amikacin or gentamicin or neomycin or streptomycin or
tobramycin):ti,ab,kw
#8 (macrolide* or erythromycin or azithromycin or clarithromycin or spiramycin or telithromycin
or clindamycin):ti,ab,kw
#9 (trimethoprim or metronidazole or tinidazole or methenamine or nitrofurantoin):ti,ab,kw
#10 (quinolone* or nalidixic acid or norfloxacin or ciprofloxacin or ofloxacin or levofloxacin or
moxifloxacin):ti,ab,kw
#11 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10)
F.3.15 Percutaneous endoscopic gastrostomy – syringes

What is the clinical and cost effectiveness of single vs. reusable syringes used to flush
percutaneous endoscopic gastrostomy tubes on tube blockages, diarrhoea, fungal colonisation,
gastrostomy site infection, peritonitis and vomiting?
Intervention /
Percutaneous Syringes 2002 to
endoscopic 18/04/2011
gastrostomy
Syringe search terms

1. (flush$ or syringe$).ti,ab.
2. Syringes/
3. or/1-2
Embase search terms

1. (flush$ or syringe$).ti,ab.
2. syringe/
3. or/1-2
Cinahl search terms

S1 mh syringes or syringe* or flush*

#1 (flush* or syringe*):ti,ab,kw
#2 MeSH descriptor Syringes, this term only
#3 (#1 OR #2)
211
F.3.16 Vascular access devices - dressings

What is the clinical and cost effectiveness of dressings (transparent semi-permeable, impregnated or
gauze and tape) covering peripherally or centrally inserted vascular access devices insertion sites that
are bleeding or oozing on catheter tip colonisation, frequency of dressing change, infection related
What is the clinical and cost effectiveness of frequency of dressing change (from daily up to 7 days)
on catheter tip colonisation, frequency of dressing change, infection related mortality, septicaemia,
bacteraemia and phlebitis?
Intervention /
Vascular access Dressings Systematic For peripheral
devices reviews, RCTs, catheters no date
observational restriction, for
studies (Medline central catheters
and Embase only) 2002 onwards.
Search run up to
18/04/2011
Dressing search terms

1. Occlusive Dressings/
2. (gauze$ or (dressing$ adj3 (occlusive or impregnat$ or plain or patch or clear or transparent or
cannula$ or VAD or antimicrobial or semi permeable or semi-permeable or IV or catheter$ or
line$ or vapo?r permeable or silver))).ti,ab.
3. (tegaderm or biopatch or vecafix or dermafilm or polyskin or hydrofilm or activheal or mepore
or bioclusive or opsite or c-view or easi-v or central gard or atrauman or urgotul or
bactigras).ti,ab
4. *bandages/
5. or/1-4
Embase search terms

1. foam dressing/ or gauze dressing/ or hydrocolloid dressing/ or hydrogel dressing/ or occlusive
dressing/ or transparent dressing/
2. (gauze$ or (dressing$ adj3 (occlusive or impregnat$ or plain or patch or clear or transparent or
cannula$ or VAD or antimicrobial or semi permeable or semi-permeable or IV or catheter$ or
line$ or vapo?r permeable or silver))).ti,ab.
3. (tegaderm or biopatch or vecafix or dermafilm or polyskin or hydrofilm or activheal or mepore
bactigras).ti,ab.
4. or/1-3
Cinahl search terms

S1 ( (MH "Bandages and Dressings+") ) or gauze* or dressing* n3 occlusive or dressing* n3
impregnat* or dressing* n3 plain or dressing* n3 patch or dressing* n3 clear or dressing* n3
transparent or dressing* n3 cannula* or dressing* n3 VAD or dressing* n3 antimicrobial or
dressing* n3 semi permeable
S2 dressing* n3 semi-permeable or dressing* n3 IV or dressing* n3 catheter* or dressing* n3
line* or dressing* n3 vapor permeable or dressing* n3 vapour permeable or dressing* n3
212
silver or tegaderm or biopatch or vecafix or dermafilm or polyskin

S3 hydrofilm or activheal or mepore or bioclusive or opsite or c-view or easi-v or central gard or
atrauman or urgotul or bactigras
S4 S1 or S2 or S3

#1 MeSH descriptor Occlusive Dressings
#2 MeSH descriptor Bandages
#3 (gauze* or (dressing* NEAR/3 (occlusive or impregnat* or plain or patch or clear or
transparent or cannula* or VAD or antimicrobial or semi permeable or semi-permeable or IV
or catheter* or line* or vapo?r permeable or silver))):ti,ab,kw
#4 (tegaderm or biopatch or vecafix or dermafilm or polyskin or hydrofilm or activheal or mepore
bactigras):ti,ab,kw
#5 #1 or #2 or #3 or #4
F.3.17 Vascular access devices - decontamination

Searches for the following four clinical questions were run as one search.
What is the most clinical and cost effective product or solution for decontaminating VAD ports and
hubs prior to access on catheter tip colonisation, infection related mortality, septicaemia,
bacteraemia and frequency of line removal?
What is the most clinical and cost effective product or solution for decontamination of the skin
prior to insertion of peripherally inserted VAD on catheter tip colonisation, infection related
mortality, frequency of line removal, septicaemia, bacteraemia and phlebitis?
What is the most clinical and cost effective duration of application of decontamination
product/solution to the skin prior to insertion of peripherally inserted VAD on catheter tip
colonisation, infection related mortality, frequency of line removal, septicaemia, bacteraemia and
phlebitis?
What is the most clinical and cost effective products or solution for skin decontamination when
changing VAD dressings on catheter tip colonisation, infection related mortality, frequency of line
Intervention /
Vascular access Decontamination Systematic For peripheral
devices reviews, RCTs, catheters no date
observational restriction, for
studies (Medline central catheters
and Embase only) 2002 onwards.
Search run up to
18/04/2011
Decontamination search terms

1. (clean$ or disinfect$ or decontaminat$).ti,ab.
2. disinfection/
3. Chlorhexidine/
213
4. Povidone-Iodine/
5. iodine/
6. (chlorhexidine or povidone iodine or providone iodine or alcohol$ or iodine or chd or pvp-
i).ti,ab.
7. (chloraPrep or sterets or hydrex or sani cloth).ti,ab.
8. or/1-7
Embase search terms

1. (clean$ or disinfect$ or decontaminat$).ti,ab.
2. chlorhexidine/
3. povidone iodine/
4. 2 propanol/
5. (chlorhexidine or povidone iodine or providone iodine or alcohol$ or iodine or chd or pvp-
i).ti,ab.
6. (chloraPrep or sterets or hydrex or sani cloth).ti,ab.
7. disinfection/
8. or/1-7
Cinahl search terms

S1 clean* or disinfect* or decontaminat* or chlorhexidine or povidone iodine or povidone-iodine
or providone iodine or providone-iodine or alcohol* or iodine or chd or pvp-i
S2 chloraPrep or sterets or hydrex or sani cloth or mh disinfection or mh Chlorhexidine or mh
Povidone-Iodine or mh iodine
S3 S1 or S2

#1 (clean* or disinfect* or decontaminat*):ti,ab,kw
#2 MeSH descriptor Disinfection
#3 MeSH descriptor Chlorhexidine
#4 MeSH descriptor Povidone-Iodine
#5 MeSH descriptor Iodine
#6 (chlorhexidine or povidone iodine or providone iodine or alcohol* or iodine or chd or pvp-
i):ti,ab,kw
#7 (chloraPrep or sterets or hydrex or sani cloth):ti,ab,kw
#8 #1 or #2 or #3 or #4 or #5 or #6 or #7
F.3.18 Vascular access devices – vials

What is the clinical and cost effectiveness of multi dose vials vs. single use vials for administrating
infusions or drugs on preventing contamination of the infusate and healthcare associated
infection?
Intervention /
Vascular access Vials No date
devices restriction to
18/04/2011
214

((single dose or single-dose or multi dose or multi-dose or multidose or multiple dose) adj3
(vial$ or phial$)).ti,ab.
Embase search terms

((single dose or single-dose or multi dose or multi-dose or multidose or multiple dose) adj3
(vial$ or phial$)).ti,ab.
Cinahl search terms

single dose n3 vial* or single dose n3 phial* or single-dose n3 vial* or single-dose n3 phial* or
multi dose n3 vial* or multi dose n3 phial* or multi-dose n3 vial* or multi-dose n3 phial* or
multidose n3 vial* or multidose n3 phial* or multiple dose* n3 vial* or multiple dose* n3
phial*

((single dose or single-dose or multi dose or multi-dose or multidose or multiple dose) NEAR/3
(vial* or phial*)):ti,ab,kw
F.3.19 Asepsis
What is the most clinically and cost effective technique (aseptic technique, non-touch, ANTT vs. a
clean technique) when handling long-term urinary catheters to reduce colony forming units,
urinary tract infections, compliance, MRSA or C. diff reduction and mortality?
Intervention /
Asepsis Long term urinary 2002 to
catheters 18/04/2011
clean technique) when handling PEGs to reduce healthcare associated infections?
Intervention /
Asepsis Percutaneous 2002 to
endoscopic 18/04/2011
gastrostomy
clean technique) when handling vascular access devices to reduce infection related bacteraemia,
phlebitis, compliance, MRSA or C. diff reduction and mortality?
Intervention /
Asepsis Vascular access 2002 to
devices 18/04/2011
A further broad search was also run, looking for systematic reviews and RCTs on the topic of asepsis
in any situation.
215
Intervention /
Asepsis Systematic 2002 to
reviews and RCTs 18/04/2011
(Medline and
Embase only)
F.4 Economic searches

Economic searches were run in Medline and Embase by combining the hand hygiene, long term
urinary catheters, vascular access devices and asepsis population search terms, and also the personal
protective equipment and sharps search terms, with the economic filters. Search terms for the CRD
and HEED databases are given below. Searches were run from 2002 to 18/04/2011.
Hand hygiene search terms
CRD search terms

#1 MeSH Handwashing EXPLODE 1
#2 handwash* OR hand AND wash* OR hand AND hygiene
#3 hand* NEAR clean*
#4 hand* NEAR disinfect*
#5 hand* NEAR decontaminat*
#6 hand* NEAR antisepsis
#7 hand* NEAR wash*
#8 #1 or #2 or #3 or #4 or #5 or #6 or #7
HEED search terms

1. AX=handwash* OR 'hand hygiene'
2. AX=clean* or disinfect* or decontaminat* or antisepsis or wash*
3. AX=hand or hands
4. CS=2 AND 3
5. CS=1 OR 4
Personal protective equipment search terms
CRD search terms

#1 gown* OR apron* OR overgown* OR covergown* OR coverall*
#2 MeSH Protective Clothing EXPLODE 1 2 3
#3 glov*
#4 #1 or #2 or #3
HEED search terms

1. AX=gown* OR apron* OR overgown* OR covergown* OR coverall*
2. AX=glov*
3. CS=1 OR 2
Sharps search terms
CRD search terms

#1 needlestick OR needle-stick OR needle AND stick OR accidental AND innoculation*
#2 MeSH Needlestick Injuries
216
#3 safe* NEAR needle* OR safe* NEAR sharp* OR safe* NEAR lancet* OR safe* NEAR cannula*
OR safe* NEAR re-sheath* OR safe* NEAR resheat*
#4 needle* NEAR retract* OR needle* NEAR covered OR needle* NEAR capped OR needle* NEAR
fixed OR needle* NEAR uncapped OR needle* NEAR guard* OR needle* NEAR protect* OR
needle* NEAR removal
#5 needleless OR needlefree OR needle-free
#6 #1 or #2 or #3 or #4 or #5
HEED search terms

1. AX=needlestick OR needle-stick OR 'needle stick'
2. AX=accidental AND innoculation*
3. AX=needleless or needlefree or needle-free
4. AX=retract* or covered or capped or fixed or uncapped or guard* or protect* or removal
5. AX=needle*
6. CS=4 AND 5
7. AX=sharp* or lancet* or cannula* or re-sheath* or resheat*
8. AX=safe*
9. CS=7 AND 8
10. CS=1 OR 2 OR 3 OR 6 OR 9
Long term urinary catheter search terms
CRD search terms

#1 MeSH Urinary Catheterization
#2 urinary OR urethr* OR indwelling OR suprapubic OR bladder OR intermittent
#3 catheter*
#4 #2 and #3
#5 #1 or #4
HEED search terms

1. AX=urinary OR urethr* OR indwelling OR suprapubic OR ureter* OR bladder OR intermittent*
2. AX=catheter*
3. CS=1 AND 2
Vascular access devices search terms
CRD search terms

#1 MeSH Catheters, Indwelling
#2 MeSH Catheterization, Central Venous
#3 MeSH Catheterization
#4 PICC OR PIC OR TPN OR midline OR mid-line
#5 venous OR intravenous OR vascular OR intravascular
#6 access OR device* OR catheter* OR line*
#7 #5 and #6
#8 venous-access OR intravenous-access OR vascular-access
#9 central* OR tunnel* OR non-tunnel* OR implanted
#10 catheter* OR line*
#11 #9 and #10
#12 MeSH Catheterization, Peripheral EXPLODE 1
217
#13 peripheral*
#14 catheter* OR line* OR cannula*
#15 #13 and #14
#16 #1 or #2 or #3 or #4 or #7 or #8 or #11 or #12 or #15
HEED search terms

1. AX=(central* OR peripheral* OR tunneled OR tunnelled OR implanted) AND (catheter* OR
line* OR cannula*)
2. AX=catheter AND (hub* OR port* OR site*)
3. AX=PICC OR PIC OR TPN OR midline OR mid-line
4. AX=(venous OR intravenous OR vascular OR intravascular) AND (access OR device* OR
catheter* OR line*)
5. CS=1 OR 2 OR 3 OR 4
218
Clinical evidence tables
Appendix G: Clinical evidence tables

G.1 Standard principles
G.1.1 What information do patients, carers and healthcare personnel require to prevent healthcare associated infections in primary and
54
Study Burnett 2008
Aim To determine whether or not patients who required assistance with personal hygiene were encouraged and provided with facilities to do so,
and to gain an insight into HCW’s perceptions towards patient hand hygiene.
Population 33 nurses and 22 patients (mean age 75 years) at an acute teaching hospital in Scotland.
Methods Six observational sessions each lasting 4 hours were undertaken. Observation was conducted by two infection control nurses working in the
same hospital.
Survey questionnaire was completed by 33 nurses. Questionnaire contained ten structured questions.
Interviews were carried out with 22 patients requiring hand hygiene assistance
Study was conducted in two medical wards, two surgical wards and two orthopaedic wards.
Interview schedule consisted of two questions requiring yes/no answers, five requiring Likert-type response and three open ended questions.
Themes with findings Hand washing is effective in reducing infection: Patient interviews indicated that majority of the patients believed hand hygiene to be an
important part of preventing HCAI (95%). However, 545 of patients interviewed did not think that staff viewed hand hygiene to be important.
Accessibility of hand washing facilities
55% of the patients said that they had never been offered facilities to wash/clean their hands during their current time in hospital and 86%
reported that they had not been offered facilities to wash/clean their hands that morning.
Variation in preference for alcohol gels and hand rubs :
82% of patients felt they would like to have the use of hand wipes especially prior to mealtimes and after visiting the toilet and 9% each said
that they would like to be offered alcohol hand rub and would prefer a basin of soap and water. 85% of the nurses agreed that hand wipes
would be beneficial.
Limitations The study was indirect to the review question in terms of population and setting. It used a self reported questionnaire and the results may have
been over estimated. It might be subject to observer bias as participants may change their behaviour when aware of being observed. Small
sample size and non-random sampling strategies may contribute to selection bias in addition to the study being conducted in an acute care
setting.
219
89
Study Curtis 2003
Aim To pinpoint particular risk practices and to understand what motivated domestic hygiene behaviour. A secondary objective was to also develop the
methodology for research into home hygiene.
Population Mothers and children in Wirral, North-West England. Ten households recruited by word of mouth from amongst those attending two local GP clinics
or via personal contact.
Inclusion criteria:
Households contained an infant aged below three months who had received a polio vaccine in the past two weeks, and a toddler under the age of
three years
Methods Structured observation, surface virology and microbiology, semi-structured interviews, projective interviews and a focus group discussion used to
study hygiene practices of care-child couples in10 households
Structured observation: Each house hold was visited by one of two observers on three separate days, with intervals of 1-15 days between visits.
Observer sat for 3 hours in the lounge or kitchen while child cares were asked to carry on daily activities as normal. At each occurrence of nappy
changing, the following information was noted: identity of individuals, time and location of changing, surface on which child was placed, condition of
nappy (dry, wet or soiled), where the dirty nappy was placed and how it was disposed and when, how and how often hands were washed during and
after nappy changing.
Themes with Disgust:
findings “They feel alright [after nappy changing] but I feel as if I need to go and wash them”
“You just have to wash your hands after you’ve been to the loo”
“When you’ve done , like the baby’s nappies or whatever if it gets on your hands and you’re walking down the road later, you can still smell it- even
though you’ve washed your hands it’s just...seems to have this incredible ability to keep the smell there”
“During I’m preparing food-just because I don’t particularly like the feel on my hands you know if you’re sticky or whatever”
“.whenever I’ve had a cigarette outside, I’ll come in and...I wash my hands”
“ if you’ve been into the garden touching anything out there, always wash your hands”
Susceptibility to infection:
“if you go the loo if you have diarrhoea for example and you go to the loo and don’t wash your hands and then start eating an apple or something
and you would have thought you’d be more likely to get worse or something”
“...eliminating some of the bacteria that are going to be around...including E.Coli, Salmonella...the big ones that everyone knows about are so hyped
up that you can’t help but try and counteract those risks can you-I can’t”
“Because, like germs and bacteria left on your hands and then you put like your fingers in your mouth you could transmit all different germs”
Responsibility:
“Just a bit frightened of more germs going about than anything because they have got no immune system really, have they, when they are under
two”
220
89
Study Curtis 2003
“I found I washed my hands more than I would have...before I had the babies”
“ ..to get rid of the smell and the odours and anything that might be kind of lingering- because it’s not good for him”
“You seem to wash your hands more with having the baby”
“Since having him I wash my hands all the time”
Limitations This study was conducted in child-carer couples and the findings may only be indirectly applicable to the population defined in the review question.
Also, small sample size and non-random sampling methods reduce the generisability of the findings. Another limitation of this study was that it
assumed that that all viruses detected was excreted by the vaccinated infants in faeces, though nasopharyngeal excretion is technically possible, as
is infection and excretion by other household members.
221
90
Study Curtis 2009 (Systematic Review)
Aim To elucidate factors associated with risky hygiene behaviour and provide insights needed to develop strategies for changing hand washing
behaviour.
Population Mothers and child carers across 11 developing countries.
Methods The review collected the results of 13 formative research studies conducted in 11 developing counties.
The studies were carried out for the purposes of designing large scale or national hand washing promotion programmes or child carers in domestic
settings. The studies used structured observations, focus group discussions, interviews and elicitation of information from key informants as tools
for qualitative data collection. Research contractors were recruited to carry out the fieldwork in every country and they developed and pre-tested
their own versions of the study instruments.
Data, consisting of verbatim transcriptions, was translated into English or French and then analysed thematically to identify tractable factors that
positively influenced hand washing behaviour
findings “I don’t want the scent of that thing *faeces+ to remain on my hands.”(Ghana)
“The dirty things are cough, what women have-periods, rotten items or dead items.”(Kerala, India)
“If they did not wash hands, when they next ate, they would be eating the microbes from their bottom” *this would be+ “like eating faeces and
would be disgusting” (Kyrgyzstan)
“I feel very bad if I come out of the toilet and I do not wash my hands. I feel like am just smelling like toilet”(Kenya)
“My hands stink after the toilet so my friends will boo at me” (Madagascar)
“After eating foods you can’t move with dirty hands. I have got to wash my hands with soap after eating fish or any other oily foods” (Uganda)
Responsibility:
“Because I am a nursing mother, I always feel good when I touch my child with clean hands”(Ghana)
“We do everything for the health of our children. We have to bathe them, wash their hands and legs, we have to give them food, look after them
when they are sick”(Kerala, India)
“My children are my pride and joy. I wash my hands to protect them”(Kenya)
“If I did not wash my hands I would get cholera and diarrhoea for the children, many people do it because of Cholera” (Uganda)
“I wash my hands before carrying a baby so that I don’t infect the child with any disease”(Ghana)
Limitations The studies were conducted in developing country settings and therefore have limited applicability in terms of population and setting to this review
question. The review itself was based on summary reports and not on original data and this may have led to filtration by report authors leading to
loss of insight. Studies by themselves were unequal in design and quality. The review in based upon a conceptual framework and it is difficult to
draw statistical links between brain factors and risk behaviour.
222
93
Study Davis 2008
Aim To investigate:
surgical patients’ willingness to question healthcare staff about their treatment
differences between patients’ willingness to ask factual versus challenging questions related to the quality and safety of their healthcare
patient characteristics that could affect patients’ willingness to ask safety related questions
the impact of doctors’ instructions on patients’ willingness to ask safety related questions
Population 80 patients from four surgical wards in an inner city London teaching hospital; 101 patients were approached and 80 agreed to participate.
Inclusion criteria: age above 18 years, spoke English, able and willing to give informed consent to participate in the study
Methods Sampling was done based on convenience. Patients were recruited post-operatively over a three month period
A “Patient Willingness to Ask Safety Questions Survey”(PWASQS) was developed comprising 28 questions
Survey assessed patients’ willingness to ask healthcare staff questions that current safety initiatives (mainly from UK and US) ask patients to ask
Researcher went through all the questions with the patient
Patients had to answer on a 4-point scale how willing they would be to ask each question in the PWASQS. Scores ranged from 1 to 4; the higher the
score, the more willing the patient was to ask the question
Themes with Employment status of HCW:
findings Patients reported that they were more likely to ask nurses whether they had washed their hands [2.13±0.91 (mean score ± SD); 1.94to 2.35 (95% CI)]
as compared to doctors [2.03±0.87 (mean score ± SD); 1.84to 2.24 (95% CI)]
Encouragement from HCW:
Patients reported that they were more likely to ask both nurses and doctors whether they had washed their hands if they had been instructed by a
doctor to do so; Nurses [3.05±1.01 (mean score ± SD); 2.81 to 3.27(95% CI)] Doctors[3.04±0.95 (mean score ± SD); 2.81 to 3.24(95% CI)]
Limitations Study was conducted in an acute care setting on a small sample of patients and the findings may not be generalisable to the population. Differences
may exist in patients’ responses and actual behaviour and conclusions drawn have to be interpreted with caution. There is no mention of piloting or
validation of the questionnaire and verification of the results after analysis. As it is a cross-sectional study, no causality can be established and any
effects of the strength of association may be under or over estimated.
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Study Duncan 2007
Aim To explore patient opinion about asking healthcare professionals to wash their hands prior to a clinical procedure and to ascertain if MRSA status
and access to patient information about infection control would influence anxiety about asking.
Population 224 inpatients admitted to an acute NHS Trust Hospital generating a stratified sample of MRSA and non-MRSA patients to be sampled randomly.
Methods Semi-structured questionnaire designed for use in a descriptive survey. Questionnaire had a set of close ended questions and small number of
optional open ended questions. During analysis, co-relation was investigated using Kendall’s Tau-b analysis
Findings Hand washing is effective in reducing infection: Knowledge of MRSA was measured by asking patients about whether it was possible to have MRSA
and be well, how is MRSA spread and what is the most effective way to reduce the spread of MRSA. 83.4% identified that is spread predominantly
from hand to hand and 99% of respondents said that hand washing was the most effective way to reduce the spread of MRSA.
Perceived need for more information regarding hand hygiene: 74.7% of respondents said that they had received no information upon
admission.57.4% of respondents said that there was not enough information about hand hygiene and MRSA in the hospital.
Comfortable in asking HCW to wash hands when :
Prior knowledge of infection/prior admissions
There was a negative co-relation between number of previous hospital admissions and anxiety over asking hospital staff to wash their hands
indicating patients were more anxious about asking hospital staff to wash their hands if they had fewer admissions
There was a weak positive co-relation between history of MRSA infection and anxiety over asking staff to wash their hands indicating patients would
be more willing to participate in program to ask health personnel to wash their hands if they had a history of MRSA infection
There was a weak positive co-relation between knowledge of MRSA and anxiety over asking staff to wash their hands indicating patients felt more
anxious about asking staff to wash their hands despite having knowledge of MRSA
There was a strong negative co-relation between availability of patient information on hand washing and MRSA upon admission to hospital and
anxiety over asking staff to wash their hands indicating that patients felt more anxious about asking staff to wash their hands if there was less
information available on admission.
Encouragement from HCW
There was a weak negative co-relation between staff wearing a badge saying ’It’s OK to ask’ and anxiety over asking staff to wash their hands
indicating that patients would feel slightly less anxious about asking staff to wash their hands if they wore a badge saying ‘It’s OK to ask’
Limitations The study was indirect evidence in terms of population and setting to the review question. As it was a cross sectional survey, any effects noted may
be over/ under estimated. Sampling was a convenience based and may have led to selection bias. The study explores patients’ perceptions and any
inferences regarding actual behaviour should be drawn with caution.
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Study Duncanson 2005
Aim To explore patients opinions on being asked to participate in a campaign to improve staff compliance with hand washing and to identify factors that
may influence the likelihood of patients asking staff to wash their hands
Population 200 patients about to be discharged from an acute NHS Trust agreed to participate in the survey. 150 completed both the questionnaires 970 men
and 80 women. Participants had been in hospital for an average of seven days.
Methods Descriptive survey using two questionnaires
First questionnaire was developed and piloted over five month period to collect information about all factors (except individual personality) using
informal focus groups, interviews and feedback from previous patients
Second questionnaire was the Neuroticism Extraversion Openness five Factor Inventory (NEO FFI) and was used to explore five aspects of
personality of each participant viz extraversion, agreeableness, conscientiousness, neuroticism and openness.
The research protocol and questionnaires were then piloted on ten patients
Survey took place before the ‘cleanyourhands campaign’ was launched nationally
Factors investigated were previous experience while in hospital (including number of previous admissions, history of hospital acquired infection and
experience of being nursed in isolation), individual characteristics and personality and feelings about asking different groups of staff to wash their
hands before providing direct patient care
Data was collected over a six week period.
Patients could complete the questionnaires on their last day of hospitalisation or take them home
Different statistical tests were used for the analysis of the data
Themes with Patient participation in improving staff compliance with hand hygiene:
findings 79% of patients felt that patients should be involved in helping healthcare staff improve hand hygiene in hospitals
Patients in the younger age group (mean age 42) were most likely to ask a surgeon to wash their hands while those in the older age group were
most likely not to (mean age 60)
Comfortable in asking HCW to wash hands:
Employment status of HCW: Student nurses, trained nurses, venepuncturists and domestics were more likely to be asked to wash their hands;
Surgeons, junior doctors, physiotherapists and porters were most likely never to be asked to wash their hands
Encouragement from HCW: At least 50% of participants found the idea of staff wearing badges saying it was OK, letters from their surgeon or ward
manager to be encouraging to be able to ask staff to wash their hands
Posters/Signs: At least 50% of patients found the idea of posters on wards telling them to ask staff or that it was OK to ask encouraging to be able to
ask staff to wash their hands
Similar behaviour from other patients: Approximately 65% of the patients felt that they would be encouraged to ask staff to wash their hands if they
saw other patients doing the same
Practical situations: 78% of patients reported wanting to be involved in helping staff improve hand hygiene when presented with practical situations
such as dealing with wound dressings or invasive devices
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Study Duncanson 2005
Limitations The study was conducted in an acute care setting on patients on the verge of discharge and therefore is indirect to the population and setting
relevant to the clinical question. Also, it explores the perceptions of patients and this may be different from what patients may actually do. A small
sample size and non-random methods of sampling also greatly limit the generalisability of the findings.
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Study Kaltenthaler 1996
Aim To provide a profile of hygiene behaviours associated with diarrhoea and to explore traditional areas ideas regarding causes of diarrhoea
Population Twelve families from two villages in north eastern rural Botswana.
Families were chose to include those with young children and people from different socio-economic backgrounds.
Methods Semi-structured observations were carried out on each family lasting from 30 minutes to three hours and activities of all family members were
recorded by the researcher
In-depth interviews were conducted with 12 caregivers on the third observation visit by the researcher and the Family Welfare Educator and
included questions regarding hand washing behaviour and what makes hands “dirty”
Seven key informant interviews were also conducted by the researcher with Family Welfare Educators, health facility nurses, traditional healer,
paediatrician and regional health inspector on perceived causes , treatment and prevention of diarrhoea
Two focus group discussion were held covering ideas regarding hand washing and diarrhoea
Field notes from all of the above were transcribed into sets of information on index cards and then grouped into categories of related sets of
information
Recurring themes were identified and summarized by the researcher with assistance from the Family Welfare Educators
findings Hand washing was performed to remove contamination or “dirt”
Hand washing was also done for comfort reasons , like when when hands were sticky, uncomfortable or smelly
Perceived sources of dirt were human and animal faeces, clothes-washing water and dish-washing water
Limitations The study was conducted in two villages in Botswana and is indirect in terms of population and setting to the clinical question. No information was
provided on whether diarrhoea was perceived to be preventable with hand washing.
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Study Longtin 2009
Aim To assess patients’ perceptions of a patient-participation program to improve healthcare worker’s compliance with hand hygiene
Population 194 patients admitted to different departments at the University of Geneva hospitals, Switzerland, a primary and tertiary health care facility.
Exclusion criteria:
Extremely ill patients
Presence of cognitive or hearing impairment
Did not speak French
Methods Respondents were interviewed at bedside by infection control nurses and medical students trained in interviewing techniques
Questionnaire consisted of 40 open- or close-ended questions
Responses consisted of short answers, 5-or 10-point Likert scale rankings, or multiple choice.
Interviews took approximately 20 minutes to complete
Respondents were asked about their knowledge of HCAI, knowledge of hand hygiene and infection control strategies, perception of HCW
compliance with hand hygiene and their beliefs on patient participation in the care process
Themes with Hand washing is effective in reducing infection:
findings Hand hygiene was identified by 39.2% of respondents to be an important preventive measure for HCAI
HCW implemented hand hygiene:
Two-third of patients believed that HCW should perform hand hygiene before shaking hands with a patient
84.5% reported that nurses and 66.5% thought that doctors cleanse their hands “most of the time”
Patient participation in improving staff compliance with hand hygiene:
40% felt that patients should remind HCW to clean their hands and 29.5% felt that this would help prevent HCAI
Patients felt that they would not feel comfortable in asking nurses (76.3%) or physicians (77.3%) to wash their hands
Encouragement from HCW: An explicit invitation from a HCW significantly increased the intention to ask a physician (from 29.9% to 77.8% of
respondents; p<.001) and the intention to ask a nurse (from 34.0% to 82.5%; p<.001) to perform hand hygiene
Employment status of HCW: Despite an explicit authorization, the intention to ask a physician remained lower than the intention to ask a nurse
(77.8% vs 82.5%; p=.04)
Limitations Study was conducted at a tertiary hospital and thus findings may not be applicable in other settings. Interviews were conducted by HCW and this
may have influenced responses towards being more socially acceptable. The study was conducted prior to introduction of any patient participation
campaigns and thus the responses may not be consistent at a later time. A convenience-based method of sampling was used and this may have led
to a selection bias. There is no mention of triangulation of the analysis and a possible interpreter bias may be present.
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Study Luszczynska 2007
Aim To evaluate the frequency of asking medical personnel about hand washing among older and younger patients with and without MRSA infection and
to evaluate the role of perceived behaviour control (PBC) and other variables in predicting intention to perform MRSA error prevention behaviour.
Population 171 patients who approached Patients Association in UK or MRSA Support, a UK charity organisation providing support for those interested in or
affected by MRSA.
Mean age of participants was 61.89 years; All participants had been hospitalised at least once prior to data collection. Patients included both who
had a diagnosis of MRSA infection (n=101) and those who did not have a diagnosis.
Methods Questionnaire based survey reviewing MRSA protective behaviour including actually asking medical staff to wash their hands, intention to ask
hospital staff to wash their hands, attitudes towards asking staff about hand washing and perceived behavioural control regarding the same.
Data collected was analysed by fitting it in a model with pre specified predictors of intention and correlation between variables was observed
findings 61.4% of participants did not try to ask a medical personnel to wash their hands even once since their last stay in hospital
56.7% of participants had never asked medical staff to wash their hands 6 months prior to the study
Prior knowledge of infection/prior admissions: Patients with MRSA tried to ask medical personnel to wash their hands since their last stay in hospital
more frequently than those without MRSA. Similarly, within 6 months prior to data collection patients with MRSA asked sometimes about hand
washing, where as patients without MRSA asked about it rarely. Knowledge predicted more frequent behaviour among patients without MRSA
infections (both younger and older);
Covariance between intention to ask medical staff about hand washing and asking about hand washing was 0.36 (p<0.001)
Covariance between PBC that is, perceptions of their ability to perform the behaviour and asking about hand washing was 0.29 (p<0.001)
Covariance between knowledge and asking about hand washing was 0.06
Limitations The study was limited by a small sample size. Data was collected only from individuals who contacted the organisations and this limits the
generizability of the findings. Study also did not control for patients’ education which is an important confounding factor.
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Study McGuckin 1999
Aim To study the effect of patient hand washing education on staff compliance with handwashing
Population 441 patients in general medical-surgical wards in four community hospitals in USA with an average length of stay of 5.3 days were enrolled in the
study. 276 completed telephone interviews two weeks after discharge and were included in the analysis. 165 were lost to follow up due to nursing
home admissions, deaths or incorrect telephone numbers.
Methods Prospective 6 week intervention/control study was conducted; Patients determined to be responsive (if alert and responded in a coherent
manner)were approached by researchers 24 hours after admission to participate in the “Partners In Your Care” hand washing intervention program.
Patients were visited by a health educator to discuss the importance of hand washing by in preventing nosocomial infections. A patient education
brochure describing the who, why, how, when and where of hand washing was distributed. Patients were asked to ask health care workers who had
direct contact with them “Did you wash your hands?” and were also given reminders to stick to their hospital gowns. Two weeks after discharge, all
enrolled patients were contacted by a member of the team for a telephone interview.
findings Of the 276 patients contacted for interview, 262 (95%) realised that patients get infections in hospitals and knew that hand washing was important
107 (68%) of patients responded that they were comfortable asking the health care worker whether they had washed their hands.
Prior knowledge: 157 (57%) asked health care workers whether they had washed their hands after reading brochure
Employment status of HCW: Of the patients who asked, 141 (90%) asked nurses and 50 (32%) asked physicians whether they had washed their
hands
Limitations The patients may have agreed to wash their hands as they knew they were under observation (observer bias). Study was conducted among
inpatients in an acute care hospital and may not be generalisable to patients accessing primary health care services. The study also suffered from a
high loss to follow up and those lost to follow up may have responded differently.
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Study McLaughlin 2008
Aim To assess the the knowledge and perception of methicillin resistant Staphylococcus aureus (MRSA) among the general public and a group of
hospital visitors
Population N: 545
Participants were approached at five different public places (shopping centres) in a hospital catchment area in Dublin, Ireland. Also hospital visitors
in front hallway of the hospital were asked to participate.
Inclusion criteria:
>16 years of age
Had sufficient language skills to complete the questionnaire
Methods Questionnaire of 35 questions divided into four broad categories: baseline data, factors thought to be involved in transmission of MRSA, treatment
of MRSA and perceived consequence of MRSA. Trained research assistants approached potential participants and asked them to complete the
questionnaire. Data was collected over a three week period.
Themes with Hand washing is effective in reducing infection: Majority of the groups thought that MRSA transmission could be reduced by hand washing (81.2%
findings of public, 86.1% of visitors and 92% of those who had had MRSA).
Responsibility: 92% of participants who had MRSA were worried about passing it to their families, and 94.8% of visitors and 90% of the public felt
the same...
Limitations The study was conducted at a time when MRSA was initially scrutinised by the media quite extensively and the general population had been made
aware of a life threatening “bug”. The effects may not be sustainable over the years and sensitisation of the population needs to be taken into
account while applying the findings.
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Study Morrison 2009
Aim To examine perceptions of influenza and in particular the anticipated likelihood of implementing a variety of infection control behaviours in a
Western culture with no recent epidemic experience to inform the development of a website-based infection control intervention to modify
respiratory infection transmission within the home, in both pandemic and non-pandemic contexts.
Population 31 participants (18 women and 13 men) aged 17 to 68 years from southern England (general population).
Inclusion criteria:
Currently living with at least one person
Ability to speak fluent English
Methods Recruitment to the study was done using advertisements (paper and online) and snowballing techniques
Purposive sampling methods were used to ensure a diverse sample
Design: A total of one interview and 8 focus groups were conducted with each group containing two to six participants. Semi structured focus groups
lasting between one to one and a half hours were conducted by the first author. Focus group schedule was used to guide the discussion and a pilot
interview was conducted first.
Participants were invited to discuss their thoughts about how colds and flu were caught and spread between people and the use of hand washing,
social distancing and cough hygiene as measures to reduce the spread of infections
The discussions were audio recorded and transcribed verbatim
Inductive thematic analysis incorporating grounded theory techniques was used to identify recurring patterns within the data.
Study enrolment ceased when saturation had been achieved
Analysis included familiarisation with the data, in-vivo coding, organisation of lower level codes into potential themes and use of the coding
framework to interpret data to identify key influences on participants’ likely adherence to infection control measures.
findings Participants recognised that infections were transmitted by touching an infected person or contaminated object
Positive attitudes were expressed towards hand washing and the belief that it was an effective prevention measure
However, over half of the participants questioned the effectiveness of infection control measures including hand washing, believing that
transmission of infection, particularly pandemics, could not be controlled.
Responsibility:
“Well yeah, obviously if you picked up a disease and you’re fighting it and nearly dying you’re not gonna want to pass it on to your little sister or
your younger brother or your mum or anyone are you?” F6 male, age 23
“Be more aware of other people and how they might get infected by you instead of relying on other people to protect themselves from you” F9
male age 19
“It’s really important to stay safe as you won’t be able to care for them if you get ill”F2 female, age 24
Although participants were mainly motivated to protect the health of family and loved ones, they also expressed a wider sense of responsibility to
protect the health of any ‘other’ in society at risk of infection
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Study Morrison 2009
Selfish attitudes were prevalent in the context of non-pandemic influenza, suggesting that it was the responsibility of others to implement the
behaviours
Reminders:
Many participants stated that even if they did wish to implement the infection control measures, they would most likely forget. Reminders such as
hand washing timers to ensure that hands were washed for an adequate length of time, adverts, posters or campaigns to remind people would
address this issue.
Not many participants were aware of behaviours recommended to prevent the spread of colds and/or influenza; “No one’s ever told you when, not
even your doctor’s told you when you get a cold you should wash your hands a lot more than you usually do” F6 male, age 23
Accessibility of hand washing facilities:
Practical difficulties such as access to required facilities represented one of the most commonly cited barriers to implementation of infection control
measures, including hand washing
Limitations Sample size may not have been large enough to make generalisations. Focus group discussion yield responses from groups and individual responses
may have been significantly different. Study was survey based on a hypothetical question regarding what participants would do in the event of an
epidemic and actual behaviour may differ significantly.
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Study Park 2010
Aim To assess the perceptions, motivating factors and behaviours associated with the use of hand washing to prevent H1N1 influenza transmission
during the peak pandemic period in Korea
Population N (enrolled): 11,085 students (M: 8485, F: 2600) at a public university campus in Suwon, Korea, between December 1 and 8, 2009.
Inclusion criteria:
Current enrolment as a student of the university
Willingness to participate in the research study
N (completed the questionnaire): 945 (M: 738,F: 204)
Methods A cross-sectional survey questionnaire was used
Questionnaire was designed to assess recent hand-washing behaviours, changes in hand-washing behaviours, information encountered regarding
hand-washing, perceived effectiveness of hand-washing in preventing infection with H1N1 influenza, perceived severity of H1N1 influenza,
perceived susceptibility to H1N1 influenza infection, and recent flu like symptoms
Questionnaire was validated by piloting the questionnaire prior to the survey
Themes with Hand washing is effective in reducing infection: 95.7% of male and 96.1% of female participants perceived hand-washing as an effective measure to
findings prevent H1N1 infection. Hand-washing frequency was positively correlated with perceived effectiveness of hand-washing (p=0.002)
Susceptibility to infection: 59.5% of participants rated their personal susceptibility to H1N1 influenza as “low” or “somewhat low” and hand-washing
frequency was positively co-related with perceived of infection(p=0.001).
Limitations Study was conducted during the H1N1 outbreak situation and this would have influenced attitudes and behaviour patterns during that time. Also,
social and cultural patterns and attitudes to hygiene may be different in this setting which may decrease the applicability of this study to this review.
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Study Pieper 2007
Aim To examine patients’ wound care knowledge and concerns prior to discharge from an acute care hospital
Population 76 patients (17 men and 59 women) scheduled for discharge home from a large urban acute care hospital. (Mean age: 48±13).
Inclusion criteria:
Patient started feeling well enough to participate and showed no overt signs of altered mental status
Presence of an acute or chronic wound
Ability to understand and respond in English
Exclusion criteria:
Patients discharged to a setting other than home
Patients who did not have a wound
Patients who verbalized feeling ill or whose health status was poor by physical assessment
Methods Patients meeting the study criteria were identified by advanced practice nurses on their wards
Questionnaire was administered to patient by a trained research assistant after obtaining consent.
Questionnaire had the following sections: demographic, wound pain, discharge concerns, beliefs about wound and their care, literacy and learning
and wound care. Completion of questionnaire took approximately 45 minutes.
Participants were asked who taught them about wound care in hospital and where or to who would they go for wound care information when they
were home.
Findings In the section about knowledge about wounds and their care, patients reported the following:
Hand washing is effective in reducing infection: 98.7% correctly reported that hands should be washed before the dressing is changed
Limitations Study was conducted on patients ready to be discharged after stay in the hospital and this may affect the nature of their responses due to an
increased level of sensitisation/ knowledge/anxiety. A self reported questionnaire was used and responses may not reflect actual practice. Study
had a small sample size.
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Study Pittet 2011
Aim To understand what acute hospitals are doing about empowering patients to ask HCWs whether they have washed their hands, to find out whether
the coordinators supported the proposal to give patients a hand rub and to gauge the degree of local support for greater patient involvement
Population 530 members of the public in England (public opinion survey) and 222 inpatients in surgical/medical wards and discharge lounges in five acute
hospitals in UK (inpatient survey)
Inclusion criteria:
Patients were conscious and willing to participate in the survey
Methods Survey carried out by the National Patient Safety Agency (NPSA) between December 2007 and March 2008 three years after the introduction of the
initial ‘cleanyourhands’campaign
Public opinion survey: Telephone survey; sample recruited on a national basis using random digit dialling; data was weighted to be nationally
representative and included a sample of 30 Muslim respondents to enable the NPSA to ascertain any differences in attitude between religious
faiths
Inpatient survey: Face-to-face interviews with inpatients in medical and surgical wards and discharge lounges; questions were adapted from the
public opinion survey; this survey was designed by the NPSA with support from five participating hospitals.
Data from questionnaires was collated and analysed using available statistical tools and summary measures were calculated and presented as
percentages.
Findings Variation in preference for alcohol gels and hand rubs :
85% of inpatient respondents said they would feel comfortable being given a bottle a hand rub and would use it for themselves. 53% reported they
would ask visitors to use it and 14% reported they would ask HCWs to use it.
Reminders:
59% of inpatients said they would like to receive information on hand hygiene and the use of hand rub on arrival at hospital a d 31% indicated a
preference for HCWs to tell them about it
94% of inpatient respondents said they had not asked their nurse or doctor to clean their hands. 53% assumed that the HCWs would have already
cleaned their hands and trusted them to do so.
Employment status of HCW: Around 50% of respondents were not very likely (28%) or not at all likely (23%) to ask a nurse to clean their hands.
Around 57% reported the same for doctors. Respondents reported that they were more likely to ask a nurse or doctor to clean their hands if they
were given a bottle of hand rub by the hospital. (Public opinion survey)
Limitations Validation and piloting of questionnaire was not reported. Study was a cross-sectional survey and responses may differ from actual practice.
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Study Rubin 2009
Aim To assess the associations between perceptions and anxiety about swine flu and behaviour change relating to swine flu
Population 1000 residents (general public) of England, Scotland and Wales.
Inclusion criteria:
18 years or older
able to speak English
Had heard of swine flu
Methods Telephonic survey using random digit dialling
Interview conducted over the phone lasting 20 minutes
Participants were asked nine questions about recent behaviours; six of these behaviours were avoidance behaviours and three were recommended
behaviours (including hand washing with soap and water) that is increased cleaning or disinfecting of surfaces, washing hands with soap and water
more often than usual and discussing with a friend or family member what to do if either person caught swine flu.
Items were assessed on whether participants believed that a specific action reduced their risk of catching swine flu, with possible response options
being strongly agree (scored as 5) to strongly disagree (scored as 1)
Binary logistic regression analysis was used to calculate univariate associations between perception variables and whether participants had engaged
in avoidance or recommended behaviours.
findings 56.9% of participants strongly agreed and a further 30.9% tended to agree that washing their hands reduced their risk of catching swine flu.
28.1% of participants reported actually washing their hands more than usual because of swine flu
There was a significant univariate association between perceived efficacy of washing hands regularly with soap and water and actually washing
hands more regularly (odds ratio 1.8. 95% CI 1.5 to 2.2)
There was a strong association between perceived susceptibility to infection and adopting one of the recommended behaviours (Adjusted OR 1.5,
95% CI 1.3 to 1.8)
Severity of infection:
There was a significant association between perceived severity of infection and adopting one of the recommended behaviours (Adjusted OR 1.4, 955
CI 1.2 to 1.7)
Limitations Study was conducted during the swine flu outbreak (May 2009) and hand washing behaviour at other times may follow different trends. It was a
cross sectional survey and therefore causality cannot be established, strength of associations may have been under/over estimated
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Study Schmidt 2009
Aim To establish the current need for enhanced hand hygiene interventions, identify barriers to their implementation and to test their acceptability and
feasibility.
Population Children (from various ethnic backgrounds) from four classes in primary schools in East London. Class grades included year 1 (one class), year 2(two
classes) and year 6(one class).
Methods Key informant interviews with head teachers, teachers and school nurses regarding current activities, perceived importance of hygiene activities for
children in relation to other educational activities, motivations for implementing hygiene activities and perceived barriers and constraints to
implementing them
Semi structured interviews, essay questions and group discussions with children including questions on illness perception and hygiene behaviour
Testing of staff and children’s acceptability of three different hygiene products for organised hand hygiene in the classroom: liquid soap, alcohol
based hand sanitiser (liquid and gel)
Interviews with children were recorded and transcribed. Thematic analysis was conducted and grouping was done according to themes.
findings ‘Cleanliness, so there’s no bits on your hands and you’re not muddy or dirty or anything’ (Year 6 child)
‘Because when you do dirty stuff like handstands you might get your hands dirty’ (Year 1 child)
‘After toilet’(Year 1 child)
‘if you have played in the garden or touched soil..’(Year 6 child)
‘After touching a bin..’ (Year 6 child)
‘So I don’t get ill’ (Year 2 child)
‘Because if you don’t you will get germs and you will start to be ill’(Year 1 child)
‘Hygiene, you always have germs on your hands so when you eat without washing your hands all those germs go into your body’ (Year 6 child)
Rinse free alcohol gel was generally well received by children and teachers alike; Liquid alcohol based sanitiser was regarded as much less suitable by
teachers and children because of its strong smell and the fact that it dripped on the ground
Limitations Small sample size limits the generalisability of the findings. Behaviour and responses may have been altered due to the presence of the researchers
(observer bias).
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Study Scott 2007
Aim To determine the level of knowledge about hand hygiene and to elicit information on the barriers to good hand hygiene practices on campus
Population 4600 graduate and undergraduate students, predominantly female, living in residence halls on campus, in Boston, USA.
Methods Online questionnaire delivered campus wide via email using an Internet survey tool. Self administered and anonymous survey.
994 survey responses received in 4 weeks and these were analysed
Themes with Prevention of infection:
findings 87% of respondents felt that hand washing was very important after touching infected skin and 60% actually washed their hands after touching
infected skin
79% of respondents felt that hand washing was very important after coughing/sneezing and 195 actually washed their hands after coughing or
sneezing
Limitations Online survey with low response rate (18%). Students’ education levels could be a confounding factor for the responses.
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Study Stoner 2007
Aim To investigate specific perceptions and preferences of parents regarding hand hygiene by their child’s doctor, highlighting areas that may yield to
educational interventions.
Population 100 HCWs and 99 parents of children presenting to accident and emergency department of Columbus Children’s hospital, Ohio, USA.
Methods Questionnaire based study which reviewed parents’ preferences regarding hand cleansers and hand hygiene practices used by doctors taking care of
their children. Similar questionnaires were distributed to HCWs
Responses between the two groups (HCW and parents) and within the HCW group were compared using Pearson chi-square and Fisher’s exact tests
Themes with Variation in preference for alcohol gels and hand rubs :
findings 14.1% of parents felt that alcohol hand rub was a better method for cleaning hands as compared to 54.3% of parents who felt that hand washing
with soap and water was a better method for cleaning hands.
Limitations The study provides indirect evidence in terms of population and setting to this review question. It is likely that responses of the parents might have
been influenced by the knowledge that the HCW were caring for their children at that point in time. The study had a small sample size and responses
from self reported questionnaires may not reflect actual practice.
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Study Tanner 2011
Aim To explore patients’ satisfaction with various hand hygiene products and identify the most popular one
Population 200 patients from eight wards at the Leicester Royal Infirmary. Wards included surgical, medical and orthopaedic patients. Thirty patients were
unable to use the bile sink as they had no plug sockets by their bedside and therefore results were presented for the rest 170 patients.
Exclusion criteria:
Patients in isolation rooms
Patients with cognitive impairment
Methods Survey was first piloted with 10 patients and its initial results were included in the main findings
Face-to face interviews were conducted with all the participants by a researcher at the bedside over a two month period. During interviews, patients
were asked to try each product once and rate them on a numerical scale of 1 to 5 with 5 being the best. Patients were also asked which was their
favourite product and asked to comment on any/all of the products. Interview questions ad a=sheets were also available in different languages
(Gujarati, Hindi and Punjabi). Data was recorded on an interview sheet by the researcher
The data was then entered into an Access database by a second researcher and statistical tests were carried out to determine which product
achieved highest mean satisfaction rating and was preferred overall
Themes with Variation in preference for alcohol gels and hand rubs :
findings Alcohol foams had the highest mean satisfaction score (3.92), followed by wet cloth with antiseptic (3.76), followed by alcohol wipes (3.48), followed
by a bowl of soapy water (3.28) and followed by a mobile sink (3.15)
Of the people who did evaluate the mobile sinks, this shared first place as the most preferred option along with alcohol foam for Muslim and Hindu
patients.
Limitations Study reported that two of the products (alcohol wipes and mobile sink) had design flaws that limited their usability. This has an effect on the
satisfaction scores and therefore results presented may be biased. Verification of findings (triangulation, cross-checking) is not reported. The study
reports the use of specific products in each category (for example, Cutan Foam Hand Sanitizer for alcohol foam and Purell Sanitizing Hand wipe) and
responses may be different to other products. Also, it is difficult to determine preferences on the basis of single use of a product and the results are
less reliable than would have been if preferences were determined after use of products over time.
239
493
Study Waterman 2006
Aim To determine how comfortable hospitalized patients were in taking error prevention actions, how often they engaged in these actions and whether
error prevention affected their hospitalization satisfaction.
Population 2078 adult patients discharged from 11 hospitals in the Midwest, USA. Patients were stratified by hospital and randomly selected for interviews.
Methods Telephonic interviews were conducted with all the patients utilising an established patient satisfaction measurement system.
Questionnaire was designed by patient safety researchers and staff
Error prevention behaviours were divided into two sets and each patient answered questions only from one set (done to minimise respondent
burden)
First set included questions on asking friends and family to assist in error detection, asking doctors about medical care, asking a medication’s
purpose and confirming their identity; Second set included questions on asking doctors and nurses whether they had washed their hands before
patient contact and helping mark a surgical site (1044 patients answered this questionnaire)
In the analysis, association between performing each error prevention behaviour and age, race, gender, length of stay, payer type, emergency room
admission, intensive care unit stay and comfort with error prevention was evaluated.
findings 46% of patients were very comfortable asking medical professionals about hand washing as opposed to 89% who were very comfortable asking
general medical questions
When hospitalised, only 5% of patients had asked about hand washing
On multivariate analysis, very comfortable patients were found to be more likely to ask staff whether they had washed their hands as compared
patient with other comfort levels [6.3 (1.4 to 28.2)]
Limitations Study only took into account patient reports after discharge and did not use chart reviews or incident forms to confirm if errors had actually
occurred (Reporting bias may be present). Patients may still have been on follow and this may have influenced responses. Selection of patients to
receive either of the two questionnaires in unclear.
240
522,522
Study Yardley 2011
Aim To test the assumption that hand washing would be viewed as the most feasible preventive behaviour and specific beliefs about hand washing
identified from literature search would be related to hand washing intentions and behaviour.
Population The study was conducted in the University of Southampton, UK.
Interviews: 13 participants (three men and ten women) were interviewed in their own home or at the university.
Questionnaire study: 176 people completed a survey; 129 (51 men and 75 women) were included in the analysis; 47 were excluded as failed to
complete measures of intention for all four behaviours.
Methods Interviews: Participants were shown paper based materials and were asked to think aloud and give their reactions to each page about proposed
website materials and what would be the good and bad aspects of following the intervention advice. An inductive thematic analysis was used to
categorize the data. Data was coded using manifest coding categories that were grounded in the text. The interpretation of this coded data included
consideration of whether statements were made spontaneously or in response to paper based or web based intervention materials.
Questionnaire based study: Questions regarding each behaviour were prefaced by a precise definition of the behaviour. The questions related to
frequency of the behaviour and behavioural beliefs. Further, perceived behaviour control was assessed by two items, measuring self-efficacy and
perceived control.
findings Respondents were unaware of the potential of hand washing in reducing their personal risk of colds/flu and were sceptical about its effectiveness.
Disgust:
Respondents reported that hand washing was learned in childhood and prompted by dirt, toilets, preparing food and getting dirty
Responsibility:
Respondents reported that hand washing was also prompted by the sense of wanting to protect others.
Respondents felt that hand gels were useful outside the home; they were convenient, however, they were not a replacement for hand washing as it
would not remove dirt.
Limitations Validation and piloting of questionnaires not reported. No mention of verification of results or triangulation. Small sample size for interviews.
Questionnaire based study which may not accurately depict actual practice.
241
G.2 Hand decontamination

G.2.1 When to wash hands
Study Patients Interventions Outcome measures Effect size Comments
details
Allegranzi Population: Implementation of the WHO Hand Group 1: 155/1932 (8.0%) Funding:
14
2010 Healthcare workers in hand hygiene improvement hygienedecontaminati Group 2: 358/1639 (21.8%) WHO, University of
University Hospital, Bamko, strategy. on compliance p value: p < 0.001 Geneva Hospitals, and
Study Mali The intervention included Overall the Swiss Society of
design: educational posters (hand Public Health
Hand Before patient contact
hygiene indications, Administration and
Cohort Inclusion criteria: decontamination Group 1: 23/503 (5.2%)
technique), 3-hour education Hospital Pharmacists.
(prospective, The strategy was compliance Group 2: 91/439 (20.7%)
before and sessions and key educational
implemented in 13 wards p value: p < 0.001
after messages promoting hand Limitations:
Exclusion criteria: rubbing as the gold standard
comparison) Low income African
for HH and the ‘5 moments for Before aseptic task country, therefore
hand hygiene’ concept. The Group 1: 11/425 (2.6%) applicability issues to
Participants: WHO knowledge questionnaire UK NHS.
Setting: Group 2: 34/230 (14.8%)
224 healthcare workers was administered before and
University after each session. All p value: p < 0.001
Study stated that HCAI
Hospital, participating HCW were given
was not intended as
Bamko, Mali a 100ml pocket sized alcohol After body fluid exposure risk
an outcome due to
rub and trained how to use it. Group 1: 34/215 (15.8%) lack of power from
Duration of Group 2: 94/229 (12.6%) the small sample size.
follow-up: Group 1: Before guideline p value: p < 0.001
14 months 4 months of preparation Additional outcomes:
followed by 4 months of After patient contact Hand
baseline evaluation.
Group 1: 91/559 (16.3%) decontamination
Group 2: After guideline compliance split by
Group 2: 201/505 (39.8%)
6 months of implementation professional category,
p value: p < 0.001
and 2 months of follow up medical specialty.
evaluation. HCW perception of
After contact with patient
As stated above, with the strategy.
surroundings
introduction of alcohol rub Other HCAIs were
Group 1: 15/457 (3.3%)
242

details
(locally produced, as per WHO Group 2: 15/410 (3.7%) surgical site infections
instructions) p value: 0.831 and pneumonia.
Healthcare associated Group 1: 25/134 (18.7%)
infections Group 2: 22/144 (15.3%)
Overall p value: 0.453
Healthcare associated Urinary tract infections

infections Group1: 8
Group 2: 10
Primary bloodstream infections

Group1: 3
Group 2: 1
243

details
Aragon 2005 Population: Aim is to increase knowledge and Hand decontamination Group 1: 761 (30%) Funding:
22
Vascular and thoracic importance of infection prevention, compliance, before Group 2: Not stated
surgery unit increase HCW compliance with hand patient care (via 6 months: 730 (36%)
Study Inclusion criteria: decontamination and isolation surveillance Q. Hand Limitations:
1 year: 696 (41%)
design: procedures, increase the use of decontamination before Unclear as to the exact
All healthcare workers p value: <0.05
alcohol-based products for hand interacting with the population of patients
Cohort
decontamination. patient/ environment. and HCW were involved
(retrospectiv Exclusion criteria: Yes/No) in the study. Limited
e
None stated Implementing CDC practice guideline Hand decontamination Group 1: 784 (71%) figures given at baseline
comparison)
(2002) compliance, after patient Group 2: e.g. numbers of
Performance improvement plan, care (via surveillance Q. 6 months: 732 (75%) infections.
surveillance of at least 30 observation Hand decontamination
Setting: 1 year: 707 (74%)
opportunities (one third isolation after interacting with the Additional outcomes:
USA patient/ environment. p value: <0.05
precaution). Compliance with gowns,
House-wide education on planned Yes/No)
masks and gloves, use of
Duration of topics (hand decontamination, Nosocomial MRSA Group 2: alcohol foam soap
follow-up: isolation precautions, patient 6 months: -17% (which increases at 6
1 year education, preventing antibiotic 1 year: -4% months them dips at 1
resistant infections). These sessions year).
were adapted from CDC material
(www.cdc.gov/handhygiene/)
Nosocomial VRE Group 2: Notes:
(vancomycin-resistant 6 months: -13% Hand decontamination –
Posters placed on individual units hand washing with
(monthly change outs). enterococcus) 1 year: +12.5%
antibacterial soap and
Measurement of alcohol foam usage water for no less than
hospital wide. 15 seconds or use of
Measurement of rate of hospital sufficient alcohol foam;
acquired infections with antibiotic Interacting with the
resistant organisms. patients’ environment –
enters room and
Group1: Before guideline touches anything in the
Group 2: After guideline room, including the
patient.
244

details
Larson 2007 Population: Site visits were made to each hospital, Central line Group 1: 5.54 Funding:
252
Hospitals that were beginning 1 year following release of associated blood Group 2: 4.76 Supported by The
members of the National the guideline (CDC guideline, 2002). stream infection p value: <0.001 National Institutes of
Study Nosocomial Infections Prior to this each hospital initiated (rates per 1000 Health, National
design: Surveillance (NNIS) System. their educational and other efforts to device days) Institute of Nursing
implement the guideline. Catheter associated Group 1: 2.90 Research, Impact of
Cohort
urinary tract hand decontamination
(retrospectiv Inclusion criteria: Group 2: 3.02
During the 2 day visit the study infection (rates per guideline on infection
e Being a NNIS hospital or p value: .033
project director collected information 1000 device days) costs.
comparison) using NNIS methods and
definitions for at least 3 from the director of the infection Hand Group 1:
control department regarding decontamination Limitations:
Setting: years prior to the study, Group 2: 56.6%
providing HAI (hospital changes in hand decontamination compliance Hand decontamination
ICUs from 40 policies and procedures before and compliance not given
hospitals, acquired infection) data from
after publication of the guideline; No data given pre guideline before guideline
USA 1 or more intensive care
obtained documentation regarding implementation. implementation.
units (ICU), and not using
alcohol products for hand staff education, infection control Survey of hand
Duration of decontamination prior to policies and procedures, product decontamination
follow-up: publication of the hand usage, and multidisciplinary meetings compliance, rather than
2 years (1 decontamination guideline regarding rates of HAIs within the direct observation.
year prior to ICUs studied. The project director also
implementat made rounds in one or more ICUs in
Exclusion criteria: Additional outcomes:
ion and 1 each hospital to record the proportion
40 hospitals were recruited of ICU rooms and areas in which Staff awareness of the
year after)
via letter and email. alcohol hand decontamination guideline, guideline
products were available, to directly implementation score
observe staff and administer a survey (scale of 0-12 with a
Mean of 417 active beds,
regarding hand decontamination median of 10.5
10% had 100 – 199 beds,
awareness. achieved), ventilator
40% had 200 – 399 beds and
associated pneumonia,
50% having ≥500 beds. Group1: Before guideline
surgical site infection.
Group 2: After guideline
245

details
Rosenthal Population: A comprehensive infection Hand decontamination Group 1: 268/1160 (23.1%) Funding:
408
2005 The study was conducted in control manual was distributed compliance (collected by Group 2: 2056/3187 (64.5%) No external funding
2 ICUs of a private, 180-bed to HCWs. The Association for a trained infection p value: <0.0001 was provided.
Study tertiary care teaching Professionals in Infection Control control practitioner; who
design: hospital in Buenos Aires. (APIC) hand hygiene guideline covertly observed Limitations:
was used as an educational tool handwashing technique Authors note that
Cohort
for this study of HCW at random other CVC and urinary
(prospective,
times, including all shifts, catheter specific
before and Inclusion criteria:
Interventions to improve hand for 30 minute intervals infection control
after The infection control team
decontamination compliance during each phase of the interventions were
comparison) composed of a medical
were educational monthly study.) also being conducted
doctor, an infection control
meetings, posters, focussed Nosocomial infections Group 1: 47.55 simultaneously.
Setting: nurse, and personnel
education of all HCWs, per 1000 bed days Group 2: 27.93
Intensive support. Handwashing
educational group sessions once (Nosocomial infections Additional outcomes:
care units of facilities are available, with 3
a week. Each participant was were identified by a
a tertiary sinks in each ICU with 4% p value: 0.0001 Ventilator associated
given was given an infection trained infection control
care chlorhexidine handwash pneumonia. Hand
control manual and the APIC nurse in the ICUs
hospital, dispensers and paper towels. hygiene compliance
guideline was used as an according to the adapted
Argentina also split by
educational tool to reinforce standard definitions of
Exclusion criteria: male/female HCW, job
classroom teaching. CDC.)
role, and time of day.
Duration of None stated
follow-up: CVC blood stream
Feedback was frequently given infections, catheter
21 months regarding hand decontamination associated UTI.
and infection rates.
Notes:
Group 1: Before guideline
Attendance to
Baseline handwashing educational classes
compliance, over 4 months. was voluntary,
supported by the
Group 2: After guideline administrator, and
Intervention period, 17 months monitored.
246
G.2.2 Cleaning preparation

details
Girou Population: All participants had been Median reduction Group1: 58% (-58-74) Funding:
154
2002 Healthcare workers previously instructed in the use bacterial Group 2: 83% (78-92) Bode SA, Hamberg,
of alcohol based solution when contamination p value: 0.012 Germany.
Study the hospital-wide handrubbing (imprint of finger
Inclusion criteria:
design: policy was launched. A written prints and palm from Limitations:
Healthcare workers protocol was available in each dominant hand onto
RCT Finger print technique
unit and no additional agar plates that rather than glove juice
Exclusion criteria: information was provided to contained technique, which
Setting: Patients assigned to the participants before the study neutralisers, recover bacterial
Intensive hand rubbing group started. incubated and CFUs burden for whole
care, France whose hands became counted. >300 CFUs hand.
visibly soiled (such as Patient care activities were were considered
Duration of with body fluids). They monitored during daily sessions confluent)
Additional outcomes:
follow-up: then had to wash their of 2-3 hours until a Bacterial counts CFUs, Before
hands with a standard (list additional
Divided into predetermined number of mean (SD) Group1: 232 (331)
antiseptic soap, and the outcomes reported in
sessions of eligible activities had been Group 2: 271 (372)
session was ended. paper but not
2-3h. performed. One session
recorded in this table)
comprised 5 patient care
activities that required hand After
All patients
decontamination before and Group1: 69 (106)
N: 23
after (direct contact with the Group 2: 35 (59)
Drop outs:
skin of a patient before invasive
care, after interruption of care,
Group 1 and after contact with any part
N: 11 of the patient that was
colonised with multiresistant Median % reduction Group1: 73 (25-93)
Age (mean):
bacteria), which corresponded (IQR) Group 2: 86 (70-96)
No. patient care
activities: 55 to 10 hand samplings.
No. (%) activities when
gloves were worn: 46 (83) Group 1
Proportion compliance Hand washing with medicated
with hand soap (chlorhexidine gluconate
decontamination: 64 4%; Hibiscrub, Zeneca Pharma.)
247

details
Group 2
N: 12 Group 2
No. patient care Hand rubbing with a waterless
activities: 59 alcohol based solution (45% 2-
No (%) activities when propanol, 30% 1-propanol, 0.2%
gloves were worn: 51 (86) mecetronium ethyl sulphate,
average 3-5 ml; Sterilium, Bode
Proportion compliance
Chemie, Hamberg, Germany)
with hand
decontamination: 71

details
Larson Population: Group 1 CHG Frequency of hand Group 1: 16.7 (9.4) Funding:
250
2001 2 critical care units (medical and 2% chlorhexidine washing (from diary of Group 2: 6.1 (10.2) Supported (in part) by
surgical) in a metropolitan gluconate containing recording, p value: 0.001 3M Healthcare.
Study academic health centre in traditional antiseptic handwashes per shift)
design: Manhattan, USA. wash (Foam Care, Group 2 only washed Limitations:
Ballard, Draper, UT) their hands once Significant difference
RCT
soiled. between CFUs at
Staff members (physicians,
nurses, housekeepers, respiratory Group 2 ALC ALC applications/shift Group 1: NA Baseline (higher for
Setting:
therapists) working full time in an Waterless handrub (from diary of Group 2: 17.7 (9.8) ALC) 5.03 compared
Critical care recordings) to 4.42 p = 0.01
ICU. containing 61% ethanol p value: N/A
units, USA
with emollients
Log 10 CFU difference 4 weeks
Inclusion criteria: (Avagard, 3M Health Additional outcomes:
from baseline (paired Group1: +0.24 p = 0.18
Duration of Care, St Paul, MN)
Working full time (>30hrs/wk) in t test) Assessment of skin
follow-up: Group 2: -0.31p = 0.12
the medical or surgical ICU of a condition, visual skin
4 weeks Reliability and validity of scaling, hand skin
large medical centre in northern
diary recordings were 2 weeks assessment form,
Manhattan, were aged 18-65,
were free from known allergies to assessed by daily visits Group1: +0.09 p = 0.59 participant
study products, were not to participants on each Group 2: -0.46 p = 0.04 preference)
currently receiving topical or shift as unexpected
248

details
systemic steroids or antibiotics, intervals, including Log 10 CFU (mean, SD) 4 weeks
and had no diagnosed current random inspection of (analysis of Group1: 4.64 (0.83)
dermatologic conditions such a diary cards in progress. covariance) Group 2: 4.72 (0.97) p = 0.4
psoriasis. If subjects had a latex
allergy but refrained from using Hands were sampled
latex gloves during the study they 2 weeks
using the glove juice
were eligible. method. Group1: 4.5 (0.78)
Group 2: 4.59 (0.97) p = 0.2
Exclusion criteria:
See above
All patients
N: 50
Drop outs: 2
Group 1
N: 24
Age (mean): 40.6 (6.95)
Group 2
N: 26
Age (mean): 40.5 (7.28)
249

details
Lucet Population: Each volunteer performed Log 10 CFU (5 finger Group 1: 1.40 ±0.70 Funding:
274
2002 Two medical ICUs, surgical ICU, 6 hand decontamination tips of dominant hand Group 2: 1.46 ±0.64 This study was
cardiac surgical ICU, surgical techniques in random pressed on a Group 3: 1.53 ±0.74 supported by a grant
Study recovery unit, two medical order immediately after a trypticase-soy agar for from Rivadis (Thours,
design: units. healthcare procedure. The 15s). Before. France) and Bode
hand decontamination Log 10 CFU (5 finger Group 1: 0.89 ±0.54 Chemie (Hamburg,
RCT –
technique was tips of dominant hand Germany).
crossover Inclusion criteria: Group 2: 0.33 ±0.45
standardised in terms of pressed on a
design 5-7 volunteers from each unit Group 3: 0.13 ±0.22
volume of product used, trypticase-soy agar for Limitations:
were asked to participate (at method for drying hands
least one doctor, nurse 15s). After Crossover design
Setting: with a towel and absence Reduction = statistically significant for
7 wards of assistant and two nurses in of hand recontamination all hand decontamination procedures
the Bichat- each service). after drying. Additional outcomes:
Claude
Bernard Exclusion criteria: Group 1 Notes
hospital, N/R Also report
Handwashing with
France Handwashing with
unmedicated soap
All patients unmedicated soap
(10 or 30 seconds)
Duration of N: 43 (for 10 seconds) and
follow-up: handwashing with
Male/female: 14/29 Group 2
1 week antiseptic soap for
Mean age: 35.5 Handwashing with
10 and 60 seconds.
antiseptic soap (Hibiscrub
All HCWs performed each hand or Betadine)
decontamination procedure. (10 , 30 or 60 seconds)
Group 3
Handrubbing with an
alcohol based disinfectant
(Sterilium) containing 2-
propanol 45%, 1-propanol
30%,
250
Study
details Patients Interventions Outcome measures Effect size Comments
Winnefeld Population: The type of washing Colony forming units Group1: -0.342 Funding:
507
2000 Nurses and nursing assistants facilities available to staff (CFU) (Sterile bag Group 2: +0.122 Not stated
were the same in every technique, Larson) p value: 0.004
Study department. The 2 agents Mean log change Limitations:
Inclusion criteria:
design: were used according to
Nurses and nursing assistants in their standard practice
RCT 12 medical and 4 surgical Additional outcomes:
and the instructions they
departments, Marseille, France. regularly received in their Skin assessment
continuing education. (Larson score,
Setting: Exclusion criteria: Sauermann score, skin
sensation).
12 medical None stated. Group 1
and 4 Alcohol-based antiseptic
surgical Notes:
All patients hand rinse (Sterilium,
departments Rivadis, Thouars, France,
N: 52
, Marseille, containing 2-propanol
France Age (mean):
45%, 1-propanol 30%,
Male/female: 2/49
ethylhexadecyl
Duration of Drop outs: 1 dimethylammonium ethyl
follow-up: sulphate 0.2%,
8 days Group 1 moisturizers and
N: 26 degreasers).
Age (mean): 3 – 5ml of Sterilium is
Drop outs: spread on both hands
(covering all surfaces) and
Mean no. of daily hand
allowed to dry on the skin
decontamination procedures:
without rinsing.
10.11± 3.44
Group 2
Group 2
Hand wash with a non-
N: 25 antiseptic soap (Savodoux,
Age (mean): Paragerm, Carros, France,
Drop outs: containing glycerine,
Mean no. of daily hand carbamide, TEA lauryl
decontamination procedures: sulphate, cocobetaine,
251
Study
10.24 ±4.47 cocamide DEA, allantoin,
perfume and CI45410)
Hands should be rubbed
together for at least 10 s,
rinsed under a stream of
water, and then dried
with a paper towel.
Study
st
Zaragoza Population: Group 1 Mean colony forming Before handwashing procedure on 1 Funding:
528
1999 4 randomly selected wards (2 regular hand washing with units (CFU) (Hand study day Partially supported by
medical and 2 surgical) and 3 liquid soap. printing onto blood- Group 1: 82 (±75) a research grant from
Study intensive care units. agar plates) Group 2: 75 (±39) Beiersdorf SA
design: Group 2 p value: 0.562
RCT – Inclusion criteria: Limitations:
Alcohol-based antiseptic
crossover Eligible HCWs included all hand rinse (Sterilium) Small sample size,
Immediately after handwashing
design permanent and temporary containing 2-propanol crossover design.
procedure
faculty, house staff physicians, 45%, 1-propanol 30%, Group 1: 42 (±39)
nurses and other HCWs). ethylhexadecyl Additional outcomes:
Group 2: 9(±11)
Setting: dimethylammonium ethyl Additional sample
sulphate 0.2%, p value: <0.0001
University of Exclusion criteria: taken at 10 to 30 mins
moisturizers and after handwashing,
252
Study
Barcelona None stated. degreasers). Percentage reduction Group 1: 49.6 while HCW was
Hospital in CFU count p value: 0.002 performing regular
Clinic, 850 The protocol for alcoholic tasks in the ward or
All patients – paired data used
bed tertiary solution use includes ICU.
N: 43 Group 2: 88.2
care referral directions for
hospital. Age (mean): N/R p value: <0.0001
handwashing (soap and Notes:
Male/female: N/R
water) before the use of
Duration of Drop outs: 7 excluded from final alcoholic solution
follow-up: analysis because they were only whenever there is visible
available for one of the dirtiness.
15 days
procedures evaluated.
All HCWs were instructed
in the use the alcoholic
solution by personal
training at the bedside
(research nurse), and a
written protocol was
available at each unit.
253
G.2.3 Bare below the elbow

details
Farrington Population group: Group 1 Compliance: Group 1: 9.3 ± 9.2 Funding:
129
2010 Doctors and medical students Bare below the elbows group Percentage of the Group 2: 11.1 ± 7.2 None
No sleeves, watches or hand areas of the hands *Mean difference: -1.80
Study jewellery below the elbows, (wrist plus palm) (95% CI: -4.46, 0.86) Limitations:
Inclusion & exclusion criteria:
design: except a simple wedding band missed No information about
Not reported p value: 0.18
RCT randomisation allocation and
Compliance: Group 1: 38.9±38.7
Group 2 concealment
All population Percentage of the Group 2: 52.8 ±27.9
Setting: Non bare below the elbows areas of the wrists The participants were observed,
N: 157 *Mean difference: 13.9 and this could have changed
Cornwall groups missed
Age (mean): Not reported (95% CI 24.77 to - 3.03) their performance (Hawthorne
UK Using a white coat, with the
Drop outs: 8 did not take part: 4 p value: 0.01 effect)
sleeves tailored to the level of
declined to participate, 4 on the carpometacaral joint of the Compliance: Group 1: 7.2± 7.1 Unclear reporting – number of
Duration annual leave Percentage of the patient rescruited/analysed in
thumb for each participant. Group 2: 8.2±6.4
of follow- areas of the palms each arm not reported
Allowed to wear hand/wrist *Mean difference: -1.00
up: missed
Group 1 jewellery if this is reflective of [-3.17, 1.17] Only doctors and medical
NA the participants usual clinical students were involved, no
N: Not reported p value: 0.37
Group 2 wear before the BBE policy other HCP
Colony forming units Not reported
N: Not reported (CFUs)
Hand washing technique for all Notes:
Cross infection of C.
participants: Not reported Personal correspondence to
No other information about Difficille
participants reported, except that Participants were asked to authors, N=73 in the BBE group,
wash hands with an alcohol Removal of physical
the participants included doctors Not reported 76 in the control group
based preparation that contamination
and medical students were from (bodily fluids and
a range of specialities and fluoresced under UV light. To *Mean differences and P values
reflect everyday clinical dirt)
seniority. Paper reported that calculated by NCGC using
practice, there were no Removal of transient
“there were no significant Not reported Review Manager 5.0, based on
limitations on the amount of organisms
differences in baseline the number of participants
demographics” between the two preparation applied, time spent Cross infection of provided by the authors.
or technique used by Not reported
comparison groups MRSA
participants. Areas not
fluorescing under the UV light
(and therefore not covered by
preparation) were recorded
254

details
onto standard hand diagrams,
using a previously validated
technology.
G.3 PPE
G.3.1 Gloves
details
Murray Patient group: Each dentist received ~ 400 Punctures (Water inflation Group 1: 513 Funding:
312
2001 Dentists in general practice gloves of the correct size, 200 method) Group 2: 157 Not stated
latex and 200 nitrile.
Study Participants were asked to Limitations:
Inclusion criteria: Length of time worn (mins) Group 1: 9739
design: wear one pair of gloves per No randomisation,
Dentists in general practice who patient on successive Group 2: 9098
Crossover were members of the PREP panel, allocation or
patients unless the patient’s concealment
trial a group of General Dental medical history precluded the
Practitioners who undertake wearing of latex gloves.
Setting: research projects within their Following treatment, their Additional outcomes:
UK dental practice. gloved hands were washed Glove time worn and
using a solution of Hibiscrub puncture rate by
Exclusion criteria: (ICI Pharmaceuticals, operator and glove
Duration of
Not stated. Macclesfield, Cheshire), the type. Position of
follow-up:
gloves were removed and punctures.
Not stated
placed in a labelled bag.
(during All
1999) Notes:
N: 5
Group 1 All dentists were right
Non-powered latex gloves handed.
Group 1
(Dermaclean: Ansell UK,
N: 5 (1000 gloves used) London)
Group 2 Group 2
N: 5 (1020 gloves used)
255

details
Non-powdered nitrile gloves
(Nitratex: Ansell UK, London)
G.3.2 Aprons and gowns

details
Callaghan Patient group: Group 1 Uniform Group 1: 44.80- Funding: No funding
57
2002 Nurses working in 2 renal dialysis Nurses not wearing contamination: Group 2: 59.40 sources
and haematology hospital wards. plastic aprons for any Mean colony count
Study activity Limitations:
design: Inclusion criteria: None stated Poorly reported
Apron contamination: Group 1: N/A
Comparative Group 2 method in paper
Mean colony count Group 2: 24.70
Study (not Nurses routinely Observational study
Exclusion criteria: None stated
randomised) wearing plastic aprons. and so open to bias.
Little information
All participants provided about
Setting:
No information is provided about baseline
2 UK the number of staff involved, the characteristics of two
hospital comparability of the tasks they test settings.
wards were undertaking and how many
treating Healthcare workers
patients were in each ward. knew they were being
immunocom
promised observed and so this
patients may have influenced
(renal results
dialysis and
haematolog Additional outcomes:
y) Colony count on
aprons at beginning,
Duration of middle and end of
follow-up: shift.
To end of Self reported uniform
shift laundering
information.
256

details
Notes:
Reported in CG02

details
Gaspard Patient group: Group 1 ‘Total compliance’ Group1: - Funding: No funding
143
2009 Nurses and care assistants Care assistants not with indications for Group 2: 35/43 (81.4%) sources
working in 3 long term care wearing plastic aprons plastic apron use: Group 3: 76/80 (95.0%)
Study facilities. for any activity Group 4: -
design: Limitations:
Group 5: 13/22 (59.1%)
Observation Inclusion criteria: None stated Group 2 Poorly reported method in
Group 6: 10/20 (50.0%)
al Study Care assistants wearing paper
Exclusion criteria: None stated plastic aprons for Observational study and so
washing and changing MRSA positive Group1: 5/16 (31.2%) open to bias.
clothing at the ‘waist Group 2: 15/43 (34.9%) Results are presented by
Setting: All patients zone’.
Group 3 Group 3: 7/80 (8.7%) care facility
3 long term N:
care facilities Care assistants wearing Group 4: 7/16 (43.7%) Healthcare workers knew
Age (mean): plastic aprons for they were being observed
in France Group 5: 7/22 (31.8%)
Drop outs: washing, changing and and so this may have
Group 6: 2/20 (10.0%)
meal assistance. influenced results
Duration of
Group 1
follow-up:
N: Group 4 Additional outcomes:
To end of
Age (mean): Nurses not wearing Number of care assistants
shift
Drop outs: plastic aprons for any and nurses changing their
activity uniform at the start of the
work shift.
Group 2
Group 5
N:
Nurses wearing plastic Notes:
Age (mean): aprons for dressing Paper also reports the
Drop outs:
number of MRSA positive
257

details
Group 6 clothing around pockets
Nurses wearing plastic relating to part of the trial
aprons for dressing and looking at education about
biological sampling. pocket contents. Results are
not presented here.

details
Srinivasan Patient group: Group 1 VRE acquisition: Group1: 11/49 (22%) Funding:
447
2002 Patients without VRE on admission to ICU Isolation procedure (patients with negative Group 2: 21/51 (41%) No funding sources
included wearing cultures on admission Relative risk*: 0.414 mentioned
Study gowns and gloves. but with a positive
Inclusion criteria: All admissions to the MICU 95% CI*: 0.175 – 0.980
design: (01/08/98 – culture during stay) Limitations:
whose admission perirectal culture did not p value*: 0.055
Observation grow VRE, but who then had a subsequent 31/10/98) No discussion of any
Acquisition Rate Group1: 1.8 other changes
al Study perirectal culture that did grow VRE..
(number of incidence Group 2: 3.78 occurring over time
Group 2 cases per 100 patient-
Isolation procedure Incidence rate ratios: 0.52 period of study which
Exclusion criteria: Patients whose admission days at risk):
included wearing 95% CI: 0.27 – 1.05 may have influenced
Setting: perirectal culture did not grow VRE and who
gloves only. Gowns p value: 0.05 results.
Medical did not have a follow-up culture. Patients
who had no perirectal cultures performed. were only worn VRE acquisition (hazard Hazard ratio: 2.5 Study conducted in
intensive ICU, not primary or
when indicated by ratio calculated using a 95% CI: 1.2 – 5.3
care unit in community care
universal multivariate
US All patients p value: 0.02
precaution proportional hazards Healthcare workers
N: 100 guidelines or may have influenced
model adjusting for
Duration of hospital policy. results as they knew
length of stay).
follow-up: Group 1 (01/11/98 – they were being
Until N: 49 31/01/99) observed.
discharge or Age (mean): 54.6 ± 16.2 Cluster design may
acquisition have overestimated
Male (%): 51.0
of effect.
Vancomycin Caucasian (%): 51.0
Resistant Drop outs: No data provided
258

details
Enterococci Group 2 Additional outcomes:
(VRE) N: 51 Colonisation pressure
Age (mean): 55.0 ± 15.1
Male (%): 62.7 Notes:
Caucasian (%): 47.1 *Calculated by the
Drop outs: No data provided NCGC team.

details
Puzniak Patient group: Group 1 VRE acquisition rate Group1 and 3(combined): 9.0 Funding: No funding
387
2002 Patients without VRE on Isolation procedure (per 1000 MICU-days) Group 2: 19.6 sources mentioned.
admission to ICU included wearing gowns
Study and gloves.
Unadjusted protective Relative risk: 0.44
design: Inclusion criteria: none stated (01/07/97 – 30/06/98) Limitations:
effect of gown use 95% CI: 0.31-0.63
Comparative relative to no gown Housekeeping
cohort study use practices were altered
Exclusion criteria: If duration of
during the study
stay <24 hr. Group 2
period (May 1998)
Setting: Isolation procedure
included wearing gloves First 18months of
Medical All patients
only (01/07/97 – study another
intensive N: 2631
30/06/98) intervention was
care unit in
Age (mean): tested in MICU to
US
Drop outs: 748 excluded for <24hr assess the effect of
Group 3 the scheduled
stay
Duration of As per Group 1 rotation of preferred
185 patients were colonised with
follow-up: (01/07/99 – 31/06/99) agents active against
VRE at admission and excluded
Until patient from acquisition rate calculations. gram negative
discharge bacteria on BRE
3 patients excluded due to no
from ICU acquisition.
discharge cultures
Study conducted in
ICU, not primary or
Group 1 – First gown period community care
259

details
(01/07/97 – 30/06/98) Healthcare workers
N: 727 may have influenced
Age (mean): 58.6 ± 17.8 results as they knew
they were being
VRE on admission: 52/779 (6.6%)
observed.
Cluster design may
Group 2 – No gown period
have overestimated
(01/07/97 – 30/06/98)
effect.
N: 622
Age (mean): 60.4 ± 17.8
VRE on admission: 87/709 (12.2%)
Selected compliance
results
Group 3 – Second gown period
(01/07/99 – 31/06/99)
Notes:
N: 335
Authors noted better
Age (mean): 58.0 ± 17.8 compliance with a
VRE on admission: 46/381 (12.0%) majority of the
infection control
procedures during the
gown period.
260
G.4 Sharps
G.4.1 IV cannulae
details
24
Asai 2002 Patient group: Group 1 Ease of insertion (10 A) IV cannulation Funding:
Patients scheduled for elective Safeguarded needles point VAS – easy to Group 1: 1.3 (1.0, 1.6) Japan Becton Dickinson
Study surgery (Insyte AutoGuard; difficult) Group 2: 1.2 (0.9, 1.6) for supplying Insyte and
design: Becton Dickinson. Insyte AutoGuard needles
Group 3: 0.8 (0.6, 1.0)
Insyte autoguard – and Johnson and Johnson
RCT Inclusion criteria: p value: p<0.005 (3 vs 1, 3 vs 2)
needle can be Medical for supplying
IV cannulation of patients scheduled Protective Acuvance
for elective surgery retracted into the
safety barrel before B) Intra-arterial cannulation needles.
Setting: removal of the Group 1: 2.8 (2.0, 3.3)
Matsue Red Exclusion criteria: needle (push button). Group 2: 1.9 (1.5, 2.2) Limitations:
Cross Patients were not studied if they had Group 3: 1.0 (0.7, 1.2) Hospital setting. Lack of
Hospital, blood borne infection or bleeding investigator and patient
Group 2 p value: p<0.001 (3 vs 1, p<0.005 3
Shimane, disorder, had any pathology of the blinding. Unclear
Protective Acuvance; vs 2)
Japan wrist, were of ASA physical status 4 randomisation and
or greater, or suffered from insulin Johnson and Ease of handling A) IV cannulation allocation concealment.
dependent diabetes mellitus. Johnson). needle (10 point VAS – Group 1: 0.6 (0.5, 0.8)
Duration of
Protective Acuvance safe to dangerous) Group 2: 1.2 (1.0, 1.4)
follow-up: Additional outcomes:
consists of 2 needles,
Not stated All patients Group 3: 1.3 (1.1, 1.8) Success rate and
one inside the other,
N: Intravenous cannulation =150 when withdrawn the p value: p<0.001 (3 vs 1, 3 vs 2) difficulties of insertion.
Intra-arterial cannulation = 150 tip of the needle is Blood contamination (site
Age (range): 18-85 years blunted. B) Intra-arterial cannulation e.g. researcher, assistant,
Group 1: 0.8 (0.5, 1.0) patient), bloodstains.
Problems with backflow
Group 1 Group 3 Group 2: 1.6 (1.3, 1.9)
of blood during attempts
N: 100 (50 IV, 50 intra arterial) Conventional Group 3: 1.4 (1.1, 1.9)
of catheterisation.
Age (mean): A: 60 (22-85) catheter needle p value: p<0.001 (3 vs 1, 3 vs 2)
(Insyte; Becton
B: 62 (23-85) Needle stick injury Group 1: 0 Notes:
Dickinson)
Group 2: 0 Main reasons for
Group 2 Group 3: 0 difficulty were noted that
A) Conducted for
N: 100 (50 IV, 50 intra arterial) Success on first A) IV cannulation for the Acuvance needle,
261

details
Age (mean): A: 58 (19-83) intravenous insertion attempt Group1: 46 backflow of blood was
B: 67 (18-85) cannulation (cephalic Group 2: 48 often too slow (authors
vein) judged more appropriate
Group 3: 48
B) Conducted for for IV cannulation),
Group 3
intra-arterial whereas for the
N: 100 (50 IV, 50 intra arterial) B) Intra-arterial cannulation AutoGuard, the chamber
cannulation (radial
Age (mean): A: 57 (18-80) artery; under general Group1: 42 sometimes filled with
B: 62 (21-82) anaesthesia and Group 2: 44 blood before
tracheal intubation) Group 3: 45 catheterisation (authors
judged more appropriate
Blood contamination A) IV cannulation
for intra-arterial
(staff, patients or Group1: 8 cannulation).
equipment) Group 2: 3
Group 3: 4
B) Intra-arterial cannulation
Group1: 8
Group 2: 5
Group 3: 7
262

details
82
Cote 2003 Patient group: Catheters were inserted Required one catheter Group 1: 150/211 Funding:
Children requiring IV cannula by 14 attending (catheterised on 1st Group 2: 94/119 Not stated
Study anaesthiologists and a attempt) P=0.117
design: number of residents and Limitations:
Inclusion criteria: Any blood spill or Group1: 30/211
fellows. All trainees had Quasi randomised
RCT Trainees and attending splatter (passive loss Group 2:12/119
prior experience with (randomised by week)
anaesthesiologists performing IV similar new IV catheter of blood from P=0.28
cannulations. systems. puncture site or IV
Setting: catheter, or forceful Limited baseline data
Exclusion criteria: propulsion of blood given for each study arm.
USA Group 1 out of the IV catheter)
None stated. Retractable needle IV Time of insertion (s) Group1: 102 +/-156 Quasi randomised; by day
Duration of catheter. Angiocath
Group 2: 78 +/- 113 of the week.
follow-up: All patients Autoguard, BD Medical
Systems, Inc. P=0.307 Hospital setting. Lack of
20 operative N: 330
Poor flashback Group1: 18 investigator and patient
days Age (range): 6.5+/- 5.1yr blinding.
Group 2 Group 2: 0
Group 1 Traditional IV catheter
N: 211 (JELCO; Johnson and
Johnson) Additional outcomes:
Age (mean): Outcomes stratified by
trainee and attending and
Group 2 also by patient age (<3
N: 119 and >3 years old).
Age (mean):
263

details
Prunet 2008 Patient group: Immediately after the procedure an Needlestick injuries Group1: 0 Funding:
384
Patients requiring peripheral assessment card was completed. Group 2: 0 Supported by
IV catheters. Group 3: 0 Sainte Anne
Study The length of surveying previously fixed Hospital and
design: as the time necessary to obtain at least Department of
Inclusion criteria:
250 informed consent assessment cards Anestheology
RCT Patients requiring peripheral
IV catheters. for each type of catheter. All catheters
Failed on first insertion Group1: 21 Limitations:
were 18 gauge diameter
Group 2: 24 Hospital setting.
Operating Exclusion criteria: Group 3: 22 Lack of
room and Group 1
If the patient’s vein’s were investigator and
emergency considered unsuitable for Passive security catheter (Introcan
Difficulty to introduce Group1: 0 (1.2, 0-2) patient blinding.
department placing an 18G catheter. Safety; B.Braun Medical). The insertion
is identical to the classic catheter, with a catheter (VAS; 0-10; 0= very Group 2: 0 (1.7, 0-3)
protective shield that automatically easy, 10 = very difficult), Group 3: 0 (0.5, 0-0) Additional
Setting: All patients median (mean, range) outcomes:
covers the needlepoint during its
France N: 759 withdrawal from the catheter top Blood splashes to
without any specific intervention from Difficulty of needle Group1: 1 (1.8, 0-4)
the environment.
Duration of withdrawal (VAS; 0-10; 0= Group 2: 0 (1.3, 0-2)
Group 1 the operator
follow-up: very easy, 10 = very difficult) Group 3: 0 (0.5, 0-0)
N: 251 median (mean, range) Notes:
5 months Age (mean): 55 +/- 20 Group 2 Immediately
period Active security catheter (Insyte Abnormal blood reflux in Group1: 18 before every
Group 2
Autoguard; BD Medical Systems) (when blood filling in the Group 2: 41 procedure, the
N: 254
requires pressing a button to trigger the catheter delivery system Group 3: 7 type of peripheral
Age (mean): 53+/-20 was considered incomplete
withdrawal of the needle in a plastic venous catheter to
Group 3 sleeve using a spring. or complete but too slow use was
N: 254 (>4 S)) determined
Age (mean): 54 +/- 20 Group 3 randomly in a 3
Staff exposure to patients Group 1: 18 ball ballot box.
Classic catheter, usually used in the
blood(when patient’s blood Group 2: 39
hospital (Vialon; BD Medical Systems)
stained the HCW’s skin, Group 3: 16
gloves, mask or any other
clothing.)
264
G.4.2 Safety needles – phlebotomy

details
66
CDC 1997 Patient group: Before introducing safety Number of phlebotomy-related Winged steel needle Funding:
Healthcare workers devices, each hospital percutaneous injuries (PI) - Group 1: 34 Not stated
Study (HCWs) conducted a comprehensive unadjusted Group 2: 53
design: training program for HCWs Limitations:
Vacuum tube collection (Punctur-
that included “hands-on” Survey data not
Observation Inclusion criteria: Guard, PG)
experience with the obtained from all
al (before HCWs who routinely Group 1: 2
equipment. HCW – response rate
and after perform phlebotomies Group 2: 14
study) (phlebotomists, nurses only 60% for one
Group 1 Vacuum tube collection question.
on (Venipuncture Needle-Pro, VNP)
Setting: medical/surgical/intensiv Safety devices
Group 1: 5
6 University e care/emergency Resheathable winged steel Additional
departments, residents needle (Safety-Lok, BD – at all Group 2: 19 outcomes:
affiliated
hospitals in 6 hospitals); a bluntable Number of phlebotomy-related Winged steel needle Under reporting
(Minnesota medical/surgical/paediat vacuum tube blood-collecting percutaneous injuries (PI) – Group 1: 58 rates of PI by
3, New York ric wards, medical needle activated while in the adjusted for underreporting by Group 2: 102 profession
1, California students in third or 4th patient’s vein (Punctur-Guard profession
Vacuum tube collection (PG)
2) year. – at 3 hospitals), and a
vacuum-tube blood collection Group 1: 4
needle with a hinged Group 2: 19
Duration of Exclusion criteria:
recapping sheath Vacuum tube collection (VNP)
follow-up: Not reported
(venipuncture Needle-Pro Group 1: 8
12 months (Smith Industries – 4 Group 2: 33
(after All patients hospitals). All require the
implementat Estimated no. of phlebotomies Winged steel needle
N: Not reported HCW to activate the safety
ion) performed Group 1: 2,540,500
Age (range): Not feature during or after
reported phlebotomy. Group 2: 1,875,995
Phase 2 (mean duration 12 Vacuum tube collection (PG)
months (6-15). Investigators Group 1: 501,596
monitored supplies of Group 2: 523,561
phlebotomy equipment, Vacuum tube collection (VNP)
continued enhanced
Group 1: 628,092
surveillance . The HCW survey
Group 2: 895,054
265

details
was repeated 1-2 months Estimated no. PIs per 100,000 Winged steel needle
before the end of the phase. phlebotomies Group1 : 3.1
Group 2: 4.0
Group 2 Vacuum tube collection (PG)
Conventional devices. Group 1: 0.9
Phase 1(mean duration 10 Group 2: 3.6
months (9-12) – hospitals
Vacuum tube collection (VNP)
used conventional devices
and conducted enhanced Group 1: 1.2
surveillance for injuries. An Group 2: 3.6
anonymous survey was No (%) safety devices with Winged steel needle
conducted. The rates of PIs activated safety features 2257/4065 (56%)
were estimated based on the observed in disposal containers Vacuum tube collection (PG)
number of reported
phlebotomy-related PIs 2984/5255 (57%)
(adjusted for underreporting Vacuum tube collection (VNP)
by occupation) by the number 3250/3319 (98%)
of phlebotomies performed No. of HCW noting technical Winged steel needle
(estimated based on daily difficulty or adverse patient 97/955 (10%)
average number of effects with safety device Vacuum tube collection (PG)
phlebotomies performed by (noted that only 60% of
each HCW, the number of 204/452 (44%)
respondents answered this
HCWs and the duration of Vacuum tube collection (VNP)
question)
study period). 19/385 (5%)
Do you prefer the safety device Yes – 822 (44%)
over the conventional No – 622 (33%)
equipment? Unsure - 435 (23%)
(1108 HCW, 1879 responses
related to one or more of the
three devices used)
266

details
Mendelson Patient group: Group 1 Total number of Group1: 86/641,282 Funding:
295
2003 Healthcare workers 19 month baseline period. A nonsafety winged winged steel needle Group 2: 28/436,180 Funded in part by the
steel needle (Terumo Corp., NJ) was used for injuries (per total no. Centers for Disease
Study performing phlebotomy procedures, drawing needles delivered to Control and Prevention
Inclusion criteria:
design: arterial blood, and obtaining venous access for units) PHS Contracts 200-94-
some peripheral intravenous infusions. Not Injury rate (number Group1: 13.41 0876
Observation Exclusion criteria:
al (before packaged with a vacutainer holder adapter, but of injuries per Group 2: 6.41
and after one could be attached by the user prior to the 100,000 winged steel Limitations:
RR (CI): 0.48 (0.31 to
study) All patients phlebotomy procedure. needles) Hospital setting.
0.73)
N:
Age (range): Group 2
Product evaluation Very easy or easy to use
Setting: Training period – 3 months training, hands on Additional outcomes:
(survey of 536 HCWs) 446 (83.2%)
Group 1 simulated insertions, unit-based training, and an Injury by occupation,
Acute care
N: instructional mailing regarding the safety work location, timing and
hospital, NY,
resheathable winged steel needle for staff. Easy to hold and
USA Age (mean): mechanism of injury.
Training updates were continued during the post manipulate
study period. Trainers included study nurses, 412 (76.9%)
Duration of Group 2 nursing educators, and infection control
follow-up: N: practitioners, as well as trainers provided by the Preferred safety needle
11 months Age (mean): manufacturer (Becton Dickinson Corp). to standard needle
implementat
337 (62.9%)
ion The study period was 11 months. The Safety-Lok
winged steel needle was used for phlebotomy
procedures throughout the institution. The
needle was prepackaged with an adapter for
vacutainer blood draws; which could also be
removed before use. The safety mechanism had
to be activated prior to removal of the needle
from the patient. Although the Safety-Lok could
be used for peripheral IV infusions, a nonsafety
winged steel needle was also available in the
paediatric department and the outpatient
oncology clinic for this purpose.
267

details
Rogues 2004 Patient group: Total needle stick Group 1: Funding:
406 injuries (phlebotomy Not stated
8500 full time equivalent Protective devices were 1993 – 413 (77)
Study employees (2900 nurses). 3600- introduced throughout related needle stick 1994 – 399 (80
design: bed university hospital the hospital on June injuries) Limitations:
1995 – 444 (87)
Observation 1996. Hospital setting. Unclear
1996 – 426 (86)
al (before Inclusion criteria: if this is prospective
and after Products evaluated (missing data for half of
Group 2: ‘before implementation
study) Exclusion criteria: were resheathable
winged steel needles 1997 – 385 (46) group’)
(SafetyLok, BD) and 1998 – 365 (47)
Setting: All patients Vacutainer blood- 1999 – 307 (34) Additional outcomes:
Bordeaux, N: collecting tubes with Estimated number of Group 1:
France
Age (range): recapping sheaths phlebotomies 1993 – data not available Notes:
(SafetyLok, BD). Each performed (estimated
Duration of product required the 1994 – data not available Over the reporting period
Group 1 by vacuum-tube blood there were no reported
follow-up: HCW to activate the 1995 – 459,499
N: collecting needles and HIV, HBV or HCV
3 years post product immediately winged steel needle 1996 – 463,899
implementat Age (mean): after phlebotomy. The 2 conversions.
purchased per year by
ion safety mechanisms the hospital) Group 2:
Group 2 required 2-handed
1997 – 455,700
N: activation. Instructions
1998 – 460,400
Age (mean): were issued on how to
activate the product 1999 – 458,120
following removal of the Rates per 1000 Group 1:
needle from the patient. devices purchased 1995 – 18.8
1996 – 16.4
Group 1
Before - baseline Group 2:
1997 – 10.1
Group 2 1998 – 10.2
After safety device 1999 – 7.4
268

details
implementation Phlebotomy Group 1:
needlestick injuries 19.4% of all needle related injuries
Group 2:
12% of all needle related injuries
RR 0.62 (95%CI 0.51-0.72)
269
G.4.3 Safety needles – dental syringe

details
Zakrzewska Patient group: A clear protocol was set up for Total number of Qualified Funding:
527
2001 Dentists changeover from non- sharps injuries relating Year 1 Septodont supplied
disposable to disposable to syringes Group 2: 2 equipment and training.
Study syringe. Key staff were aware
Inclusion criteria: Year 2
design: of the need for high Limitations:
All dental trainees and attendance at training sessions Group 2: 1
Observation qualified staff. Small number of injuries
and the date of introduction of Year 3
al (before – underpowered to see
the new syringes which was Group 2: 2 effect
and after
Exclusion criteria: widely publicised. Staff were Year 4
study)
trained over a 2 week period Group1: 2
with the manufacturers Authors report incidence
All patients Year 5 of avoidable incidence
personnel explaining
N: Group1: 0 using the second year of
Setting: technique. Change over
Age (range): occurred once staff had implementation. The first
UK dental
undergone training and Trainee year data is excluded
school
Group 1 training videos were available which has 4 needle stick
Year 1
for continued training and for injuries (3/4 reported as
Duration of N: Group 2: 5
new staff. Follow up included being due to lack of
follow-up: Age (mean): Year 2 training)
careful monitoring and
2 years manufacturer’s maintained Group 2: 4 Equipment and training
implementat Group 2 close contact to make any Year 3 supplied by safety device
ion N: necessary modifications. Group 2: 4 manufacturer.
Age (mean): Change over occurred at year Year 4
4. Group1: 2 Additional outcomes:
Year 5 Number of avoidable
Group 1 Group1: 0 injuries, total sharps
Disposable (safety) syringes. injuries.
Septodont Safety Plus system. Number of staff at risk Qualified
The handle of the Septodont Notes:
Year 1
Safety Plus syringe does not The use of non disposable
Group 2: 68
require autoclaving unless it syringes means that
has been contaminated with Year 2 needles must be re-
Group 2: 68
270

details
blood and saliva but it should Year 3 sheathed in order for the
be disinfected by immersal in Group 2: 68 syringes to be dismantled
hypochlorite solution of and the appropriate parts
Year 4
appropriate strength and for autoclaved.
Group1: 68
sufficient time as used for
other dental items such as Year 5
3 safety syringes were
shade guides. Group1: 68
compared and tested
The needle is already attached prior to implementation
and the cartridge is disposed Trainee to identify the syringe of
with the needle. Year 1 choice.
Group 2: 173
Group 2 Year 2 The 3/4 injuries reported
Non-disposable metal syringe Group 2: 170 using the safety syringe
The needle is not already Year 3 were attributed to lack of
attached and the cartridge is training and were
Group 2: 186
not disposed with the needle. avoidable.
Year 4
Group1: 176
The use of non disposable
Year 5
syringes means that needles
must be re-sheathed in order Group1: 176
for the syringes to be
dismantled and the Incidence of avoidable Group1: 20.5
appropriate parts autoclaved. needle stick injury per Group 2: 0 (in second year)
1000 employees
271
G.4.5 Safety needles – safety lancets

Study Outcome
details Patients Interventions measures Effect size Comments
Peate 2001 Patient group: Subjects were instructed to report Needle stick Group 1: 2 (2 per 477 Funding:
356
477 emergency all needlestick injuries (NSI) due to injuries worker years) Not stated.
service workers glucometer lancets and other Group 2:16 (16 per
(EMS) for a exposures, as directed by OSHA 954 worker years) Limitations:
municipal fire Bloodborne Pathogens Standard,
Study The cases of testing positive for hepatitis cannot
department. to a designated fire department
design: Statistically be conclusively attributed to glucometer lancet
medical officer; subsequent follow-
Observation significant change at NSI – other exposures were possible.
up was done by a board certified
al (before Inclusion criteria: 0.05 alpha level using Self reporting of needlestick injuries rather than
occupational medicine physician.
and after Z Test of Proportions direct observation.
All active-duty personnel were (Z – 2.071787)
study) Exclusion criteria: Rate of needlestick injury calculated using worker
trained in the use of the new
device, specifically to hold the years rather than total number of lancets used.
All patients point against the skin, press the Number of lancets used is not reported, needle
Setting: N: plunger until the sharp was stick injury is reported against worker years.
Emergency Age (range): released and lanced the skin,
service, confirm visually that the lancet had Additional outcomes:
paramedics automatically retracted into its No additional hepatitis C or B cases were
Group 1 protective housing, and then
USA. detected after the introduction of the new
N: dispose the lancet into a sharps device. 7 tested positive to Hepatitis C and 2 to
Age (mean): Range container. hepatitis B prior to implementation. No HIV
Duration of from 20-61 EMS worker turnover was reported positive cases were identified.
follow-up:
Male/female: as minimal during the study.
12 months 81%/9% Group 1 Notes:
after
implementat Self-retracting glucometer lancet. Lancet-related needle stick were chosen by the
ion Study period – 12 months. authors for analysis as they represented the
majority of needlestick injuries in this population.
Group 2 In October 2000, 6 EMS workers sustained a NSI
Straight stick non-retracting lancet with a straight stick non-retracting lancet type
type device Study period – 2 years. device. The decision was then made to change
to a self-retracting glucometer lancet
272
G.5 Long term urinary catheterisation

G.5.1 Antibiotics
details
Firestein Patient group: Group 1 Death Group 1: 1/36 Funding:
132
2001 Residents with long-term urinary 1gm of IV meropenem Group 2: 2/34 not reported
catheters (LTUC). 30 minutes before Relative risk: 0.47 [0.04, 4.97]
Study catheterisation P value: 0.53 Limitations:
design: Inclusion criteria: Randomisation
Urine culture - Day 0
RCT – open All residents with LTUC Group 2 allocation and
positive Group 1:36/36 (100%)
label No treatment received concealment method
Group 2: 33/34(97%) not reported
Exclusion criteria:
Setting: Catheters replaced No blinding – control
Urinary catheter in place for less Day 1-3 group did not receive
Geriatric than 4 weeks every 4 weeks. Open
urinary collecting Group 1: 32/35 (91%) treatment
Centre. Antibiotics use within 2 week of
Israel. catheter system and Group 2: 27/31 (87%) Baseline values not
enrolment. clearly reported –
Nov 1998 to silicon catheter used. All not stat sig
more hypertension
Aug 1999 Infection Group 1 Group 2 RR
All patients and cerebro vascular
All (total) 9/36 8/34 cases in intervention
N: 70
Duration of Urosepsis 1/36 3/34 group
Age (mean): 79.3±9.6 years
follow-up: Bacteremia 0/36 0/34
M/F: 21/49
28 days Soft tissue 2/36 1/34 Notes:
Drop outs: 0
Pneumonia 0/36 1/34 Non parametric tests
Unknown 3/36 3/34 performed – t-tests or
Group 1
All not stat sig chi-square test
N: 34
Age (mean): NR Hypersensitivity to Group 1: 0/36
antibiotics Group 2: 0/34
(meropenem) p value: Not sig
Group 2
N: 36 Antibiotics resistance Group 1: 0/36
Age (mean): NR (meropenem) Group 2: 0/34
p value: Not sig
273

details
Other baseline details not

reported.
“Cerebrovascular disease and
hypertension more prevalent in
the treatment group”.
274
G.5.2 Catheter type

details
53
Bull 1991 Patient group: Catheters were ‘Mean catheter time Group 1: 89.61 (36.31) Funding:
Patients undergoing long-term changed as in situ, days (SD) Group 2: 56.7 (38.8) Not stated
Study urethral catheterisation necessary, patients (Student’s unpaired t p value: 0.0014
design: assessed at test) Limitations:
biweekly intervals Encrustation leading Group 1: 11
RCT Inclusion criteria:
and patients kept a to catheter change
Patients aged over 18 years Group 2: 9
daily diary card
Setting: undergoing long-term urethral recording comfort, Mean diary score Comfort Additional outcomes:
England, catheterisation assessed to be pain and leakage on Group 1: 1.22 Number of patients
Community mentally sound. a 3 point scale (1 = requiring 1 or more
Group 2: 1.30
Reasons for catheterisation included good, 2 = average catheter changes and
p value: not sig
atonic bladder, prostate cancer, spinal and 3 = bad). total numbers of
Duration of
injury, MS, paralysis, Parkinson’s catheter changes.
follow-up: Pain
disease, incontinence, retention, Patient reported
16 weeks Any patient who Group 1: 1.14
prostatic enlargement and post TURP leakage. Patient
required admission
incontinence. Group 2: 1.24 preference to the
to hospital for more
p value: not sig catheter they were
than 4 days was
Exclusion criteria: randomised to
withdrawn from the Mean pH over study Group1: 6.3
compared to their
Patients with known sensitivity to study period Group 2: 6..6 previous. Washouts,
hydrogel materials p value: not sig bypassing episodes
Group 1 Catheter related Group1: 1 – reason not stated (missing data from
All patients Bard Biocath Foley adverse events control group).
Group 2: 7 – 5 pain, 1 catheter did not
N: 69 catheter. A latex drain, 1 catheter was repeatedly
Age (mean): substrate coated on expelled. Notes:
Drop outs: the inner and outer
Standard deviation
surfaces with a
Male:female: 57:12 not given for several
special hydrophilic
continuous outcomes,
polymer (hydrogel)
Group 1 which therefore
cannot be entered
N: 36 Group 2 into a meta-analysis.
Age (mean): 75.61 (12.6) Dow Corning Silastic
Drop outs: 9 catheter (silicone
Male:female: 31:5 elastomer coated
275

details
Mean days catheter change: 77 (66.9) catheter)
Group 2
N: 33
Age (mean): 70.03 (16.6)
Drop outs: 12
Male:female: 26:7
Mean days catheter change: 60 (22.6)
276

details
Cardenas Patient group: After randomisation patients Total UTI at 1 year Group1: 1.18 (1.3) Funding:
59
2009 Patients with spinal cord injury (SCI) were instructed how to use (t test) Group 2: 1.00 (1.0) No commercial party
the hydrophilic catheter or p value: 0.61 had a direct financial
Study how to use proper clean interest in the result
Inclusion criteria: Total antibiotic Group1: 0.77 (0.87)
design: technique for those in the of the research
SCI 6 months or more ago, self reported control group. treatment episodes Group 2: 1.65 (1.46) reported.
RCT history of ≥2 UTIs during the past year, use of at 1 year p value: 0.02
IC with a noncoated catheter and an open
The definition of a Subjects who had Group1: 12 Limitations:
system, no plan to change the method of
symptomatic UTI is significant at least 1 UTI Group 2: 14 Imbalance in male:
Setting: bladder drainage during the study period,
naïve to hydrophilic catheters and at least 18 bacteriurea (>105 cfu/mL) p value: 0.67 female ratio between
USA. Seattle. plus at least 1 sign or groups.
years of age. Subjects who had Group1: 11
symptom suggestive of a UTI
Exclusion criteria: at least 1 antibiotic Group 2: 16
Duration of (self reported from a diary). Small sample size –
Patients with evidence of upper urinary tract treatment episode p value: 0.18
follow-up: Urine was collected at author states that it
abnormalities or renal or bladder calculi in a intervals of 6, 9 and 12
1 year screening renal ultrasound. may have been
months, whereas the underpowered.
All patients symptom diary was collected
N: 56 Drop outs: 11 on a monthly basis. Subjects
visited their regular health Use of self reported
(1 dropped out at subjects request, 3 lost to
provider as normal for symptoms to
follow up, 3 discontinued as a result of
treatment of UTIs. determine
placement of an indwelling Foley catheter, 3
symptomatic UTIs.
withdrew as a result of nonurologic medical
complications, and 1 withdrew as a result of Group 1
developing renal stones LoFric hydrophilic coated PVC
Group 1 catheter
N: 22
Mean age (SD): 42.3 (10.4) Group 2
Male/Female: 17/5 Control catheter. Patients
Group 2 used their usual noncoated
N: 23 catheter with clean
technique, but used a new
Mean age (SD): 40.1 (9.3)
catheter with each
Male/female: 12/11 catheterization.
277

details
DeRidder Patient group: Both catheters were UTI – (clinical 1 or more during the study. Funding:
95
2005 Men with spinal cord injury available for the study in infection with Group1: 39 Not stated
presenting with functional size Ch10, 12 and 14. symptoms of UTI Group 2: 51
Study neurogenic bladder-sphincter Patients kept a log book and for which Limitations:
design: disorders. of symptoms and had treatment was High drop out rate (54%) due
visits at day 15 then 1, 2, prescribed) No UTI
RCT to restored urinary function
3, 6, 9 and 12 months. Group1: 22
Inclusion criteria: and thus no further need for
Group 2: 11 catheterisation, change of
Men aged 16 or over that have
been injured less than 6 months Group 1 bladder management to an
Setting: p value: 0.02 indwelling catheter and
Exclusion criteria: Hydrophilic-coated
Multi-centre SpeediCath withdrawal of consent.
Patients with symptomatic UTI, Mean Group1: 3.4
(5 in Spain, 3 polyurethane catheter
urethral stenosis or fibrosis were catheterisations per Group 2: 3.6
in Belgium) (Coloplast). Single use
excluded, as were mentally day There was a higher number of
ready-to-use catheter. Haematuria Group1: 38/55 patients with microscopic
unstable patients and those
Duration of hematuria and bacteriuria in
participating in another clinical Group 2: 32/59
follow-up: Group 2 the intervention group
trial. During the trial, those that Stenosis Group1: 0
1 year received prophylactic antiseptic or Uncoated PVC catheter, compared to control – actual
which were lubricated Group 2: 1 numbers not stated but p =
antibiotic treatment or used a
permanent catheter was used for a manually with a water- 0.02 and 0.03 respectively.
period of more than 10 days were soluble lubricant gel, p value: not sig Additional outcomes:
also excluded. containing no active Patients/helpers 6 months (list additional outcomes
ingredients and who were very reported in paper but not
Group1: 10
delivered in 5g sachets satisfied with the recorded in this table)
All patients Group 2: 6
(Aquagel lubricating catheter
N: 123 Jelly, Adams Healthcare p value: not sig
Group 1 Notes:
Ecolab.). Catheters are
N: 61 reused. Majority of patients had
12 months
urethral indwelling catheters
Mean age (SD): 37.5 (14.6) Group1: 9 prior to trial.
Group 2 Group 2: 7
N: 62 p value: not sig Patients still hospitalised at
Mean age (SD): 36.7 (14.6) study inclusion.
278

details
Giannantoni Patient group: All patients were Symptomatic UTI (cloudy and Group 1: 12/54 Funding:
150
2001 Neurogenic bladder transferred from the odorous urine, onset of urinary Group 2: 4/54 not stated
due to recent spinal intensive care unit with an incontinence, increased spasticity,
Study cord injury indwelling catheter. automatic dysreflexia, increased Limitations:
P = 0.003
design: Subsequently trained to sweating and malaise or a sense of Where 54 is stated as
perform intermittent unease associated with pyuria and the n number please
Randomised Inclusion criteria:
catheterisation significant bacteriuria) note that this is a sum
crossover
independently. Asymptomatic bacteriuria Group 1: 18/54 of 3 measurements
trial Exclusion criteria: Intermittent (uropathogenic colonization of the per patients (i.e. 3
Group 2: 8/54
catheterisation was urinary tract without symptoms of x18). Therefore
Setting: All patients performed every 5 hours. infection) sample size seems
Rehabilitatio N: 18 larger than it actually
Patient satisfaction (visual Learning
n hospital, Group 1 is.
Age (SD): 38.2 (16.4) analogue scale) Group1: 1.1 (2.7)
Italy
Drop outs: 0 Sterile, single use pvc,
Group 2: 1.1 (2.7) p = 0.16
Male/Female: 16/2 silicone coated catheter Additional outcomes:
Duration of Inserting
(Orlycatnel: Nelaton, Orly Additional patient
follow-up: General Supply, Italy). Group1: 6.7 (3.4)
demographics.
7 weeks in Lubricated by the patient Group 2: 3.6 (3.7) p = 0.00007
Urethral wall trauma
each arm using a gel. Extracting
Group 2. Group1: 5.0 (3.4)
Prelubricated non- Group 2: 3.0 (3.0) p = 0.004
hydrophilic Comfort
catheter.(Isantcath: Group1: 5.8 (3.9)
Hollister, Illinois). Silicone
Group 2: 2.5 (3.1) p = 0.00002
coated catheter
prelubricated with glicerol Handling ease
polymethacrylate and Group1: 5.0 (3.4)
propylene glycerol gel. Group 2: 1.4 (2.3) p = 0.000004
Mean satisfaction score
Group1: 2.33 (1.06)
Group 2: 4.72 (2.13) p = 0.022
279

details
Pachler Patient group: Patients were taught Bacteriuria (growth of Group 1: 14 Funding:
346
1999 Patients with urinary retention how to perform clean >104 c.f.u./mL was Group 2: 17 Not stated.
caused by prostatic enlargement. intermittent self considered significant) p value: not significant
Study catheterisation by a Limitations:
specially trained nurse Problems in None
design: Inclusion criteria: introducing the Small sample size,
in the outpatient clinic. Group 1: 31
Randomised Men with urinary retention catheter crossover study.
Group 2: 30
prospective
crossover Patients used one Some
Exclusion criteria: catheter for 3 weeks Group1: 1
trial Notes:
then transferred to the Group 2: 2
All patients other type for 3 weeks. Questionnaire
Setting: Many completed after 3
N: 43 Group1: 0
Community, weeks of using each
Denmark Age (mean): Group 1 Group 2: 0 type of catheter.
Drop outs: 11 (5 had no lasting Prelubricated,
need for intermittent (hydrophilic coated),
Duration of p value: not significant
catheterisation, 3 didn’t enter the disposable PVC catheter
follow-up: Burning sensation None
study, 2 could not insert the non- (Lofric, AstraZenenca,
3 weeks hydrophilic catheter and did not UK) when introducing the Group1: 30
want to use the hydrophilic catheter Group 2: 31
catheter and 1 developed a rash Group 2 Some
around the external urethral Non-hydrophilic PVC Group1: 2
meatus while using the non catheter (Mentor, Santa Group 2: 1
hydrophilic catheter. Barbara) plus lubrication Many
(gel) applied by the
Group1: 0
Crossover trial (all patients used patient. This catheter
both intervention) was used several times Group 2: 0
N: 32 within 24h and was then p value: not significant
Age (mean): 71.3 (range 50-87) discarded. After each Pain when introducing None
use it was rinsed under the catheter Group 1: 29
lukewarm water and left
1st 3 weeks 20 patients in group Group 2: 30
to dry on a clean towel.
1and 12 in group 2. Some
Group1: 3
Group 2: 2
280

details
Many
Group1: 0
Group 2: 0
p value: not significant
Burning sensation or None
pain after removal of Group1: 30
the catheter Group 2: 30
Some
Group1: 2
Group 2: 2
Many
Group1: 0
Group 2: 0
Handling of catheter Easy
before introduction Group1: 30
Group 2: 25
Tolerable
Group1: 1
Group 2: 6
Troublesome
Group1: 1
Group 2: 1
Handling of catheter Easy
after use Group1: 30
Group 2: 27
Tolerable
Group1: 2
Group 2: 3
281

details
Troublesome
Group1: 0
Group 2: 2
Transient gross Group 1: 14
haematuria Group 2: 17
282

details
Sutherland Patient group: Follow-up – weekly Microscopic Group 1: 6 Funding:
455
1996 Men with neurogenic bladder due urine C&S and Haematuria > 3 red Group 2: 11 not stated
to spinal cord injury, Hinman microscopy x 8 weeks. blood cells per high
Study syndrome or spinal dysraphism powered field Limitations:
design: Group 1 Bacteriuria Group 1: 3 Unclear allocation
RCT Inclusion criteria: Hydrophilic coated PVC When suspected on Group 2: 4 concealment and
Boys who were adept at catheter (Lofric) single the basis of symptoms randomisation
Setting: performing clean intermittent use and urinalysis, a urine
catheterisation and who had culture was obtained. Additional outcomes:
Community,
voiding dysfunction due to spinal Group 2 Positive cultures Additional patient
USA
dysraphism, spinal cord injury or PVC reused catheter defined as10x5 deomgraphics.
non-neurogenic bladder. (Mentor). Non- CFU/ml- subjects were
Duration of treated and reentered
Exclusion criteria: hydrophilic polyvinyl Notes:
follow-up: into the trial 1 week
Patients with a history of urethral chloride catheter.
8 weeks after cessation of No difference in
pathology (false passage, stricture bacteriuria between
antibiotic therapy.
or bladder neck reconstructive the groups
surgery) Visual analogue scale Convenience
for satisfaction ( 0 = Group 1: 3.3 (2.8)
All patients
most and 10 = least Group 2: 4.9 (2.7) P <0.05
N: 33
favourable)
Age (mean):
Drop outs: 3 Handling
Group 1: 3.8 (2.7)
Group 1 Group 2: 3.8 (2.6)
N: 17
Age (mean): 11.7 (3.8) Comfort with insertion
Drop outs: 1 Group 1: 2.7 (2.4)
Group 2: 4.2 (2.6) P <0.05
Group 2
N: 16 General opinion
Age (mean): 12.1 (5.7) Group1: 3.3 (3)
Drop outs: 2 Group 2: 3.9 (2.1)
283

details
Vapnek Patient group: Following enrolment, Urinary tract infection Baseline Funding:
480
2003 Men who perform intermittent patients presented for (SD) (Baseline self Group1: 0.45 (0.62) Lead author declared
self-catheterisation used to follow up once every 3 reported, but during Group 2: 0.20 (0.2) financial interest
Study manage neurogenic bladder months for 1 year. A 3 study this was self and/or other
design: month supply of reported plus relationship with
catheters was issued at quarterly urine 3 months Pharmacia and Merck.
RCT Inclusion criteria: Group1: 0.16
each visit. Patients were cultures)
Men able to perform intermittent instructed to use clean Group 2: 0.23 Limitations:
Setting: self catheterisation. technique and discard Catheters re-used up
3 American each catheter after 1 6 months to 5 times a day for
sites Exclusion criteria: use. control, where as
Group1: 0.12
Patients with a history of intervention is single
Group 2: 0.17
Duration of vesicoureteral reflux, unexplained Most catheters were use only.
follow-up: hematuria or bladder calculi, 14Fr, but some patients
those requiring prophylactic preferred 16Fr or 12Fr 9 months
12 months Baseline rates of UTI
antibiotics and those considered Group1: 0.12
differ.
incapable of following the study Group 2: 0.16
Group 1
schedule were excluded from the
analysis. Hydrophilic coated
LoFric catheter. Plastic 12 months
catheter - polyolefin- Group1: 0.13 (0.18)
All patients based elastomer. 120 Group 2: 0.14 (0.14) p value: NS
N: 62 catheters were issued
Microscopic 3 months
Age (mean): monthly.
hematuria (SD) Group1: 0.21
Drop outs: (Degree of hematuria Group 2: 0.71
Group 2 and pyuria was
Group 1 Standard polyvinyl classified as none (0)
chloride catheter. ,mild (1), moderate (2) 6 months
N: 31
30 catheters were or heavy (3) according Group1: 0.28
Age (mean +/- SD): 39.8 (12.9)
issued monthly. Patients to the number of cells Group 2: 0.63
Drop outs: 1 (used both catheter
were instructed to clean per high power field.)
types)
and reuse the catheter 4 9 months
8 or 5 times before Group1: 0.30
284

details
Group 2 discarding at the end of Group 2: 0.63
N: 31 the day. 12 months
Age (mean +/- SD): 39.6 (16.0) Group1: 0.31 (0.46)
Drop outs: Group 2: 0.65 (0.69)
5 p value: 0.027
Microscopic pyuria 3 months
Group1: 1.6
Group 2: 1.4
6 months
Group1: 1.6
Group 2: 1.5
9 months
Group1: 1.6
Group 2: 1.6
12 months
Group1: 1.7
Group 2: 1.6
p value: NS
Bacteriuria Measured, but not reported.
p value: NS
Adverse events Group1: 3
(1 gross haematuria, 1 episode of
epididymitis, 1 infected penile
prothesis requiring surgical removal)
Group 2: 3
(1 gross haematuria, 1 episode of
epididymitis, 1 bladder stone).
p value: NS
285
Study Patients Interventions Outcome Effect size Comments

details measures
Duffy 1995 Patient group: Consistency was assured across Number of Group1: 29 treatment Funding:
110
Residents of long term care facilities sites by preliminary and symptomatic episodes/2452 days Supported by a grant from
bimonthly staff inservice UTIs Group 2: 35 treatment the Department of Health
Study programs plus reliability checks episodes/2672 days Services Research and
Inclusion criteria:
design: on the nursing care units. Development, Department
Patients with indwelling catheters for of Veteran Affairs,
RCT relief of residual urine, were currently Group1: 11.8/1000 days
Group 1 Washington, DC.
managed by intermittent Group 2: 13.1/1000
Setting: catheterisation, or had significant Clean intermittent days
catheterisation. Does not require Limitations:
3 long residual urine and had an anticipated
length of stay of at least 110 days. a sterile field and can be done in Catheterisation was
term care Catheter Group1: 3.0 (+/- 1.1) performed by nurses, rather
bed or chair as patient desires. No
sites, USA replacement / Group 2: 2.8 (+/- 1.1) than by the patient.
cleaning of the meatus was done
Exclusion criteria: frequency of
if normal daily hygiene (daily
Duration Patients with a medical diagnosis of cleansing with soap and water) catheter
P = 0.455 Length of time enrolled in
of follow- urethral stricture, which would put the appeared sufficient and there was change, at day
study varied.
up: patient at high risk for complication, or no obvious contamination with 15, Mean (SD)
mean 63 the presence of combativeness (striking stool or other drainage.
out or kicking at the nurse caregiver) or Additional outcomes:
days in However, after the 1st use and for
each other behavioural problems, which Risk factors for UTI, primary
each catheterisation done during
group, would make a program of intermittent diagnosis and cause of
a one week period, the catheter
range 15 catheterisation impossible for staff to residual urine. (no statistical
was washed with mild soap and
to 107 carry out. significance between
running water, dried on a clean,
days groups)
lint free towel and stored at the
All patients patient’s bedside in a clean, dry
N: 82 container. Clean catheters were Notes:
Drop outs: 2 replaced each week. Drop out of the study before
end of 90 day protocol were:
Group 2 death unrelated to study,
Group 1
Sterile intermittent request for discontinuation,
N: 38 hospitalisation of the patient
catheterisation. This required all
Age (mean +/- SD): 70.9 (12.1) for >21 days for an unrelated
sterile equipment for each
20 completed 90 day protocol catheterisation, setting up of a problem, subject discharged
sterile field with drapes, and from facility, combativeness,
Group 2 cleansing of the urinary meatus reduction in volume of
286

details measures
N: 42 with Betadine before residual urine so that patient
Age (mean +/- SD): 72.6 (10.8) catheterisation. no longer required
All catheterisation was supplied catheterisation, and end of
19 completed 90 day protocol
by the pharmacy in a sterile study funding period.
condition.

details measures
224
King 1992 Patient group: Patients with sufficient hand Number of Group1: 5 Funding:
Patients with spinal cord injuries (SCI) function and willingness to learn symptomatic Group 2: 3 Supported by a grant
Study were taught self catheterisation. UTIs from The American
design: Others were catheterised by a Association of Spinal
Inclusion criteria:
nurse or family member. Cord Injury Nurses
RCT Patients admitted to an inpatient rehab Number of Group1: 1497 and was
programme at any time postinjury, placed catheterisation catheterisation/256 days supplemented by the
on intermittent catheterisation either Group 1
Setting: per risk days (no. Group 2: 1758.5 Rehabilitation
before or during their hospitalisation. Clean intermittent of study days on
Inpatient catheterisation/311 days Institute Foundation.
Also, if catheterisation was performed catheterisation which the subject
rehab, USA.
every 6 hours, had normal serum Patients did not wear gloves; staff did not meet the Limitations:
creatinine, and urinalysis, no prophylactic and family care givers wore non criteria for
Duration of antibiotics, absence of drug-resistant sterile gloves. A sterile catheter Not possible to
infection.
follow-up: organism on urine culture and bacteremia was used at the beginning of estimate total time on
28 days, or less than 10,000 colonies/ml each 24 hour period. The intermittent
until catheter was lubricated, and the catheterisation (61%
Exclusion criteria:
infection urinary meatal area was cleansed clean and 74% of
Patients were discontinued from the study sterile group started
occurred. with a castile soap wipe. After
before 28 days if catheterisations were intermittent
(range 1-28) each use the catheter was
ordered less frequently than every 6 hours catheterisation in
or if they were discharged. washed with bar soap, rinsed
with tap water, dried, and stored acute setting.
in a plastic bag for reuse.
All patients Additional outcomes:
Group 2
N: 46 Sterile intermittent Bacteriurea
Drop outs: 2 catheterisation.
Group 1 Carried out using a sterile
287

details measures
N: 23 catheterisation kit for each Notes:
Age (mean +/- SD): 27.9 (10.3) procedure and following 35 patients
principles of asepsis such that catheterised every
Drop outs: 3 patients catheterised less
care was taken to avoid ≤4h
than 2 weeks
contaminating the catheter. The
Group 2 10 every 6h
external meatus was cleansed
N: 23 1 every 4h in the day
with povidone iodine before
Age (mean +/- SD): 32.8 (13.7) and 6 at night.
sterile catheterisation.
Drop outs: 1 catheterised <2 weeks
288
G.5.3 Bladder instillations and washouts

details
Kennedy199 Patient group: Patients allocated to all three Bacteriuria (%patients Group 1: 100% Funding:
220
2 “Elderly females” from 6 interventions by random number with bacteriuria present Group 2: 75% NR
long-term care wards in 3 tables. in washout fluid) Group 3: 76%
Study geriatric hospitals. Limitations:
Catheter blockage Group 1: 18/44 (41%)
design: Patients underwent normal saline No baseline data
(catheters with lumen or Group 2: 14/29 (48%)
Randomised Inclusion criteria: washout twice a week (neutral reported.
eyes completely blocked Group 3: 7/27 (26%)
cross over All long term catheterised period) prior to and following
resulting in no flow of
trial female patients (not twice weekly washouts with Allocation
urine)
specified). Patients had sodium chloride, Suby G and concealment not
Solution R. Partially blocked Group 1: 14/44 (32%)
been catheterised for a reported
catheter (catheters still Group 2: 12/29 (42%)
Setting: median of 12 months.
able to allow catheter Group 3: 10/27 (10%)
Catheter type was the one Group 1: Saline (Sodium chloride Blinding not reported
UK drainage)
the patient was already 0.9%)
Geriatric using (no further details Catheters Not encrusted Group 1: 12/44 (27%)
units in 3 provided). Group 2: 3/29 (10%) Insufficient data
hospitals Group 2: Solution G (Suby G) presented for a
Citric acid 3.23%, light magnesium Group 3: 10/27 (37%)
number of outcomes.
Exclusion criteria: oxide 0.38%, sodium bicarbonate Catheter removal/ Group 1: 16.3 days
Duration of Catheter outcomes
NR 0.7%, disodium edentate 0.01%. replacement (mean time Group 2: 14.3 days
follow-up: reported per number
in situ) Group 3: 14.2 days
12 weeks of catheters
All patients Group 3: Solution R Catheters in only 3 patients
N: 25 Citric acid 6%, gluconolactone remained in situ for 28 days Additional outcomes:
Age (mean): 82 years 0.6%, light magnesium carbonate p value: Not sig Type and frequency of
(range 65-100 years) 2.8%, disodium edentate 0.01%.
Red blood cells (% Group 1: 21% crystals in washout
Drop outs: 11 (5 died, 3 had patients with cells Group 2: 17% fluid, catheter
catheters removed, 2 “Washout fluid instilled” by present in washout fluid) bypassing and
Group 3: 14%
withdrawn at request of allowing 100ml sterile pre-packed percentage patients
sachet contents to flow into the p value: 0.028
nursing staff, 1 discharged with urothelia cells
and unavailable for follow- bladder by gravity. Solution left in White blood cells (% Group 1: 100% present in washout
up). the bladder for 20-30mins. patients with cells Group 2: 87% fluid
Catheters were changed at weeks present in washout fluid) Group 3: 84%
Cross over trial (all patients 1, 5, 9 and 12. p value: Not sig
used all 3 interventions)
289

details
Moore2009 Patient group: Group assignment Symptomatic UTI (at Group 1: 0/17 Funding:
305
Adults (males and females) with determined by computer least one of five; fever Group 2: 0/16 Alberta Heritage
long term indwelling catheters generated list of random >=38 degrees, Group 3: 0/20 Foundation for
Study that required changing every 3 numbers urgency, dysuria or Medical Research and
design: weeks or less suprapubic the Canadian Nurses
Catheters were inserted tenderness, Foundation
RCT
on day 0. Assessment haematuria or positive
Inclusion criteria:
occurred weekly for 8 urine culture) Limitations:
Patients with long term (>30
days) indwelling catheters weeks, until 3 changes or a Authors report
Setting: UTI was reported blinding attempted,
blocking more than once a Mean time to first Group 1: 4.75 (SD 2.61)
Canada but was not possible
month and residing in a long catheter change Group 2: 5.18 (SD 2.90)
Long term term care setting or receiving Group 1: Solution G due to nature of
(weeks) Group 3: 4.55 (SD 2.91)
care settings home care. Eighteen years or (Contisol) intervention and
or patients older and scoring >24 on the p-value: Not sig packaging of washouts
Patients received catheter
own homes Mini Mental State Examination. washout weekly with 50ml
sterile Contisol (citric acid Authors report that 2-
Duration of Exclusion criteria: 3.23%, light magnesium 3 patients in each
follow-up: oxide 0.38%, sodium group did not
Symptomatic UTI on admission
8 weeks bicarbonate 0.7% and complete data
to the study (patients were
disodium edentate 0.01%), collection due to self
eligible after a symptom free
which were squeezed reported UTI and
period of 14 days), urethral
through the catheter over initiation of antibiotic
erosion, history of bladder
60 seconds. The flushing treatment, but none
cancer, radiation or interstitial
action was repeated 5 met study criteria for
cystitis, impaired renal function,
times. symptomatic UTI
gross haematuria or indwelling
catheter changed less than
every 8 weeks. Group 2: Saline washout Additional outcomes:
Patients received catheter All patients had
All patients washout weekly with 50ml haematuria
sterile normal saline consistently (no data
N: 73
290

details
Age (mean): NR Mean urine pH pH 6.3 (SD 1.04) reported)
Drop outs: 16 (3 catheter Group 3: No washout pH range 5 – 8.5
changes, self-reported UTI, (Control) Not reported per group Notes:
hematuria, latex sensitivity, Patients received standard Authors acknowledge
deceased/ severe illness, or care, no washout blinding not possible
personal choice) due to nature of
sterile packaging.
Group 1
N: 26 Authors report that
Age (mean): 63.92 (SD 17.25) measuring the cross
Drop outs: 9 section of catheters
was not useful for
comparing
Group 2
effectiveness of
N: 21 washouts.
Age (mean): 66.24 (SD 17.38)
Drop outs: 5
Group 3
N: 26
Age (mean): 68.56 (SD 18.65)
Drop outs: 6
No significant differences
between groups at baseline
291

details
Muncie1989 Patient group: Patients entered a 2 week Bacteriuria (mean Group 1: 4.0 Funding: Supported
311
Long term catheterised women. run-in period of no number of species per Group 2: 3.8 by grants from the
Catheter type: double lumen, 18F, irrigation. urine specimen, at The four most prevalent National Institute on
Study silicone-coated latex urethral Patients randomly >=105/ml) organism in each group were Aging, National
design: catheter. allocated to 10 weeks of Providencia stuartii, Escherichia Institutes of Health.
Randomised once daily normal saline coli, P mirabilis and
crossover irrigation or 10 weeks of enterococcus Limitations:
Inclusion criteria:
trial no irrigation. Patients then Sequence generation
Female patients aged 18 years and entered a 2 week washout not clear
older with indwelling urethral period of no irrigation Catheter replacements Group 1: 5.5
catheter in situ for 30 consecutive before entering the per 100 days of Group 2: 4.7
Setting: days or more. Pt were afebrile (>= catheterisation (mean) Allocation
alternate phase. p value: Not sig
37.7 degrees) for 7 days and had not concealment not clear
USA SD not reported
received antibiotics for 14 days.
Deaton Group 1: Saline irrigation Number of non- Group 1: 87
Hospital and Blinding not reported
Trained nurses “irrigated” prescribed catheter Group 2: 63
Medical Exclusion criteria:
the catheters daily by removals
Centre Patients with bladder malignant pushing 30ml of sterile 32 patients analysed,
neoplasms or physician insistence on Number of catheter Group 1: 39*/32 when 23 patients
normal saline into the
continued bladder irrigation. replacements due to Group 2: 32/32 completed the study.
Duration of irrigation port with the use
obstruction (absence p value: Not sig Cross over and partial
follow-up: of a catheter tipped
of urine flow from crossover patients not
24 weeks All patients syringe.
catheter that irrigation distinguished in
N: 44 did not restore) *Some catheters replaced more
results reported
Age (mean): 71 years Group 2: No than once.
Drop outs: 21 (10 died, 4 discharged, washout/irrigation Number of catheter Group 1: 11/32
3 had catheters removed and 4 at replacements due to Group 2: 21/32
physician’s request) New catheters were leakage (patient’s bed Febrile episodes of
p value: Not sig possibly urinary origin
inserted at the beginning being wet with urine
32 patients analysed: 23 crossovers and end of each study when catheter still
and 9 partial crossovers (no further phase. connected to
details provided) connection tube)
292

details
Waites2006 Patient group: 30mls of each irrigant Symptomatic UTI Group 1: 1/29 Funding: Not
486
Community residing persons with was instilled for 20 mins (number of patients Group 2: 6/30 reported
neurogenic bladder using using a bladder syringe, discontinuing use of Group 3: 4/30
Study indwelling catheters twice weekly. irrigation due to
design: symptomatic UTI) Limitations:
Randomised Inclusion criteria: Group 1: Saline Adverse effects/non- Group 1: 0/29 Sequence generation
non- Community residing men and washout/irrigation acceptability Group 2: 1/30 not clear
controlled women; at least 19 years of age; Group 3: 2/30
trial at least 6 months post spinal cord Group 2: Acetic acid 3 patients experienced manifestations Allocation
injury or other neurological washout/irrigation of autonomic dysreflexia after concealment not
disease; with an indwelling Foley (0.25%) ‘instillation of irrigant’ reported
Setting: catheter or suprapubic tube and
evidence of microscopic Group 3: Neomycin Blinding not clear
USA
bacteriuria and pyuria at polymyxin GU irrigation
Community enrolment.
residence (40mg/ml neomycin
settings sulphate and 200000
Exclusion criteria: units/ml polymixcin B)
Generation of
Symptoms of UTI requiring
Duration of antimicrobial resistant
systemic antibiotics, use of urine- Neomycin is not
follow-up: organisms, urinary pH,
acidifying agent, bladder irrigant included in the protocol
8 weeks urinary leukocytes and
or systemic antibiotic within the for this question, but
patients with
previous 7 days, prior has still been included in
Enterococcus species.
abnormalities in renal function, the evidence table for
pregnancy, and inability or completeness.
unwillingness to provide informed No data reported for
consent bacteriuria or pyuria
at study arm level.
All patients
N: 89 (49 men and 40 women)
Age (mean): 45.8 years (range 19-
82 years)
Drop outs: 37 [withdrew due to
symptomatic UTIs (11), other
293

details
health reasons (14), perceived
difficulty, inconvenience or
unwillingness to perform twice
daily irrigations (12)]
Group 1
N: 29
Age (mean): N/R
Drop outs: N/R
Group 2
N: 30
Age (mean): N/R
Drop outs: N/R
Group 3
N: 30
Age (mean): N/R
Drop outs: N/R
294
G.6 PEGs
No clinical evidence identified
295
G.7 Vascular access devices

G.7.1 Types of dressings – peripheral
details
Craven 1985 Patient group: All patients had a Teflon Catheter tip colonisation Group1: 28/316 Funding:
84
Patients with a peripheral IV catheter catheter inserted and (≥15 CFU) Group 2: 24/421 Not stated
maintained by an IV team
Study nurse. The skin site was Limitations:
Inclusion criteria:
design: prepared with 70% Catheter sites given
Adult patients hospitalised on the medical isopropyl alcohol followed
RCT and surgical services at Boston City rather than individual
by povidone iodine patient, therefore
Hospital solution prior to insertion each patient was
Exclusion criteria: of the IV catheter. IV counted up to 8 times.
Setting: Patients who were hospitalised in the catheters were routinely
Boston, USA intensive care unit or who had IV catheter removed or replaced
inserted by a house officer. every 48 to 72 hours. Additional outcomes:
Seasonal colonisation,
Duration of insertion site
follow-up: All patients Group 1
colonisation, organism
Up to 72h N: 437 Transparent polyurethane isolated.
dressing (OpSite, Acme
Group 1 United Corp., Bridgeport,
CT) Notes:
N: 200 Once randomised
No. of catheters randomised: 316 patients were
Group 2
Age (mean): 47.8 (18.6) excluded when the IV
Dry gauze – dressing
Male/female: 220/96 catheter was removed
changed daily
without a member of
the IV team being
Group 2
notified.
N: 237
No. of catheters randomised: 421
Age (mean): 53.7 (19.5)
Male/female: 239/182
296

details
Hoffmann Patient group: Hospital policy was Catheter tip colonisation Group1: 14/246 Funding:
194
1988 Patients with peripheral intravenous to rotate sites for IV (>15 CFU) Group 2: 10/224 Not stated
access sites catheters every 48h –
Study policy carried out by Limitations:
design: the IV team. A Teflon No intention to treat
Inclusion criteria: Phlebitis (criteria- After 24h
IV catheter was used analysis, allocation
RCT Inpatients older than 21 years of age on warmth and
on all patients. A Group1: 10/246 concealment or
4 services: cardiac medicine, general single IV site from erythematous skin over Group 2: 4/224 blinding.
medicine, orthopaedic surgery, and each patient was an indurated or tender
thoracic-cardiovascular surgery. p value: 0.179
Setting: studied and patients vein)
were only entered Additional outcomes:
University of
Exclusion criteria: into the study one After 48h Organism isolated
Virginia
Hospital, Patients under 21 years of age and those time. Group1: 14/246 from catheter tip.
USA admitted with a diagnosis of vasculitis or Group 2: 13/224 Colonisation at
bacteremia were excluded. p value: 1.000 insertion site.
Duration of Group 1
follow-up: All patients Notes:
Bioclusive
48 hours N: 598 transparent Reason for
polyurethane discontinuation given,
Age (mean):
dressing main reasons were
Drop outs: 128 discontinued by staff,
Group 1 infiltration and
N: 300 Group 2 transferred to another
Cotton gauze floor.
Age (mean): 58 ±18
Male/female: 154/92
Drop outs: 54
Group 2
N: 298
Age (mean): 55 ± 21
Male/female: 128/96
Drop outs: 74
297

details
Maki 1987 Patient group: Each catheter was inserted by a Local catheter- Group 1: 25 Funding:
281
Patients with peripheral venous house officer or nurse related infection (a Group 2: 24 This study was
catheters percutaneously into a new site. A positive semi Group 3: 32 supported in part by a
Study team of research nurses quantitative culture grant from the
Group 4: 26
design: randomised each catheter to the of the catheter, ≥15 Medical-Surgical
Inclusion criteria:
appropriate dressing group. colony-forming units) Division/3M, St Paul
RCT Consenting adult patients older
than 18 years, without Phlebitis (2 or more Group 1: 50
10% povidone-iodine was used for signs or symptoms at Group 2: 50 Limitations:
granulocytopenia, who were
scheduled to have a peripheral cutaneous antisepsis before the catheter site – Group 3: 48 Catheters randomised
Setting: catheter insertion and for tenderness, rather than patients,
venous catheter inserted. Group 4: 49
Wisconsin recleansing the skin at later erythema, swelling, some patients were
Hospital, dressing changes. purulence, or a entered into the study
Madison, Exclusion criteria: palpable venous more than once.
USA Catheters that had been in place cord)
Whenever dressings became
for less than 24h.
soiled or non adherent, the old Bacteraemia Group 1: 0 Additional outcomes:
Duration of dressing was removed, the site Group 2: 0 Adherence, moisture
follow-up: The N given below is for number was assessed, and after accumulation,
Group 3: 0
3 days of catheters recleansing the site with povidone- contamination of
Group 4: 0
All patients iodine, a new sterile dressing of catheter hubs,
N: 1259 the same type was applied. contamination of IV
Age (mean): fluid, infecting
Drop outs: Group 1 organisms.
Sterile gauze and tape, replaced
Group 1 every 48 hours Notes:
N: 544 Over half of the
Group 2 catheters were
Age (mean): 53.5
Sterile gauze and tape, left on for inserted in the
% intensive care: 30 operating room or in
the lifetime of the catheter
Mean hours in place: 54 ±38 an intensive care unit,
a quarter had been in
Group 3
Group 2 place for over 72
Polyurethane transparent hours
N: 519 dressing, left on until the catheter
Age (mean): 51.9 was removed (Tegaderm, 3M)
298

details
% intensive care: 25
Mean hours in place: 55 ±35 Group 4
Iodophor antiseptic incorporated
Group 3 in the adhesive, left on until the
catheter was removed
N: 527
(transparent dressing with a poly-
Age (mean): 51.5
N-vinyl-pyrolidone-acrylated
% intensive care: 27 adhesive that contained 3%
Mean hours in place: 52 ±33 titratable iodine).
Group 4
N: 498
Age (mean): 51.9
% intensive care: 27
Mean hours in place: 52 ±31
299

details
Tripepibova Patient group: Preparation of the IV site included Phlebitis (Inflammation Group 1: 2 Funding:
473
1997 Patients with peripherally determination of the vein on which of a vein as evidenced Group 2: 4 Support for this study
inserted lines. to initiate therapy, cleansing of the by redness, pain, p value: not significant was provided by The
Study area with a pad saturated with warmth, or swelling) Cleveland Clinic
design: povidone-iodine preparation, and Foundation Research
Inclusion criteria:
allowing the area to dry. Programs Committee
RCT Adult patients with a
Catheter insertion sites were grant #4833
physician’s prescription for
rotated every 72h.
Setting: peripheral IV therapy to be
Limitations:
Cleveland initiated in a vein in the
forearm. One RN from each shift on each No blinding, no
Clinic baseline
study unit was designated as a shift
Foundation. characteristics given.
research co-ordinator
6 units (2 Exclusion criteria:
medical Patients were excluded if they
oncology, Group 1 Additional outcomes:
were less than 18 years old,
surgical showed evidence of Transparent polyurethane dressing Infiltration, catheter
cardiology, thrombocytopenia or (Opsite, Smith and Nephew) dislodgment by
general immunosupression, or if they The dressing was applied directly patients
internal were pregnant. over the insertion site for the IV
medicine, catheter; no additional tape was
orthopaedic, used to secure the catheter in
All patients
and place.
neurological N: 229
intensive Age (mean):
Group 2
care Drop outs:
Dry gauze
USA
(Mirasorb Sponges, Johnson and
Group 1 Johnson)
Duration of N: 108 Gauze dressings were applied over
follow-up: the IV catheter with tape applied to
3 days Group 2 secure the IV tubing
N: 121 Dressing changed every 24 hours.
300
G.7.2 Types of dressings – Centrally inserted VADs

details
Brandt 1996 Patient group: Patients received assigned Exit site infection Group1: 2 Funding:
45
Bone marrow transplant recipients with dressing until one of the (erythema, tenderness, Group 2: 4 Not stated
tunnelled, long-term central venous following occurred: induration, purulence
Study catheters development of definitive within 2cm of skin exit of Limitations:
design: catheter-related sepsis and catheter exclusive of the Unclear
subsequent catheter removal, first 48h following randomisation,
(e.g. RCT) Inclusion criteria:
removal of catheter for any catheter placement.) allocation
Patients aged 18 years or older, alert, reason, or hospital discharge.
orientated and able to give written and Catheter-related sepsis Group1: 1 concealment and
Skin cleansing – 3 alcohol (systemic signs and Group 2: 5 blinding
Setting: verbal informed consent. They had to
swabs, followed by 3 povidone- symptoms consistent with
have had a central venous catheter
Bone iodine swabs and povidone infection, fungemia or
inserted following hospital admission for Additional outcomes:
marrow iodine ointment to the catheter bacteremia, catheter tip
autologous bone marrow transplant. Dressing
transplant site at the time of dressing culture growth more an 30
unit, Exclusion criteria: change. – same for each group. occlusiveness, tunnel
cfu)
Oncology Preexisting bacteremia or fungemia Dressings were changed sooner infection, suspected
within 14 days of study entry or if the Bacteremia/fungemia – Group1: 6 CVC sepsis,
centre. than protocol specifications if
unknown origin (more Group 2: 3 microbiologic isolates.
Pittsburgh, CVC placement was intended to be short the dressing became wet or
than 15 colonies culture
PA term. contaminated or lost adherence
forming units of
USA or if drainage at the site
bacteria/ml)
All patients compromised dressing integrity.
Duration of N: 101
follow-up: Group 1 Group 1
Mean 21.7 N: 53 Age (mean): 40.7 Standard care protocol with
days (range Male/female: 13/40 dry, sterile gauze dressing
3-68 days) changed every 24h
Catheter duration: 22.3 days
Group 2
Group 2
N: 48 Age (mean): 42.3
Opsite 3000 moisture vapour
Male/female: 10/38 permeable (transparent)
Catheter duration: 21 days dressing changed weekly.
301

details
Petrosino Patient group: Staff watched a video tape covering Infection (skin culture, Group 1: 4/7 Funding:
362
1988 Adults with long-term the covering the specifics of each erythema, tenderness, Group 2: 3/7 Supported in part by the
indwelling central venous protocol for patient teaching. and drainage) at 7-10 Group 3: 1/7 University Research
Study catheters. The catheters used were all either days Institute of the University
Group 4: 2/10
design: single-or multiple lumen tunnelled of Texas at Austin.
RCT Inclusion criteria: catheters.
Limitations:
Oncology patients with a
long term central venous Group 1 Data at 60 days was not
catheter. Tegaderm transparent –changed reported as none of the
Setting: remaining patients had
every 3 days
Medical any infection.
oncology Exclusion criteria: Skin cleansed with peroxide, alcohol
and povidone-iodine swab Baseline data for each
units, Patients who were not on arm is not given.
Texas USA the study for at least the Group 2
Opsite transparent –changed every 3 Unclear randomisation,
first 7 days to collect basic
days allocation concealment or
culture data.
Duration of blinding.
Skin cleansed with peroxide, alcohol
follow-up: Unclear which study arm
All patients and povidone-iodine swab
60 days the drop outs were from.
N: 52
Age (mean): 56 (range 17- Group 3
Gauze – changed daily Additional outcomes:
73)
Skin cleansed with peroxide, alcohol Mean composite infection
Male/Female: 21/31 rates, observation 2
and povidone-iodine swab
Drop outs: (infection defined by skin
culture and drainage –
Group 3 only available for n = 28),
No dressing
Skin cleansed with peroxide, alcohol
and povidone-iodine swab and
povidone-iodine ointment - daily
302

details
Shivnan Patient group: All subjects received dry Exit site infection Group 1: 1 Funding:
435
1991 Patients undergoing bone marrow sterile gauze dressings for (defined in aplastic Group 2: 2 Provided in part by the 3M
transplant the first 24h, then began subjects at the study Company; a grant awarded by
Study their assigned dressing institution as ≥3 days the American Nurses’
design: regimen. Gauze dressing of pain and erythema ± Foundation Competitive
Inclusion criteria:
were covered during induration with a Extramural Granted Program;
RCT Patients with long term central venous showers, whereas positive site culture) by the Sigma Theta Tau
catheters. transparent dressings were International Nursing Honour
Catheter-related sepsis Group 1: 0
Setting: Hematologic malignancy or immune- not. Society Grants Program; and
(positive blood culture Group 2: 1
Hepa- deficiency disease, had a pre-existing Staff nurses caring for the by the Nursing Department at
with growth of the
filtered bone indwelling silastic right atrial catheter subjects assessed catheter JHOC
organism from the tip
marrow or a catheter recently inserted under sites daily and recorded of the LTCC following
transplant sterile conditions in an operating dressing change times. Limitations:
its removal)
unit of a room, and were admitted to the unit
Decontamination technique Blood cultures reported for
regional for either allogenic or autologous bone
– cleanse exit site with entire group, not given for
oncology marrow transplant.
hydrogen peroxide, cleanse each dressing type – stated
centre. with povidone-iodine twice, that there is no difference
Baltimore, All patients allow to dry for 2 minutes, across the groups. Skin
USA N: 103 apply ½ cm antibiotic cultures only analysed for the
Age: range 2-60y ointment (bacitracin, first 75 subjects – n not given
Duration of Drop outs: 5 (3 – unexpected discharge neomycin, and polymyxin). for each group.
follow-up: or transfer from the unit, 2 –
30 days dissatisfaction with the assigned Group 1 High number of dressings
dressing) Dry sterile gauze – changed requiring modification –
Group 1 daily 27.5%
N: 47
Age (SD): 31.5 (12.2) Group 2 Additional outcomes:
Male/female: 31/16 Transparent adherent Skin irritation, wet dressings,
Group 2 dressing (Tegaderm, 3M, other complications, patient
MN) – changed every 4 days comfort and satisfaction.
N: 51
Age (SD): 34.1 (13.1)
Male/female: 28/23
303

details
Wille 1993 Patient group: All catheter sites were Catheter-related sepsis Group 1: 3 Funding:
503
Patients hospitalised for major elective newly created and the (Defined by a semi- Group 2: 1 Supported by Smith
surgery central-lines were inserted quantitative catheter and Nephew Research
Study by one of the anaesthetists culture and a peripheral Limited
design: in the operating theatre. blood culture positive
Inclusion criteria:
Topical antiseptics or for the same species.) Limitations:
RCT Patients older than 16 years,
antibiotic creams were not N = catheters
hospitalised for major elective surgery
used. Mean days in place Group 1: 5.1
Setting: and scheduled to have a single – lumen
Bleuland subclavian or jugular central venous Group 2: 5.1 Additional outcomes:
catheter After 7 days the dressing Dressing condition,
Hospital,
was removed and the site durability, moisture
district
inspected and re-cleansed accumulation, pain,
general All patients
hospital with N: 101 ease of removal.
medical and Group 1
Age (mean):
surgical Transparent dressing
Drop outs: (13 patients were
wards. (polyurethane film,
randomised, but not analysed – no
Netherlands continuously spread with
intention to treat performed)
vinyl ether adhesive) –
Group 1 (OpSite, Smith and Nephew,
Duration of N: 50 Age (mean): 70.1 Hull, UK)
follow-up:
Male/female: 27/23
Up to 3
No of catheters: 50 Group 2
weeks
Total catheter days: 402 Transparent dressing
No. of dressings: 79 (hydrophilic polyurethane
Group 2 film pattern-spread with a
water-based acrylic
N: 51 Age (mean): 64.1
adhesive) - (OpSite IV3000,
Male/female: 27/24 Smith and Nephew, Hull,
No of catheters: 51 UK)
Total catheter days: 378
No. of dressings: 74
304

details
Lecorre Patient group: The catheter used for Bacteremia Group1: 1 Funding:
256
2003 Haemodialysis patients with a haemodialysis was a double Group 2: 2 Funded in part by
long term central venous lumen, tunnelled and inserted in research grants from
Study catheter. the intern jugular vein. 3M Canada Company,
Per 1000 catheter days
design: An aqueous solution of CR Bard Canada and
Group1: 0.30 SoluMed Canada.
RCT Inclusion criteria: chlorhexidine 2% was used for
skin asepsis. The exit site was Group 2: 0.47
Patients aged at least 18 years P = 0.44
covered temporarily with dry Limitations:
Setting: old, require hemodialysis
gauze until the next dressing
Canada treatment for chronic terminal
change. Local infection (exit site Group1: 0
renal insufficiency, had a
tunnelled central venous catheter No ointments or topical infection) Group 2: 1 Additional outcomes:
Duration of inserted in the jugular vein by a antimicrobial creams were used.
Skin condition, quality
follow-up: vascular radiologist and were Per 1000 catheter days of life – states no
6 months competent and able to sign the Group 1 significant difference
Group1: 0
informed consent form. Standard polyurethane between the 2 groups,
Group 2: 0.23
transparent dressing (3M but actual values not
Tegaderm 1635 transparent Iv P = 0.43 given.
Exclusion criteria:
Patients with any other type of dressing) that was replaced
permanent or temporary catheter every 7 days during scheduled Total catheter days Group1: 3348
or a catheter inserted at a visit to the Haemodialysis unit Group 2: 4286
different site than the jugular
vein, were on systemic antibiotic Group 2
therapy, had a history of 4x4 sterile dry gauze attached
bacteremia during the last 3 with stretch bandage (Mefix
months and their catheter was Tendra) that was replaced every
not changed. Also subjects with 2-3 days depending on the
known dermatitis at the exit site scheduled visit for hemodialysis
or known hypersensitivity to a treatment (3 times/week)
component of either dressing.
All patients
N: 62 (58 enrolled)
305

details
Age (mean):
Drop outs: 2 voluntarily withdrew,
1 catheter was removed prior to
study start date, 1 patient died.
Group 1
N: 29
Age (mean): 74 (36-87)
Male/female: 13/16
Group 2
N: 29
Age (mean): 71 (50-88)
Male/female: 14/15
306
G.7.3 Frequency of dressing change

details
Vokurka Patient group: Transparent Local cutaneous Healthy skin Funding:
484
2009 Patients with acute myeloid leukaemia polyurethane semi- damage Group1: 25 Unsponsored
treated with intensive chemotherapy. permeable occlusive Group 2: 26
Study dressings (Bioclusive, Limitations:
design: Johnson and Johnson) In the once weekly
Inclusion criteria: Erythema
and non-tunneled group, only 58% of the
RCT Adults with AML treated with intensive Group1: 11
polyurethane CVCs dressing changes were
chemotherapy containing cytosine- were used. The CVCs Group 2: 6
arabinoside and anthracyclines. performed to protocol
were inserted into the The mean interval was
Setting: vena subclavia. Erythema with itching or dry reduced to 5.4 days,
Hospital, Exclusion criteria: Povidone-iodine was desquamation, instead of the original
Czech Patients with damaged skin at baseline, used for skin 7 days. The main
Group1: 5
Republic those allergic to disinfectant, acrylate, or disinfection at the time reasons for these
of CVC insertion and Group 2: 7
polyurethane, and patients with unplanned dressing
radiotherapy of the chest in their history before any occlusive changes were an
Duration of
were excluded. dressing application. Moist desquamation, unstitched or soiled
follow-up:
Group1: 1 dressing (52%), local
1 month
All patients Group 1 Group 2: 0 bleeding (28%),
N: 81 Dressing changed insertion site
twice weekly (3-4 days) Deep ulceration, necrosis inflammation in 10%
and other reasons
Group 1 Group1: 0
10%.
N: 42 Group 2 Group 2: 0
Dressing changed once
Age (mean + SD): 49.9 (10.7) 80% of the changes
weekly (every 7 days)
Male/female: 26/16 p value: not significant were performed to
Mean days (SD) with occlusive dressing: CVC insertion site Group1: 55% protocol in group 1,
22.8 (8.6) inflammation (local Group 2: 25% with a mean interval
The dressings could be circular redness of 3.8 days.
Mean (SD) number of dressing changes:
changed sooner in case accompanied, in the
5.9 (2.5) p value: 0.008
of an unstitched, loose, case of larger
or soiled dressing, Additional outcomes:
reactions, with
Group 2 insertion site Tolerance and pain
swelling and pain on
N: 39 inflammation, local palpation in the area
307

details
Age (mean + SD): 41.4 (14.9) cutaneous damage, in- surrounding the point
Male/female: 19/20 site bleeding, or other of percutaneous
significant (technical) insertion).
Mean (SD) days with occlusive dressing:
reason. Blood culture positivity Group1: 21%
25.1 (13.2)
Mean (SD) number of dressing changes: Group 2: 21%
4.5 (2.4)
308
G.7.4 Skin decontamination during dressing change for vascular access devices (peripheral and central access)
details
Maki1991 Patient group: patients with Group 1 Catheter tip Group 1: 5/214 Funding:
282 CVC inserted colonisation defined as
2% chlorhexidine Group 2: 21/227 Stuart Corporation,
gluconate aqueous growth of ≥ 10 3 cfu per Group 3: 11/227 manufacturer of CHG
Inclusion criteria: ml from the distal 4-5 gluconate
Study Relative risk: see full guideline
cm of the catheter.
design: All patients over 18 years old Group 2
RCT scheduled for insertion of 10% povidone iodine Limitations:
VAD line removal or Not reported
central or arterial catheters aqueous solution Methods of
frequency of line
randomisation allocation
Setting: removal
All patients Group 3 and concealment unclear
Surgical ICU, Infection-related Not reported
N: 306 catheters in 125 70% isopropyl alcohol Randomised according to
US 1986- mortality
patients catheter, not patients
1987 Septicaemia Not reported
Drop outs: 83/306 catheters For both groups: Blinding not possible for
did not meet inclusion VAD related Group 1: 1/214 staff, but microbiologist
Duration of Catheter insertion:
criteria bacteraemia: Group 2: 6/227 blinded.
follow-up: All catheters were
Semiquantitative Group 3: 3/227
inserted by house
catheter culture and **Relative risk: see full guideline
Group 1: 2% CHG aqueous officers wearing sterile
blood cultures positive
N: 214 catheters included in gloves using the P value: Not stat sig
for the same microbial
analysis Selfdinger technique.
species, with a negative
Drop outs: culture of infusate and
*Age mean : 51±19 Before insertion, the no other apparent
M/F: NR entry site was scrubbed source of septicaemia
vigorously with the
VAD related phlebitis Not reported
solution for 30s, and the
Group 2: 10% aqueous iodine excess wiped off with VAD related local Erythema
N: 227 catheters included in sterile gauze. infection Group 1: 45.3%
analysis Group 2: 28.3%
Drop outs: Catheters were dressed Group 3:39.2%
*Age mean: 53±19 with sterile gauze and
M/F: NR tape Pain at site of insertion:
Group 1: 20.4%
Group 2: 70% isopropyl Dressing change: Group 2: 19.3%
309

details
alcohol Dressing removed every Group 3: 20.4%
N: 227 catheters included in 48 hours, site inspected
analysis and released with the Tenderness
Drop outs: designated agents.
Group 1: 31.1%
*Age mean: 53±19 Group 2: 32.7%
M/F: NR Group 3: 25.0%

details
Valles2008 Patient group: Group 1 Catheter tip Intention to treat analysis Funding:
476 colonisation defined as MediFlex ( supplier of
Consecutive central venous 2% CHG in aqueous Group 1: 36/116 (31%)
Study catheter or arterial catheter solution (prepared in the growth of ≥ 15 cfu from Group 2: 27/116 (23%) 0.5% tincture of
design: inserted pharmacy) a semiquantitative chlorhexidine), and
**Relative risk: 1.33 [95% CI: 0.87,
culture of the catheter Physician Services
RCT, block 2.04]
tip by the roll plate Incorporated.
randomisati Inclusion criteria: Group 2 P value: Not stat sig
technique
on > 18 years of age 0.5% CHG in alcohol
Limitations:
Catheter tip colonisation ( per Allocation concealment
Setting: Exclusion criteria: Group 3 protocol analysis) potentially compromised
Medical catheters inserted into 10 % PVP-I in aqueous Group 1: 31/92(34%) 34 cases per – block randomisation
surgical ICU patients before they were solution 1000 catheter days followed by treatments
of teaching admitted to the ICU Group 2: 24/88 (27%) 46 cases per that are visually different
hospital, catheters inserted with the For all groups: 1000 catheter days Baseline catheter
Spain from use of a guidewire For insertion: The site of **Relative risk: 1.24 [95% CI: 0.79, characteristics only
January 1, catheters inserted for CVC or AC insertion was 1.93] reported for patients
2005, to hemodialysis or for long- prepared with the who had catheter in
P value: Not stat sig
June 30, term total parenteral appropriate agent and place for more than 72
2006, VAD line removal or Not reported
nutrition or chemotherapy was allowed to dry hours
frequency of line
pulmonary artery catheters according to a
removal
Duration of catheters removed within standardized protocol.
follow-up: All catheters were Infection-related Not reported
less than 24 hour of their Additional outcomes:
mortality
310

details
insertion inserted by medical or All cause mortality Hypersensitivity: none
catheters that remained in nursing staff using Group 1: 29/106(27.1%) reported
place 72 hours after patients maximal barrier
Group 2: 22/106(19%)
were discharged from the precautions (ie, using
Group 3: 25/106(23.6%) Notes:
ICU. sterile gloves, gowns,
VAD related Per protocol analysis ** values calculated by
masks, and large
Septicaemia NCGC
drapes). Group 1: 17 per 211 catheters (8%)
All patients Microbiological
semiquantitative Group 2: 15 per 226 catheters (6.6%)
N: 631 CVCs and ACs catheter-tip culture was techniques performed by
inserted into 329 patients Dressing change: Sterile Group3: 19 Per 194 catheters (10%) laboratory staff blinded
gauze dressings were positive for a
were included in the study **Relative risk: to treatment assignment
changed every 72 hours, microorganism, the
for per protocol analysis out patient had a Group 1 vs 2:
of 998 catheters were or sooner if soiled or
temperature of 38.5°C Group 1 vs 3:
inserted in 420 patients wet, and the catheter
insertion site was or more, and the Group 2 vs 3:
cleansed with the agent patient had a sustained P value: Not stat sig for all
Group 1: Chlorhexidine 2% to which the patient had reduction of at least
aq been randomized. 1°C of body
Tincture temperature within 48
N: 339 catheters for ITT hours after catheter
All catheters were cared removal, with no other
107 patients, 211 catheters for in a similar manner. apparent cause of fever
for per protocol analysis
Age, mean ± SD, years: 60±16 VAD related Group 1: 9 per 211 catheters (4.26%)
bacteraemia, Group 2: 9 per 226 catheters (3.98%)
APACHE II score, mean ± SD:
20±7 the same Group3: 9 Per 194 catheters (4.63%)
microorganism (ie, the **Relative risk:
Duration of catheterization,
same species with the
mean ± SD: 7.5±4.5 Group 1 vs 2: 1.07 [0.43, 2.65]
same antibiotic
CVC used: 129/211(61.1%) susceptibility profile) Group 1 vs 3: 0.92 [0.37, 2.27]
AC used: 82/211(38.9% was recovered from the Group 2 vs 3: 0.86 [0.35, 2.12]
catheter-tip culture and P value: Not stat sig for all
Group 2 Chlorhexidine 0.5% from blood culture.10
alc VAD related phlebitis Per protocol analysis
N: 329 catheters for ITT, Measured as local Group 1: 35 per 211 catheters (16.8%)
116 patients, 226 catheters inflammation at the site Group 2: 38 per 226 catheters (17%)
311

details
for per protocol analysis of catheterisation Group3: 30 per 194 catheters (15.6%)
Age, mean ± SD, years: P value: Not stat sig for all
61±17 VAD related local Not reported
APACHE II score, mean ± SD: infection
19±6
mean ± SD: 7.1±4.1
CVC used: 139/226(61.5%)
AC used: 87/226(38.5 %)
Group 3: 10% PVP-I in aq

N: 329 for ITT, 106 patients,
194 catheters for per
protocol analysis
Age, mean ± SD, years: 61±17
APACHE II score, mean ± SD:
18±9
mean ± SD: 7.7±4.8
CVC used: 112/194(57.7%)
AC used: 82/194(42.3%)
312

details
Humar2000 Patient group: Group 1 Catheter tip Intention to treat analysis Funding:
199 colonisation defined as MediFlex ( supplier of
Patients with central venous 0.5% tincture of Group 1: 36/116 (31%)
catheter inserted for any chlorhexidine (alcoholic) growth of ≥ 15 cfu from Group 2: 27/116 (23%) 0.5% tincture of
purpose a semiquantitative chlorhexidine), and
Study **Relative risk: 1.33 [95% CI: 0.87,
culture of the catheter Physician Services
design: Group 2 2.04]
tip by the roll plate Incorporated.
RCT, block Inclusion criteria: 10% povidone iodine P value: Not stat sig
technique.
randomisati > 18 years of age
Limitations:
on Treating physician felt that For both groups: Catheter tip colonisation ( per Allocation concealment
the inserted catheter would The agents were prior to protocol analysis) potentially compromised
Setting: be present for minimum of insertion and Group 1: 31/92(34%) 34 cases per – block randomisation
3 teaching 72 hours subsequent catheter 1000 catheter days followed by treatments
hospitals, The CVC consistent of care. Group 2: 24/88 (27%) 46 cases per that are visually different
including 2 conventional singe- or multi- 1000 catheter days Baseline catheter
surgical lumen polyurethane For insertion: Site for the **Relative risk: 1.24 [95% CI: 0.79, characteristics only
ICUs, 1 catheters, silicone catheters, CVC cannulation was 1.93] reported for patients
medical ICU and pulmonary arterial prepared with the agent P value: Not stat sig who had catheter in
and 1 catheters and allowed to dry place for more than 72
neurological according to standard VAD line removal or Not reported
hours
ICU All patients protocol. All catheters frequency of line
were inserted by staff removal
N: 374 Additional outcomes:
Duration of who used maximum Infection-related Not reported
Drop outs: 132/374 had line Purulent exit site
follow-up: barrier precautions with mortality
removed before 72 hours or infection: CHG: 0/125,
died sterile gloves, gown, Septicaemia Stated in protocol but not reported in
mask and large drapes. mean 3.1±1.9 x105
results
cfu/mL per 25cm2
Group 1: Chlorhexidine 0.5% VAD related Intention to treat analysis Povidone Iodine: 4/117
tincture Dressing change: Sterile bacteraemia, defined as Group 1: 4/193 (2.1%) 3.9 cases per (3.4%), mean 5.9±2.6
gauze dressings were single positive blood 1000 catheter days
N: 193 (baseline data for x105 cfu/mL per 25cm2
changed every 72 hours culture, with no other
125 patients reported) Group 2: 5/181(2.8%) 4.4 cases per
or sooner if soiled or source of bacteraemia
Drop outs: 68/193 (35.3%) 1000 catheter days Secondary bacteraemia
wet. The catheter exit in the presence of a
Age mean±SD (range): site was cleansed for 20- **Relative risk: 0.75 [95% CI: 0.20, (from a source other
culture of a catheter
58.3±16.8 30s with the agent. 2.75] than CVC): 22/125
segment from which
M/F: 78/47 the same organism was P value: Not stat sig (17.6%) in the
313

details
APACHE II score: 21.2±8.9 isolated. If results of chlorhexidine and
Other devices: No silver antiseptic or molecular subtyping These were two other “probable 13/117 (11.1 %) patients
antimicrobial was discordant, cases” – catheter tip not retrieved to in the povidone iodine
Endotracheal tube:
impregnated catheters patients were verify diagnosis, one in each group
97/125(77.6%)
were allowed for considered to have treatment arm.
Mean amount of time
patients involved in the bacteraemia from Notes:
catheter in situ (days): 6.9 ±
study. another source
3.6 VAD related bacteraemia ** values calculated by
Group 1: 4/125 (3.2%) 4.6 cases per NCGC
Group 2: Povidone Iodine 1000 catheter days Study reported the
Group 2: 4/117(3.4%) 4.1 cases per intention to treat
N: 181 (baseline data for 117
1000 catheter days analysis results and per
patients reported for
protocol analysis (only
baseline data) **Relative risk: 0.94 [95% CI: 0.24,
including patients who
Drop outs: 64/181 (35.4%) 3.66]
had catheter for more
Age mean±SD P value: Not stat sig
than 72 hours)
(range):62.2±16.0 VAD related phlebitis Not reported Catheter sites inspected
M/F: 96/204 VAD related local Intention to treat analysis: every 72 hours for
APACHE II score: 19.7±8.1 infection – purulent Group 1: 0/193 evidence of infection,
Other devices: discharge from the exit Group 2: 4/181 including erythema, and
Endotracheal tube: 89/125 site, regardless of purulent discharge at the
**Relative risk: 0.10 [ 95% CI: 0.01,
(76.1%) whether an organism exit site. Decisions to
1.91]
was cultured from the remove catheters were
Mean amount of time P value: 0.053
catheter in situ (days): 8.3 ± site made independently by
6.9 days – reported in text the treating physicians.
Per protocol analysis: Microbiological
(reported as 8.3 ±7.8 in table
2) Group 1: 0/125 techniques performed by
Group 2: 4/117 ( 4.1/1000 catheter laboratory staff blinded
days) to treatment assignment
**Relative risk: 0.10 [95% CI: 0.01,
1.89]
P value: 0.053
314

details
Mimoz2007 Patient group: Group 1 Catheter tip colonisation All evaluable cases Funding:
298 defined as quantitative Bayer Healthcare,
Patients in a surgical ICU with 0.25% chlorhexidine Group 1: 28/242 (11.6%) 9.7 per
central venous catheter gluconate, 0.025 culture of at least 1 1000 catheter days Viatris
benzalkanium microorganism at a Group 2: 53/239 (22.2%) 18.3 per Pharmaceuticals,
Study
chloride, and 4% concentration of 1000 catheter days Centrale Hospitalier
design: Inclusion criteria:
benzylic alcohol 1000cfu/ML or greater. et Universitaire de
RCT – Consecutively scheduled non- Relative risk: 0.52 [0.34, 0.80]
(Biseptine TM, Bayer) Pottiers
randomised tunnelled central venous catheters P value: 0.002
by catheter expected to remain in place for 3
Group 2 Limitations:
days or more. Ultrasound was not Catheter in place for > 3 days
used to guide catheter reinsertion 5% povidone Iodine in Consecutively
Setting: Group 1: 28/204 (13.7%) scheduled CVC
70% alcohol (Betadine
May 2004 to TM Viatris) Group 2: 52/211(24.6%) insertion was
June 2006 in Exclusion criteria: randomised and
VAD line removal or Mean duration of catheter
ICU surgical Catheters inserted outside ICU, in stratified by site of
Method of frequency of line placement:
unit of a patients with a history of allergy to insertion in blocks of
disinfection: removal Group1:12.0±9.1
university any of the agents, at an existing site 8
affiliated of a guide wire, via femoral route or At insertion: Skin was Group2: 12.1±9.2
Allocation
hospital for hemodialysis disinfected twice Infection-related 3 patients with VAD related blood concealment
(once before and once mortality stream infection died, but “the potentially
after placement of medical staff did not consider any
Duration of Group 1: Chlorhexidine based compromised
large disposal drapes) death to be unequivocally linked to
follow-up: solution because interventions
with the assigned catheter related sepsis)
72 hours N: 195 patients, 242 catheters are visually different (
solution for at least
post IV line Drop outs: 28 catheters not Septicaemia Not reported non blinded).
30s and allowed to dry
removal evaluable out of 270 randomised VAD related blood Group 1: 4/242 (1.7%) 1.4 per 1000 However,
between each
stream infection defined catheter days investigators
Age mean±SD (range):57±18 antiseptic application.
as the isolation of the assessing outcomes
M/F: 163/32) Group 2: 10/239 (4.2%) 3.4 per
same microorganism and microbiologists
SAPSII: 42±17 Dressing change: 1000 catheter days
from the catheter and were blinded to
every 72 hours, Relative risk: 0.40 [0.13, 1.24] intervention type.
from ≥ 1 cultured
Group 2: 5% Povidone Iodine in 70% dressings removed by P value: 0.09
peripheral blood sample
ethanol nurse wearing a cap, a
drawn 48 hours before Additional outcomes:
surgical mask and
N: 204 patients, 239 catheters or after catheter Independent factors
sterile gloves.
Drop outs: 29 catheters not removal in patients with for catheter
Catheter insertion
clinical manifestations
315

details
evaluable out of 268 randomised sites was then and no other apparent colonisation were
Age mean±SD (range):58±19 inspected for signs of source except the insertion at the
M/F: 181/23* infection or catheter jugular vein
inflammation and VAD related phlebitis Group 1: 64/242 (26.4%) (ARR2.01), use of
SAPSII: 43±16
disinfected with the povidone iodine(ARR
Skin inflammation at Group 2: 64/239 (26.8%)
assigned antiseptic 1.87) and time from
*More male patients in povidone insertion sites Relative risk: 0.99 [0.73, 1.33]
solution, and a new ICU admission to
iodine group (P=0.04) sterile gauze was P value: 0.93 catheter
applied VAD related local Not reported insertion(ARR1.02).
infection
Catheter: 20-cm long, Notes:
7F triple lumen, SAPSII = Simplified
unimpregnated Acute Physiology
polyurethane central Score II
venous catheters were
placed percutaneously
using Seldinger
techniques
316

details
Parienti Patient group: Group 1 Catheter tip Group 1: 41 per 117 catheters (35.0%) Funding:
2004 All consecutive CVCs inserted 10% PVP-I aqueous colonisation defined as Group 2: 14 per 106 catheters (13.2%) Supported in part, by
347 growth of ≥ 10 3 cfu per
solution **Relative risk: 2.65 [1.54, 4.58] government grants
ml from the distal 4-5 P value: <0.001
Inclusion criteria:
cm of the catheter. Limitations:
Study All consecutive CVC inserted Group 2
design: 5% PVP-I in 70% ethanol VAD line removal or Not reported The denominators are
Cross over solution frequency of line the number of catheters
Exclusion criteria: removal
trial, used, instead of number
CVC insertion over a of patients. Number of
randomised For both groups: Infection-related One death was a consequence of CVC
guidewire (allowed in case of patients randomised to
by unit mortality related bacteraemia (MRSA
CVC malfunction if no Catheter insertion:
endocarditis) in the aqueous povidone each arm not reported
infection was present) All catheters were
Setting: iodine arm This was a cluster
CVC removal within 72 hours inserted by staff who
Septicaemia Not reported randomised trial
Two medical used maximum barrier
ICU units in a precautions with sterile VAD related Group 1: 4 per 117 catheters (3.4%)
All patients Additional outcomes:
teaching gloves, gown, mask and bacteraemia Group 2: 1 per 106 catheters (0.9%)
hospital, Jan N: 306 catheters in 125 large drape using defined as catheter tip **Relative risk: 3.62 [0.41, 31.91]
2001 to Jan patients Selfdinger technique. colonisation plus a P value: Not stat sig Notes:
2002. France Drop outs: 83/306 catheters Before insertion, the peripheral or central ** values calculated by
did not meet inclusion entry site was scrubbed blood culture yielding NCGC
criteria with 4% povidone iodine the same species as
solution, rinsed with catheter tip within 48
Duration of A random number was
Group 1: 10% aqueous iodine sterile water and dried hours of CVC removal
follow-up: used to assign the
N: 117 catheters included in with sterile gauze. with no other apparent
12 month Protocol solution was alcoholic povidone iodine
analysis source of sepsis
study then applied for ≥2 to one of two units.
period, cross Drop outs: VAD related phlebitis Not reported Every 3 months, each
minutes. After
over every 3 *Age mean: 61.5 placement of sterile VAD related local Not reported unit switched from one
months M/F: NR drapes, the physician infection product to another. The
APACHE II score: 26.3 again disinfected the assigned product was
skin with the protocol used before CVC
*Organ failure score ≥2:
solution. insertion and during the
68/117
following care. When
Mean amount of time protocols are switched,
catheter in situ (days): Dressing change:
317

details
9.0±4.4 Transparent sterile CVCs already in place
dressings were inspected continued to be cared for
Group 2: 5% PI in 70% daily and changed every using the same antiseptic
ethanol 72 hours. Connections until their ablation.
were manipulated with
N: 106 catheters included in
gauze soaked in the
analysis
protocol solution.
Drop outs:
*Age mean : 54.4
Others:
M/F: NR
Peripheral skin
APACHE II score: 27.8 disinfection before
*Organ failure score ≥2: catheter ablation were
87/106 performed with 10%
Mean amount of time aqueous povidone iodine
catheter in situ (days):
8.7±4.8
*statistically significant
(P<0.05) between the two
groups
318
G.7.5 Skin decontamination prior to insertion of vascular access devices (peripheral access)
details
Small et al Patient group: Group 1 Catheter tip colonisation, Group 1: 18/91 (19.8%) Funding:
442
2008 Elective cardiology patients 2% chlorhexidine gluconate determined by Group 2: 39/79 (49.4%) Enturia, manufacturer
admitted for ablation or (CHG) in IPA solution (in a quantitative tip culture. Relative risk (95% CI): or 2 % CHG tips used
Study pacemaker insertion at Sepp 0.67 mL applicator; The distal 3 cm of each
0.40 (0.25, 0.64)
design: Enturia) PVC tip was vortexed in 1 Limitations:
mL of saline solution for p value: 0.0001
RCT Inclusion criteria: Large proportion of
60 seconds, then 100 μL of drop outs 60/230 (26%)
Not stated Applied using a standard
the liquid was inoculated Calculated by NCGC using
Setting: back‐and‐forth stroke over Not blinded –
onto a blood agar plate methods in Cochrane
the entire skin insertion site interventions physically
University Exclusion criteria: (Oxoid) that was Handbook
for 30 seconds. different
Hospital Less than 18 years of age, had incubated in air at 37° C
Birmingham, for 48 hours. The number Length of follow up not
skin dermatoses, had a Additional info:
United Group 2 of colony‐forming units specified
chlorhexidine allergy Mean number of CFUs yielded
Kingdom. Wipes containing 0.6 mL of was determined, and Only reported there
70% IPA (Steret; Seton from each culture‐positive PVC were no evidence of
microorganisms were
All patients Prebble) tip : infection* (see
Duration of identified by routine
N: 230 methods Group 1: 4 “Notes”)
follow-up:
Age (mean): 61.3 years (range, Applied for 30 seconds, Group 2: 2 Method of
Unclear 21–96 years) utilizing a circular randomisation and
M/F: 107/63 movement as in routine More than one type of allocation concealment
Drop outs: 60** clinical practice. microorganism was present on unclear
5 tips from the CHG in IPA
Group 1 Both groups: group and on 8 tips from the Additional outcomes:
IPA group. Chlorhexidine
N: 91 Each antiseptic was allowed
Age (mean): Not reported to dry for 2 minutes before VAD line removal or Group 1: 2.3 days (range, 1–6 sensitivity: None
a polyurethane PVC (Optiva frequency of line removal days) Treatment with
M/F: 60/31
2, Medex Medical) was (measured as mean Group 2: 2.2 days (range, 1–4 antibiotics: None
Drop outs: Not reported indwelling period of the
inserted into a superficial days) Antibiotic prophylaxis
vein of the hand. A PVC tips ) Mean difference: 0.1 days for the cardiologic
Group 2 semipermeable dressing procedure
P value: 0.07
N: 79 was applied over the (flucloxacillin) : given
Infection-related Group 1: 0/91
Age (mean): Not reported insertion site. for 24 hours to 16
mortality* Group 2: 0/79
319

details
M/F: 47/32 Relative risk: Not estimable patients in the 2% CHG
Drop outs: Not reported Prior to PVC removal, the Septicaemia Not reported in IPA group and to 18
insertion sites were cleaned patients in the IPA
VAD related blood stream Group 1: 0/91 group.
** Reasons for exclusions: with 70% IPA. Clean, non-
infection/ Bacteraemia Group 2: 0/79
sterile gloves, but not
discharged prior to study Relative risk: Not estimable
masks, were worn by the Notes:
completion (n=1)
operator, and the PVC tips VAD related phlebitis – Not reported *the paper only
the PVC was in situ less than 24 were not handled during VAD related soft tissue Group 1: 0/91 reported that “None of
hours (n=10), explantation. infection/local Group 2: 0/79 the patients exhibited
the PVC was accidentally
infection/skin infection* Relative risk: Not estimable evidence of infection”
discarded (n=23),
Clarifications obtained
a PVC different from all the from author – VAD
others in the study was used related blood stream
(n=1) infection and local
the explanted PVC was placed in infections were
a nonsterile dressing (n=25). measured.
With the achieved

sample sizes, the study
had a 90% power to
detect a difference of
infection rates of 50%
with 70% IPA and a
25% with 2% CHG in
IPA; the level of
significance was set at
0.05
320
Study details Patients Interventions Outcome measures Effect size Comments

deVries et al Patient group: Group 1 Catheter tip colonisation, Not reported Funding:
96
1997 Admitted to pulmonary ward for 2% iodine in 70% alcohol VAD line removal or Not reported Not reported
parenteral prednisone for exacerbation frequency of line removal
Study design: of COPD Group 2 Infection-related mortality Not reported Limitations:
RCT Inclusion criteria: 70% alcohol Not blinded
Septicaemia Not reported
Not reported Small sample
VAD related blood stream Not reported size
Setting: Exclusion criteria: Both groups: infection/ Bacteraemia*
400 bed Previous skin reactions to one of the skin Catheters inserted by medical
disinfectants VAD related phlebitis Group 1: 12/54 (22.6%)
municipal students or house officers.
teaching Imminent death Skin shaved before inserted in “Phlebitis” diagnosed if Group 2: 6/55 (10.6%) Additional
hospital, patient consented. two or more of these Relative risk (95% CI): 2.04 outcomes:
Netherlands criteria were present at (0.82, 5.04)
All patients Phlebitis rates
the insertion site : pain, P value: 0.12
N: 125 Age (mean): NR Following skin disinfection, with and
tenderness, erythema,
Duration of skin was allowed to dry. The Calculated by NCGC using without
Drop outs: 16 (4 accidental removal of swelling, purulence and a
follow-up: infusion sites covered with methods in Cochrane theophylline
catheter, 3 removed catheter because of palpable venous cord
96 hours gauzes measuring 5x5cm, and Handbook infusions
technical problems, 4 had dressings
which did not conform to protocol and 5 an open dressing(Hypafix
had stopped prednisone infusion before Smith & Nephew, Hull UK). None of these patients Notes:
endpoint) Venflon 2 catheters, 18 and had purulence Chi square test
20 G were used (BOC Ohmeda VAD related soft tissue Not reported was used
Group 1
AB, Helsingborg, Sweden). infection/local
N: 54 Age (mean): 65.3 (12.4)
infection/skin infection*
M/F: 38/17
Usual infusion scheme:
Catheters inserted on hands: 7(13.0%)
2 days of prednisone infusion
Inserted by physicians: 13(24.1) 60mg/day, dissolved in
Drop outs: not reported normal saline, two days 50
Group 2 mg/day, and 2 days 40mg/day
N: 55 Age (mean): 69.5(10.5) after which prednisone was
M/F: 38/17 continued orally. Theophylline
600mg/day added in
Catheters inserted on hands: 4 (7.3%)
indicated.
Inserted by physicians: 16(29.1%)
Drop outs: not reported (%)
321

details
Cobbett Patient group: Group 1 Catheter tip colonisation Not significant (p=0.62) different Funding:
1999 Patients from various nursing units, 0.5% chlorhexidine defined as growth of ≥ between groups. Not reported
77 from a proximal or distal
including medical, surgical, obstetrical gluconate/70%
and outpatient/emergency isoprophyl alcohol catheter segment in the Limitations:
swab absence of accompanying Number of patients
Study
clinical symptoms followed up or
design: Inclusion criteria:
RCT Ability to read in English and providing Group 2 VAD line removal or Not reported analysed in each
consent Alcohol swab frequency of line removal group not reported
required a peripheral IV line followed by povidone Infection-related mortality Not reported
Setting:
iodine swab Septicaemia Not reported Additional
Canadian
outcomes:
regional All patients VAD related blood stream Not reported
hospital Group 3 infection/ Bacteraemia* There were
N: 300
Povidone iodine significantly less
Drop outs: not reported swab followed by VAD related phlebitis Not reported redness (p=0.001),
Duration of Age mean±SD (range):55.1±19.5 (13 to alcohol swab VAD related local Group 1: 1.2% pain (p<0.0001)
follow-up: 94) infection, Group 2: 12.5% and increase in
72 hours M/F: 96/204 “probable infection” temperature
Group 3: 9.88%
post IV line Most common category of admission: defined as one or more of (p=0.03) in Group 1
P value: 0.008 (“analysis of
removal gynaecological (32%) the following: fever, compared to the
variance”, reported by author)
Received continuous IV solution: 94% (>38.5%) or pain, others at 72 hours
erythema or heat at the post IV removal at
Mean amount of time IV in situ (hours): There were a total of 19
involved vascular access the insertion site
43.5 ±48.9 infections. The number of
site and more than 15
colony forming units patients followed up in each
group not reported. Notes:
Note: cultured from
Chi square test was
Baseline information for each group not intravascular cannula tip
used
reported separately. Authors reported using semi quantitative “majority of identified infections
no significant difference in the following culture method. were assessed in post-discharge
variables: age, gender, medical patients”.
diagnosis, type of IV fluid, catheter size,
type of IV medication, classification of
initiator, and length of time IV in place.
322
Economic evidence tables
Appendix H: Economic evidence tables

H.1 Hand decontamination
H.1.1 When to wash hands
K.L. Cummings, D.J. Anderson, K.S. Kaye. Hand hygiene noncompliance and the cost of hospital-acquired methicillin-resistant staphylococcus aureus infection.
87
Infection Control and Hospital Epidemiology. 31(4):357-364. 2010.
Study details Population & interventions Costs Health outcomes Cost effectiveness
Economic analysis: Population: Total cost of MRSA infection Primary outcome measure: Primary ICER (Intvn 2 vs Intvn 1):
CCA Healthcare settings with a risk (mean): Contaminated encounters NA
of MRSA transmission Scenario 1: £30, 610 (per 1 million noncompliant
Approach to analysis: Scenario 2: £34, 839 direct patient contacts): Other:
A stochastic model was Scenario 1: Normal risk Scenario 3: £37, 337 Scenario 1: 44, 284 Mean cost per noncompliant direct patient
developed to simulate Healthcare worker hand Scenario 2: 953, 912 contact :
a scenario in which the decontamination Currency & cost year: Scenario 3: 44, 173 Scenario 1: £1.29 (95% CI, £0.59 - £1.98)
healthcare worker noncompliance between US dollars, year NR (assumed Scenario 2: £34.14 (95% CI, £31.02 - £37.25)
contacts 2 patients contacts with two patients of to be 2009; presented here as Other outcome measure: Scenario 3: £1.01 (95% CI, £0.30 - £1.71)
consecutively and fails unknown MRSA status. 2009/10 UK pounds‡) Episodes of hospital-
to comply with hand
acquired MRSA colonisation Analysis of uncertainty: The simulation
hygiene guidelines Scenario 2: High risk Cost components (per 1 million noncompliant analyses were applied to a hypothetical 200-
after contact with the
Healthcare worker hand incorporated: direct patient contacts): bed hospital at 85% occupancy. Sensitivity
first patient and before
decontamination Total hospital cost of treating Scenario 1: 143 analysis was performed on the hand
contact with the
noncompliance between two an MRSA infection. Scenario 2: 3, 340 decontamination compliance rate to
second patient (NDCs).
patient contacts when the determine the cost-benefit of increasing
One million NDCs were Scenario 3: 83
first patient was colonised or hand decontamination compliance by 1%
simulated in order to infected with MRSA and the
quantify the cost of a and 5%.
MRSA status of the second Episodes of hospital-
single NDC. patient was unknown. acquired MRSA infection
Perspective: (per 1 million noncompliant Increasing hand decontamination compliance
USA Hospital direct patient contacts): by 1% resulted in a decrease of annual NDCs
Scenario 3: Alternative model by 20,046, prevention of 0.84 MRSA
Scenario 1: 42
Transmission of MRSA was infections and a mean decrease in expected
Time horizon: not caused exclusively by Scenario 2: 980
323
K.L. Cummings, D.J. Anderson, K.S. Kaye. Hand hygiene noncompliance and the cost of hospital-acquired methicillin-resistant staphylococcus aureus infection.
87
Infection Control and Hospital Epidemiology. 31(4):357-364. 2010.
direct patient contact – Scenario 3: 27 MRSA-related costs of £25, 772.
Treatment effect transmission could occur via
duration: contaminated environmental Increasing compliance by 5% resulted in a
surfaces. This scenario decrease in NDCs of 100, 232, prevention of
NA
assumed that each 4.21 MRSA infections and a mean decrease in
noncompliant event exhibited MRSA-related costs of £128, 863.
Discounting: an equal probability of MRSA
N/A transmission regardless of
whether direct patient
contact had occurred.
Data sources
Health outcomes: Data regarding hospital admissions and episodes of contact obtained from Duke University Medical Centre. MRSA prevalence rates and rates of hand
decontamination compliance obtained from reports by Jarvis 2007 and Dedrick 2007. The daily noncompliant direct patient contact rate was calculated by multiplying
daily healthcare worker-patient contact rate by (1 - rate of compliance).
Quality-of-life weights: NA
Cost sources: The cost of each episode of MRSA infection was based on the median value reported by Abramson and Sexton 1999, who reported the cost distribution
among published studies. The autors used the upper and lower estimates of the published ranges as the upper and lower CIs in order to generate a lognormal distribution
for this range.
Comments
Source of funding: National Institute of Aging; John A. Hartford Foundation; Department of Infectious Disease at Duke University Medical Centre. Limitations: Cost of
hand decontamination product not accounted for; rate of patient contact, exposure, and transmission may be different in a UK community setting; health effects not
expressed as QALYs. Other: In the model it is assumed that: every day a healthcare worker enters a patient’s room 56.38 times and 57.24% of room visits involve direct
patient contact (=32.27 direct contacts per day), hand decontamination compliance is 55.13%, the prevalence of MRSA is 4.63% (therefore the probability of being MRSA
+ve is 0.463), 31% of MRSA cases would be detected more than 48 hours after admission, transmission of MRSA to previously uncolonised patients is 1.43%.
Overall applicability*: Partially applicable Overall quality**: Minor limitations
Abbreviations: CEA = cost-effectiveness analysis; NDC = noncompliant direct patient contact; CI = confidence interval; NR = not reported; ‡ Costing year not reported – assumed 2009 –
converted using 2009 Purchasing Power Parities and Hospital and Community Health Services Pay and Prices Inflation Indices.
* Directly applicable / Partially applicable / Not applicable; ** Minor limitations /Potentially serious Limitations / Very serious limitations
324
451
P.W. Stone, S. Hasan, D. Quiros, E.L. Larson. Effect of guideline implementation on costs of hand hygiene. Nursing Economics. 25(5): 279-284. 2007.
Economic analysis: Population: Total cost (per 100 beds): Primary outcome measure: Primary ICER:
CCA 40 hospitals with a mean Intvn 1: £847 Compliance (mean) Hospitals with high compliance† had an
number of 417 active hospital (range: 0- to £18, 385) Intvn 1: 56.6% annual hand decontamination product cost
Study design: beds each. (range: 24% to 89%) that was £2, 995 greater than hospitals with
Observational study low compliance†.
Currency & cost year:
designed to investigate Intervention 1: 2002 US dollars (presented Other outcome measures
the costs of hand CDC Guideline stating that here as 2009/10 UK pounds‡) (median per hospital): Other:
decontamination in hand decontamination should Hospitals with more frequent alcohol
Ratio of alcohol product use
hospitals with high and be preformed: product use had an annual hand
Cost components compared to soap and water
low hand - before direct patient contact decontamination product cost that was £3,
decontamination incorporated: Intvn 1: 2.87
- before donning sterile 174 greater than hospitals with less frequent
compliance, as well as Hand decontamination (range: 0-22) alcohol product use.
gloves when inserting CVCs products and costs associated
high and low frequency
of alcohol hand rub - before inserting invasive with implementaiotn of the
devices guideline (e.g. educational Subgroup analyses:
use.
- before moving from a materials, staff time, None
contaminated to a clean body posters/flyers, mailings, etc).
Perspective: USA
site in the same patient Analysis of uncertainty:
Hospital
- after touching the patient’s None
intact skin, body fluids, or
Time horizon: 1 year wounds
- after contact with inanimate
Treatment effect objects in patient’s vicinity
duration: NA - after removing gloves
Discounting: N/A For each hand

decontamination indication,
whether or not hand
decontamination was
preformed was recorded and
if so, whether the healthcare
worker used soap and water
or an alcohol hand rub.
325
451
P.W. Stone, S. Hasan, D. Quiros, E.L. Larson. Effect of guideline implementation on costs of hand hygiene. Nursing Economics. 25(5): 279-284. 2007.
Data sources
Health outcomes: The Hand Hygiene Observation Instrument was used to observe hand decontamination at each hospital. The rate of compliance was calculated by
dividing the numberof actual hand decontamination episodes by the total number of indications for hand decontamination. To estimate the ration of alcohol rub usage
for hand decontamination, the number of hand decontamination episodes that occureed with alcohol was divided by the number of episodes that occurred with soap
and water.
Cost sources: Cost data were collected from each hospital using standardised abstraction forms.
Comments
Source of funding: National Institute of Nursing Research Limitations: should match checklist ; Other:
Overall applicability*: Partially applicable Overall quality**: Potentially serious limitations
‡ Converted using 2002 Purchasing Power Parities and Hospital and Community Health Services Pay and Prices Inflation Indices.
H.1.2 Cleaning preparation

74
J.P. Cimiotti, P.W. Stone, E.L. Larson. A cost comparison of hand hygiene regimes. Nursing Economics. 22(4):196-204. 2004.
Economic analysis: Population: Cost components Primary outcome measure: Basecase ICER (Intvn x vs Intvn 1):
CEA Neonatal ICU nurses at two incorporated: Hand decontamination Alcohol based hand rub was the dominant
sites Product cost, nurse time quality intervention (less costly with better hand
Study design: Intvn 1: 3.9 decontamination quality)
Non-randomised cross- N: NR Total costs (mean): Intvn 2: 4.6
over study. Age (mean): NR Mean cost per 1,000 patient Other:
Intervention 1 was M/F: NR days (product cost only):: Other outcome measures None
used by the subject Intvn 1: £229 (mean):
group for 12 months, Intervention 1: Intvn 2: £880 Mean time required for Subgroup analyses:
followed by 2% chlorhexidine gluconate hand decontamination None
intervention 2 for 12 hand soap Other: regime:
months. Follow-up at Intvn 1: 17.0 seconds
Mean cost per 1,000 hand Analysis of uncertainty:
monthly intervals. Intvn 2: 13.2 seconds
Intervention 2: decontamination episodes None
Water-less, 61% alcohol- (includes cost of nurse time):
Perspective: based hand sanitizer and mild Intvn 1: £147
USA Hospital soap Intvn 2: £117
326
74
J.P. Cimiotti, P.W. Stone, E.L. Larson. A cost comparison of hand hygiene regimes. Nursing Economics. 22(4):196-204. 2004.
Time horizon: Currency & cost year:
Follow-up time of 2 2003 US dollars (presented
years here as 2009/10 UK pounds‡)
Discounting: Cost components

NA incorporated:
Product cost (including
additional hand lotion)
Data sources
Health outcomes: Hygiene quality reported by two trained observers with good inter-rater reliability.
Cost sources: Product costs provided by the manufacturer.
Comments
Source of funding: NR Limitations: No patient outcomes, non-community setting, US cost data, observational design, no control of unknown sample size.
Abbreviations: NR=not reported, NA=not applicable, M/F=male/female, N=total number of patients randomised, SA=sensitivity analysis, SD= standard deviation
E.L. Larson, A.E. Aiello, J. Bastyr, C. Lyle, J. Stahl, A. Cronquist, L. Lai, P. Della-Latta. Assessment of two hand hygiene regimens for intensive care unit personnel.
250
Critical Care Medicine. 29(5):944-950. 2001
Economic analysis: Population: Total costs (mean): Primary outcome measure: Basecase ICER (Intvn x vs Intvn 1):
CCA Full-time healthcare workers Per healthcare worker per Mean microbial count Alcohol based hand rub was dominant (less
in the surgical ICU at a single shift: Intvn 1: 4.64 costly and reduction in microbial hand
Study design: site Intvn 1:£ 0.83 Intvn 2: 4.72 cultures).
RCT Intvn 2:£0.74
N: 50 Other outcome measures Other:
Perspective: Age (mean): 40.5 Currency & cost year: (mean): None
USA Hospital M/F: 11/39 2003 US dollars (presented Deviations from protocol:
here as 2009/10 UK pounds‡) Intvn 1: 22.6% Subgroup analyses:
Time horizon: Intervention 1: Intvn 2: 7.9% None
4 week follow-up 2% chlorhexidine gluconate Cost components
327
E.L. Larson, A.E. Aiello, J. Bastyr, C. Lyle, J. Stahl, A. Cronquist, L. Lai, P. Della-Latta. Assessment of two hand hygiene regimens for intensive care unit personnel.
250
Critical Care Medicine. 29(5):944-950. 2001
(CHG) hand soap incorporated: Mean application time: Analysis of uncertainty:
Discounting: Product costs Intvn 1: 21.5 seconds None
NA Intervention 2: Intvn 2: 12.7 seconds
61% alcohol-based hand rub
with emollients
Data sources
Health outcomes: Microbial counts were measured using the glove juice technique.
Quality-of-life weights: N/A
Cost sources: Mean cost per shift calculated from reported values of applications (16.7 hand washes/shift for CHG; 6.1 hand washes and 17.7 applications/shift for
alcohol group at a cost of $0.05/application and $0.025/application, respectively). Calculation does not account for cost of staff time or use of hand lotion.
Comments
Source of funding: 3M Health Care Limitations: No patient outcomes, intensive care setting, US perspective, no prospective costing, small sample size, short time
duration. Other: Those in the alcohol-based group had significantly improved skin condition – based on both subjective and objective measures.
Abbreviations: NR = not reported, N/A= not applicable, M/F = male/female, N = total number of patients randomized, RCT = randomized control trial, SE = standard error,
CFU = colony forming units.
H.1.3 Bare below the elbow

328
H.2 Sharps
H.2.1 IV cannulae
H.2.2 Safety needles – phlebotomy

H.2.3 Safety needles – dental syringe

H.2.4 Safety needles – safety lancets

356
W.F. Peate. Preventing needlestick injuries in emergency medical system workers. Journal of Occupational and Environmental Medicine. 2001;43: 554-557.
Economic analysis: Population: Total costs (mean): Primary outcome measure: Primary ICER (Intvn 2 vs Intvn 1):
CBA Active duty EMS workers for a Intvn 1: £16, 430 Needlestick injuries NA
municipal fire department Intvn 2: £2, 052 Intvn 1: 16 injuries over 2
Study design: Incremental (1-2):£14, 014 years (954 worker-years) Other: The use of self-retracting safety
Before and after study Cohort settings: Intvn 2: 2 injuries over 1 year lancets resulted in a department-wide net
of introduction of a N: 477 Currency & cost year: (477 worker-years) benefit of £14, 014. This figure was calculated
spring-loaded Age (range) =20-61 based on estimated averted treatment costs
1998 US dollars (presented
automatic retracting Other outcome measures from sharps injuries.
M = 81% here as 2009/10 UK pounds‡)
glucometer lancet. (mean):
None Subgroup analyses:
Intervention 1: Cost components
Perspective: USA None
Standard straight stick non- incorporated:
hospital perspective
retracting glucometer used Device cost, physician
for two years evaluation and counselling for Analysis of uncertainty:
Time horizon: needlestick injury, antiviral None
3 years medication, hepatitis
Intervention 2:
boosters, and laboratory tests
Self-retracting safety
for both health care worker
329
356
W.F. Peate. Preventing needlestick injuries in emergency medical system workers. Journal of Occupational and Environmental Medicine. 2001;43: 554-557.
Treatment effect glucometer used for one year and source patient. Indirect
duration: (e.g. 5 yrs) costs were included but not
reported here.
Discounting: N/A
Data sources
Health outcomes: All health outcomes were obtained from the current study.
Quality-of-life weights: None
Cost sources: Cost source not specified. It was reported that each needlestick injury was associated with a medical cost of £1, 026, with indirect costs including time lost
from active duty and decreased working efficiency due to the side effects of medication and stress.
Comments
Source of funding: NR Limitations: Resource use and cost source not clearly stated, observational before-after study; US setting Other: None
H.3 PPE
H.3.1 Gloves
330
H.3.2 Aprons and gowns

L.A. Puzniak, K.N. Gillespie, T. Leet, M. Kollef, L.M. Mundy. A cost-benefit analysis of gown use in controlling vancomycin-resistant enterococcus transmission: is it
386
worth the price? Infection Control and Hospital Infection. 2004. 24; 418-425.
Economic analysis: Population: Total costs (mean): Primary outcome Basecase ICER (Intvn x vs Intvn 1):
CBA Patients admitted to the Intvn 1:£164 194 measure: Intvn 1: dominant strategy
medical ICU for more than 24 Intvnn 2:£96 627 VRE infections and Net benefit of gown policy: £382 914
Study design: hours associated intensive care
A decision pathway was built Currency & cost year: costs averted. Other:
based on an observational before Intervention 1: 1998 US dollars None
and after study comparing All healthcare workers and (presented here as Attributable cost per case
isolation procedures with gowns visitors were required to wear 2009/10 UK pounds‡) of VRE: £10 947 Subgroup analyses:
and gloves against isolation gowns and gloves on entry to None
procedures with gloves alone. rooms of patients colonised Cost components Total averted attributable
The primary outcome was or infected with VRE from July incorporated: cost for annual gown
Analysis of uncertainty:
prevention of the acquisition of 1997 to June 1998 and July period: £450 481
Cost of gowns, gloves, Results were most sensitive to the
vancomycin resistant 1999 to December 1999.
hand decontamination, probability of acquiring VRE. Gowns are
enterococci. microbiology tests, Other outcome measures more likely to impact transmission
Intervention 2: isolation cart components, (mean): when there are high rates of VRE
Perspective: Between June 1998 to July time required for staff to None colonisation. The breakeven point (at
USA Hospital 1999, healthcare workers and don and doff gowns. which gowns become cost-saving) was
visitors were not required to 80% of the no-gown transition
Time horizon: wear gowns. probability.
1 year
Variation in the number of patient
Discounting: contacts, cultures per patient, cost of
NA labour and materials did not change
the dominant strategy, but did change
the magnitude of the net benefit.
Data sources
Health outcomes: A matched before and after study design was used to determine the attributable cost of VRE: patients with and without VRE were matched based on
APACHE II scores, DRG code, and age; clinical endpoints obtained from hospital system used to check for differences in co-infections between pairs. Number of VRE
cases averted calculated by multiplying the difference in VRE rates between the study periods by the number of patients in the gown period.
Cost sources: Costs estimated from Barnes-Jewish Hospital: ICU costs estimated by dividing patient’s total hospitalisation cost by total days of hospitalisation and
multiplying the quotient by the patient’s total ICU days; time required to don and doff gowns obtained from observation of 128 healthcare workers on three occasions,
331
L.A. Puzniak, K.N. Gillespie, T. Leet, M. Kollef, L.M. Mundy. A cost-benefit analysis of gown use in controlling vancomycin-resistant enterococcus transmission: is it
386
worth the price? Infection Control and Hospital Infection. 2004. 24; 418-425.
multiplied by average nurse salary; microbiology costs inclusive of all related testing costs.
Comments
Source of funding: NR Limitations: Based on a cross-over trial designed to assess the impact of a policy change; results could be biased by behaviour change; USA
hospital perspective; ICU setting. Other:
Overall quality*: Potentially serious limitations Overall applicability**: Partially applicable
Abbreviations: CBA = cost-benefit analysis; ICU = intensive care unit; VTE = vancomycin-resistant enterococcu; ICER = incremental cost-effectiveness ratio; N/A= not applicable; NR = not
reported; ‡ Converted using 1998 Purchasing Power Parities and Hospital and Community Health Services Pay and Prices Inflation Indices.
H.4 Long term urinary catheterisation

H.4.1 Antibiotics
H.4.2 Catheter type

H.4.3 Bladder instillations and washouts

H.5 PEGs
332
H.6 Vascular access devices

H.6.1 Types of dressings – peripheral
H.6.2 Types of dressings – Centrally inserted VADs

A.G. Crawford, J.P. Fuhr, B. Rao. Cost-benefit analysis of chlorhexidine gluconate dressing in the prevention of catheter related bloodstream infections. Infection
85
Control and Hospital Epidemiology. 2004. 668-674.
Study details Population & Health outcomes Costs Cost effectiveness
interventions
Economic analysis: Population: Primary outcome measures Total costs (mean per Basecase ICER (Intvn 2 vs Intvn 1):
CEA Adult patients based on RCT: patient): N/A
requiring a central CRBSI NR
Study design: venous or arterial Intvn 1: 2.37% Other:
Decision analytic catheter Intvn 2: 6.12% Other: Use of chlorhexidine dressings results in 3.76% fewer
model. Primary N: 589 (P=<.05) CHD dressing: £3.44 each x 2 CRBSIs, 6.84% fewer local infections and £300 to
clinical outcomes Age (mean):NR every 5-7 days. £885 in averted treatment costs compared to
based on one RCT, M/F: NR Local infection Transparent dressing: NR transparent film dressings.
other outcomes Drop outs: NR Intervention 1: 28.14% Local infection: £367
based on published Intervention 2: 45.24% CRBSI: £7, 336 to £22, 925 Subgroup analyses:
literature Intervention 1: None
(P=<.001)
CHD impregnated Currency & cost year:
Perspective: dressing (Biopatch) Other outcome measures 2000 US dollars (presented Analysis of uncertainty:
Healthcare system covered with based on literature: here as 2009/10 GBP‡) Scenario analysis: As the cost of treating CRBSI was
transparent dressing – Catheter colonisation leading adjusted to a low of £7, 336 and high of £22, 925,
Time horizon: changed every 5-7 to local infection the estimated averted treatment cost varied
Duration days between £367 and £885, respectively.
40%
hospitalised (5-7
days) Intervention 2:
CRBSI-related mortality
Transparent film
1% to 4%
Discounting: dressing – changing
NA regime NR
Data sources
Health outcomes:
333
Incidence of local infection and CBRSI based on industry sponsored, non-published RCT (Chiacchierni et al, An evaluation of Biopatch antimicrobial dressing compared to
routine standard of care in the prevention of catheter-related blood stream infection, Sommerville, NJ: Johnson and Johnson Wound Management; 1999; Maki et al,
The efficacy of a chlorhexidine-impregnated sponge (Biopatch) for the prevention of intravascular catheter-related infection: a prospective, randomised controlled,
multicenter study. Washington, DC: American Society for Microbiology; 2000); percentage of catheter colonisations leading to local infection based on an estimate by
Saint et al 2000; mortality attributed to CRBSI based on estimates by Veenstra et al 1999, Saint et al, 2000, Wenzel and Edmond 2001, Mermel et al 2000, Byers et al
1995.
Cost sources: Cost of dressings obtained from Johnson and Johnson; cost of local infection obtained from Saint et al 2000; cost of treating CRBSI based on estimates by
Pittet et al 1994; Saint et al 2000 and O’Grady et al 2002.
Comments
Source of funding: Johnson & Johnson Wound Management Limitations: Key clinical data was based on an industry-funded non peer-reviewed study, efficacy study
lacking key methodological details, short time horizon, US perspective, secondary-care setting, limits to generalisability of results, no incremental sensitivity analysis
Other: Industry funded
Abbreviations: CEA = cost-effectiveness analysis; ICER = incremental cost-effectiveness ratio; CHD = chlorhexidine; CRBSI = catheter-related blood stream infection; NR = not reported; N/A= not
applicable; GBP = Great British Pounds
334
J.C. Shivnan, D. McGuire, S. Freedman, E. Sharkazy, G. Bosserman, E. Larson, P. Grouleff. A comparison of transparent adherent and dry sterile gauze dressings for
435
long-term central catheters in patients undergoing bone marrow transplant. Oncology Nursing Forum. 1991. 18(8):1349-1356.
Study details Population & Health outcomes Costs Cost effectiveness
interventions
Economic analysis: Population: Health outcomes measured: Cost components incorporated: Primarly ICER (Intvn 2 vs Intvn 1):
CEA Patients undergoing Exit site infections Dressing unit cost, number of N/A
bone marrow transplant Intervention 1: 1/47 dressings per patient, nursing
Study design: N: 103 Intervention 2: 2/51 time and cost Other:
RCT with secondary Age (range): 2 to 60 Transparent dressings were less costly in
consideration of Dropouts: 5 Exit site infection progression to Total costs (mean per patient terms of resource use and nursing time than
costs and nursing systematic infection per 30 days): gauze dressings. However, they were
time Intervention 1: Intervention 1: 0/1 Intervention 1: associated with a small (non significant)
Dry sterile gauze – Intervention 2: 0/2 Dressings per patient: 26 increase in infections.
Perspective: changed daily Total material cost: £83
Healthcare system CRBSI Nurse time: 377 min (range 201- Subgroup analyses:
Intervention 2: Intervention 1: 0/47 515) NA
Time horizon: Transparent dressing Intervention 2: 1/51 Total cost of nursing time: £120
Duration of follow- (Tagaderm) – changed Analysis of uncertainty
up 30 days every 4 days Intervention 2: NA
Dressings per patient:10.7
Discounting: Total material cost: £27
N/A Nurse time: 172.7 min (range
100-360)
Total cost of nursing time: £45
Currency & cost year:

1989 US dollars (presented here
as 2009/10 GBP‡)
Data sources
Health outcomes: Outcomes assessed based on the current study (Shivnan et al, 1991)
Cost sources: Cost of materials based on hospital supply costs, cost of nurse time based on the hospital unit’s average nursing salary in 1989.
Comments
Source of funding: 3M Scholar’s Award, Sigma Theta Tau International Nursing Honour Society Grants Program, and the Nursing Department at Johns Hopkins
Oncology Center. Limitations: US perspective, secondary care setting, short time frame. Other: Industry funded
335
J.C. Shivnan, D. McGuire, S. Freedman, E. Sharkazy, G. Bosserman, E. Larson, P. Grouleff. A comparison of transparent adherent and dry sterile gauze dressings for
435
long-term central catheters in patients undergoing bone marrow transplant. Oncology Nursing Forum. 1991. 18(8):1349-1356.
Abbreviations: CEA = cost-effectiveness analysis; ICER = incremental cost-effectiveness ratio; CHD = chlorhexidine; CRBSI = catheter-related blood stream infection; NR = not reported; N/A= not
applicabl; GBP = Great British Pounds; USD = United States Dollars; ‡ Converted using 1998 Purchasing Power Parities and Hospital and Community Health Services Pay and Prices Inflation
Indices. * Directly applicable / Partially applicable / Not applicable; ** Minor limitations /Potentially serious Limitations / Very serious limitations
I. LeCorre, M. Delorme, S. Cournoyer. A prospective, randomised trial comparing a transparent dressing and a dry gauze on the exit site of long term central venous
256
catheters of hemodyalisis patients. Journal of Vascular Access. 2003. 4; 56-61.
Economic analysis: Population: Total costs (mean per patient Primary outcome measure: Primary ICER (Intvn 2 vs Intvn 1):
CCA Haemodyalisis patients with a per week): Bacteraemia Transparent dressings were less costly and
long-term central venous Intvn 1: £8.23 Intvn 1: 2 more effective than gauze dressings.
Study design: catheter. Intvn 2 : £5.11 Intvn 2: 1
RCT Incremental: £3.11 Other:
Cohort settings: Other outcome measures None
Approach to analysis: N: 58 Currency & cost year: (mean):
An estimate of the cost Mean age = 72.5 2000 Canadian dollars Bacteraemia per 1000 Subgroup analyses: None
of each dressing M =47% (presented here as 2009/10 catheter days
change was analysed GBP‡) Intvn 1: 0.47 Analysis of uncertainty: None
during a 4-week period Intervention 1: Intvn 2: 0.30
on 10 subjects Dry sterile gauze – changed Cost components
randomly selected every 2-3 days incorporated: Local infection
from each group. Material cost per week Intvn 1: 1
Efficacy estimates Intervention 2: (included costs of masks, non Intvn 2: 0
related to the patients sterile gloves, dressings,
Transparent dressing –
enrolled in the whole chlorhexidine sticks, and
changed every 7 days Local infection per 1000
study – these results tape), cost of nursing time. catheter days
along with the cost
estimates derived from Intvn 1: 0.23
the 10 patients are Intvn 2: 0
reported here.
Quality of life
Perspective: Canadian Report that there was no
healthcare system significant difference
336
I. LeCorre, M. Delorme, S. Cournoyer. A prospective, randomised trial comparing a transparent dressing and a dry gauze on the exit site of long term central venous
256
catheters of hemodyalisis patients. Journal of Vascular Access. 2003. 4; 56-61.
between the two groups in
Time horizon: quality of life. SF-36 values
Study duration: 6 NR.
months
Treatment effect
duration: 4 weeks
Discounting:
NA
Data sources
Health outcomes: LeCorre 2003.
Cost sources: NR
Comments
Source of funding: Funded in part by research grants from 3M Canada Company, CR Bard Canada and SoluMed Canada. Limitations: Cost source not reported, Canadian
healthcare system Other: Industry funded
Abbreviations: CCA = cost consequence analysis; ICER = incremental cost-effectiveness ratio; CRBSI = catheter-related blood stream infection; NR = not reported; N/A= not applicabl; GBP =
Great British Pounds; ‡ Converted using 2000 Purchasing Power Parities) and Hospital and Community Health Services Pay and Prices Inflation Indices.
H.6.3 Frequency of dressing change

H.6.4 Skin decontamination during dressing change for vascular access devices (peripheral and central access)
No economic evidence was identified
H.6.5 Skin decontamination prior to insertion of vascular access devices (peripheral access)
No economic evidence was identified
337
Forest plots
Appendix I: Forest plots

I.1 Hand decontamination ...................................................................................................... 339
I.2 Personal protective equipment .......................................................................................... 344
I.3 Sharps ............................................................................................................................... 345
I.4 Long term urinary catheterisation ...................................................................................... 348
I.5 PEGs .................................................................................................................................. 355
I.6 Vascular access devices ...................................................................................................... 355
338
Forest plots
I.1 Hand decontamination

I.1.1 Before vs. after implementation of a hand hygiene guideline (when to wash hands)
Figure 1: Hand hygiene compliance - overall (APIC guideline)

After Before Risk Ratio Risk Ratio
Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI
Rosenthal 2005 2056 3187 268 1160 100.0% 2.79 [2.51, 3.11]
Total (95% CI) 3187 1160 100.0% 2.79 [2.51, 3.11]

Total events 2056 268
Heterogeneity: Not applicable
0.1 0.2 0.5 1 2 5 10
Test for overall effect: Z = 18.62 (P < 0.00001) Favours after Favours before
Figure 2: Nosocomial infections per 1000 bed days (APIC guideline)

Risk Ratio Risk Ratio
Study or Subgroup log[Risk Ratio] SE Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Rosenthal 2005 -0.5276327 0.121282 100.0% 0.59 [0.47, 0.75]
Total (95% CI) 100.0% 0.59 [0.47, 0.75]

0.1 0.2 0.5 1 2 5 10
Test for overall effect: Z = 4.35 (P < 0.0001) Favours after Favours before
Figure 3: Hand hygiene compliance - overall (WHO 5 moments)

Allegranzi 2010 358 1639 155 1932 100.0% 2.72 [2.28, 3.25]
Total (95% CI) 1639 1932 100.0% 2.72 [2.28, 3.25]

0.1 0.2 0.5 1 2 5 10
Test for overall effect: Z = 11.12 (P < 0.00001) Favours before Favours after
339
Forest plots
Figure 4: Hand hygiene compliance - WHO 5 moments

1.4.2 Before patient contact
Allegranzi 2010 91 439 23 503 100.0% 4.53 [2.92, 7.03]
Subtotal (95% CI) 439 503 100.0% 4.53 [2.92, 7.03]
Total events 91 23
Test for overall effect: Z = 6.75 (P < 0.00001)
1.4.3 Before aseptic task

Allegranzi 2010 34 230 11 425 100.0% 5.71 [2.95, 11.06]
Subtotal (95% CI) 230 425 100.0% 5.71 [2.95, 11.06]
Total events 34 11
1.4.4 After body fluid exposure risk

Allegranzi 2010 94 229 34 215 100.0% 2.60 [1.84, 3.67]
Subtotal (95% CI) 229 215 100.0% 2.60 [1.84, 3.67]
Total events 94 34
1.4.5 After patient contact

Allegranzi 2010 201 505 91 559 100.0% 2.44 [1.97, 3.04]
Subtotal (95% CI) 505 559 100.0% 2.44 [1.97, 3.04]
Total events 201 91
1.4.6 After contact with patient surroundings

Allegranzi 2010 15 410 15 457 100.0% 1.11 [0.55, 2.25]
Subtotal (95% CI) 410 457 100.0% 1.11 [0.55, 2.25]
Total events 15 15
Test for overall effect: Z = 0.30 (P = 0.76)
0.1 0.2 0.5 1 2 5 10

Favours before Favours after
340
Forest plots
Figure 5: Healthcare associated infections - WHO 5 moments

1.5.1 Overall
Allegranzi 2010 22 144 25 134 100.0% 0.82 [0.49, 1.38]
Subtotal (95% CI) 144 134 100.0% 0.82 [0.49, 1.38]
Total events 22 25
1.5.2 Urinary tract infections

Allegranzi 2010 10 144 8 134 100.0% 1.16 [0.47, 2.86]
Subtotal (95% CI) 144 134 100.0% 1.16 [0.47, 2.86]
Total events 10 8
1.5.3 Primary blood stream infections

Allegranzi 2010 1 144 3 134 100.0% 0.31 [0.03, 2.95]
Subtotal (95% CI) 144 134 100.0% 0.31 [0.03, 2.95]
Total events 1 3
0.1 0.2 0.5 1 2 5 10

Favours after Favours before
Figure 6: Hand hygiene compliance (CDC 2002 guideline)

1.6.1 Before patient care
Aragon 2005 696 1698 761 2537 100.0% 1.37 [1.26, 1.48]
Subtotal (95% CI) 1698 2537 100.0% 1.37 [1.26, 1.48]
1.6.2 After patient care

Aragon 2005 707 955 784 1104 100.0% 1.04 [0.99, 1.10]
Subtotal (95% CI) 955 1104 100.0% 1.04 [0.99, 1.10]
0.1 0.2 0.5 1 2 5 10

Favours before Favours after
341
Forest plots
Figure 7: Healthcare associated infections (CDC 2002 guideline)
Cleaning preparation
Experimental Control Risk Ratio Risk Ratio
1.7.1 Catheter associated urinary tract infection
Larson 2007 524 173154 498 171625 100.0% 1.04 [0.92, 1.18]
Subtotal (95% CI) 173154 171625 100.0% 1.04 [0.92, 1.18]
1.7.2 Central line associated blood stream infection

Larson 2007 771 161954 848 153003 100.0% 0.86 [0.78, 0.95]
Subtotal (95% CI) 161954 153003 100.0% 0.86 [0.78, 0.95]
0.1 0.2 0.5 1 2 5 10

Favours after Favours before
I.1.1.1 Alcohol handrub vs non-antiseptic soap hand wash
Figure 8: Colony forming units (Log10)

Experimental Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Lucet 2002 0.13 0.22 43 0.89 0.54 43 100.0% -0.76 [-0.93, -0.59]
Total (95% CI) 43 43 100.0% -0.76 [-0.93, -0.59]

-50 -25 0 25 50
Test for overall effect: Z = 8.55 (P < 0.00001) Favours experimental Favours control
Figure 9: Mean colony forming units

Zaragoza 1999 75 39 43 82 75 43 100.0% -7.00 [-32.27, 18.27]
Total (95% CI) 43 43 100.0% -7.00 [-32.27, 18.27]

-50 -25 0 25 50
Test for overall effect: Z = 0.54 (P = 0.59) Favours experimental Favours control
342
Forest plots
I.1.1.2 Alcohol handrub vs 4% CHG soap hand wash

Lucet 2002 0.13 0.22 43 0.33 0.45 43 100.0% -0.20 [-0.35, -0.05]
Total (95% CI) 43 43 100.0% -0.20 [-0.35, -0.05]

-10 -5 0 5 10
Figure 11: Colony forming units

Alcohol Soap Mean Difference Mean Difference
Girou 2002 35 59 12 69 106 11 100.0% -34.00 [-104.98, 36.98]
Total (95% CI) 12 11 100.0% -34.00 [-104.98, 36.98]

-200 -100 0 100 200
Test for overall effect: Z = 0.94 (P = 0.35) Favours alcohol Favours soap
I.1.1.3 Alcohol handrub vs 2% Chlorhexidine gluconate (CHG) soap hand wash
Figure 12: Colony forming units

Alcohol Soap Mean Difference Mean Difference
3.1.1 2 weeks
Larson 2001 4.59 0.97 26 4.5 0.78 26 100.0% 0.09 [-0.39, 0.57]
Subtotal (95% CI) 26 26 100.0% 0.09 [-0.39, 0.57]
3.1.2 4 weeks
Larson 2001 4.72 0.97 26 4.64 0.83 24 100.0% 0.08 [-0.42, 0.58]
Subtotal (95% CI) 26 24 100.0% 0.08 [-0.42, 0.58]
-10 -5 0 5 10
Favours alcohol Favours soap
Test for subgroup differences: Chi² = 0.00, df = 1 (P = 0.98), I² = 0%
I.1.1.4 4% CHG soap hand wash vs non-antiseptic soap hand wash

Lucet 2002 0.33 0.45 43 0.89 0.54 43 100.0% -0.56 [-0.77, -0.35]
Total (95% CI) 43 43 100.0% -0.56 [-0.77, -0.35]

-10 -5 0 5 10
343
Forest plots
I.1.2 Bare below the elbow vs usual policy
Figure 14: Percentage of areas of different parts of the hands missed in hand washing
1.1.1 Percentage of areas in the hands ( wrists and palms) missed
FARRINGTON2010 9.3 9.2 73 11.1 7.2 76 100.0% -1.80 [-4.46, 0.86]
Subtotal (95% CI) 73 76 100.0% -1.80 [-4.46, 0.86]
1.1.2 Percentage of areas of the wrists missed

FARRINGTON2010 38.9 38.7 73 52.8 27.9 76 100.0% -13.90 [-24.77, -3.03]
Subtotal (95% CI) 73 76 100.0% -13.90 [-24.77, -3.03]
1.1.3 Percentage of areas of the palms missed

FARRINGTON2010 7.2 7.1 73 8.2 6.4 76 100.0% -1.00 [-3.17, 1.17]
Subtotal (95% CI) 73 76 100.0% -1.00 [-3.17, 1.17]
-50 -25 0 25 50
Favours BBE policy Favours control
Test for subgroup differences: Chi² = 5.23, df = 2 (P = 0.07), I² = 61.8%
The sample sizes shown in this forest plot was based on the personal correspondence from the author and used to estimate
the effect sizes.
I.2 Personal protective equipment

I.2.1 Gloves
I.2.1.1 Nitrile versus latex gloves
Figure 15: Glove punctures

Nitrile Latex Risk Ratio Risk Ratio
Murray 2001 58 1020 19 1000 100.0% 2.99 [1.80, 4.99]
Total (95% CI) 1020 1000 100.0% 2.99 [1.80, 4.99]

Total events 58 19
0.1 0.2 0.5 1 2 5 10
Test for overall effect: Z = 4.21 (P < 0.0001) Favours nitrile Favours latex
344
Forest plots
I.2.2 Aprons and gowns
I.2.2.1 Aprons vs no aprons
Figure 16: MRSA Positive Clothing - Care assistants

Apron No Apron Risk Ratio Risk Ratio
1.1.1 Care Assistants Washing and changing
GASPARD2009 15 43 5 16 100.0% 1.12 [0.48, 2.57]
Subtotal (95% CI) 43 16 100.0% 1.12 [0.48, 2.57]
Total events 15 5
1.1.2 Care Assistants wash, change and meal

GASPARD2009 7 80 5 16 100.0% 0.28 [0.10, 0.77]
Subtotal (95% CI) 80 16 100.0% 0.28 [0.10, 0.77]
Total events 7 5
0.05 0.2 1 5 20
Favours Aprons Favours No Aprons
Figure 17: MRSA positive clothing

Apron No Apron Risk Ratio Risk Ratio
1.2.3 Nurses - Dressing change
GASPARD2009 7 22 7 16 100.0% 0.73 [0.32, 1.66]
Subtotal (95% CI) 22 16 100.0% 0.73 [0.32, 1.66]
Total events 7 7
1.2.4 Nurses - Dressing and biological sampling

GASPARD2009 2 20 7 16 100.0% 0.23 [0.05, 0.95]
Subtotal (95% CI) 20 16 100.0% 0.23 [0.05, 0.95]
Total events 2 7
0.05 0.2 1 5 20
Favours Aprons Favours No Aprons
I.3 Sharps
I.3.1 Safety cannulae (active) vs. standard cannulae
Figure 18: Needlestick injury

Asai 2002 0 50 0 50 Not estimable
Prunet 2008 0 254 0 254 Not estimable
Total (95% CI) 304 304 Not estimable

Total events 0 0
0.1 0.2 0.5 1 2 5 10
Test for overall effect: Not applicable Favours experimental Favours control
345
Forest plots
Figure 19: Success on first insertion attempt

Asai 2002 46 50 48 50 12.0% 0.96 [0.87, 1.06]
Cote 2003 150 211 94 119 30.0% 0.90 [0.79, 1.02]
Prunet 2008 230 254 232 254 58.0% 0.99 [0.94, 1.05]
Total (95% CI) 515 423 100.0% 0.96 [0.91, 1.01]

Heterogeneity: Chi² = 2.32, df = 2 (P = 0.31); I² = 14%
0.1 0.2 0.5 1 2 5 10
Figure 20: Blood contamination

Asai 2002 8 50 4 50 11.3% 2.00 [0.64, 6.22]
Cote 2003 30 211 12 119 43.4% 1.41 [0.75, 2.65]
Prunet 2008 39 254 16 254 45.3% 2.44 [1.40, 4.25]
Total (95% CI) 515 423 100.0% 1.94 [1.32, 2.86]

Total events 77 32
0.1 0.2 0.5 1 2 5 10
I.3.2 Safety cannulae (passive) vs. standard cannulae

Asai 2002 0 50 0 50 Not estimable
Prunet 2008 0 251 0 254 Not estimable

Total events 0 0
0.1 0.2 0.5 1 2 5 10
Test for overall effect: Not applicable Favours experimental Favours control
Figure 22: Success on first insertion attempt

Asai 2002 48 50 48 50 17.2% 1.00 [0.92, 1.08]
Prunet 2008 230 251 232 254 82.8% 1.00 [0.95, 1.06]
Total (95% CI) 301 304 100.0% 1.00 [0.96, 1.05]

0.1 0.2 0.5 1 2 5 10
Figure 23: Blood contamination

Asai 2002 3 50 4 50 20.1% 0.75 [0.18, 3.18]
Prunet 2008 18 251 16 254 79.9% 1.14 [0.59, 2.18]
Total (95% CI) 301 304 100.0% 1.06 [0.59, 1.92]

Total events 21 20
0.1 0.2 0.5 1 2 5 10
346
Forest plots
I.3.3 Safety resheathable winged steel needle vs conventional devices

Favours experimental Control Risk Ratio Risk Ratio
Mendelson 2003 28 436180 86 641282 100.0% 0.48 [0.31, 0.73]
Total (95% CI) 436180 641282 100.0% 0.48 [0.31, 0.73]

Total events 28 86
0.1 0.2 0.5 1 2 5 10

Risk Ratio Risk Ratio
Study or Subgroup log[Risk Ratio] SE Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
Rogues 2004 -0.4780358 0.08797 100.0% 0.62 [0.52, 0.74]
Total (95% CI) 100.0% 0.62 [0.52, 0.74]

0.1 0.2 0.5 1 2 5 10

3.3.1 Winged steel needle
CDC 1997 34 2540500 53 1875995 100.0% 0.47 [0.31, 0.73]
Subtotal (95% CI) 2540500 1875995 100.0% 0.47 [0.31, 0.73]
Total events 34 53
3.3.2 Bluntable vacuum tube

CDC 1997 2 501596 14 523561 100.0% 0.15 [0.03, 0.66]
Subtotal (95% CI) 501596 523561 100.0% 0.15 [0.03, 0.66]
Total events 2 14
3.3.3 Vacuum tube with recapping sheath

CDC 1997 5 628092 19 895054 100.0% 0.38 [0.14, 1.00]
Subtotal (95% CI) 628092 895054 100.0% 0.38 [0.14, 1.00]
Total events 5 19
0.1 0.2 0.5 1 2 5 10

Favours experimental Favours control
Figure 27: User preference

Control Experimental Risk Ratio Risk Ratio
CDC 1997 622 1939 882 1939 100.0% 0.71 [0.65, 0.76]
Total (95% CI) 1939 1939 100.0% 0.71 [0.65, 0.76]

0.1 0.2 0.5 1 2 5 10
347
Forest plots
Figure 28: User preference

Control Experimental Risk Ratio Risk Ratio
Mendelson 2003 199 536 337 536 100.0% 0.59 [0.52, 0.67]
Total (95% CI) 536 536 100.0% 0.59 [0.52, 0.67]

0.1 0.2 0.5 1 2 5 10
I.3.4 Disposable safety syringe vs non-disposable syringe

Zakrzewska 2001 0 1000 21 1000 100.0% 0.02 [0.00, 0.38]
Total (95% CI) 1000 1000 100.0% 0.02 [0.00, 0.38]

Total events 0 21
0.02 0.1 1 10 50
I.3.5 Safety lancet vs standard lancet

Peate 2001 2 477 16 954 100.0% 0.25 [0.06, 1.08]
Total (95% CI) 477 954 100.0% 0.25 [0.06, 1.08]

Total events 2 16
0.1 0.2 0.5 1 2 5 10
I.4 Long term urinary catheterisation

I.4.1 Catheter type
I.4.1.1 Hydrogel coated latex vs. control (silicone elastomer coated) for long term indwelling
catheterisation
Figure 31: Mean catheter time in situ

Bull 1991 89.61 36.31 36 56.7 38.8 33 100.0% 32.91 [15.14, 50.68]
Total (95% CI) 36 33 100.0% 32.91 [15.14, 50.68]

-50 -25 0 25 50
Test for overall effect: Z = 3.63 (P = 0.0003) Favours control Favours experimental
348
Forest plots
Figure 32: Encrustations leading to catheter change

Bull 1991 11 36 9 33 100.0% 1.12 [0.53, 2.36]
Total (95% CI) 36 33 100.0% 1.12 [0.53, 2.36]

Total events 11 9
0.1 0.2 0.5 1 2 5 10
Figure 33: Catheter related adverse events

Bull 1991 1 36 7 33 100.0% 0.13 [0.02, 1.01]
Total (95% CI) 36 33 100.0% 0.13 [0.02, 1.01]

Total events 1 7
0.02 0.1 1 10 50
I.4.1.2 Hydrophilic coated vs. control (non-coated) for long term intermittent catheterisation
Figure 34: Mean monthly urinary tract infection

2.1.4 12 months
Vapnek 2003 0.13 0.18 31 0.14 0.21 31 100.0% -0.01 [-0.11, 0.09]
Subtotal (95% CI) 31 31 100.0% -0.01 [-0.11, 0.09]
-1 -0.5 0 0.5 1
Test for subgroup differences: Not applicable
Figure 35: UTIs and antibiotics (per year)

2.2.1 Total urinary tract infections at 1 year
Cardenas 2009 1.18 1.3 22 1 1 23 100.0% 0.18 [-0.50, 0.86]
Subtotal (95% CI) 22 23 100.0% 0.18 [-0.50, 0.86]
2.2.2 Total antibiotic treatment episodes at 1 year

Cardenas 2009 0.77 0.87 22 1.65 1.46 23 100.0% -0.88 [-1.58, -0.18]
Subtotal (95% CI) 22 23 100.0% -0.88 [-1.58, -0.18]
-10 -5 0 5 10
Figure 36: Patients with 1 or more urinary tract infection

Cardenas 2009 12 22 14 23 21.3% 0.90 [0.54, 1.48]
DeRidder 2005 39 61 51 62 78.7% 0.78 [0.62, 0.97]
Total (95% CI) 83 85 100.0% 0.80 [0.65, 0.99]

Total events 51 65
0.05 0.2 1 5 20
349
Forest plots
Figure 37: Patients/helpers who were very satisfied with the catheter
2.9.1 6 months
DeRidder 2005 10 55 6 59 100.0% 1.79 [0.70, 4.59]
Subtotal (95% CI) 55 59 100.0% 1.79 [0.70, 4.59]
Total events 10 6
2.9.2 12 months
DeRidder 2005 9 55 7 59 100.0% 1.38 [0.55, 3.45]
Subtotal (95% CI) 55 59 100.0% 1.38 [0.55, 3.45]
Total events 9 7
0.01 0.1 1 10 100

Favours control Favours experimental
Figure 38: Patient satisfaction (Low = good)

Sutherland 1996 3.3 3 17 3.9 2.1 16 100.0% -0.60 [-2.36, 1.16]
Total (95% CI) 17 16 100.0% -0.60 [-2.36, 1.16]

-20 -10 0 10 20
Figure 39: Catheter preference

2.15.1 Problems in introducing the catheter
Pachler 1999 1 32 2 32 100.0% 0.50 [0.05, 5.24]
Subtotal (95% CI) 32 32 100.0% 0.50 [0.05, 5.24]
Total events 1 2
2.15.2 Burning sensation when introducing the catheter

Pachler 1999 2 32 1 32 100.0% 2.00 [0.19, 20.97]
Subtotal (95% CI) 32 32 100.0% 2.00 [0.19, 20.97]
Total events 2 1
2.15.3 Pain when introducing the catheter

Pachler 1999 3 32 2 32 100.0% 1.50 [0.27, 8.38]
Subtotal (95% CI) 32 32 100.0% 1.50 [0.27, 8.38]
Total events 3 2
2.15.4 Burning sensation or pain after removal of the catheter

Pachler 1999 2 32 2 32 100.0% 1.00 [0.15, 6.67]
Subtotal (95% CI) 32 32 100.0% 1.00 [0.15, 6.67]
Total events 2 2
0.01 0.1 1 10 100

Favours control Favours experimental
350
Forest plots
I.4.1.3 Gel reservoir vs. control (non-coated) for long term intermittent catheterisation
Figure 40: Patients with 1 or more urinary tract infection

Giannantoni 2001 4 54 12 54 100.0% 0.33 [0.11, 0.97]
Total (95% CI) 54 54 100.0% 0.33 [0.11, 0.97]

Total events 4 12
0.05 0.2 1 5 20
Figure 41: Patient comfort (High = good)

Giannantoni 2001 4.72 2.13 18 2.33 1.06 18 100.0% 2.39 [1.29, 3.49]
Total (95% CI) 18 18 100.0% 2.39 [1.29, 3.49]

-100 -50 0 50 100
Test for overall effect: Z = 4.26 (P < 0.0001) Favours control Favours experimental
I.4.1.4 Noncoated catheters reused multiple times vs. single use for long term intermittent
catheterisation
Figure 42: Symptomatic UTI

Clean technique Sterile technique Risk Ratio Risk Ratio
Duffy 1995 29 38 35 42 91.7% 0.92 [0.73, 1.14]
King 1992 5 23 3 23 8.3% 1.67 [0.45, 6.17]
Total (95% CI) 61 65 100.0% 0.98 [0.77, 1.25]

Total events 34 38
0.1 0.2 0.5 1 2 5 10
Test for overall effect: Z = 0.18 (P = 0.86) Favours sterile technique Favours clean technique
Figure 43: Frequency of catheterisations, per day

Clean technique Sterile technique Mean Difference Mean Difference
Duffy 1995 3 1.1 38 2.8 1.1 42 100.0% 0.20 [-0.28, 0.68]
Total (95% CI) 38 42 100.0% 0.20 [-0.28, 0.68]

-10 -5 0 5 10
I.4.2 Washouts and instillations
I.4.2.1 Solution G vs. saline (sodium chloride 0.9%)
Figure 44: Catheter blockage

Suby G Sodium chloride Risk Ratio Risk Ratio
KENNEDY 1992 14 29 18 44 100.0% 1.18 [0.70, 1.98]
Total (95% CI) 29 44 100.0% 1.18 [0.70, 1.98]

Total events 14 18
0.01 0.1 1 10 100
Test for overall effect: Z = 0.63 (P = 0.53) Suby G Sodium Chloride
351
Forest plots
Figure 45: Partial catheter blockage

KENNEDY 1992 12 29 14 44 100.0% 1.30 [0.71, 2.40]
Total (95% CI) 29 44 100.0% 1.30 [0.71, 2.40]

Total events 12 14
0.01 0.1 1 10 100
Figure 46: Cathters not encrusted

KENNEDY 1992 3 29 12 44 100.0% 0.38 [0.12, 1.23]
Total (95% CI) 29 44 100.0% 0.38 [0.12, 1.23]

Total events 3 12
0.01 0.1 1 10 100
Figure 47: Catheter removal/ replacement

KENNEDY 1992 14 84 16 84 100.0% 0.88 [0.46, 1.68]
Total (95% CI) 84 84 100.0% 0.88 [0.46, 1.68]

Total events 14 16
0.01 0.1 1 10 100
I.4.2.2 Solution R vs. saline (sodium chloride 0.9%)

Solution R Sodium chloride Risk Ratio Risk Ratio
KENNEDY 1992 7 27 18 44 100.0% 0.63 [0.31, 1.31]
Total (95% CI) 27 44 100.0% 0.63 [0.31, 1.31]

Total events 7 18
0.01 0.1 1 10 100
Test for overall effect: Z = 1.22 (P = 0.22) Solution R Sodium Chloride

KENNEDY 1992 10 27 14 44 100.0% 1.16 [0.60, 2.24]
Total (95% CI) 27 44 100.0% 1.16 [0.60, 2.24]

Total events 10 14
0.01 0.1 1 10 100
352
Forest plots
Figure 50: Catheters not encrusted

KENNEDY 1992 10 27 12 44 100.0% 1.36 [0.68, 2.70]
Total (95% CI) 27 44 100.0% 1.36 [0.68, 2.70]

Total events 10 12
0.01 0.1 1 10 100

KENNEDY 1992 14 84 16 84 100.0% 0.88 [0.46, 1.68]
Total (95% CI) 84 84 100.0% 0.88 [0.46, 1.68]

Total events 14 16
0.01 0.1 1 10 100
I.4.2.3 Solution G vs. solution R

Suby G Solution R Risk Ratio Risk Ratio
KENNEDY 1992 14 29 7 27 100.0% 1.86 [0.89, 3.90]
Total (95% CI) 29 27 100.0% 1.86 [0.89, 3.90]

Total events 14 7
0.01 0.1 1 10 100
Test for overall effect: Z = 1.65 (P = 0.10) Suby G Solution R

KENNEDY 1992 12 29 10 27 100.0% 1.12 [0.58, 2.15]
Total (95% CI) 29 27 100.0% 1.12 [0.58, 2.15]

Total events 12 10
0.01 0.1 1 10 100
Figure 54: Catheters not encrusted

KENNEDY 1992 3 29 10 27 100.0% 0.28 [0.09, 0.91]
Total (95% CI) 29 27 100.0% 0.28 [0.09, 0.91]

Total events 3 10
0.01 0.1 1 10 100
353
Forest plots

KENNEDY 1992 14 84 14 84 100.0% 1.00 [0.51, 1.97]
Total (95% CI) 84 84 100.0% 1.00 [0.51, 1.97]

Total events 14 14
0.01 0.1 1 10 100
I.4.2.4 Solution G vs. no washout
Figure 56: Mean time to first catheter change

Solution G No washout Mean Difference Mean Difference
MOORE 2009 4.75 2.61 17 4.55 2.91 20 100.0% 0.20 [-1.58, 1.98]
Total (95% CI) 17 20 100.0% 0.20 [-1.58, 1.98]

-10 -5 0 5 10
I.4.2.5 Saline vs. no washout
Saline No washout Mean Difference Mean Difference

MOORE 2009 5.18 2.9 16 4.55 2.91 20 100.0% 0.63 [-1.28, 2.54]
Total (95% CI) 16 20 100.0% 0.63 [-1.28, 2.54]

-10 -5 0 5 10
Solution G vs. saline

Solution G Saline Mean Difference Mean Difference
MOORE 2009 4.75 2.61 17 5.18 2.9 16 100.0% -0.43 [-2.32, 1.46]
Total (95% CI) 17 16 100.0% -0.43 [-2.32, 1.46]

-10 -5 0 5 10
I.4.2.6 Acetic acid vs. Saline
Figure 59: Symptomatic UTI

Acetic acid Normal saline Risk Ratio Risk Ratio
WAITES 2006 6 30 1 29 100.0% 5.80 [0.74, 45.26]
Total (95% CI) 30 29 100.0% 5.80 [0.74, 45.26]

Total events 6 1
0.01 0.1 1 10 100
Test for overall effect: Z = 1.68 (P = 0.09) Acetic acid Normal saline
354
Forest plots
Figure 60: Adverse events

Acetic acid Normal saline Risk Ratio Risk Ratio
WAITES 2006 1 30 0 29 100.0% 2.90 [0.12, 68.50]
Total (95% CI) 30 29 100.0% 2.90 [0.12, 68.50]

Total events 1 0
0.01 0.1 1 10 100
Test for overall effect: Z = 0.66 (P = 0.51) Acetic acid Normal saline
I.4.3 Antibiotics
Figure 61: Antibiotics resistance

Antibiotics Placebo Risk Ratio Risk Ratio
FIRESTEIN2001 0 36 0 34 Not estimable

Total events 0 0
0.01 0.1 1 10 100
Test for overall effect: Not applicable Favours Antibiotics Favours Placebo
Figure 62: Mortality

FIRESTEIN2001 1 36 2 34 100.0% 0.47 [0.04, 4.97]
Total (95% CI) 36 34 100.0% 0.47 [0.04, 4.97]

Total events 1 2
0.01 0.1 1 10 100
Test for overall effect: Z = 0.62 (P = 0.53) Favours Antibiotics Favours Placebo
Figure 63: Bacteraemia

FIRESTEIN2001 0 36 0 34 Not estimable

Total events 0 0
0.01 0.1 1 10 100
Test for overall effect: Not applicable Favours Antibiotics Favours Placebo
I.5 PEGs
No clinical evidence.
I.6 Vascular access devices

I.6.1 Skin decontamination prior to insertion of peripheral vascular access devices
2% Iodine in 70% alcohol vs. 70% alcohol
355
Forest plots
Figure 64: VAD related phlebitis
2% Chlorhexidine gluconate in alcohol vs. 70% alcohol
Figure 65: Catheter tip colonisation
I.6.2 Dressing type
I.6.2.1 Peripherally inserted VADs - transparent polyurethane vs. gauze and tape

Craven 1985 28 316 24 421 66.3% 1.55 [0.92, 2.63]
Hoffmann 1988 14 246 10 224 33.7% 1.27 [0.58, 2.81]
Total (95% CI) 562 645 100.0% 1.46 [0.94, 2.26]

Total events 42 34
0.1 0.2 0.5 1 2 5 10
Figure 67: Phlebitis

Hoffmann 1988 14 246 13 224 20.4% 0.98 [0.47, 2.04]
Maki 1987 48 527 50 544 73.9% 0.99 [0.68, 1.45]
Tripepibova 1997 2 108 4 121 5.7% 0.56 [0.10, 3.00]
Total (95% CI) 881 889 100.0% 0.96 [0.69, 1.34]

Total events 64 67
0.1 0.2 0.5 1 2 5 10
356
Forest plots
I.6.2.2 Peripherally inserted VADs - transparent polyurethane + iodophor antiseptic vs. gauze and tape
Figure 68: Phlebitis

Maki 1987 49 498 50 544 100.0% 1.07 [0.74, 1.56]
Total (95% CI) 498 544 100.0% 1.07 [0.74, 1.56]

Total events 49 50
0.1 0.2 0.5 1 2 5 10
I.6.2.3 Centrally inserted VADs - highly permeable transparent polyurethane vs gauze and tape
Figure 69: Catheter related sepsis

Brandt 1996 5 48 1 53 100.0% 5.52 [0.67, 45.59]
Total (95% CI) 48 53 100.0% 5.52 [0.67, 45.59]

Total events 5 1
0.02 0.1 1 10 50
Figure 70: Exit site infection

Brandt 1996 4 48 2 53 100.0% 2.21 [0.42, 11.52]
Total (95% CI) 48 53 100.0% 2.21 [0.42, 11.52]

Total events 4 2
0.05 0.2 1 5 20
Figure 71: Bacteraemia/fungemia

Brandt 1996 3 48 6 53 100.0% 0.55 [0.15, 2.09]
Total (95% CI) 48 53 100.0% 0.55 [0.15, 2.09]

Total events 3 6
0.05 0.2 1 5 20
I.6.2.4 Centrally inserted VADs - highly permeable transparent polyurethane vs transparent semi
permeable membrane

Wille 1993 1 51 3 50 100.0% 0.33 [0.04, 3.04]
Total (95% CI) 51 50 100.0% 0.33 [0.04, 3.04]

Total events 1 3
0.01 0.1 1 10 100
357
Forest plots
I.6.2.5 Centrally inserted VADs - transparent semi permeable membrane vs gauze and tape

Shivnan 1991 1 51 0 47 100.0% 2.77 [0.12, 66.36]
Total (95% CI) 51 47 100.0% 2.77 [0.12, 66.36]

Total events 1 0
0.01 0.1 1 10 100
Figure 74: Exit site infection

Lecorre 2003 0 29 1 29 42.4% 0.33 [0.01, 7.86]
Petrosino 1988 4 7 1 7 28.2% 4.00 [0.58, 27.41]
Shivnan 1991 2 51 1 47 29.4% 1.84 [0.17, 19.67]
Total (95% CI) 87 83 100.0% 1.81 [0.54, 6.10]

Total events 6 3
0.01 0.1 1 10 100
Figure 75: Bacteraemia

Lecorre 2003 1 29 2 29 100.0% 0.50 [0.05, 5.21]
Total (95% CI) 29 29 100.0% 0.50 [0.05, 5.21]

Total events 1 2
0.01 0.1 1 10 100
I.6.2.6 Frequency of dressing change
Figure 76: Positive blood culture

Once weekly Twice weekly Risk Ratio Risk Ratio
Vokurka 2009 8 39 9 42 100.0% 0.96 [0.41, 2.23]
Total (95% CI) 39 42 100.0% 0.96 [0.41, 2.23]

Total events 8 9
0.1 0.2 0.5 1 2 5 10
Test for overall effect: Z = 0.10 (P = 0.92) Favours once weekly Favours twice weekly
Figure 77: CVC insertion site inflammation

Once weekly Twice weekly Risk Ratio Risk Ratio
Vokurka 2009 10 39 23 42 100.0% 0.47 [0.26, 0.85]
Total (95% CI) 39 42 100.0% 0.47 [0.26, 0.85]

Total events 10 23
0.1 0.2 0.5 1 2 5 10
Test for overall effect: Z = 2.47 (P = 0.01) Favours once weekly Favours twice weekly
I.6.2.7 Decontaminating skin when changing dressings
2% Chlorhexidine gluconate (CHG) vs 10% Povidone Iodine (PVP-I) in aqueous
358
Forest plots
Figure 78: VAD related bacteraemia
2% CHG in aq 10% PVP-I in aq Risk Ratio Risk Ratio

MAKI1991 1 214 6 227 38.3% 0.18 [0.02, 1.46]
VALLES2008 9 211 9 194 61.7% 0.92 [0.37, 2.27]
Total (95% CI) 425 421 100.0% 0.63 [0.29, 1.41]

Total events 10 15
0.01 0.1 1 10 100
Test for overall effect: Z = 1.12 (P = 0.26) Favours 2% CHG in aq Favours 10% PVP-I in aq
Figure 79: VAD related septicaemia

VALLES2008 17 211 19 194 100.0% 0.82 [0.44, 1.54]
Total (95% CI) 211 194 100.0% 0.82 [0.44, 1.54]

Total events 17 19
0.01 0.1 1 10 100

MAKI1991 5 214 21 227 11.4% 0.25 [0.10, 0.66]
VALLES2008 130 329 158 329 88.6% 0.82 [0.69, 0.98]
Total (95% CI) 543 556 100.0% 0.76 [0.64, 0.90]

0.01 0.1 1 10 100
2% Chlorhexidine gluconate (CHG) in aqueous vs 70% Isopropyl alcohol (IPA)

2% CHG in aq 70% IPA Risk Ratio Risk Ratio
MAKI1991 1 214 3 227 100.0% 0.35 [0.04, 3.37]
Total (95% CI) 214 227 100.0% 0.35 [0.04, 3.37]

Total events 1 3
0.01 0.1 1 10 100
Test for overall effect: Z = 0.90 (P = 0.37) Favours 2% CHG in aq Favours 70% IPA

2% CHG in aq 70% IPA Risk Ratio Risk Ratio
MAKI1991 5 214 11 227 100.0% 0.48 [0.17, 1.36]
Total (95% CI) 214 227 100.0% 0.48 [0.17, 1.36]

Total events 5 11
0.01 0.1 1 10 100
Test for overall effect: Z = 1.37 (P = 0.17) Favours 2% CHG in aq Favours 70% IPA
2% Chlorhexidine gluconate (CHG) in aqueous vs 0.5% Chlorhexidine gluconate (CHG) in alcohol
359
Forest plots

2% CHG in aq 0.5% CHG in alc Risk Ratio Risk Ratio
VALLES2008 9 211 9 226 100.0% 1.07 [0.43, 2.65]
Total (95% CI) 211 226 100.0% 1.07 [0.43, 2.65]

Total events 9 9
0.01 0.1 1 10 100
Test for overall effect: Z = 0.15 (P = 0.88) Favours 2% CHG in aq Favours 0.5% CHG in alc
Figure 84: VAD related septicaemia

VALLES2008 17 211 15 226 100.0% 1.21 [0.62, 2.37]
Total (95% CI) 211 226 100.0% 1.21 [0.62, 2.37]

Total events 17 15
0.01 0.1 1 10 100

VALLES2008 130 329 119 339 100.0% 1.13 [0.92, 1.37]
Total (95% CI) 329 339 100.0% 1.13 [0.92, 1.37]

0.01 0.1 1 10 100
0.5% Chlorhexidine gluconate (CHG) in alcohol vs 10% Povidone Iodine (PVP-I) in aqueous

0.5% CHG alc 10% PVP aq Risk Ratio Risk Ratio
HUMAR2000 4 193 5 181 34.8% 0.75 [0.20, 2.75]
VALLES2008 9 226 9 194 65.2% 0.86 [0.35, 2.12]
Total (95% CI) 419 375 100.0% 0.82 [0.39, 1.72]

Total events 13 14
0.1 0.2 0.5 1 2 5 10
Test for overall effect: Z = 0.52 (P = 0.60) Favours 0.5% CHG alc Favours 10% PVP aq
Figure 87: VAD related local infection

0.5% CHG alc 10% PVP aq Risk Ratio Risk Ratio
HUMAR2000 0 193 4 181 100.0% 0.10 [0.01, 1.92]
Total (95% CI) 193 181 100.0% 0.10 [0.01, 1.92]

Total events 0 4
0.01 0.1 1 10 100
Test for overall effect: Z = 1.52 (P = 0.13) Favours 0.5% CHG alc Favours 10% PVP aq

VALLES2008 130 329 119 339 100.0% 1.13 [0.92, 1.37]
Total (95% CI) 329 339 100.0% 1.13 [0.92, 1.37]

0.1 0.2 0.5 1 2 5 10
360
Forest plots
10% Povidone Iodine (PVP-I) in aqueous vs 5% Povidone Iodine (PVP-I) in 70% ethanol

10% PVP-I in aq 5% PVP-I in 70% ethanol Risk Ratio Risk Ratio
PARIENTI2004 4 117 1 106 100.0% 3.62 [0.41, 31.91]
Total (95% CI) 117 106 100.0% 3.62 [0.41, 31.91]

Total events 4 1
0.01 0.1 1 10 100
Test for overall effect: Z = 1.16 (P = 0.25) Favours 10% PVP-I in aq Favours 5% PVP-I in alc

10% PVP-I in aq 5% PVP-I in 70% ethanol Risk Ratio Risk Ratio
PARIENTI2004 41 117 14 106 100.0% 2.65 [1.54, 4.58]
Total (95% CI) 117 106 100.0% 2.65 [1.54, 4.58]

Total events 41 14
0.01 0.1 1 10 100
Test for overall effect: Z = 3.50 (P = 0.0005) Favours 10% PVP-I in aq Favours 5% PVP-I in alc
10% Povidone Iodine (PVP-I) in aqueous vs 70% Isopropyl alcohol (IPA)

10% PVP-I aq 70% IPA Risk Ratio Risk Ratio
MAKI1991 6 227 3 227 100.0% 2.00 [0.51, 7.90]
Total (95% CI) 227 227 100.0% 2.00 [0.51, 7.90]

Total events 6 3
0.01 0.1 1 10 100
Test for overall effect: Z = 0.99 (P = 0.32) Favours 10% PVP-I in aq Favours 70% IPA

10% PVP-I aq 70% IPA Risk Ratio Risk Ratio
MAKI1991 21 227 11 227 100.0% 1.91 [0.94, 3.87]
Total (95% CI) 227 227 100.0% 1.91 [0.94, 3.87]

Total events 21 11
0.01 0.1 1 10 100
Test for overall effect: Z = 1.80 (P = 0.07) Favours 10% PVP-I in aq Favours 70% IPA
0.25% Chlorhexidine gluconate (CHG) in aqueous proprietary solution vs 5% PVP-I in 70% alcohol

0.25 CHG in aq 5% PVP-I in alcohol Risk Ratio Risk Ratio
MIMOZ2007 4 242 10 239 100.0% 0.40 [0.13, 1.24]
Total (95% CI) 242 239 100.0% 0.40 [0.13, 1.24]

Total events 4 10
0.01 0.1 1 10 100
Test for overall effect: Z = 1.59 (P = 0.11) 0.25 CHG in aq 5% PVP-I in alcohol
361
Forest plots
Figure 94: VAD related phlebitis

0.25% CHG in aq 5% PVP-I in alcohol Risk Ratio Risk Ratio
MIMOZ2007 64 242 64 239 100.0% 0.99 [0.73, 1.33]
Total (95% CI) 242 239 100.0% 0.99 [0.73, 1.33]

Total events 64 64
0.1 0.2 0.5 1 2 5 10
Test for overall effect: Z = 0.08 (P = 0.93) 0.25% CHG in aq 5% PVP-I in alcohol

0.25% CHG in aq 5% PVP-I in alcohol Risk Ratio Risk Ratio
MIMOZ2007 28 242 53 239 100.0% 0.52 [0.34, 0.80]
Total (95% CI) 242 239 100.0% 0.52 [0.34, 0.80]

Total events 28 53
0.01 0.1 1 10 100
Test for overall effect: Z = 3.02 (P = 0.002) 0.25% CHG in aq 5% PVP-I in alcohol
Figure 96: VAD line removal - mean duration of catheter placement (days)
0.25 CHG in aq 5% PVP-I in alcohol Mean Difference Mean Difference
MIMOZ2007 12 9.1 242 12.1 9.2 239 100.0% -0.10 [-1.74, 1.54]
Total (95% CI) 242 239 100.0% -0.10 [-1.74, 1.54]

-10 -5 0 5 10
Test for overall effect: Z = 0.12 (P = 0.90) 0.25 CHG in aq 5% PVP-I in alcohol
I.6.2.8 Decontaminating peripheral and centrally inserted catheter ports and hubs before access
No clinical evidence was identified.
I.6.2.9 Multi dose vials
No clinical evidence.
362
Cost utility analysis
Appendix J: Cost-utility analysis: Intermittent

self catheterisation
J.1 Introduction…………………………………………………………………………………………………………………..365
J.2 Methods……………………………………………………………..…………………………………………………………365
J.2.1 Model overview……………………………………………………………………………………………..365
J.2.1.1 Comparators……………………………………………………………………………………………365
J.2.1.2 Population……………………………………………………………………………………………….366
J.2.1.3 Time horizon, perspective, discount rates used……………………………………….366
J.2.2 Approach to modelling………..……………………………………………………………………………366
J.2.2.1 Key assumptions………………………………………………………………..…………………….367
J.2.2.2 Model structure……………………………………………………………………………………….367
J.2.2.3 Uncertainty………………………………………………………………………………………………368
J.2.3 Model inputs…………………………………………………………...……………………………………….369
J.2.3.1 Summary table of model inputs………………………………………………………………..369
J.2.3.2 Baseline event rates………………………………………….………………………………………369
J.2.3.3 Relative treatment effects………………………………………………………………………..371
J.2.3.4 Cohort probabilities………………………………………………………………………………….372
J.2.3.5 Life expectancy…………………………………………………………………………………………374
J.2.3.6 Utilities …………………………………………………………………………………………………….374
J.2.3.7 Resource use and cost………………………………………………………………………………376
J.2.4 Sensitivity analyses…………………………………………………………………………………………..380
J.2.5 Value of information analysis……………………………………………………………………………383
J.2.6 Interpreting results……………………………………………………………………………………………386
J.2.7 Validation………………………………………………………………………………………………………….387
J.3 Results……………………………………………………………………………………………………………………………388
J.3.1 Base case analysis……………..………………………………………………………………………………388
0 Sensitivity analysis………..…………………………………………………………………………………..389
J.3.3 Value of information analysis…………….……………………………………………………………..393
0 Discussion………………………………………………………………………………………………………………………394
363
J.4.1 Summary of results…………………………………………………………………………………………..394
J.4.2 Patient preference and compliance……………………………………………………………………394
J.4.3 Limitations and interpretation……………………………………………………………………………395
J.4.4 Generalisability to other populations / settings………………………………………………….395
J.4.5 Comparisons with published studies…………………………………………………………………..395
J.4.6 Conclusion = evidence statement……………………………………………………………….………396
J.4.7 Implications for future research………………………………………………………………………….396
364
J.1 Introduction
Catheter-associated urinary tract infection (CAUTI) is the most common healthcare acquired
infection in the world, accounting for 20% to 45% of all nosocomial infections 376. While most urinary
tract infections (UTIs) are mild and easily resolved with appropriate antibiotic treatment, more
severe infections can be devastating, resulting in bacteraemia, sepsis and death. Due to the
frequency with which they occur, they also impose a substantial economic burden on the NHS 377.
The most important risk factor for the development of CAUTI is the prolonged use of an indwelling
catheter. For this reason, intermittent self catheterisation (ISC) has become the preferred method of
catheterisation for patients in which it is clinically indicated 369 247. ISC aims to reduce CAUTIs and
promote greater independence among people who have bladder emptying problems. Nevertheless,
CAUTI remains the most frequent and serious complication of ISC 515.
There are several different approaches to ISC. Patients may use disposable catheters with a
hydrophilic polymer surface coating, disposable catheters with pre-packaged water based lubricant
(gel reservoir), or non-coated catheters. Non-coated catheters may be discarded after use, or washed
and re-used for up to one week. Which material and method constitutes the best approach is an
issue of considerable uncertainty.
Our aim in constructing the model was to determine the most cost-effective type of catheter for
patients performing ISC in the community. The relative effectiveness of each type of intermittent
catheter was based on the results of the randomised controlled trials included in our systematic
review. Several different versions of the model were built to reflect the diversity of patient groups
using ISC. The model was built probabilistically in order to take into account uncertainty and
imprecision around parameter point estimates.
J.2 Methods
J.2.1 Model overview
J.2.1.1 Comparators
There are several types of catheters available for ISC. The catheters included in the model are all
those that are available for patients residing in the community:
Hydrophilic catheters are coated with a hydrophilic polymer coating. Hydrophilic catheters
must be immersed in water prior to use or may be packaged in a casing of water or saline.
These catheters are designed for single use.
Gel reservoir catheters are pre-packaged with a small sachet of sterile water-soluble
lubricant which must be released and spread over the catheter before use. These catheters
are also designed for single use.
Non-coated catheters do not have a surface coating and patients often apply a water-based
or anaesthetic lubricant before use. These catheters may be washed and reused for up to
one week, although some patients choose to use them as single use catheters. In the
model we chose to explore both methods of non-coated catheter use:
o Non-coated catheters which are discarded immediately after use – sometimes referred
to as ‘sterile’ non-coated ISC.
o Non-coated catheters which are washed, dried and reused multiple times – sometimes
referred to as ‘clean’ non-coated ISC.
The decision to include multiple use non-coated ISC as a treatment alternative was made in
consultation with the GDG, expert continence advisor, NICE commissioning managers, Medicines and
365
Healthcare products Regulatory Agency, British Association of Urological Nurses, staff at Stoke
Mandeville Hospital, and the manufacturers of each non-coated catheter listed on the Drug Tariff
(Bard, Teleflex Medical, Pennine Healthcare, and Hunter Urology). The conclusion from these
conversations was that in the community, clean ISC remains a valid method of catheterisation.
However, in settings where facilities are not available, patients are catheterised by others, or
patients are below 16 years of age (see below), re-use is not advisable. Therefore, two sets of models
were built:
One for when clean ISC is an option, and
One for when it is not.
J.2.1.2 Population
There are multiple causes of bladder dysfunction which affect a heterogeneous population. ISC may
be used by patients with neurogenic bladder, dysfunctional voiding syndromes, and patients
recovering post-operatively for procedures to the urinary tract or reproductive system 219.
Because the majority of the included clinical effectiveness studies were conducted in patients with
spinal cord injury (SCI), the base case model considered a population of adult patients with
neurogenic bladder due to SCI.
In order to create a model that would be broadly applicable to all individuals using ISC in the
community, separate cost-utility analyses were conducted for adult patients with bladder
dysfunction caused by a condition other than SCI as part of the sensitivity analysis.
The GDG noted that in children and young people (≤ 16 years old), symptomatic UTI can cause
progressive renal scarring which may lead to renal failure later in life. Renal failure carries a high risk
of mortality and morbidity, is associated with very high cost and decreased quality of life. The most
recent NICE guideline for Urinary Tract Infection in Children 314 concluded that it was not possible to
estimate the true risk of renal failure as a result of childhood UTI, did not identify any quality of life
values for children with UTI, and did not consider economic modelling a valid option in this
population. The current GDG agreed with this decision and noted that none of the studies included in
the clinical review which contained symptomatic UTI as an outcome were conducted in children.
Given the uncertain risk of harm as a result of symptomatic UTI in childhood, the GDG decided to
employ the precautionary principle in their approach to ISC in children. Therefore, only single use
catheters were considered an option for ISC in children and modelling was not explicitly undertaken
in this population.
J.2.1.3 Time horizon, perspective, discount rates used
The analysis was undertaken from the perspective of the NHS and personal social services, in
accordance with NICE guidelines methodology 315. Relevant costs consisted of the cost of catheters
(and lubricant, where applicable) and treatment for UTIs of varying severity at the primary and
secondary care level. All costs are reported in 2009/10 British pounds. The primary measure of
outcome is the quality-adjusted life-year (QALY). The model was evaluated over a lifetime horizon
with both costs and QALYs discounted at a rate of 3.5% per year.
J.2.2 Approach to modelling

Symptomatic UTI is the most meaningful outcome for evaluating the efficacy and costs of
intermittent catheterisation. Although asymptomatic bacteriuria is common in patients using ISC
over the long term, it has little clinical impact and treatment is not recommended 491. As in the
clinical review, symptomatic UTI was defined one or more symptom suggestive of UTI and/or self-
reported UTI requiring treatment.
366
Current management of symptomatic UTI usually includes a clinical assessment of symptoms and
dipstick urinalysis, followed by empiric treatment (referred to as ‘first-line antibiotic’ treatment
throughout the model). The most clinically relevant outcome following treatment is the resolution of
symptoms. In the model, this state is referred to as ‘clinical cure’.
Although empiric treatment is effective in the majority of cases, a small proportion of these patients
will experience persistent symptomatic infection and contact their healthcare provider for further
treatment. ‘First-line antibiotic resistant UTI’ was used to describe patients with symptomatic relapse
who require a further antibiotic prescription within 28 days of the initial prescription. Because
antibiotic resistance is a key cause of treatment failure, at this point in the treatment pathway the
healthcare provider will normally obtain a urine specimen and initiate targeted treatment based on
the results of the culture.
UTIs may be caused by a number of different strains of bacteria. Over the past several years,
antimicrobial resistant strains have emerged as important causes of UTI in the UK and around the
world 370,398. In order to accurately capture the full impact of UTI on patient morbidity, mortality and
cost, the GDG considered it important to incorporate the effects of antibiotic resistance into the
model.
‘Multidrug resistant UTI’ was defined as resistance to two or more classes of antimicrobial agents. It
was assumed that all patients with a multidrug resistant infection are admitted to hospital for
treatment with intravenously administered carbapenem antibiotics. Catheter-associated
bacteraemia occurs when a patient’s blood and urine cultures reveal growth of the same organism.
All patients with catheter-associated bacteraemia were assumed to have symptomatic UTI and it was
assumed that they were immediately admitted to hospital upon diagnosis.
Long-term studies have demonstrated that the incidence of urethral complications such as structures
and false passages tend to increase over time 515. Although proponents of hydrophilic catheters often
cite the lower surface friction associated with their coating detected by cytological investigation 475
449
as evidence of a reduction in urethral complications, no comparative clinical studies have been
published. Therefore, in the base case analysis it was assumed that the incidence of urethral
complications does not vary between the different catheter types. The model was built to allow
exploration of this assumption in sensitivity analysis.
J.2.2.1 Key assumptions
The main simplifying assumption of the model is that the probability of antibiotic resistance does not
change over time. The decision to build a static model was based on a lack of available data about
current and historical resistance rates, the complexity of forecasting antibiotic resistance trends over
time and within populations, and a lack of examples on which to base methodological approaches.
The GDG deemed the assumption of a static model to be reasonable and the impact of extreme
scenarios was explored in sensitivity analysis.
J.2.2.2 Model structure
A Markov model was constructed to calculate lifetime costs and QALYs for each comparator. Figure
97 illustrates the key health states in the model and possible transitions between them in each cycle.
The model is divided into one year cycles, which was thought to be a reasonable cycle length based
on available evidence of clinical efficacy and baseline risk. The model was built in TreeAge Pro 2009.
The hypothetical SCI population entering the model had an average age of 40 years and was 80%
male; this is the average age at injury and gender ratio of spinal cord injury patients according to the
US National SCI Database 318.
367
The model structure did not explicitly account for patients who experience more than one UTI within
a one year cycle length. Because the data used to inform the clinical effectiveness for each type of
catheter measured the occurrence of ‘one or more UTI’, it was assumed that recurrent infections
were implicitly included in the baseline and relative risk estimates. In the absene of more specific
randomised evidence of comparative efficacy for recurrent UTI, this was a necessary assumption.
In addition, the analysis also did not explicitly model the transition from first-line or multidrug
resistant UTI to bacteraemia. Again, this structural assumption was necessary due to data limitations.
A search of the literature only identified the probability of developing bacteraemia after
symptomatic UTI of non-specific severity. It was therefore assumed that this value represents the
cumulative probability of bacteraemia as a result of all UTI and was only included once in the model.
Figure 97: Markov model structure
Catheter-associated
bacteraemia
Multidrug resistant
No symptomatic UTI Symptomatic UTI Death
UTI
First-line antibiotic
resistant UTI
Schematic diagram of the Markov model designed to analyse the cost-effectiveness of different types of intermittent
catheter. The Markov modelling approach involves a transition between different health states over time. The model is
divided into 1 year cycles. At the end of each cycle a transition to another health state is possible unless patients enter into
an ‘absorbing’ health state from which they do not recover. In this model, the absorbing state is death. At each cycle there is
also an age-related probability of all-cause mortality; these transitions are not depicted in the diagram.
J.2.2.3 Uncertainty
The model was built probabilistically to take account of the uncertainty surrounding each input
parameter. In order to characterise uncertainty, a probability distribution was defined for each
parameter based on error estimates from the data sources (e.g. standard errors or confidence
intervals). When the model was run, a value for each input was randomly selected from its respective
distribution. The model was run repeatedly to obtain mean cost and QALY values.
The number of simulations used to obtain the probabilistic results was chosen according to methods
described by Koehler and colleagues 228. The model was set to ensure that the Monte Carlo error was
not more than 1% of the standard error of the mean incremental cost and QALY estimate for each
type of catheter. For this model, the number of simulations necessary to obtain this level of accuracy
is approximately 10, 000.
368
Various sensitivity analyses were also undertaken to test the robustness of model assumptions and
data sources. In these analyses, one or more inputs were changed and the analysis was rerun in
order to evaluate the impact of these changes on the results of the model.
J.2.3 Model inputs
J.2.3.1 Summary table of model inputs
The probability of acquiring a CAUTI was based on clinical evidence identified in the systematic
review undertaken for the guideline. All other model inputs were identified by supplementary
literature reviews and were validated with members of the GDG. A summary of the probability, cost,
and utility inputs used in the base-case analysis is provided in the tables below. More details about
sources, calculations and rationale underpinning data selection can be found in the section preceding
each summary table.
J.2.3.2 Baseline event rates
Symptomatic UTI
The baseline probability of developing symptomatic UTI was calculated from the studies included in
the clinical review (Table 23)59,95,110,150,224. The annual rate was obtained by dividing the total number
of events observed in patients using single use non-coated catheters by the total number of patient
years (Equation 1).
Table 23: Baseline risk of symptomatic UTI in patients with SCI using single use non-coated
catheters
Column 4:
Total person years of
Column 1: Column 2: Column 3: observation
Patients with one Patients without UTI Follow-up (Column 1 x Column 3 +
Study or more UTI (Total N – Column 1) (years) Column 2 x Column 3)
Cardenas 2009 14 9 1.00 23.00
de Ridder 2005 51 11 1.00 62.00
Giannatoni 2001 12 42 0.13 7.27
Duffy 1995 35 7 0.17 7.27
King 1992 3 20 0.08 1.77
Total 115 89 N/A 101.31
Equation 1. Rate
A standard error for the rate was derived using the delta method as described by Kirkwood and
Sterne 2003 (Equation 2)226.
369
Equation 2. Standard error of the rate
For the purpose of clinical validation, the 95% confidence interval for the rate was derived from the
standard error. In order to take account of the constraint that the rate must be greater than or equal
to zero, it is preferable to work on the log scale and to derive a confidence interval for the log rate,
then calculate the exponential to give a confidence interval for a rate 226. The formula for the
standard error of the log rate is derived using the delta method (Equation 3)226.
Equation 3. Confidence interval for a rate
A gamma distribution was applied to the rate according to the method of moments approach
described by Briggs et al 2006 (Equation 4)51.
Equation 4. Gamma distribution (α, β)
In order to transform the baseline rate of symptomatic UTI to a probability the following equation
was used (Equation 5) 133.
370
Equation 5. Converting a rate to a probability
Therefore, based on the rate of symptomatic UTI observed in the included studies, the baseline
probability of symptomatic UTI associated with sterile non-coated catheter use was 68% (Table 24).
This is consistent with other epidemiological and observational studies in the literature 515,518.
In the base case analysis, the baseline probability of developing a urethral complication was derived
from an observational study of patients using ISC over an average length of 9.5 years 359. Over this
time, 19% of this group developed urethral strictures. According to the equations described above,
this results in a 2.38% annual probability of developing a urethral complication (Table 24).
This value is on the upper end of estimates reported by other papers 515. It was chosen to represent
the possibility of developing urethral complications of any type, whether they are strictures, false
passages, urethritis, or any other complication that could be expected as a result of urethral trauma.
J.2.3.3 Relative treatment effects
Symptomatic UTI
The between-strategy differences in costs and QALYs are driven by the relative risk (RR) of
symptomatic UTI for each catheter compared to single use non-coated catheters. The RR for each
catheter is based on the results of the systematic review and meta-analysis of randomised controlled
trials identified in the clinical review (see section I.4), where single use non-coated catheters were
used as the baseline comparator.
The probability of symptomatic UTI associated with each catheter strategy was calculated by
multiplying the baseline risk of symptomatic UTI by the RR of symptomatic UTI for each catheter. The
results of the meta-analysis and the distribution assigned to each RR are reported below in Table 24.
In the absence of any comparative clinical evidence, it was assumed that the risk of developing
urethral complications did not differ between catheters. This assumption was explored in sensitivity
analysis.
371
Table 24: Baseline event rate and relative treatment effects

Point Confidence Probability Distribution
Input estimate interval distribution parameters Source
Baseline annual event rate
Baseline rate of UTI (non- 1.14 0.933 -1.347* Gamma α = 115.0000 Cardenas
coated catheter used once β = 0.0099 2009, de
only) Ridder 2005,
Duffy 1995,
Giannantoni
2001 & King
59,95,110,1
1995
50,224
Baseline probability
Baseline probability of 0.68 See text (Equation 5)
symptomatic UTI
Baseline probability of 0.02 0.01-0.06 Beta α = 0.5000 Prieto-
urethral complication β = 20.5000 Fingerhut
383
1997
Relative treatment effect
RR of UTI with hydrophilic 0.80 0.65 - 0.99 Lognormal LM = -0.2289 Cardenas
catheter LSD = 0.1073 2009 & de
Ridder
59,95
2005
RR of UTI with gel reservoir 0.33 0.11 - 0.97 Lognormal LM = -1.2628 Giannantoni
150
catheter LSD = 0.5553 2001
RR of UTI with non-coated 0.98 0.77 - 1.25 Lognormal LM = -0.0278 Duffy 1995
catheter used multiple times LSD = 0.1236 & King
110,224
1992
RR of urethral complications 1.00 N/A Fixed N/A Assumption
(All catheters)
* Estimated based on mean rate and standard error according to the delta method and intended for the purpose of clinical
validation only (see Equation 3). RR = relative risk, LM = log of the relative risk, LSD = standard deviation of the log of the
relative risk.
J.2.3.4 Cohort probabilities
Antibiotic resistance in UTI
Despite the clinical and political importance of antimicrobial resistant infections, evidence of the
prevalence of resistant infections in the urinary tract is scarce. Only one paper which examined the
incidence of first-line antibiotic treatment failure among patients with SCI who use ISC was identified
107
. In this Canadian study, patients were randomised to receive either a 3-day or 14-day course of
ciprofloxacin. At 23-day follow-up, symptomatic relapse was experienced by 5 out of 30 patients in
the 3-day treatment group 107. The probability of clinical failure after treatment for symptomatic UTI
was therefore 15.4%.
Among individuals with SCI, it is thought that prolonged, repeated exposure to healthcare settings
and antimicrobial agents increases the risk of infection with multidrug resistant organisms. The most
common mechanism of resistance in UTI-causing organisms is the production of extended-spectrum
beta-lactamases (ESBL). These enzymes inactivate certain antibiotics. Like all forms of antimicrobial
resistance, the prevalence of ESBL varies by geography, healthcare setting, and patient demographic.
Recent studies have found that the annual probability of multidrug resistant UTI observed in the SCI
population ranges from 4.3% in community dwelling persons using ISC 487 to 9% acute rehabilitation
372
settings 313. Based on these estimates, it was assumed that on average, 7% of individuals with
catheter-associated UTI are infected with a multidrug resistant pathogen (Table 25); this assumption
was further explored in sensitivity analysis.
If on average, 15.4% of patients with SCI who use ISC experience treatment failure for symptomatic
UTI and 7% of SCI patients using ISC fail treatment by virtue of having multidrug resistant UTI, it was
assumed that the remaining patients experience treatment failure due to first-line antibiotic resistant
infections.
Mortality due to multidrug resistant UTI
Patients infected with ESBL-producing bacteria are generally sicker than patients who are not
infected with ESBL producing strains. However, there are very few studies of mortality in patients
with multi-drug resistant UTI. Even among the few studies that addressed the issue in patients with
bacteraemia, the question of whether ESBL-production significantly increases the risk of death
remains unclear 391.
A retrospective analysis 201 of ESBL-producing bacteria found an overall mortality rate of 12.1%
among patients with UTI caused by ESBL-producing E.Coli and Klebsiella bacteria. However, there was
no control group for this population and it was not clear whether the analysis controlled for the
contribution of antibiotic resistance to the reported mortality rates. A recent retrospective study by
Klevens et al (2008)227 determined that 8 out of a total of 43 deaths in patients with UTI caused by
ciprofloxacin resistant E.Coli were directly caused or contributed to by the resistant organism. Out of
a total of 3112 ciprofloxacin resistant isolates collected from 2000 to 2004, 9.8% were UTIs caused by
ciprofloxacin-resistant E.coli. Therefore, the mortality rate in patients with UTIs caused by drug-
resistant bacteria was 2.6%. The GDG thought this to be a reasonable estimate of mortality to
include in the base case analysis.
Bacteraemia
In order to estimate the incidence of bacteraemia following UTI, we looked primarily to the economic
evaluations retrieved by our systematic reviews and completed a search of PubMED to identify other
data. In 2000 Saint et al418 published a systematic review of the incidence of bacteraemia in patients
with UTI; this was the most recent and comprehensive source of data identied to inform this
parameter. Each of the five studies included in this review reported similar estimates ranging from
2.6%to 4.0%. The pooled estimate for the risk of developing bacteraemia as a result of catheter-
associated UTI was 3.6% with a 95% CI of 3.4% to 3.8%418. The studies included in this review were
from a heterogeneous hospital-based population. In the absence of any specific data regarding
individuals with SCI, the same probability was assumed to apply to both the SCI and non-SCI
population (Table 25).
Mortality due to bacteraemia
There have been few studies of bacteraemia in patients with SCI. Two retrospective analyses of
deaths occurring within 30 days of diagnosis of bacteraemia in patients with SCI were identified 303
488
. The study by Montgomerie and colleagues (1991) reported 4 deaths in 50 bacteraemic episodes
were directly related to bacteraemia with a UTI origin (probability of 7.7%), while Wall et al (2003)
report a total of 8 deaths in 95 bacteraemic episodes (probability of 8.1%). The former was used to
inform the base case analysis as this rate was derived from patients with UTI-associated bacteraemia
only. The slightly lower probability of mortality in these patients compared to non-SCI individuals
(Table 29) appears to be a well-recognised phenomenon in the literature 303.
373
Table 25: Overview of baseline probabilities and probability distributions

95% Beta
Point Confidence Distribution
Parameter description estimate interval parameters Source
107
Treatment failure 0.154 0.067-0.330* α = 4.6055 Dow 2004
β = 25.3945
First-line antibiotic resistant 0.085 See text
UTI
Multidrug resistant UTI 0.070 0.043-0.090* α = 40.4460 Estimate based
β = 537.3540 on Mylotte 2000
& Waites
313,487
2000
227
Multidrug resistant mortality 0.026 0.013-0.051* α = 7.8960 Klevens 2008
β = 297.1040
418
Bacteraemia 0.036 0.034-0.038 α = 867.5640 Saint 2000
β = 23231.436
Bacteraemia mortality 0.077 0.029- 0.192* α = 3.8442 Montgomerie
303
β = 46.1558 2011
* Estimated based on mean rate and standard error according to the delta method and intended for the purpose of clinical
validation only (see Equation 3).
J.2.3.5 Life expectancy
Although there have been dramatic improvements in the care of patients with spinal cord injuries
over the past 50 years, life expectancy remains slightly below normal. Mortality rates are significantly
higher during the first year after injury than during subsequent years, particularly for more severely
injured individuals. For the purposes of this analysis, it was assumed that patients using IC in the
community had survived beyond the one-year time point.
To date, there is only one study of mortality among spinal cord injury patients in Britain. Frankel et al
(1998) 135 conducted a review of medical records from patients with spinal cord injury of at least one
year duration at Stoke Mandeville hospital and the Regional Spinal Injuries Centre in order to
calculate standardised mortality ratios (SMRs) for subjects injured between 1973 and 1990. The
gender distribution of this cohort (81% male) closely matched that of our baseline demographic and
the analysis combined mortality ratios for all levels of disability. Age-dependant annual mortality
rates were calculated by multiplying the SMR of 5.41 for patients aged 31-41 at time of injury by
central mortality rates obtained from life tables for England and Wales in 2007-2009 337.
J.2.3.6 Utilities
In accordance with the NICE reference case, health outcomes were estimated using the Quality
Adjusted Life Year (QALY). In order to calculate QALYs, it is necessary to quantify both the quality of
life of each health state and the time spent in each state. A systematic literature search was
performed in order to identify all health related quality of life studies related to UTI and UTI-
associated bacteraemia. The results of this review are reported in Appendix K.
The literature search revealed two recent studies which measured the impact of UTI in people with
SCI using a validated generic measure of health-related quality of life 174,257,483. The authors of these
studies were contacted for additional information and both replied. Although Haran and co-workers
were unable to provide any further data, Vogel and colleagues granted us access to recent patient-
level SF-12 responses collected as part of a longitudinal study of adults who sustained SCI as children
and adolescents 483,529. The responses were classified into three groups according to our outcome of
interest: no UTI, UTI and severe UTI (requiring intravenous antibiotics or hospitalisation). The recall
374
period for each group was one year (i.e. patients were asked to describe their health over the past
year). Using an algorithm developed by Gray et al 2006 164, this data was mapped to EQ-5D values for
the UK population. Because of the random component contained within this mapping algorithm, a
simulation was run 1000 times in order to calculate a mean value, standard error and confidence
interval for each of the three health states measured (Table 26).
In order to calculate a utility value for first-line resistant UTI, it was assumed that the quality of life
associated with this health state is worse than that for UTI but better than that for multidrug
resistant UTI. The mean value of these two health states was taken and the standard error was
assumed to be 5% of the mean in order to generate the probability distribution (Table 26).
In the absence of published utility values for UTI-associated bacteraemia, it was assumed that a
linear decrease in health-related quality of life applies to those in this health state and that the
standard error was 5% of the mean. The implications of this assumption were explored in sensitivity
analysis.
The values calculated from the studies by Zebracki et al 2010529 and Vogel et al 2002483 were chosen
to inform the base case analysis as they better account for the range of health states within the
model and were elicited with a recall period that more accurately matches the model cycle length
than the data reported by Lee and Harran 174,257.
A recent Cochrane review of procedures for urethral narrowing did not find any quality of life data
among patients treated for urethral strictures 512. A search of the Tufts cost-effectiveness analysis
registry 3 also failed to identify any relevant utility weights in the literature. Given that urethral
complications would likely involve significant discomfort and stay in hospital, it was assumed that the
quality of life associated with this health state would be comparable to that experienced by patients
with multidrug resistant UTI.
Table 26: Health state utility weights for people with SCI
Point Gamma
estimate 95% Confidence distribution
Health state (QALY) interval parameters Source
No symptomatic UTI 0.831 0.809-0.852 α = 5707.1157 Vogel 2002 and
β= 0.0001 Zebracki
483,529
2010
Symptomatic UTI 0.782 0.764-0.799 α = 7549.6790 Vogel 2002 and
β = 0.0001 Zebracki
483,529
2010
First-line resistant UTI 0.760 0.685-0.834* α = 400.0000 Expert opinion
β = 0.0019
Multidrug resistant UTI 0.738 0.688-0.787 α = 805.6864 Vogel 2002 and
β = 0.0009 Zebracki
483,529
2010
Bacteraemia 0.716 0.645-0.786* α = 400.0000 Expert opinion
β = 0.0018
Urethral complication 0.738 0.688-0.787 α = 805.6864 Assumed to be
β = 0.0009 same as multi-
drug resistant
UTI
*Estimated based on mean and standard error - intended for the purpose of clinical validation only.
375
J.2.3.7 Resource use and cost
Cost of catheters
All catheters available through the NHS Drug Tariff323 were classified as either hydrophilic, gel
reservoir or non-coated with the help of the continence expert and manufacturer information
provided on-line. In cases where there was uncertainty about catheter type, manufacturers were
contacted by telephone. The average cost of each type of catheter was used as the point estimate;
the maximum and minimum listed costs formed the range used to inform each distribution (Table
27).
Most individuals using ISC catheterise between four and six times a day regardless of the type of
catheter they use 513. In order to calculate the annual cost of gel reservoir, hydrophilic and single-use
non-coated catheters, it was assumed that patients catheterise an average of 5 times per day.
Depending on personal habits and preferences, individuals using non-coated catheters multiple times
use a highly variable number of catheters per month. To ensure consistency with prescribing data
from the NHS Drug Tariff323 and the literature478, an average of 5 catheters per month (ranging from
4 to 6 per month) was used to calculate the annual cost of non-coated catheters used multiple times
in the base case analysis. This was varied in sensitivity analysis.
Non-coated catheters require an application of lubricant before use. Although most patients use a
water-based lubricant, the GDG estimated that an average of five percent of patients who self
catheterise regularly use lidocaine lubricant. This estimate was probabilistically incorporated in the
cost of lubricant by assuming a range of between 0% and 10%. Because lubricant is applied to the
catheter each time it is used, it was assumed that patients with single use and multiple use non-
coated catheters consume equal amounts of lubricant.
In order to accurately capture the cost of catheter use in the community, a monthly prescription
dispensing fee was added to the cost of catheters and lubricant (i.e. one prescription charge per
month for gel reservoir and hydrophilic catheters and a total of two prescription charges per month
for noncoated catheters) .The range used to inform this distribution was based on the highest and
lowest dispensing fee scales for authorised dispensing practitioners.
Table 27: Catheter unit costs and annual resource use

Gamma
Point Distribution
estimate Value range parameters Source
Mean unit cost per catheter
Hydrophilic catheter £1.28 £0.97 - £1.66 α = 56.6920 NHS Drug Tariff
323
β = 0.0226 2010
Gel reservoir catheter £1.36 £0.98 - £1.43 α = 184.9600 NHS Drug Tariff
323
β = 0.0074 2010
Non-coated catheter £1.19 £0.39 - £1.47 α = 62.9378 NHS Drug Tariff
323
β = 0.0189 2010
Water-based lubricant £0.19 £0.18 - £0.19 α = 258.7902 NHS Drug Tariff
323
(per 5g sachet) β = 0.0007 2010
Lidocaine lubricant (per 8.5g £1.20 £0.96 - £1.44* α = 100.0000 NHS Drug Tariff
323
sachet) β = 0.0120 2010
Dispensing fee (per month) £1.96 £1.87 - £2.11 α = 61.4656 NHS Drug Tariff
323
β = 0.0319 2010
Mean number of catheters and lubricant sachets used per year
Single use hydrophilic, gel 1825 1460 - 2190 α = 102.7970 Woodbury
376
Gamma
Point Distribution
513
reservoir and non-coated β = 17.7534 2008
Multiple use non-coated 60 48 - 72 α = 105.1939 NHS Drug Tariff
323
β = 0.5703 2010
Sachets of lubricant 1825 1460 - 2190 α = 102.7970 Assumption
(for both single use and β = 17.7534 based on the
multiple use non-coated number of
catheters) catheters used
per year
Equivalent mean annual cost
Single use hydrophilic catheter £2359.40
Single use gel reservoir catheter £2505.50
Single use non-coated catheter £2657.76
Multiple use non-coated catheter £557.35
*Estimated based on mean and standard error - intended for the purpose of clinical validation only.
Cost of treatment for infection
CAUTI treatment costs were estimated based on recommended diagnostic and treatment pathways
for UTI in adults 474 181. Costs regarding contact time with primary healthcare workers were obtained
from the 2009/10 Personal and Social Services Research Unit 88 Costs incurred in the community
were based on data from the 2010 NHS Drug Tariff 323. The cost of secondary care was calculated
according to 2009/10 NHS Reference costs. A detailed breakdown of the cost of treating catheter-
related infections is presented in Table 28.
Please note the following for costing purposes:

Patients may consult a number of different healthcare professionals for treatment of UTI. It
was assumed that the healthcare provider most frequently contacted for UTI was a GP (in
80% of cases), followed by community nurse specialist (in 10% of cases) and hospital
emergency room (in 10% of cases) 513. The cost of GP consultations and community nurse
specialist were obtained from the Unit Costs of Health and Social Care 2009/10 88, the cost
of emergency room visit was obtained from the NHS reference costs 2009/10100. These
costs were incorporated into the model probabilistically according to the following
distributions:
o The average cost of a GP consultation was estimated at £30, based on a 12.6 minute
surgery consultation with upper and lower confidence intervals based on the mean cost
of home visit (£60) and 10 minute surgery consultation (£23) used to inform the
distribution parameters (α = 100.0000, β = 0.3000)
o The cost of a 20 minute home visit from a community nurse specialist (£20) was used as
the mean cost per nurse consultation, with the cost of the same length of visit by a
community specialist (£23) and clinical support worker (£8) forming the upper and lower
confidence intervals (α = 44.4444, β = 0.4500).
o The mean national unit cost of an emergency room visit is £62 with an inter quartile
range of £37 (α = 4.8985, β = 12.6510).
First-line therapy for symptomatic UTI in England currently includes the antibiotics
trimethoprim, nitrofuratonin, cefalexin, and pivmecillinam; what drug is prescribed varies
by region and between practices 13. In the base case analysis, the model assumes an
377
average treatment length of 5 days for each drug (with the exception of pivmecillinam),
based on an average treatment duration of 3 and 7 days for women and men, respectively
13
. Mean unit cost was calculated as a simple mean based on the following costs listed in
the NHS Drug Tariff 2010 323 and dosages from the prescribing support unit 467 (the most
expensive and least expensive course of treatment was used as confidence intervals used
to inform the parameter distribution):
o Trimethoprim 200mg twice daily for five days (£0.75)
o Nitrofuratonin 50mg four times daily for five days (£1.91)
o Cefalexin 500mg twice daily for five days (£1.30)
o Pivmecillinam 200mg three times daily for three days (£4.05)
The same sources and methods were used to calculate the average cost of second-line
antibiotics used to treat first-line resistant UTIs. The cost of second-line antibiotics was
calculated as a simple mean of the costs of the following individual drugs:
o Ciprofloxacin 250mg three times daily for seven days (£2.33)
o Cefaclor 250mg three times daily for seven days (£5.28)
o Cefixime 200mg once daily for seven days (£13.23)
o Norfloxacin 400mg twice daily for seven days (£3.81)
o Ofloxacin 400mg once daily for seven days (£5.82)
o Pivmecillinam 400mg four times daily for seven days (£50.40).
In both first- and second-line treatment, it is assumed that patients are fully compliant.
Given the short duration of the course of antibiotics, this is considered reasonable 131.
Increased fluid intake and frequent urination associated with UTI will result in increased
catheter use while the patient is symptomatic. Therefore, the cost of additional catheters
(and lubricant for non-coated catheters) was added to the cost of each infection treated in
the community. The GDG indicated that an average of 12 catheters per infection (and
infection exacerbation) would be a reasonable estimation.
Patients with multidrug resistant infections are usually admitted to hospital for intravenous
drug therapy 13. The cost of treatment for a multidrug resistant infection was calculated as a
weighted average reference cost for kidney or urinary tract infection with intermediate
complications (LA04E; £2,097 (£1, 681 to £2417)) and without complications (LA04F; £1,
618 (£1, 203 to £1, 822)). The average excess bed day cost for each HRG is £197 (£154 to
£224) and £195 (£154 to £222)100, respectively. These costs were weighted according to
reported activity, with 73% of the total cost attributed to LAO4E, in order to produce a total
average cost for people with multi-drug resistant UTI.
The cost of treatment for bacteraemia secondary to UTI was assumed to be equivalent to
the non-elective reference cost for kidney or urinary tract infection with major
complications (code LA04D) with a national average unit cost of £2938 (£2264 to £3352)
and average excess bed day cost of £198 (£152 to £227)100. In the UK, bacteraemia caused
by resistant organisms does not appear to have a significant impact on length of hospital
stay compared to bacteraemia caused by susceptible organisms (Melzer and Petersen
2007)294.
378
Cost of treatment for urethral complication
The cost of treating a urethral complication was estimated based on reference cost group LB30B:
urethra disorders and intermediate/minor procedures without complications with a national average
unit cost of £1,268 and lower and upper quartile unit cost of £908 and £1,399 100. The effect of
increased treatment cost due to failed or repeat procedures was explored in sensitivity analysis.
Table 28: Cost of treatment

Gamma
Point distribution
Symptomatic UTI
88
Healthcare consultation £32.20 See text PSSRU 2010
Dipstick analysis £0.07 £0.06 - £0.08 α = 0.5432 NHS Drug Tariff
323
β = 0.1357 2010
First-line antibiotic £2.00 £0.75 - £4.05 α = 1.7826 NHS Drug Tariff
323
treatment β = 1.1235 2010
Dispensing fee £1.96 £1.87 - £2.11 α = 61.4656 NHS Drug Tariff
323
β = 0.0319 2010
Additional catheters Dependant on type of catheter (assumed an NHS Drug Tariff
323
average of 12 additional catheters per 2010
infection)
Equivalent mean total cost £36.23 + additional catheters
First-line antibiotic resistant UTI
88
Urine analysis £7.00 £5.00 - £9.00 α = 5.4444 NHS Reference
β = 1.2857 costs
Second line antibiotic £13.48 £2.33 - £50.40 α = 1.5016 NHS Drug Tariff
323
treatment β = 8.9768 2010
Dispensing fee £1.96 £1.87 - £2.11 α = 61.4656 NHS Drug Tariff
323
β = 0.0319 2010
Additional catheters Dependant on type of catheter (assumed an NHS Drug Tariff
323
average of 12 additional catheters per 2010
infection)
Equivalent mean total cost £54.64 + additional catheters
Multidrug resistant UTI
88
100
β = 1.2857 Costs
Non elective inpatient £2, 097 £1, 681 - £2, α = 13.535 NHS Reference
100
admission (LA04E) 417 β = 154.93 Costs
Non elective inpatient £1, 618 £1, 203 - £1, α = 8.6577 NHS Reference
100
admission (LA04F) 822 β = 186.92 Costs
Average number of excess 0.92 NA Fixed NHS Reference
100
bed days (LA04E) Costs
Average number of excess 1.02 NA Fixed NHS Reference
100
bed days (LA04F) Costs
Cost per excess bed day £197 £154 - £224 α = 12.829 NHS Reference
100
(LA04E) β = 15.355 Costs
379
Gamma
Point distribution
100
(LA04F) β = 13.866 Costs
Equivalent mean total cost £2019.02
Bacteraemia
88
100
β = 1.2857 Costs
Blood test £7.00 £5.00 - £9.00 α = 5.4444 NHS Reference
100
β = 1.2857 Costs
Non elective inpatient £2938 £2, 264 - £3, α = 14.558 NHS Reference
100
admission (LA04D) 352 β = 201.80 Costs
Average number of excess 0.97 N/A Fixed NHS Reference
100
bed days (LA04D) Costs
100
(LA04D) β = 21.318 Costs
Equivalent mean total cost £3197.83
Urethral complication
Urethral procedure £1, 268 £908 - £1,399 α = 17.8748 NHS Reference
100
β = 70.9659 Costs
J.2.4 Sensitivity analyses
ISC in people who do not have SCI
In the absence of any clinical data, it was assumed that the relative risk of symptomatic UTI for each
type of catheter was the same as that observed in the SCI population. This was a necessary
assumption in order to explore the cost-effectiveness of intermittent catheter types across a wider
group of people with bladder dysfunction. The GDG indicated that it was also a reasonable
assumption as there is no clinical reason to suspect that SCI patients would respond any differently
to any one type of catheter than any other patient using ISC.
Cohort probabilities
People with bladder dysfunction not caused by SCI are a highly diverse group of patients, with a wide
range of ages, health states, disabilities. Several cohort probabilities were changed to reflect the
probability of antibiotic resistance and mortality in a more heterogeneous population. There is very
little epidemiological evidence about the prevalence and morbidity of UTI in this population as a
whole; young women appear to be the most common subject of UTI-related research in the
literature. The GDG indicated that if the sample size were large, this population may represent a
sufficiently heterogeneous group from which to draw the parameters to inform probabilities for the
sensitivity analysis.
A study of over 75,000 patients from the UK General Practice Research Database was used to
estimate the probability of treatment failure in this group of patients. This study found that between
12% and 16% of women treated for UTI return within 28 days for a further course of treatment,
regardless of the antibiotic initially prescribed 255. This is consistent with the findings of a study of a
large pharmaceutical database in the Netherlands 158. Following input from experts at the Health
Protection Agency (Neil Woodford and Alan Johnson; personal communication), and review of
380
several other data sources10,79,227,294,379,398,514,it seems likely that between 4% to 8% of community

acquired urinary isolates in the UK and USA are resistant to ciprofloxacin or contain extended-
spectrum beta-lactamase (ESBL) producing bacteria. Therefore, it was assumed that approximately
6% of UTIs in the UK are multidrug resistant (Table 29). The same probability of developing
bacteraemia and of dying from multidrug resistant UTI as in the base case analysis was assumed to
apply to this analysis. The probability of mortality from bacteraemia was obtained from a meta-
analysis by Bryan and Reynolds (1984) 52.
Utilities
The life expectancy and utility values informing the model were also updated. Three studies were
identified through our quality of life review (Appendix K:) which allowed a series of multiplicative
relationships to be used to calculate utility values per symptom day for patients without SCI. The per-
day utility value for patients who recover from symptomatic UTI after empirical treatment was
derived from a study by Ellis and Verma (2000) 120, in which the SF-36 questionnaire was
administered to a group of otherwise healthy women suffering from UTI and their matched controls.
The algorithm suggested by Ara and Brazier (2008) 21 was used to convert SF-36 responses into EQ-
5D health state valuations, which were adjusted based on average mapped EQ-5D values for the UK
population 207.
A study by Ernst et al (2005)123 used the Quality of Well Being to evaluate the effect of failed
antibiotic treatment compared to clinical cure in patients being treated for UTI. In order to calculate
the proportional utility decrease for patients with first line resistant infections, the reported value for
patients who failed treatment at 7 days was divided by the score for patients who were cured after 3
days. A multiplicative relationship was assumed to apply to the EQ-5D value derived from Ellis and
Verma (2000) in order to estimate the utility value for patients with first-line resistant UTI. The same
calculation was applied to patients experiencing treatment failure at 14 days in order to estimate the
daily utility value for patients with multidrug resistant UTI. In the absence of any utility values for
UTI-associated bacteraemia, a value derived from inpatients with bloodstream infections of
unspecified origin was used to inform this health state 428.
The recall period used by Ellis and Verma (2000) asked patients about their quality of life within the
past 24 hours. To obtain QALYs, the daily utility value for each health state was multiplied by the
duration of the health state, assuming that the rest of the year was lived in a state of full health
(Equation 6). For patients who achieve clinical cure after empiric treatment, an average symptom
duration of 3.5 days was assumed based on expert opinion. The duration of first-line resistant UTI
was assumed to be 8.5 days allowing time for the patient to realise treatment failure, consult a
healthcare professional, and begin a second course of antibiotics. Given that patients with multidrug
resistant UTI and bacteraemia would be admitted to hospital for treatment, it was assumed that
these infections would last an average of 10 days based on expert opinion and NHS Reference Cost
data.
Equation 6. QALYs for patients without SCI
Resource use and cost
All costs remained the same as in the base case.
381
Table 29: Summary of probability and utility values for people without SCI
Point Probability Distribution
Parameter description estimate Value range distribution parameters Source
Cohort probabilities
Treatment failure 0.14 0.120-0.160 Beta α = 139.165 Lawrenson
255
β = 854.875 2001
First-line antibiotic resistant 0.080 See text See text
UTI
Multidrug resistant UTI 0.060 0.040-0.080 Beta α = 27.9070 Expert
β = 437.2088 opinion
informed by
al Hasan
2010,
Cohennahu
m 2008,
Klevens
2008,
Melzer
2007, Potz
2006,
Reynolds
2009,
Woodford
10,79,227,2
2004
94,379,398,514
Multidrug resistant mortality 0.026 0.013-0.051* Beta α = 7.8960 Klevens

227
β = 297.1040 2008
418
Bacteraemia 0.036 0.034-0.038 Beta α = 867.564 Saint 2000
β = 23231.440
52
Bacteraemia mortality 0.127 0.091-0.176* Beta α = 28.0528 Bryan 1984
β = 192.9471
Utility per day of symptoms
No symptomatic UTI 0.858 0.775 - 0.943* Beta α = 55.6619 Jenkinson
207
β = 9.1594 1999
Symptomatic UTI 0.674 0.608 - 0.741* Beta α = 129.5527 Ellis
120
β = 62.5388 2000 ‡
First-line resistant UTI 0.630 0.568 - 0.692* Beta α = 147.1142 Ellis 2000,
β = 86.1642 Ernst
120 123
2005 ‡
Multi-drug resistant UTI 0.617 0.557 - 0.678* Beta α = 152.3615 Ellis 2000,
β = 94.3569 Ernst
120 123
2005 ‡
Bacteraemia 0.530 0.478 - 0.582* Beta α = 187.4700 Greenwell
β = 166.2470 2004, Selai
166,428
1995
Urethral complications 0.617 0.557 - 0.678* Beta α = 152.3615 Expert
β = 94.3569 opinion
Symptom duration (days)
Symptomatic UTI 3.5 2.625-4.374* Gamma α = 61.5837 Expert
β = 0.0568 opinion
First-line resistant UTI 8.5 6.373-10.626* Gamma α = 61.3731 Expert
382
Point Probability Distribution

Parameter description estimate Value range distribution parameters Source
β = 0.1385 opinion
Multidrug resistant UTI 10.0 7.493-12.506* Gamma α = 61.1306 Expert
β = 0.1636 opinion
Bacteraemia 10.0 7.493-12.506* Gamma α = 61.1306 Expert
β = 0.1636 opinion
Urethral complications 10.0 7.493-12.506* Gamma α = 61.1306 Expert
β = 0.1636 opinion
Equivalent mean utility per year (QALY)
No UTI 0.858
Symptomatic UTI 0.856
First-line resistant UTI 0.853
Multidrug resistant UTI 0.852
Bacteraemia 0.850
Urethral complications 0.852
*Estimated based on mean and standard error – intended for the purpose of clinical validation only.
‡
Adapted from reference
Currently, there is no comparative clinical evidence to suggest that the use of one type of catheter
results in fewer urethral complications compared to another. However, there have been animal and
laboratory studies suggesting that the coated catheters reduce removal friction and cell adhesion
compared to non-coated catheters 275,489. This is sometimes interpreted as evidence that hydrophilic
catheters cause less urethral trauma and may lead to a decrease in urethral complications. The effect
of a reduction in urethral complications associated with hydrophilic and gel reservoir catheters was
explored in the sensitivity analysis.
Parameter uncertainty
One- and two-way sensitivity analyses were undertaken to evaluate the relative impact of the
probability of antimicrobial resistance, mortality, utility, resource use and cost on the outcome of the
model.
J.2.5 Value of information analysis

All decisions about the cost-effectiveness of interventions are associated with a certain degree of
uncertainty in the evidence base. As a result of this uncertainty there will always be a chance that the
wrong decision will be made. A wrong decision would be costly in terms health benefit and resources
forgone. The best way to resolve this uncertainty is to gather more information, but this may also be
costly and time consuming. Value of information (VOI) analysis provides a framework for determining
the expected benefit of future research by taking into account both the probability that further
information will change the adoption decision, the sample size necessary to achieve maximal benefit,
and the opportunity cost of conducting a research project of this size. VOI aims to answer the
question of whether future research should be conducted, and if so, on which uncertain parameters,
and provides and estimate of the optimal sample size for each study.
383
Expected value of perfect information (EVPI)
Per-patient EVPI
The first step of VOI is to estimate the expected value of perfect information (EVPI) per patient. As
stated in section J.2.6, the decision rule that we must use when making recommendations is to
choose the option that maximises net benefit based on current information. If we had perfect
information, we would always choose the correct option and there would be no loss. However, in
order to achieve perfect information we would require a study with infinite sample size.
In reality, there will always be a degree of error associated with each data input in the decision
problem. The expected cost of uncertainty is determined jointly by the probability that the decision
based on based on existing information will be wrong and the consequences of a wrong decision. The
expected loss as a result of uncertainty is equivalent to the expected gain from eliminating
uncertainty (i.e. the EVPI). Mathematically, the EVPI is the difference between expected maximum
net benefit with perfect information and the maximum expected net benefit with current
information. The per-patient EVPI for each model was generated directly from the simulated output
(over 10 000 iterations) from TreeAge 2009.
Population EVPI
The next step in determining the EVPI is to calculate the upper limit for future research expenditure
by taking into account both the current and future patient populations who might be expected to
benefit from the intervention in question. Multiplying the per-patient EVPI by the number of current
and future people using intermittent catheterisation in England and Wales who will be affected by
the decision provides us with an upper boundary for future research expenditure (Equation 7).
Equation 7. Population EVPI
Current and future patients affected by the decision problem
Several sources of data and a series of assumptions were used to inform the population estimate for
the value of information analysis:
Prevalence and incidence of traumatic SCI in England and Wales: There are currently
40,000 people in the UK living with SCI (Kennedy 1998). The majority of these injuries are
caused by trauma. The annual incidence of traumatic-SCI is approximately 15 new cases per
million per year in Western Europe 86.
Prevalence and incidence of non-traumatic SCI in England and Wales: There is little
information about the prevalence of other conditions causing SCI such as spinal stenosis,
tumours, ischaemia and inflammation, but it is thought that approximately 36% of spinal
cord injuries are non-traumatic291. The annual incidence of non-traumatic SCI is estimated at
26.3 cases per million321,322
Proportion of patients with SCI who use ISC: Roughly 80% of people with SCI have some
degree of difficulty with bladder function269,269; it was assumed that 60% of these patients
would use ISC. Approximately 90% of individuals with SCI live in private residences following
384
rehabilitation318 and 40% are in school or employment318. It was assumed that the same
proportion applies to those with non-traumatic SCI.
Proportion of patients who should not use multiple use non-coated catheters: It was
assumed that people who do not live in a private residence and people who are at work or
school do not have regular access to facilities needed to wash and dry catheters. Clean
multiple use non-coated ISC was assumed to be an option for the remainder of the SCI
population.
Lifetime of the technology: Current guidelines recommend that the selected time horizon
should reflect the effective lifetime of the technology. A search of PubMed and Google
Scholar did not reveal any evidence of imminent new developments in catheter material
research, but there is active work in this field. Ten years was thought to represent a
reasonable estimate of time before a new type of intermittent catheter might be expected
to be brought to market.
Current and future population of England and Wales: The population of England and Wales
is currently 62 million, projected to rise to approximately 67 million over the next 10 years
337
.
Given current population and incidence estimates and discounting at a rate of 3.5%, over the next 10
years approximately 13, 437 people will have a choice between using clean or sterile ISC.
Approximately 11, 500 will have a choice between different types of sterile ISC.
Expected value of partial parameter information (EVPPI)
It is also possible to identify which type of additional evidence is most valuable to the decision
problem by calculating the expected value of partial parameter information (EVPPI). The EVPPI is an
estimate of the value of eliminating uncertainty regarding a particular parameter or set of
parameters (for example, baseline risks or quality of life). This information can be used to indicate
which endpoints should be included in further experimental research, or to focus research on
obtaining more precise estimates for values which may not require an experimental design. As with
the EVPI, the per-patient EVPPI must also be multiplied by the affected population over the
appropriate time period to obtain the population EVPPI. The population EVPPI provides an upper
boundary for the cost of research into particular parameters.
The method of calculating EVPPI is conceptually very similar to EVPI. It is the difference between the
expected value with perfect and current information about a parameter or group of parameters. The
crucial difference is that EVPPI requires a two-level, or ‘nested’, Monte Carlo procedure. The
procedure begins with an outer loop sampling values from the distribution of the parameters of
interest, and for each of these, an inner loop sampling the remaining parameters from their
conditional distribution.
The per patient EVPPI for the current model was calculated using TreeAge 2011. The outer loop was
run 400 times (that is, each parameter of interest was sampled 400 times) and the inner loop was
run 5 000 times (that is, for each of the 400 outer samples, the Monte Carlo analysis was run for 5
000 iterations). Given time constraints, this was thought to represent a pragmatic solution to the
suggestion that the inner loop should be run 1000 to 10 000 times 335.
Expected value of sample information (EVSI) & expected net benefit of sampling (ENBS)
Although the population EVPI and EVPPI provide an estimate of the maximum budget for research, a
positive value does not mean that such a budget should be set. In order to determine the net benefit
of conducting research into a particular topic or specific set of parameters, it is essential to first
determine the optimal sample size.
385
With increasing sample size, the EVSI will reach a ceiling which equals the maximum EVPI/EVPPI
(representing an infinite sample size). However, with increasing sample size, the costs of research will
also increase. The expected net benefit of sampling (ENBS) is defined as the difference between the
expected value of sample information (EVSI) with sample size n and the cost of conducting research
with sample size n. The point at which EVBS is maximised is the optimal sample size for the proposed
study. If there is no positive sample size for which the EVBS is greater than zero, then additional
research is not warranted and the decision should be based on current information only.
The EVSI was calculated by repeatedly running the EVPPI analyses for different n values (outer loops).
These analyses were only undertaken for parameters with EVPPI values greater than zero. The
analyses were run 5 times for each sample size and an average EVSI obtained for each sample size.
Cost of research
Clinical trial budgets are a mixture of direct, indirect, fixed and variable costs. A search was
preformed to identify average research budgets for similar types of trials but no information was
identified. It was assumed that a trial of this type would be relatively inexpensive to administer. A
fixed cost of £50, 000 was used to account for the estimated full time salary of a study coordinator,
to supplement the costs of a clinician/researcher and cover the cost of any additional expertise
needed for data analysis. An estimated incremental cost of £500 per patient was also assumed to
relate to the costs of administration associated with each patient. It was assumed that the costs of
the catheters themselves would be covered by the NHS, not the research grant.
J.2.6 Interpreting results

The results of cost-effectiveness analysis are presented as incremental cost-effectiveness ratios
(ICERs). ICERs are calculated by dividing the difference in costs associated with two alternative
treatments by the difference in QALYs:
Where more than two interventions are being compared, the ICER is calculated according to the
following process:
1. The interventions are ranked in terms of cost, from least to most expensive.
2. If an intervention is more expensive and less effective than the preceding intervention, it is
said to be 'dominated' and is excluded from further analysis.
3. ICERs are then calculated for each drug compared with the next most expensive non-
dominated option. If the ICER for a drug is higher than that of the next most effective
strategy, then it is ruled out by 'extended dominance'
4. ICERs are recalculated excluding any drugs subject to dominance or extended dominance.
5. When there are multiple comparators, the option with the greatest average net benefit may
also be used to rank comparators.
NICE’s report ‘Social value judgements: principles for the development of NICE guidance’ sets out the
principles that GDGs should consider when judging whether an intervention offers good value for
money 316.In general, an intervention is considered to be cost-effective if either of the following
criteria apply:
The intervention dominates other relevant strategies (that is, is both less costly in terms of
resource use and more clinically effective compared with all the other relevant alternative
strategies), or
386
The intervention costs less than £20,000 per quality-adjusted life-year (QALY) gained compared
with the next best strategy
J.2.7 Validation
The model was developed in consultation with the GDG; model structure, inputs and results were
presented to and discussed with the GDG for the purpose of clinical validation and technical
interpretation.
The model was systematically checked by the health economist undertaking the analysis; this
included inputting null and extreme values and checking that results were plausible given inputs. The
model was also peer reviewed by the lead health economist at the NCGC; this included systematic
checking of many of the model calculations.
387
J.3 Results
J.3.1 Base case analysis
For patients who are able to wash and re-use catheters, this represents the most cost-effective
option for intermittent self catheterisation. For patients who may not be in a situation that allows
them to wash and re-use catheters, gel reservoir catheters are most cost-effective. Results of the
base case probabilistic analysis are summarised in Table 30 and shown graphically in Figure 98.
In both scenarios, gel reservoir catheters are the most effective type of catheter (i.e. associated with
more QALYs than the other catheter types). However, they are not always the most cost-effective
option. According to NICE decision making rules (page 387), an intervention can only be considered
cost-effective if its ICER falls below the £20,000 to £30,000 threshold. According to the results of our
model, when gel reservoir catheters are compared to multiple-use non-coated catheters, the ICER is
£51, 345. In other words, the QALY gain associated with gel reservoir catheters compared to multi-
use non-coated catheters is not enough to justify the large difference in cost.
When it is not possible to re-use non-coated catheters, gel reservoir is the most cost-effective type of
catheter. Compared to hydrophilic catheters, gel reservoir catheters are more effective and slightly
more expensive, with an ICER of approximately £3, 270 per QALY.
Table 30: Base case analysis results (probabilistic)

Catheter Total cost QALYs cost* QALYs* ICER CE
In cases where non-coated catheters can be washed and reused
multiple times
Hydrophilic £38, 883 12.005 £26, 899 0.109 ED 0.00%
Gel reservoir £40, 346 12.449 £28, 326 0.552 £51, 345 0.4%
Non-coated used £43, 611 11.882 £31, 627 -0.014 D 0.00%
once only
In cases where non-coated catheters cannot be washed and reused
Gel reservoir £40, 391 12.446 £1,454 0.445 £3, 270 84.2%
Non-coated used £43, 642 11.879 £4, 705 -0.122 D 0.7%
once only
The health gain to individuals using ISC is presented in terms of total and incremental QALYs. Cost is presented as total and
at a threshold of £20,000.*Incremental costs and QALYs are calculated compared to the option with the lowest cost – non-
coated multiple use catheters and hydrophilic catheters, respectively.
388
Figure 98: Base case analysis results (probabilistic)

All four comparators Single use catheters only
£50,000 £50,000

£45,000 £45,000
£40,000 £40,000
£35,000 £35,000
£30,000 £30,000
£25,000 £25,000
£20,000 £20,000
£15,000 £15,000 ICER £3, 270
£10,000 £10,000
ICER £51, 345
£5,000 £5,000
£0 £0
-0.200 0.000 0.200 0.400 0.600 0.800 -0.2 0.0 0.2 0.4 0.6 0.8
Results for each subgroup are plotted on the incremental cost-effectiveness ratio axis. The non-coated multi-use catheter is
the least costly strategy and has been used as the baseline comparator. Therefore, it is plotted at the axis. The slope of the
line is the ICER.
As outlined in Table 31, the main cost driver in the model is the cost of the catheters (and lubricant
where applicable). The cost attributed to treating infections is lowest for gel reservoir catheters,
however these catheters are associated with the greatest catheter cost. The opposite is true of
multiple use non-coated catheters.
Table 31: Discounted total cost per patient with SCI over a lifetime horizon (deterministic)
Noncoated Noncoated single
Cost category multiple use Gel reservoir Hydrophilic use
Catheters £1, 428 £38, 379 £35, 623 £33, 008
Lubricant £6, 956 £0 £0 £6, 953
(noncoated only)
Symptomatic UTI £539 £266 £492 £545
First-line resistant £202 £107 £191 £204
UTI
Multi drug £1, 421 £673 £1, 254 £1, 436
resistant UTI
Bacteraemia £1, 201 £569 £1, 072 £1, 214
Urethral £438 £447 £440 £437
complications
J.3.2 Sensitivity analysis
ISC in people who do not have SCI
The results of the model are unchanged in patients with bladder dysfunction that is not caused by
SCI, assuming the same relative effectiveness as observed in the SCI population. Where it is possible
to wash and re-use non-coated catheters, gel reservoir catheters are not recommended on the basis
389
that the ICER is £149, 559. When re-use of non-coated catheters is not an option, gel reservoir
catheters represent the most cost-effective option. In both cases, single-use non-coated catheters
are excluded from the analysis by dominance.
Table 32: Sensitivity analysis results (probabilistic) – patients without SCI

Catheter Total cost QALYs cost QALYs ICER CE
In situations where non-coated catheters can be washed and reused
multiple times
Hydrophilic £52, 807 17.825 £37, 129 0.051 ED 0.0%
Gel reservoir £54, 549 18.034 £38, 871 0.260 £149, 559 0.0%
Non-coated used £59, 339 17.767 £43, 661 -0.007 D 0.0%
once only
In situations where catheters cannot be washed and reused
Gel reservoir £54, 450 18.029 £1, 730 0.207 £8, 364 58.0%
Non-coated used £59, 213 17.764 £6, 493 -0.058 D 4.2%
once only
The health gain to individuals using IC is presented in terms of total and incremental QALYs. Cost is presented as total and
at a threshold of £20,000.
Figure 99: Sensitivity analysis results (probabilistic) – patients without SCI

Non-SCI population - all comparators Non-SCI population - single use catheters only
£50,000 £7,000
£45,000
£6,000
£40,000
£35,000 £5,000
£30,000
£4,000
£25,000 ICER £8, 364
£3,000
£20,000
ICER £149, 559
£15,000 £2,000
£10,000
£1,000
£5,000
£0 £0
-0.1 0.1 0.3 0.5 0.7 -0.1 2E-16 0.1 0.2 0.3 0.4 0.5 0.6
Baseline risk of infection in people without SCI
The baseline risk of infection in people without SCI is likely to differ according to the specific
population in question. Older women in particular are likely make up a large proportion of people
performing ISC and are very susceptible to UTIs448. The baseline probability of infection used in the
base case model was 67.8%, based on an annual risk of 1.14; no higher estimates were identified in
the literatrure. In exploratory analysis, the baseline risk of UTI was increased to 2 and 4, with an
390
associated annual probability of 86% and 98%, respectively. In both cases, noncoated multiple use
catheters remain the most cost-effective option for ISC.
Table 33: Baseline risk of UTI in people without SCI – exploratory analysis (probabilistic)
Incr. costs vs. non- Incr. QALYs vs. non-
coated multiuse coated multiuse Optimal strategy
Sensitivity Analysis Gel Res Hydro Gel Res Hydro (probability of being CE)
Increased baseline risk of UTI
Baseline risk of UTI = 2 (baseline £38, 471 £36, 881 0.041 0.283 Non-coated multiple use
probability of UTI = 86%) (100.0%)
Baseline risk of UTI = 4 (baseline £38, 695 £36, 934 0.041 0.212 Non-coated multiple use
probability of UTI = 98%) (99.4%)
In situations where non-coated catheters can be washed and reused (in patients with SCI)
When the relative risk of urethral complication associated with the use of hydrophilic catheters is
half that of other catheters, they are still excluded from the analysis by extended dominance. This
remains the case when the probability of urethral complications associated with hydrophilic
catheters is eliminated and the cost associated with urethral complications is doubled. The same is
true for gel reservoir catheters (i.e. when the risk of urethral complication associated with the use of
gel reservoir catheters is reduced by half or eliminated and cost doubled, the ICER remains well
above the £20,000 cost-effectiveness threshold). The results of these exploratory analyses are
presented in Table 34.
Probability of antimicrobial resistance and mortality
Antimicrobial resistance is dynamic and difficult to predict. The probability of treatment failure,
multidrug resistance and mortality were each examined at the upper limit of their confidence
intervals in one- and two-way sensitivity analysis. In each case, clean non-coated catheterisation is
the most cost-effective strategy (Table 34).
Table 34: Results of one- and two-way sensitivity analyses (probabilistic) –Clean ISC
Analysis Gel Res Hydro Gel Res Hydro (probability of being CE)
In situations where non-coated catheters can be washed and reused
Base case
Base case analysis £28, 326 £26, 899 0.552 0.109 Non-coated multiple use
(99.5%)
Sensitivity analyses
Hydrophilic urethral complications £28, 316 £26, 721 0.552 0.124 Non-coated multiple use
halved (RR = 0.5) (99.5%)
Gel reservoir urethral complications £28, 031 £26, 899 0.574 0.109 Non-coated multiple use
halved (RR = 0.5) (99.4%)
Hydrophilic urethral complications £28, 339 £26, 077 0.552 0.140 Non-coated multiple use
eliminated (RR = 0) and cost doubled
391

Analysis Gel Res Hydro Gel Res Hydro (probability of being CE)
(£2, 536) (99.6%)
Gel reservoir urethral complications £27, 382 £26, 935 0.586 0.109 Non-coated multiple use
eliminated (RR = 0) and cost doubled (98.6%)
(£2, 536)
Antibiotic resistance probability & mortality
Increased probability of treatment £28, 209 £26, 845 0.577 0.112 Non-coated multiple use
failure (33%) (99.2%)
Increased probability of multidrug £28, 095 £26, 783 0.575 0.112 Non-coated multiple use
resistant UTI (9%) (99.3%)
Increased probability of both £28, 004 £26, 865 0.603 0.117 Non-coated multiple use
treatment failure (33%) and (99.0%)
multidrug resistant UTI (9%)
Increased probability of mortality £28, 265 £26, 640 0.626 0.122 Non-coated multiple use
from multidrug resistant UTI (5.1%) (98.8%)
Increased probability of mortality £28, 108 £26, 372 0.717 0.138 Non-coated multiple use
from UTI-associated bacteraemia (97.7%)
(17.6%)
Increased probability of treatment £27, 751 £25, 871 0.859 0.166 Non-coated multiple use
failure (33%), multidrug resistant UTI (91.1%)
(9%), mortality due to multidrug
resistant UTI (5.1%), and mortality
due to UTI-associated bacteraemia
(17.6%)
Threshold analysis – catheter use
The number of clean non-coated catheters used per year was varied between an average of 60 per
year (average 5 per month) and 1825 per year (average 5 per day) in a threshold analysis. Clean ISC
ceases to be the most cost-effective option when an average of 208 non-coated catheters is used per
year; this equivalent to approximately 4 catheters per week. Therefore, if on average patients use
more than four non-coated catheters per week, gel reservoir catheters are the most cost-effective
option for ISC.
In situations where non-coated catheters cannot be cleaned (in patients with SCI)
When the probability of urethral complications associated with hydrophilic complications is halved,
gel reservoir remain the most cost-effective option in situations where clean ISC is not an option. Gel
Reservoir catheters are also the most cost effective option when the probability of urethral
complications associated with the use of hydrophilic catheters is eliminated and the cost is doubled.
Table 35: Results of one- and two-way sensitivity analyses (probabilistic) – Probability and cost of
urethral complications in situations where non-coated catheters cannot be washed and
reused
Incremental costs Incremental QALYs Optimal strategy
Gel reservoir vs. Gel reservoir vs. (probability of
Analysis Hydrophilic Hydrophilic being CE)
Base case
392
Incremental costs Incremental QALYs Optimal strategy

Gel reservoir vs. Gel reservoir vs. (probability of
Analysis Hydrophilic Hydrophilic being CE)
Base case analysis £1, 393 0.447 Gel reservoir
(84.5%)
Sensitivity analyses
Hydrophilic urethral complications halved £1, 637 0.430 Gel reservoir
(RR = 0.5) (82.5%)
Hydrophilic urethral complications £1, 827 0.413 Gel reservoir
eliminated (RR = 0) (80.0%)
Hydrophilic urethral complications £2, 328 0.413 Gel reservoir
eliminated (RR = 0) and cost doubled (£2, (78.3%)
536)
J.3.3 Value of information analysis

The per-patient and population EVPI is presented in Table 36. At a threshold of £20, 000, the maximum budget for research
into the cost-effectiveness of different types of catheter for ISC is approximately £2.5 million. Source/Note: At a
threshold of £20, 000 per QALY.
Table 37 presents the EVPPI for each group of parameters. Of the five general parameter groups
across each of the two models, only one had a nonzero EVPPI. Note that EVPPI is not expected to
sum to EVPI due to interaction between parameters (for example, collecting information about one
parameter may affect the value of collecting information on another with which it is closely related).
Calculating EVSI and ENBS for the parameter distributions of the relative risk of symptomatic UTI
associated with gel reservoir and hydrophilic catheters revealed that under our estimates of the cost
of research, conducting additional research into this decision question will not yield a net benefit
(Table 36).
Table 36: Expected value of perfect information

Population over 10 years
Per patient EVPI (discounted at 3.5%) Population EVPI
Patients with a choice £34.28 13, 437 £460, 625
between all four types of ISC
Patients with a choice £176.83 11, 447 £2, 024, 075
between types of sterile ISC
Total £2, 484, 700
Source/Note: At a threshold of £20, 000 per QALY.
Table 37: Expected value of perfect parameter information

Baseline Relative Urethral
probabilities effectiveness Quality of life Cost of infection complications
Patients with a choice between all four types of intermittent catheters
Per patient £0 £0 £0 £0 £0
EVPPI
Population £0 £0 £0 £0 £0
EVPPI
Patients with a choice between types of single-use intermittent catheters
Per patient £0 £13 £0 £0 £0
EVPPI
Population £0 £213, 651 £0 £0 £0
EVPPI
393
Source/Note: At a threshold of £20, 000 per QALY.
Table 38: Expected value of sample information and expected net benefit of sample information:
Relative effectiveness of gel reservoir vs. hydrophilic catheters
Per-patient Population Fixed cost of Variable cost of Total cost of
n EVSI EVSI sampling° sampling ‡ sampling ENBS
0 £0 £0 £0 £0 £0 £0
300 £9 £103, 014 £50, 000 £150, 000 £200, 000 £-96, 986
400 £13 £154, 452 £50, 000 £200, 000 £250, 000 £-95, 548
600 £19 £213, 651 £50, 000 £300, 000 £350, 000 £-136, 349
800 £21 £237, 047 £50, 000 £400, 000 £450, 000 £-212, 953
Source/Note: At a threshold of £20, 000 per QALY. °Assuming that the fixed costs of a clinical trial are £50, 000. ‡Assuming
that the variable costs of a clinical trial are £500 per patient.
J.4 Discussion
J.4.1 Summary of results
This analysis combines the best available evidence about the costs and consequences of each type of
catheter used for intermittent catheterisation. Based on the results of the model, we can conclude
that the small decrease in symptomatic infections associated with single-use gel reservoir and
hydrophilic catheters is not enough to justify the large increase in the cost of these catheters
compared to multiple use non-coated catheters. As a result, clean multiple use non-coated catheters
represent the most cost-effective type of catheter for ISC. This conclusion was robust to a wide range
of sensitivity analyses, including the increased probability of urethral complications that may be
associated with the use of non-coated catheters. However, multiple use non-coated catheters cease
to be the most cost-effective choice when patients use an average of more than two catheters per
day. Compliance and behaviour are therefore important factors for healthcare workers to consider
when prescribing an ISC regime.
Healthcare workers must also consider other patient-specific situations when deciding which
catheter to prescribe. Washing and re-using non-coated catheters may not be an appropriate option
for all patients. When clean ISC is not an alternative, gel reservoir catheters may be considered the
most cost-effective choice for ISC. If hydrophilic catheters are preferred to gel reservoir catheters,
they may also be considered as an option.
J.4.2 Patient preference and compliance

Under the current decision rule, the recommended treatment is identified as that with the highest
ICER that falls below the cost-effectiveness threshold. Preferences are incorporated into the cost-
utility analysis through the values that are attached to each health state; these values represent the
average weight attached to each health state by the general population and are assumed to be
independent of factors related to the health care process.
The use of societal values creates the potential for conflict where individual patients hold a strong
preference for a particular treatment that is not reflected in the decision made at the societal level49.
It has been suggested that one way to incorporate individual patient preference into cost-
effectiveness decisions would be to adopt a two-part decision process which gives the patient the
choice of the most cost-effective treatment plus all cheaper options 103.
394
Of the five RCTs included in our review of clinical efficacy, three included a measure of patient
preference and comfort; none found any difference between catheter types. Nevertheless, it is still
possible that patients may find one type of catheter more comfortable or easier to use than another
and therefore derive a benefit from the catheter that is not captured in the model102. When deciding
between gel reservoir and hydrophilic catheters for patients who cannot use multiple non-coated
catheters, the GDG did not wish to force the consumption of more costly gel reservoir catheters. If a
patient has a strong preference for hydrophilic catheters then the GDG agreed that they should be
able to choose this less costly option.
It is important to note that under this rule patients should not be given a choice of therapies that are
more expensive and more costly than the most cost-effective treatment 103. In other words, this line
of reasoning cannot be extended to patients who are able to use clean multiple use non-coated
catheters but prefer not to, nor to patients who prefer single use non-coated catheters to single use
gel reservoir or hydrophilic catheters.
J.4.3 Limitations & interpretation

This analysis did not take into account the dynamic and extremely complex nature of antimicrobial
resistance. Although we sought to use the most current, relevant estimates to inform this analysis,
data about the prevalence and mortality associated with antibiotic resistant UTIs is limited and it is
impossible to predict the future of this phenomenon. If the prevalence, clinical and economic impact
of antimicrobial resistance increases beyond the upper estimates used in this model, then the cost-
effectiveness of clean intermittent catheterisation in this population may have to be re-visited.
The clinical review undertaken as part of this analysis was not designed to evaluate the most
effective method of cleaning non-coated catheters. There are many different methods of cleaning
advocated in the literature (such as soap and water, boiling, microwave sterilisation, and peroxide
application) and no consensus as to which is best. Only two of the manufacturers contacted during
the development of this guideline provided any direction as to how to clean and store non-coated
catheters – both advised washing with soap and water and leaving to dry in a clean area, using paper
towels to absorb excess water if necessary.
J.4.4 Generalisability to other populations / settings

The analysis presented in this report compared all four options for performing ISC from a UK NHS
perspective, taking into account a wide range of considerations with extensive sensitivity analyses. It
is directly applicable to this guideline and the current UK NHS.
This analysis was designed to assess the cost-effectiveness of different types of intermittent
catheters for patients performing intermittent self catheterisation in the community. Outside of the
community and primary care setting, there may be other considerations which must be taken into
account when considering the cost-effectiveness of each strategy.
The main driver of cost differences in the model is the cost of the catheters themselves. Therefore,
the results of this model are only applicable to healthcare systems in which a single payer is
responsible for both the cost of the catheter regime and the cost of treatment for UTI and UTI-
associated complications.
J.4.5 Comparisons with published studies

Several studies have noted similar effectiveness and lower costs with the use of a clean multiple use
non-coated catheters compared to single use catheters 110,182,383. However, none have attempted to
evaluate the costs and quality of life associated with symptomatic UTI or its downstream
consequences. To the best of our knowledge, this represents the first cost-utility analysis of
395
intermittent self catheterisation. By combining the best available evidence about the relative
efficacy and costs of the different methods of ISC, this analysis aimed to address an issue which has
been a source of debate for many years516.
Clean intermittent self catheterisation was first introduced in the 1970s as the preferred method of
intermittent catheterisation for patients in the community. Lapides et al (1972)246 proposed that
bladder distension was the main contributing factor to UTI rather than the introduction of bacteria to
the bladder. Partly on the basis of this theory (which still holds sway within the urological literature)
and partly based on non-systematic reviews of the clinical evidence, it is interesting to note that
several evidence- and consensus-based guideline groups have recently made recommendations
which are very similar to the conclusion reached by our analysis:
In 2010, the Infectious Diseases Society of America195 published clinical guidance
recommending the use of multiple-use catheters in outpatient and institutional settings,
while recognising that multiple use catheters may not always be an option if patients find it
inconvenient to clean their catheters when away from home.
The European Association of Urology Nurses 144 further specifies that catheterisation should
be sterile when preformed by someone other than the patient.
In 1996, the Agency for Healthcare Policy and Research8 clinical practice guideline on the
management of urinary incontinence supported the use of clean intermittent self
catheterisation.
J.4.6 Conclusion = evidence statement

Washing and re-using non-coated catheters is the most cost-effective option for intermittent self
catheterisation. In situations where it may not be feasible or appropriate to wash and reuse non-
coated catheters, gel reservoir catheters appear to be the most cost-effective catheter type.
However, if patients prefer hydrophilic catheters to gel reservoir catheters, they may also be
considered cost-effective. Single use non-coated catheters are never a cost-effective option for
intermittent self catheterisation.
J.4.7 Implications for future research

The expected value of future research is a function of the amount of uncertainty associated with the
current adoption decision. Based on best available evidence, the current model reveals that among
patients for whom multiple use non-coated catheters are an option, there is very little uncertainty
associated with the optimal choice of intermittent catheter. Concequently, the results of our value
of information analysis suggest that obtaining more information about this decision would not be a
cost-effective use of NHS resources.
396
Systematic review of health related quality of life for symptomatic UTI
Appendix K: Systematic review of health related

quality of life for symptomatic UTI
K.1 Introduction
In cost-utility analyses, measures of health benefit are valued in terms of quality adjusted life years
(QALYs). The QALY is a measure of a person’s length of life weighted by a valuation of their health
related quality of life (HRQoL) over that period. The quality of life weighting comprises two elements:
the description of changes in HRQoL and an overall valuation of that description.
In order to ensure comparability and consistency across appraisals and reduce bias in the selection of
values, the NICE reference case 315 requires that:
Measurement of changes in HRQoL should be reported directly from patients
Valuation of changes in patients’ HRQoL should be based on public preferences elicited using a
choice-based method…such as the time-trade-off or standard gamble, but not rating scale…in a
representative sample of the UK population
Use of utility estimates from published literature must be supported by evidence that
demonstrates that they have been identified and selected systematically.
To date, the majority of existing economic evaluations which include urinary tract infection as a
health state 131,153,474,500 refer to an analysis by Barry et al (1997) 33 in which the Index of Well Being
(IWB) was used to estimate the quality of life experienced by young women with UTI.
The IWB was first introduced in the 1970s as one of the first attempts to develop a generic
measurement of health utility. Using medical textbook case descriptions and items from community-
wide health surveys, a series of 29 function levels (defined across three dimensions: mobility,
physical activity, and social activity) and 42 symptom complexes were described 351. By randomly
combining different functional levels and symptoms complexes across five different age groups, a
matrix of 400 case descriptions was developed to represent a wide range of health states that may
exist within a population. In order to derive weights or social preferences, a group of 62 American
nurses and non-medical graduate students were then asked to rank each case description according
to its desirability by placing it on a 16 point scale.
The IWB was the first instrument specifically designed to measure quality of life for the estimation of
QALYs. For a long time, it was also one of only a few available measures. However, because it has not
been used to elicit health status from patients with UTI and preference-weightings are neither
representative of the general population nor elicited according to time-trade-off or standard gamble
techniques, it was deemed an unsuitable source for the purposes of our economic evaluation.
The aim of this reviewwas to systematically search the literature for generic preference-based
measures of health derived from patients experiencing UTI, severe UTI and UTI-associated
bacteraemia in order to identify appropriate utility values for our cost-utility analysis of intermittent
self catheterisation.
K.2 Search strategy

We conducted a systematic search of the literature using the electronic databases Medline (Ovid
MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1948 to Present) and
Embase (Ovid 1980 to 2010 week 47). A list of the search terms used in Medline is provided in
Appendix F.2.4. This search strategy was adapted for use in Embase. In addition to these biomedical
397
databases, the NHS Economic Evaluations Database (NHS EED) and Health Technology Assessment
(HTA) databases (via the Centre for Reviews and Dissemination (CRD) interface) and the Health
Economics Evaluations database (HEED) were searched for relevant literature. The terms used to
search HEED are shown in Appendix F.2.4. These terms were adapted for the CRD interface to search
the NHS EED and HTA databases. Both databases were searched from their date of inception to 3rd
December 2010.
In February 2011, the Cost-Effectiveness Analysis Registry was searched for utility weights using the
keywords ‘urinary tract infection’, ‘bladder infection’, ‘cystitis’, ‘pylonephritis’, ‘kidney infection’ and
‘bacteraemia/bacteraemia’ in the basic search field. The reference search section of the EuroQol
website was searched using the same terms.
Studies presenting utility values derived from a generic HRQoL measurement tool or expert opinion
were retrieved for full review based on title and abstract sifting. In addition to generic preference-
based utility measures such as the EQ-5D, studies using the SF-12 and SF-36 instruments were also
included. Although these instruments are not preference-based, there are several established
mapping functions which allow the estimation of preference-based utility scores using these
descriptive systems.
Studies using disease-specific instruments were excluded. Although mapping techniques could
theoretically be extended to disease specific instruments, the use of mapping functions beyond the
Short Form questionnaires is currently limited. Also excluded were studies published in a language
other than English.
When the method of elicitation or included health states could not be determined from the abstract,
full papers were retrieved for further examination. The reference lists of all retrieved studies were
also searched for relevant sources.
There is a wide range of clinical manifestations and anatomic levels used to categorise UTI. For the
purposes of this review, health states described in the literature were categorised according to the
following criteria: ‘UTI’ was used to refer to an infection confined to the lower urinary tract or
bladder; ‘severe UTI’ to describe an upper urinary tract infection, acute pyelonephritis, or any UTI
requiring intravenous treatment or hospitalisation; ‘UTI-associated bacteraemia’ was used to refer to
a blood stream infection with urinary tract origin.
K.3 Results
A total of 529 papers were identified by the MEDLINE and EMBASE search. Excluding duplicates, a
further 98 were identified from HEED. The Cost-Effectiveness Analysis Registry returned six results
(three of which were identified in the MEDLINE & EMBASE search) and the EuroQol website
identified seven studies (none of which were identified in the MEDLINE EMBASE search). One
additional relevant publication was uncovered by supplementary citation searching.
Eleven studies (reported in fifteen separate papers) met our inclusion criteria. With the exception of
two papers 159,445which were identified through the Cost-Effectiveness Analysis Registry and citation
searching, all were retrieved through MEDLINE and EMBASE. Six studies reported utility values
elicited using a method a method other than time-trade-off or standard gamble, or by expert
opinion. Five elicited utility values using a validated generic measure of HRQoL; just two of these
studies measured quality of life using a generic preference-based measure.
Given the heterogeneity between studies in terms of patient characteristics and elicitation methods,
there was no attempt to pool results. Instead, the population, methods and results of each study are
reported below. More detailed reports of studies using preference-based measures and non-
preference based measures with mapped estimates are presented in Table 39 and Table 40.
398
The search did not identify any primary studies of quality of life in patients with UTI-associated
bacteraemia. Several studies contained utility values for sepsis; however, the infections were not of
urinary tract origin and were thought to describe a more severe health state than the one under
review.
K.3.1 Health state values derived by a generic measure of health weighted with a method
other than time-trade-off or standard gamble, or elicited by time-trade-off or standard
gamble alone
As previously discussed, Barry and colleagues (1997) 33 estimated a monthly disutility of 0.2894 for
persistent dysuria and a disutility of 0.3732 for patients with pylonephritis using the IWB.
Ackerman et al. (2000) 5 elicited utility values from 13 men with moderate to severe benign prostatic
hyperplasia (BPH). A series of BPH-specific health states were described according to three
treatments, five short-term clinical events, and 17 possible long-term outcomes. In order to assign
preference weights to each health state, the standard gamble was administered to patients by a
trained interviewer. Results were reported according to patients’ risk attitudes. Risk-averse
individuals (n = 6) reported an average utility value of 97.2 (SE 1.1; range 94-99) for severe UTI, while
non-risk-averse patients (n = 7) reported an average value of 89.3 (SE 4.6; range 77-99).
In 1998, Gold et al 159 published a catalogue of 130 health state values developed using the Health
and Activity Limitation Index (HALex). The HALex score was derived from the answers to two
questions asked in the US National Health Interview Survey about activity limitations and self-rated
health. Between 1987 and 1992, 84 443 people were included in the survey; at the time of each
survey, a total of 384 people reported having a bladder infection and 387 reported having a kidney
infection. Based weights developed from a correspondence analysis and multi-attribute utility model,
bladder infections were assigned a mean HRQoL value of 0.73 (median 0.84; IQR 0.4) and kidney
infection a value of 0.66 (median 0.63; IQR 0.36).
K.3.2 Health state values based on expert opinion

Unable to find relevant utility data for patients with acute pylonephritis, Yen and colleagues (2003)
525
asked a panel of six emergency physicians and internists to develop utility weights using the
standard reference gamble technique. Based on the results from the expert panel, pylonephritis was
assigned a QALY of 0.90, 0.87 for pylonephritis with mild side effects, and 0.81 for pylonephritis with
serious side effects.
Sonnenberg et al (2004) 445 elicited the utility associated with UTI from ‘a convenience sample of
female members of the research team and advisor pannel’ using the time-trade-off technique. They
report a short-term disutility of 0.0192 associated with UTI. Similarly, Lawler and colleagues (1991)
254
used their own judgement to arrive at an estimated utility value of 0.99 for patients suffering from
UTI.
K.3.3 Health state values elicited using a generic preference-based measure of health or
generic measure of health with validated mapping algorithm
Two studies measured the impact of UTI on quality of life among otherwise healthy adult women. In
2000, Ellis and Verma 120 conducted a case-control study to evaluate the effect of UTI on quality of
life in women using the SF-36. Although the authors mentioned that quality of life was lower in
patients with severe UTI, these results were not reported. The authors of this study were contacted
for further information; a reply was received but additional data was not available. The algorithm
published by Ara and Brazier (2008) 21 was used to map the mean reported SF-36 dimension scores
to EQ-5D health state values (Table 40).
399
More recently, Ernst et al (2005) 123 conducted a study to evaluate quality of life among 157 women
with acute cystitis and the impact of treatment on quality of life. Patients were randomised to
receive either trimethoprim/ sulfamethoxazole for 3 days or nitrofuratonin for 7 days. The Quality of
Well Being (QWB) questionnaire was administered at baseline and 3, 7, 14, and 28 days after the
initial visit. The QWB value at baseline (i.e. suffering from UTI) was 0.68 (SD 0.03) and 0.81 (SD 0.11)
at 28 day follow-up (i.e. cured from UTI). Patients who experienced clinical cure had significantly
better quality of life scores at days 3 (0.77 vs. 0.72), 7 (0.82 vs. 0.71) and 14 (0.83 vs. 0.76) compared
to those who failed treatment; this difference was not due to treatment assignment. To our
knowledge, this is the only study to examine the effect of treatment failure on quality of life in
patients with UTI.
Maxwell et al (2009) 286 measured quality of life in older adults living in care homes using the Health
Utilities Index Mark 2 (HUI2). Results were reported according to the presence or absence of several
different clinical conditions, including urinary tract infection. The HUI2 was scored according to the
published Canadian preference weights.
Two different research groups have used the Short Form questionnaires to evaluate the effect of UTI
on individuals with spinal cord injury. Haran and colleagues have published a series of articles
reporting the use of the SF-36 in individuals with spinal cord injury 174,257,258. The 2005 paper specifies
that individuals suffering UTI have worse general health, vitality, and mental health domain scores
than those who do not have UTI, but does not report specific domain values for these groups. This
paper cites a website containing SF-36 data stratified by age, sex, and impairment group, but at the
time of press this link was not functional. The authors were contacted but were unable to provide
additional information. In 2008, the group published mapped SF-6D values derived from both the full
SF-36 and the recalculated SF-12 scores 257.
A long-term cohort study of individuals with spinal cord injury (SCI) by Vogel and co-workers (2002)483
was identified in the literature search. This study reported a statistically significant difference in SF-
12 scores for subjects suffering from UTI and severe UTI compared to patients who did not
experience UTI. However, SF-12 values for these groups were not reported. Upon request, the
research group provided us with anonymised patient-level SF-12 responses from their most recent
follow-up 482,529. Five of the 415 cases contained missing data; they were assumed to be missing
completely at random and were omitted from the analysis. Using an algorithm developed by Gray et
al (2006) 164 and the accompanying spreadsheet available on the Health Economics Research Centre
website 180, EQ-5D values were estimated based on raw SF-12 data. Because the Gray algorithm
contains random number generators, it was necessary to run a simulation (10 000 times) in order to
obtain mean EQ-5D estimates for each health state. All calculations were performed using Microsoft
Excel 2007. The results of the mapping, as well as the physical and mental component summary
scores are presented in Table 40.
400
Table 39: Sample characteristics and data collection methods of studies using validated generic health state utility measures
Health state description
Country of system and valuation
Study respondents Respondents Recruitment and selection Sample characteristics technique
123
Ernst et al (2005) USA Women suffering from UTI Patients with diagnosed UTI were No UTI Descriptive system:
recruited from two family medicine n: 146 QWB
n: 146 clinics and randomised to receive one of Mean age (SD): 34 (12)
Mean age (SD): 34 (12) three different antibiotics. The QWB was Valuation technique:
Male: 0% administered in-person at baseline and UTI Original scoring algorithm
over the telephone by a trained developed by an American
n: 146
interviewer at 3, 7, 14 and 28 days after population using a visual
Mean age (SD): 34 (12)
the initial visit. analogue rating scale
Ellis and Verma Canada Women suffering from UTI The SF-36 was administered to women No UTI Descriptive system:
120
(2000) and healthy age-matched with diagnosed UTI attending a family n: 71 SF-36
controls medicine clinic, student health services Mean age (SD): 34.0 (12.8)
or urology outpatient clinic. A group of Valuation technique:
Total n: 118 healthy undergraduate women were UTI Not applicable
Mean age (SD): NR recruited to act as the control
n: 47
Male: 0% population.
Mean age (SD): 32.3 (12.5)
Maxwell et al USA and Older adults living in care Adults age 65+ living in two care homes No UTI Descriptive system:
286
(2009) Canada homes (Calgary, Canada and Michigan, USA) n: 496 HUI2
that were able to communicate and Mean age (SD): NR
Total n: 514 provide informed consent were invited Valuation technique:
Mean age (SD): 80.5 (8.4) to participate. A trained interviewer UTI: Original Canadian weights
Male: 28% administered the HUI2 and MSD-HC. as calculated using multi-
n: 18
Mean age (SD): NR attribute utility theory
482
Vogel et al (2011) USA and Individuals with SCI Eligible participants were former No UTI Descriptive system:
and Zebracki et al Canada patients enrolled in SCI programs at n: 134 SF-12
529
(2010) Total n: 415 Shriners Hospitals for Children and were Mean age (SD): 31.3 (5.4)
Mean age (SD): 30.9 (5.3) located using the hospitals’ databases, Valuation technique:
Male: 63% White Pages directories, and a UTI Not applicable
professional search service. Subjects
Mean time since SCI (SD): n: 238
were administered the SF-12 by
16.6 years (6.2) Mean age (SD): 30.7 (5.2)
401
Health state description

Country of system and valuation
Study respondents Respondents Recruitment and selection Sample characteristics technique
Aetiology of SCI: telephone. Information about medical
Trauma 89% complications was also obtained. Severe UTI
Medical 9% n: 42
Other 2% Mean age (SD): 29.5 (4.3)
Tetraplegia: 54%
Haran et al Australia Individuals with SCI Subjects were identified from a register No UTI Descriptive system: SF-36
174
(2005) , Lee et al predominantly living in the comprised of a state-wide database and n: 167
257
(2008) community admissions records for two acute spinal Mean age (SD): NR Valuation technique:
units. They were invited to participate in Australian factor
Total n: 305 a clinical trial of antiseptic agents for the UTI SF-6D utility scores were
Mean age (SD): 44 (14) prevention of UTI. Subjects completed derived using two
n: 138
Male: 83% the SF-36 at enrolment and again on algorithms developed by
Mean age (SD): NR
development of UTI. If no UTI was Brazier et al
47,48
Mean time since SCI (SD):
15.7 years (11.6) experienced, the SF-36 was completed
at 6 month follow-up.
Aetiology of SCI: NR
Tetraplegia: 55%
Table 40: Generic preference-based health utility values for patients experiencing UTI and severe UTI
Respondents Study Recall Method No UTI UTI Severe UTI
period
Measure Domain Mean SE Mean SE Mean SE
Adult women Ellis and Verma 1 day SF-36 GH 78.90 NR 63.30 NR NR NR
120
(2000) PF 87.60 NR 76.60 NR
RP 93.00 NR 53.80 NR
RE 88.30 NR 67.40 NR
VT 64.90 NR 43.00 NR
MH 80.20 NR 64.40 NR
BP 91.50 NR 58.70 NR
SF 90.40 NR 60.40 NR
402
Respondents Study Recall Method No UTI UTI Severe UTI

period
Mapped EQ-5D°
0.922 ---- 0.724 ----
123
Ernst et al (2005) 28 days QWB 0.81 0.11 0.68 0.03 NA NA
¥ ¥
Older adults Maxwell et al (2009) 1 week HUI2 0.49 0.01 0.40 0.04 NA NA
286
482
Adults with spinal Vogel et al (2011) 1 year SF-12 MCS-12 53.73 7.58 52.56 9.40 52.12 9.79
cord injury and Zebracki et al PCS-12 47.39 10.13 43.53 10.64 42.73 10.92
529
(2010)
Mapped EQ-5D‡ 0.831 0.01 0.782 0.01 0.738 0.03
174
Haran et al, 2005 6 months SF-36 NR NR NR NR NR NA NA
257
and Lee et al 2008 (no UTI) Mapped SF-6D
α
0.68 0.01
¥
0.58 0.01
¥
β ¥ ¥
Mapped SF-6D 0.70 0.01 0.60 0.01
1 week
(UTI)Δ
Abbreviations: SF-36 = Short-Form 36-item questionnaire; SE = standard error; GH = general health; PF = physical functioning; RP = role physical; RE = role emotional; VT = vitality; MH = mental
health; BP = bodily pain; SF = social functioning; ; EQ-5D = EuroQol 5-Dimension; HUI2 = Health Utilities Index Mark 2; MCS = mental component summary; PCS = physical component summary;
NR = not reported; N/A= not applicable.
21
° Mapped based on algorithm developed by Ara and Brazier (2008)
¥Calculated as SD/SQRT(n)
164
‡ Mapped based on algorithm developed by Gray et al (2006)
48
α Derived from SF-36 responses using algorithm developed by Brazier et al (2002)
47
β SF-12 values were calculated from SF-36 scores and mapped to SF-6D based on an algorithm developed by Brazier and Roberts (2004)
Δ For subjects who developed UTI, follow-up assessments were completed on development of UTI. Specific recall time not reported; we assumed the assessment occurred within one week. For
subjects who did not develop UTI, follow-up assessments were completed at 6 months.
403
Excluded studies
K.4 Discussion
Health state utility values are key parameters in economic decision models. Values for equivalent
health states can vary substantially depending on the measure used and method of valuation 46. This
has a direct impact on the results of economic analyses.
This review identified utility values elicited from adult women, older adults and adults with spinal
cord injuries using generic preference-based measured compatible with the NICE reference case.
Currently, similar health related quality of life values do not appear to to have been elicited from
chidren experiencing UTI. By performing this review we were able to systematically identify and
select the most appropriate utility values with which to populate the economic model and identify
important gaps in the literature.
K.4.1 Acknowledgements
We are very grateful to Drs Kathy Zebracki, Lawrence Vogel, Caroline Anderson, and Ms. Kathleen
Chlan for providing us with access to SF-12 data collected from their research cohort and for their
comments on the manuscript.
404
Excluded studies
Appendix L: Excluded studies

L.1 Excluded clinical studies
L.1.1 Standard principles
L.1.1.1 Patient information

Ref Id Reason for exclusion
15
Allison 2010 Focused on feasibility of implementation of hand gel
and masks in a school. Conducted in the UK, but only
teachers (not students) were surveyed about the
acceptabilty of implementing the interventions on
students.
31
Banfield 2005 A review of literature (not systematic review).
78
Cochrane2003 UK study of availability of handwashing facilities in a
non-acute hospital.
260
Lee 2005 Focused on the transmission of respiratory and
gastrointestinal illnesses among families with
children attending child care, and the the link of
alcohol hand gel use and respiratory or
gastrointestinal illnesses.
272
Lopez-Quintero 2009 Focused on hand washing behaviour in relation to
availablility of basic hand washing facilities, illnesses
and personality trait among school children in
Bogota.
393
Ray 2009 Focused on frequency of hand washing, methods
and when hand washing was done rather than on
factors which affect hand washing behaviour in
urban and rural West Bengal, India.
481
Vivas 2010 Ethiopian study conducted among school children.
Focused on quantitative data on when or how hands
are washed, no explanatory information. Looks at
practices and facilities availabilty
519
Xiang 2010 Most of the content of the survey focused on poultry
to human transmissions, including handling of food
521
Yalcin 2004 Conducted in adolescents Turkey. Survey of
frequency of hand washing in 6 conditions, and how
hand washing was done.
405
Excluded studies
L.1.2 Hand decontamination
L.1.2.1 When to wash hands

12
Alemagno 2010 No relevant outcomes.
22
Aragon 2005 Based on local hospital hand hygiene policy (not
based on published guidelines).
115
Ebnother 2008 Based on local hospital hand hygiene policy (not
152
Gill 2009 Based on local hospital hand hygiene policy (not
165
Grayson 2008 Based on local hospital hand hygiene policy (not
209
Johnson 2005 Based on local hospital hand hygiene policy (not
185
Helder 2010 Based on local hospital hand hygiene policy (not
244
Lam 2004 Based on local hospital hand hygiene policy (not
284
Makris 2000 Based on local hospital hand hygiene policy (not
345
Owusuofori 2010 No control or baseline data reported.
361
Pessoasilva 2007 Based on local hospital hand hygiene policy (not
431
Sharek 2002 Based on local hospital hand hygiene policy (not
511
Won 2004 Based on local hospital hand hygiene policy (not
L.1.2.2 Cleaning preparation

32
Barbut 2007 Prospective cohort. Higher quality study data (RCT)
available.
60
Cardoso 1999 Laboratory study. Volunteers artificially
contaminated.
101
Dharan 2003 Laboratory study. Volunteers artificially
contaminated.
69
Chamorey 2011 Not relevant to review question.
114
Dyer 1998 Laboratory study. Volunteers artificially
contaminated.
140
Gaonkar 2005 Laboratory study. Volunteers artificially
contaminated.
169
Guilhermetti 2001 Laboratory study. Volunteers artificially
contaminated.
190
Herruzocabrera 2001 Implementation study, introduction of alcohol gel in
acute setting.
215
Kampf 2003B Laboratory study. Volunteers artificially
contaminated.
213
Kampf 2005A Laboratory study. Volunteers artificially
406
Excluded studies

contaminated.
249
Larson 2000 Intervention is a surgical scrub.
251
Larson 2005A Non randomised trial
300
Moadab 2001 Laboratory study. Volunteers artificially
contaminated.
308
Moralejo 2003 Commentary on Girou 2002 (included RCT).
325
Nhung 2007 Laboratory study. Volunteers artificially
contaminated.
343
Oughton 2009 Laboratory study. Volunteers artificially
contaminated.
352
Paulson 1999 Laboratory study. Volunteers artificially
contaminated.
368
Pietsch 2009 Laboratory study. Volunteers artificially
contaminated.
411
Rupp 2008 Implementation study, introduction of alcohol gel in
acute setting.
427
Seal 2005 Laboratory study. Volunteers artificially
contaminated.
436
Sickbertbennett 2005 Laboratory study. Volunteers artificially
contaminated.
L.1.2.3 Bare below the elbow

206
Jeans 2010 Cross-sectional study. Higher quality study data
(RCT) available.
490
Ward 2007 Non-systematic review.
504
Willis-Owen 2010 Observational study. Higher quality study data (RCT)
available.
L.1.3 Sharps
L.1.3.1 Safety needles and cannulae

7
Adams 2006 Before and after observational studies. Mixed
interventions (not just 1 safety needle or cannulae
introduced).
42
Bouza 2003 Not relevant to review question, connector not a
sharps device.
63
Casey 2007A Not relevant to review question, connector not a
sharps device.
64
Casey 2003 Not relevant to review question, connector not a
sharps device.
124
Esteve 2007 Not relevant to review question, connector not a
sharps device.
307
Moorjani 2008 Reciprocating procedure device with safety needle.
Intervention is the syringe device, not the safety
needle. Does not answer review question.
407
Excluded studies

342
Oto 2007 Not relevant to review question, connector not a
sharps device.
394
Reddy 2001 Before and after observational studies. Mixed
introduced).
423
Schilling 2006 Not relevant to review question, connector not a
sharps device.
444
Sohn 2004 Before and after observational studies. Mixed
introduced).
498
Whitby 2008 Before and after observational studies. Mixed
introduced).
524
Yebenes 2004 Not relevant to review question, connector not a
sharps device.
523
Yebenes 2008A Not relevant to review question, connector not a
sharps device.
L.1.4 Personal protective equipment
L.1.4.1 Gloves
232
Korniewicz 2003 Laboratory study. Does not meet our inclusion
criteria.
266
Lierman 2007 Laboratory study. Does not meet our inclusion
criteria.
510
Wittmann 2010 Laboratory study. Does not meet our inclusion
criteria.
L.1.4.2 Gowns and aprons

40
Bischoff 2004 Lab study investigating whether they are
contaminated when wearing different outfits. The
outfits do not include either gowns or aprons
71
Chiang 2008 Focus on cardiopulmonary resuscitation and use of
PPE (not only aprons and gowns, but also masks and
gloves)
200
Huntley 1998 Previous guideline ref. Does not answer our review
question. Microbiological sampling of long sleeved
scrub jackets worn during routine dental hygiene
procedures.
205
Ishihama 2008 No control. Aim was to evaluate incidence of blood
exposure during oral surgery, when HCW wore gown
and visor.
309
Morgan 2010 Does not answer our review question. Focus on
colonisation of PPE with multi drug resistant
organisms. Samples gloves/gowns hands for
contamination. No comparison of with/without
gowns/aprons.
340
Orji 2003 Just looks at whether gowns became infected with
408
Excluded studies

microorganisms during work rather than whether
gowns had a protective effect. No comparison
360
Perry 2001 Previous guideline ref. Does not answer our review
question. Microbiological sampling of uniforms
before and after duty.
417
Safdar 2006 MRSA outbreaks. Intervention is enhanced pre-
emptive barrier precautions (microbiological
surveillance and full barrier precautions; gowns and
gloves). Mixed intervention
506
Wilson 2007 Does not answer our review question. Focus on
laundering uniforms and HCAI adherence to
different types of fabric.
L.1.5 Long term urinary catheters
L.1.5.1 Antibiotics
264
Leone 2007 Short term urinary catheters.
327
Nicolle 2005 Review/ clinical summary.
328
Nielweise 2005 Short term urinary catheters.
329
Nielweise 2005A Included daily antibiotics and intermittent self
catheterisation.
364
Pfefferkorn 2009 Short term urinary catheters. 6-7 days
363
Pfefferkorn 2009B Editorial comment.
388
Qazi 2005 Comment on Wazait 2004.
407
Romanelli 1990 Population unclear. Patients most likely had a
urethral catheter inserted for the first time.
419
Saint 1999 Non systematic review.
421
Salomon 2006 Historical comparison.
422
Schaeffer 2006 Review/opinion.
462
Tenke 2008 Summary of European/ Asian guidelines.
494
Wazait 2004 Short term urinary catheters.
L.1.5.2 Catheter type

75
Cindolo 2004 Short term urinary catheters.
83
Crabtree 2003 No relevant outcomes
94
Day 2003 No relevant interventions. Investigating closed vs.
open system.
122
Erickson 2008 Short term urinary catheters. 14-21 days
389
Quigley 1993 No relevant interventions. Investigating closed vs.
open system.
401
Roadhouse 2004 Retrospective case-control. Short term urinary
catheters.
429
Seymour 2006 Audit. Short term urinary catheters.
446
Srinivasan 2006 Prospective crossover. Short term indwelling
catheters.
409
Excluded studies

509
Witjes 2009 PVC vs. polyvinyl chloride free. Not prioritised in the
protocol
L.1.5.3 Instillations and washouts

11
Al-Juburi 1989 comparison of a drainage system not instillations or
washouts
1
ANON 1982 Not a comparison of instillations or washouts.
Outcomes not relevant
34
Bastable 1977 Post-op irrigation
109
Dudley 1981 review - antimicrobial irrigations
148
Getliffe 1994A In vitro study using artificial urine
149
Getliffe 2000 In vitro study using artificial urine
225
Kirk 1979 Short term catheterisation
280
Maizels 1980 Short term catheterisation
450
Stickler 1987 in vitro study - assessing antiseptic properties
469
Thompson 1984 Short term catheterisation
492
Warren 1978 Short term catheterisation
526
Zacharias 2009 Not long term catheter - duration of up to 29 days
only.
L.1.6 Percutaneous endoscopic gastrostomy

221
Kenny 2010 Non systematic review. Single vs. reusable syringes
not covered.
365
Phillips 2008 Systematic review. Single vs. reusable syringes not
covered.
397
Reising 2005 Non systematic review. Single vs. reusable syringes
not covered.
L.1.7 Vascular access devices
L.1.7.1 Dressing type

58
Callaghan 2002 Primary outcome is securement of dressing
61
Carrer 2005 Intensive care setting – identified as exclusion
criteria
141
Garland 2001 Intensive care setting – identified as exclusion
criteria
151
Giles 2002 Mixed intervention. investigates type of
decontamination and dressing type
222
Khattak 2010 No relevant outcomes. Investigating systemic silver
absorption
192
Hill 2010 Intensive care setting – identified as exclusion
criteria
265
Levy 2005 Intensive care setting – identified as exclusion
criteria
410
Excluded studies

268
Little 1998 Intensive care setting – identified as exclusion
criteria
270
Livesley 1993 Primary outcome is securement of dressing
278
Madeo 1998 Intensive care setting – identified as exclusion
criteria
283
Maki 1994 Intensive care setting – identified as exclusion
criteria
330
Nikoletti 1999 Intensive care setting – identified as exclusion
criteria
413
Ruschulte 2009 High dependency unit – identified as exclusion
criteria
433 Primary outcome is securement of dressing
Sheppard 1999
440 Primary outcome is securement of dressing
Sivasangari 2005
L.1.7.2 VAD decontamination

6
Adams 2007 Study design, non systematic review.
25
Assadian 2004 Study design, letter.
30
Balamongkhon 2007 Study design, implementation study.
62
Carson 2004 Study design, non systematic review.
68
Chaiyakunapruk 2003 Study design, decision analysis.
142
Garland 2009 Population, neonates.
204
Inwood 2007 Study design, discussion paper.
396
Reichel 2009 Population, healthy volunteers.
399
Richardson 2006 Study design, non systematic review.
471
Traore 2000 Population, healthy volunteers.
L.1.7.3 Multidose vials

23
Archibald 1998 No relevant intervention or comparison
176
Harnett 2001 No relevant intervention or comparison
236
Krause 2003 No relevant intervention or comparison
302
Montenegro 2000 No relevant intervention or comparison
385
Pugliese 2000 No relevant intervention or comparison
438
Silini 2002 No relevant intervention or comparison
501
Widell 1999 No relevant intervention or comparison
502
Wiersma 2010 No relevant intervention or comparison
411
Excluded studies
L.2 Excluded economic studies

L.2.1 Hand decontamination
L.2.1.1 When to wash hands

372
Pittet 2000 Wrong intervention (posters and performance
feedback; no guidance as to hand hygiene policy)
374
Pittet 2004 Wrong intervention (posters and performance
277
MacDonald 2004 Wrong intervention (posters and performance
317
NPSA 2004 Wrong intervention (multimodal hand hygiene
promotional campaign)
212
Kampf 2003 Review of economic evaluations
L.2.1.2 Cleaning preparation

177
Harrison 2003 No costs or economic considerations
198
Huber 2006 Inadequate sample size (n = 2)
155
Gleich 2004 Cost study with no consideration of comparative
effectiveness
248
Larson 2001 Wong comparison (surgical scrub)
326
Nicolay 2006 Review, wrong comparison (surgical scrubs)
317
NPSA 2010 Wrong comparison (implementation study rather
than comparative study of hand decontamination
products)
331
Nthumba 2010 Wong comparison (surgical scrub)
400
Ritchie 2005 Review
460
Tavolacci 2006 Wong comparison (surgical scrub)
L.2.1.3 Bare below the elbow
L.2.2 Sharps
L.2.2.1 Safety needles and cannulae

108
Drain 2003 Wrong comparison; wrong settting
156
Glennard 2009 National cost analysis specific to Sweden
261
Lee 2005A Review
262
Lee 2005 Review
263
Leigh 2007 Review
333
Nwokolo 2002 Review
412
Excluded studies
L.2.3 Personal protective equipment
L.2.3.1 Gloves
9
Akridge 2009 Review of US glove industry requirements
91
Danchaivijitr 2005 Wrong comparison and setting (surgical glove
recycling in Thailand)
138
Fritzsche 2008 Wrong comparison and setting (cut-resistant gloves
in pathology)
161
Gottrup 2001
173
Hampton 2002 Review. Some discussion of economic considerations
but no comparative analysis.
231
Korczak 2010 Review
245
Lamont 2004 Wong setting (neonatal intensive care), no cost
considerations.
253
Latza 2005 Review of latex allergy insurance claims
395
Reed 2003 Review of latex allergy
468
Thomas-Copeland 2009 Wrong comparison and setting (Double gloving in
surgery)
472
Trick 2004 Wrong comparison (glove use in contact-isolation
procedures)
L.2.3.2 Gowns and aprons

35
Baykasoglu 2009 Societal perspective with incomparable costing
method. Not relevant to UK NHS perspective.
39
Bischoff 2007 No costs or economic considerations.
80
Conterno 2007 Multiple interventions; not possible to separate
effects
197
Hu 2004 Wrong comparison and setting (maximal sterile
barriers for inserting central VADs)
L.2.4 Long term urinary catheters
L.2.4.1 Antibiotics
456
Sutkin 2009 Wrong comparison (prophylactic antibiotics for
intermittent self catheterisation); decision model
with no cost considerations
L.2.4.2 Catheter type

216
Karchmer 2000 Short term catheterisation
233
Kovindha 2004 Non-OECD country; observational non-comparative
study of non-coated catheters used over 3 years
243
Lai 2002 Short term catheterisation; retrospective study
375
Platt 1989 Wrong comparison (sealed catheters vs. antibiotics)
376
Plowman 2001 Short term catheterisation; wrong comparison
413
Excluded studies

(sealed catheters vs. antibiotic prophylaxis vs.
selective catheterisation)
410
Rupp 2004 Short term catheterisation
418
Saint 2000 Short term catheterisation
L.2.4.3 Instillations and washouts
L.2.5 Percutaneous endoscopic gastrostomy

L.2.6 Vascular access devices
L.2.6.1 Dressing type

193
Ho 2006 Wrong setting (neonatal ICU)
420
Salles 2007 Wrong comparison (micro porous dressings vs.
transparent dressings – micro porous dressings
described as ‘water-permiable and non-sterile’ and
therefore assumed to be similar to common
plasters)
139,139
Gallieni 2004 Review
218,218
Keene 2009 Wong intervention (CVC dressing security)
L.2.6.2 Decontamination
68
Chaiyakunapruk 2003 Wrong intervention/population (5/7 studies
informing the clinical evidence were for insertion of
CVCs and 3 appear unpublished). The GDG made a
consensus decision to exclude.
26,29
Bakke 2010 Multiple interventions (chlorhexidine skin and
port/hubdecomtamination, hand washing, aseptic
technique for dressing change, and BSI monitoring);
not possible to separate effect.
171,172
Halton 2010 Multiple interventions (CVC ‘bundle’)
279,279
Maenthaisong 2006 Non OECD setting (Thailand)
L.2.6.3 Multidose vials

459
Tarricone 2010 Wrong comparison (intravenous infusion
containers); wrong setting (intensive care)
414
High priority research recommendations
Appendix M: High priority research

recommendations
M.1 Standard Principles of infection prevention and control
M.1.1 What are the barriers to compliance with standard principles of infection prevention
and control that patients and carers experience in their own homes?
Recent changes to the delivery of healthcare mean that care is increasingly delivered within a
patient’s home environment. Infection in this setting is just as important as in hospital. There are
currently approximately 6 million unpaid carers in the UK, a number that is likely to increase with an
aging population. The association between carer training and infection rates is unknown. No
evidence of surveillance of healthcare-associated infections in the community is currently available in
the UK.
A qualitative study is required to investigate the themes surrounding the barriers to patient and carer
compliance with the standard principles of infection prevention in their own homes. It would be
important to assess whether lack of awareness or knowledge is a barrier. If patients and carers have
received education this should be assessed to see if this was applicable to the patient’s home setting.
The areas where there is low compliance in the home environment need identifying and could have
far reaching implications for discharge planning and duty of care.
415
What are the barriers to compliance with standard principles of infection prevention and control that patients and carers experience in their own homes?
PICO/SPICE question Population and setting: Patients and people who care for a family or friend in their own homes
Focus of Interest: Barriers or factors that promote the ability and/or likelihood of adherence to the standard principles of infection
prevention and control. This includes knowledge or understanding of these principles.
Comparison: None
Evaluation: The following areas should be explored through qualitative studies (interviews, focus groups, observations) or surveys
Hand decontamination
Use of personal protective equipment
Use and disposal of sharps
Importance to patients or the It is important to understand compliance with the standard principles of infection prevention and control which could potentially
population increase patient safety through decreasing healthcare associated infections. Given that much care is provided by lay people in the
community it would be important to highlight the barriers to compliance with standard principles of infection prevention and control in
order that these issues can be addressed.
Relevance to NICE guidance This research recommendation is relevant to all chapters within this guideline. It is also relevant to any other guidance where
patient/carer information delivery and the risk of infection are particular concerns.
Relevance to the NHS The prevention and control of infection within the patients’ own home (including care homes) will reduce hospital admissions/re-
admissions, morbidity and mortality, reduce the amount of antibiotics prescribed and reduce the number of community staff visits, e.g.
GP, District Nurses. It will also reduce carer and patient stress, and have a large impact on quality of life both for the patient and the
carer.
National priorities Reduce demand for emergency/urgent care (in National Operating Framework for the NHS).
Current evidence base The existing evidence base was systematically reviewed for literature related to barriers to hand decontamination. There was a lack of
evidence of patient/carer education in a UK community setting.
Study design Qualitative study of a range of carers regarding the education they received regarding infection control, their understanding of hand
decontamination, supplies and use of protective equipment and disposal. The focus should be on barriers to compliance.
Economic considerations When training is delivered in an ineffective or inappropriate manner it represents an inefficient use of NHS resources. By determining
the factors with the greatest influence on the efficacy of training provided to patients and carers, more targeted and cost-effective
training packages can be delivered. If more effective training packages lead to a reduction in healthcare associated infections, this will
also have an impact the cost of treating infections, quality of life and mortality rates among patients. Outcomes with economic
consequences (such as the cost and resource use associated with training interventions and associated infection rates) should be
recorded.
Feasibility The GDG thought that it would be feasible to conduct a qualitative study in this area, so long as it was designed to be focused and
specific. The time scale of such as study would ideally be designed to feed into the development and implementation of educational
initiatives, but a three to six month impact study should be sufficient.
416
What are the barriers to compliance with standard principles of infection prevention and control that patients and carers experience in their own homes?
Equalities Education needs to be tailored to the needs of patients and carers. This is particularly important for patients with specific cultural,
religious, linguistic, or educational needs. Mental ability and physical capability should also be considered.
It should also be remembered that some people, particularly the elderly, have very little money to spare on purchasing items such as
handrub.
Other comments This area is of potential interest to psychosocial and educational research institutes, in addition to health and social care researchers.
The GDG highlighted that education around the cleaning of reusable equipment was an important theme that could be incorporated in
the study.
417
M.2 Hand decontamination

M.2.1 When clean running water is not available what is the clinical and cost effectiveness of
using wipes, gels, handrubs or other products to remove visible contamination?
Community healthcare workers often encounter challenges in carrying out hand

decontamination when there is no access to running water. This particularly affects
ambulance service staff, who often provide emergency care at locations where running
water is not available. No evidence from randomised controlled trials is available on the most
effective way for community-based healthcare workers to remove physical contamination,
such as blood, from their hands in the absence of running water. In recent years other hand
decontamination products that can be used without running water, such as gels, handrubs
and wipes, have become available. However, their efficacy and suitability in actual clinical
practice for use with visibly dirty hands has not been determined. A randomised controlled
trial is required to compare hand wipes (detergent and disinfectant), hand gels and other
hand decontamination products that can be used without running water, to determine the
most effective way to remove physical dirt in the absence of running water, in order to make
a recommendation for their use in real situations. The primary outcome measure should be
colony forming units on the basis of the adenosine triphosphate (ATP) surface test.
418
When clean running water is not available what is the clinical and cost effectiveness of using wipes,gels, handrubs or other products to remove visible
contamination?
PICO question Population: Community based healthcare workers
Intervention: All types of hand wipes, hand rinses, gels and handrubs used on physically dirty hands without running water.
Comparison: Each other
Outcomes: Colony forming units (CFUs) based on the Adenosine triphosphate (ATP) surface test or swabbing on agar plates.
Compliance with different methods and acceptability to healthcare workers.
Importance to patients or the Need to know which products are effective and what healthcare workers should be using when running water is not available.
population
Relevance to NICE guidance Particularly relevant to community based healthcare workers, especially the ambulance service.
Relevance to the NHS As more care is being provided in the community and at patient’s residence setting, the evidence behind maintaining hand
decontamination with no running water will be of vital importance to inform healthcare workers, patients, carers and patients
undertaking care treatments what to do in this situation.
National priorities No relevant national priorities
Current evidence base No RCT evidence was identified in the clinical review for hand decontamination without running water for the removal of blood and /or
body fluid.
Study design RCT. Power calculations should be conducted to establish the required sample size of the trial. It is important that the study is
adequately powered to detect a clinically important effect size.
Economic considerations Yes, this study would affect a large number of the population, including patient groups and community based healthcare workers.
Feasibility This proposed research should be able to be carried out within a realistic timescale and cost. There may be technical issues around
conducting this as an RCT as compared to in laboratory settings.
Equalities None identified.
Other comments None.
419
M.3 Long term urinary catheters

M.3.1 For patients performing intermittent self-catheterisation over the long term, what is
the clinical and cost effectiveness of single-use non-coated versus single-use hydrophilic
versus single-use gel reservoir versus reusable non-coated catheters with regard to the
following outcomes: symptomatic urinary tract infections, urinary tract infection-
associated bacteraemia, mortality, patient comfort and preference, quality of life, and
clinical symptoms of urethral damage?
Long-term (more than 28 days) intermittent self-catheterisation is performed by many people living
in the community. It is important that the choice between intermittent catheters is informed by
robust evidence on clinical and cost effectiveness.
The cost-effectiveness model developed for this guideline combined evidence of clinical
effectiveness, costs and quality of life with respect to symptomatic urinary tract infection and
associated complications. The results of the analysis showed that reusable non-coated catheters
were the most cost-effective option for intermittent self-catheterisation. However, the clinical
evidence informing this model was of low to very low quality. Currently, non-coated catheters are
considered to be single-use devices. In order to make an ‘off-licence’ recommendation for the use of
these catheters, better quality evidence is needed.
A four-arm randomised controlled trial is required. The trial population should be diverse, including
wheelchair users, people with spinal cord injuries and people over 16 who regularly self-catheterise.
The primary outcome measures should be incidence of symptomatic urinary tract infections, urinary
tract infection-associated bacteraemia, mortality, patient comfort and preference, quality of life,
clinical symptoms of urethral damage, and costs.
420
For patients performing intermittent self-catheterisation over the long term, what is the clinical and cost effectiveness of single-use non-coated versus single-use
hydrophilic versus single-use gel reservoir versus reusable non-coated catheters with regard to the following outcomes: symptomatic urinary tract infections, urinary
tract infection-associated bacteraemia, mortality, patient comfort and preference, quality of life, and clinical symptoms of urethral damage?
PICO question Population: People performing intermittent self catheterisation in the community.
This heterogeneous population should include:

People aged 16 and over, wheelchair users, people with spinal cord injuries, older people, males and females.
This population should not include:

People living in residential care
Interventions:
Multiple-use non-coated catheters, single use non-coated catheters, single use gel reservoir catheters and single use hydrophilic
catheters.
Comparisons:
Multiple-use non-coated catheters, single use non-coated catheters, single use gel reservoir catheters and single use hydrophilic
catheters.
Outcomes:
Symptomatic urinary tract infection, bacteraemia, mortality, patient comfort & preference, clinical symptoms of urethral damage
quality of life and costs .
Trial duration: Follow-up should be a minimum of 1 year

Importance to patients or the Catheter-associated UTIs are the most common type of healthcare-acquired infection in the world. While most urinary tract infections
population (UTIs) are mild and easily resolved with appropriate antibiotic treatment, more severe infections can be devastating, resulting in
bacteraemia, sepsis and death. ISC is an intimate procedure which is often associated with anxiety and discomfort; compliance and
patient acceptability are key considerations informing the choice of catheter.
It is important that high quality clinical evidence is available to determine which type of intermittent catheter is the most effective for
preventing catheter-associated infections and urethral damage and which represents the most acceptable option for patients.
Relevance to NICE guidance Currently, all non-coated intermittent catheters are considered as single use devices as they have a single use logo on them. This is in
contrast to the Department of Health, who recommend that five non coated catheters represents one month’s supply and require that
421
manufacturers provide instructions for cleaning these items. Due to the uncertain legal status of these devices, concerns raised by
stakeholders, and the low to very low quality clinical evidence base, non coated catheters were not recommended for multiple-use in
the current guideline.
NICE consider the reuse of these items to be ‘off-licence’. In order to make an ‘off-licence’ recommendation, NICE requires sound
clinical and cost-effectiveness evidence. The current clinical evidence base is of low to very low quality and better quality evidence is
needed. If the results of the proposed research are found to contradict the current recommendation, the recommendation may be put
forward for rapid update.
Relevance to the NHS The uncertainty inherent in the current recommendation represents a large opportunity cost for patients within the NHS. The results of
this trial have the potential to change this recommendation. A change in this recommendation would represent a significant cost savings
and would result in a more efficient use of resources across the NHS.
National priorities This research is relevant to two key national priority areas: reducing healthcare-associated infections and identifying efficiency savings
as set out in the Operating Framework for the NHS in England in 2010/11.
Current evidence base The current clinical evidence base consists of five randomised controlled trials: one comparing single use gel reservoir to single use non-
coated catheters; two comparing single use hydrophilic to single use non-coated catheters; and two comparing re-used single use
catheters to single use non-coated catheters. These studies varied in length of follow up between patients and had unclear
randomisation, allocation concealment, and blinding. All were assigned a GRADE rating of low to very low quality.
The cost-effectiveness model developed for this guideline combined evidence of clinical effectiveness, costs, and quality of life of
symptomatic UTI and its associated complications. The results of this analysis showed that in 100% of model simulations, non-coated
catheters used multiple times are the most cost-effective option for ISC. This conclusion was robust to a wide range of sensitivity
analyses, including exploratory analysis of the impact of urethral strictures to cost and quality of life and varying levels of use of non-
coated catheters.
Study design This research should be a randomised controlled trial with a minimum follow-up of one year. Although blinding will not be possible, the
trial should have good randomisation and allocation concealment. Sample size should be calculated using appropriate statistical
methods. It is important that the study is adequately powered to detect a clinically important effect size. ISC technique (including the
use of lubricant for non coated catheters) and patient characteristics should be clearly reported. The trial should include a diverse
community-based population who regularly self catheterise. The primary outcome measures should be symptomatic urinary tract
infections, UTI-associated bacteraemia, mortality, patient comfort & preference, quality of life, clinical symptoms of urethral damage,
and costs. Clinical results should be fully reported and uncertainty surrounding cost-effectiveness should be explored using appropriate
bootstrap analyses.
The criteria for symptomatic UTI, UTI-associated bacteraemia and mortality should be clearly defined, consistently applied and clearly
422
reported. Clinical symptoms of urethral damage could include stricture, epididymitis and urethritis; these outcomes should be
confirmed in a clinically appropriate manner and be clearly described. Patient comfort and preference should be measured using a
validated score or scale.
At a minimum, quality of life should be captured using the EQ-5D. If other measures of quality of life are also thought to be appropriate
these could also be included. Costs should be measured from the NHS and personal social services perspective and should include both
the cost associated with each type of catheter (and lubricant for non-coated catheters) and costs associated with treating UTI, urethral
damage and any other catheter-associated complications. In order to ‘future proof’ this research, cost data could also be collected from
a societal perspective; however these costs should be reported and analysed separately.
Economic considerations See “current evidence base” above. There is a proportion of the community that require long-term intermittent catheterisation. The net
gain of finding the most cost effective catheter that minimises the risks of catheter associated urinary tract infection and bacteraemia
would be of ongoing benefit.
Feasibility It should be possible to undertake this trial within a realistic timescale and at reasonable cost.
Equalities Equality considerations apply regarding patients’ physical abilities, such as problems with manual dexterity or mobility, including
wheelchair users. Other equality issues such as cognitive and visual impairment would be taken into consideration prior to selecting an
intermittent catheter.
Other comments The research is of high priority. The results of this research have the potential to alter future guidance on the use of intermittent urinary
catheters. If the results of this research are found to contradict the current recommendation, the recommendation may be put forward
for rapid update.
423
M.3.2 In patients using long-term indwelling urinary catheters what is the clinical and cost
Long-term indwelling catheters (both urethral and suprapubic) are commonly used in both
hospital and community care settings. Long-term catheterisation carries a significant risk of
symptomatic urinary tract infection, which can lead to more serious complications. Several
different types of impregnated and hydrophilic long-term indwelling catheters on the market
claim to be more effective than non-coated catheters, but are also more expensive.
The clinical evidence review revealed an absence of evidence for the effectiveness of
indwelling catheters over the long term. A comparison of impregnated (for example with
silver) catheters, hydrophilic catheters and silicone catheters is needed. The primary
outcome measures should be symptomatic urinary tract infections, encrustations, blockages,
cost/resource use and quality of life. Secondary outcome measures should include mean
number of days the catheter remains in situ (mean dwell time) and patient comfort.
424
In patients using long-term indwelling urinary catheters what is the clinical and cost effectiveness of impregnated versus hydrophilic versus silicone catheters on
reducing symptomatic urinary tract infections, encrustations and/or blockages?
PICO question Population: Patients with indwelling LTUC in the community
Intervention: Impregnated silver or antimicrobial catheters, hydrophilic catheters (both urethral and suprapubic)
Comparison: Silicone catheters
Outcomes: Symptomatic urinary tract infections, encrustations, blockages, mean no of days catheter in situ/mean dwell time and
patient comfort.
Importance to patients or the The impact would be that future guidance could recommend the most appropriate long-term urinary catheter type to minimise catheter
population associated urinary tract infection, bacteraemia and unnecessary urinary catheter changes due to blockage and encrustations. Patients
will benefit from preventive measures that are appropriate.
Relevance to NICE guidance The results would ensure that long-term catheter choice is informed by evidence to ensure the best patient outcome.
Relevance to the NHS The study results would ensure the minimisation of catheter associated urinary tract infection and bacteraemia in patients with long-
term urinary catheterisation with inherent cost savings on treatment and additional service delivery due to morbidity. The minimisation
of additional professional resources involved in unscheduled urinary catheter changes, due to encrustations and blockage. Minimisation
of patient discomfort would also lead to reduced costs generated by catheter changes.
Patients will benefit from preventive measures that are appropriate and reduce variation in clinical practice and patient care.
National priorities This study is in line with national antibiotic prescribing, reducing the variation in practice thereby supporting the patient safety agenda.
Current evidence base No evidence was identified in the clinical review for any impregnated catheters (silicone vs. hydrogel only).
Study design RCT. Power calculations should be conducted to establish the required sample size of the trial. It is important that the study is
adequately powered to detect a clinically important effect size.
The study should be in non-hospitalised patients but could include residential/nursing homes.
Economic considerations There is a proportion of the community that require long-term catheterisation. The net gain of finding the most cost effective catheter
that minimises the risks of catheter associated urinary tract infection and bacteraemia would be of ongoing benefit.
Feasibility This research could be completed within a reasonable timescale. There are technical issues over trial design but it is unlikely there
would be ethical problems as both types of catheter are already in widespread clinical use and there is no denial of treatment or
placebo involved.
Equalities No specific equality issues identified

M.3.3 When recatheterising patients who have a long-term indwelling urinary catheter, what
is the clinical and cost effectiveness of single-dose antibiotic prophylaxis in reducing
symptomatic urinary tract infections in patients with a history of urinary tract infections
associated with catheter change?
The immediate clinical and economic impact of urinary tract infection is so great that
patients at risk of infection are sometimes offered the option to receive prophylactic
antibiotics. However, the widespread use of antibiotics, including their prophylactic use, has
been identified as a major factor in the increasing levels of antibiotic resistance observed
across England and Wales. There is currently an absence of evidence about the short-term
and long-term effects of prophylactic antibiotic use during catheter change. The GDG
identified this as an important area for research to establish the benefits and harms of this
practice in order to develop future guidance (the recommendation on this topic in the
current guideline was based on GDG consensus).
A randomised controlled trial or cohort trial to compare single-dose antibiotic prophylaxis

with selected major antibiotic groups isneeded. The primary outcome measures should be
symptomatic urinary tract infection, cost and quality of life. This is an important area for
patients as it could minimise the inappropriate use of antibiotics.
426

When recatheterising patients who have long term indwelling urinary catheters what is the clinical and cost effectiveness of single-dose antibiotic prophylaxis in
reducing symptomatic urinary tract infections in patients with a history of urinary tract infections associated with catheter change?
PICO question Population: Patients with long term indwelling urinary catheters
Intervention: single dose antibiotic prophylaxis
Comparison: no antibiotic prophylaxis
Outcomes: symptomatic urinary tract infections.
Importance to patients or the The importance would be:
population to avoid the use of unnecessary antibiotic prescribing
to minimise the development of antibiotic resistance organisms
to minimise the risk of infective antibiotic diarrhoea e.g. clostridium difficile
to minimise symptomatic urinary tract infections.
Relevance to NICE guidance A recommendation on using antibiotic prophylaxis has been made in the current guideline but the quality of evidence was low and the
decision largely made on consensus. RCT/cohort evidence would be important to inform update of this guideline.
Relevance to the NHS This has the potential to produce cost savings either through reduced prescribing or, if the research concludes that antibiotics are
effective, by reducing the associated costs from catheter associated urinary tract infection.
427
National priorities This research would have impacts in the reduction of catheter associated urinary tract infection, reduction in antibiotic resistant
bacteria and the risk of infective antibiotic diarrhoea e.g. clostridium difficile.
Current evidence base Low quality evidence that supports the current recommendation. One small RCT was identified in the clinical review that had serious
limitations.
Study design The most feasible design would be a cohort study, however an RCT study design would be preferable in terms of study quality.
Economic considerations Economic considerations include appropriate use of antibiotics, reducing the risk of infective antibiotic diarrhoea e.g. clostridium
difficile, reducing the risk of antibiotic resistant bacteria.
Feasibility Although an RCT is preferable there are likely to be ethical issues over withholding antibiotics from high risk groups, therefore a cohort
study is more feasible.
Equalities None identified.
M.4 Vascular access devices
M.4.1 What is the clinical and cost effectiveness of 2%chlorhexidine in alcohol versus 0.5%
chlorhexidine in alcohol versus 2% chlorhexidine in aqueous solution versus 0.5%
chlorhexidine in aqueous solution for cleansing skin (beforeinsertion of peripheral
vascular access devices [VADs] and during dressing changes of all VADs) in reducing
VAD-related bacteraemia and VAD site infections?
The effective management of vascular access devices (VADs) is important for reducing phlebitis and
bacteraemia. In the community, compliance is improved when a single solution is used for all aspects
of VAD-related skin care. There is no direct evidence comparing different percentages of
chlorhexidine in aqueous and alcohol solutions, and little evidence looking at the use of such
solutions in the community. A randomised controlled trial is required to compare the clinical and
cost effectiveness of the different solutions available. The trial should enrol patients in the
community with a VAD. The protocol would need to follow the same skin preparation technique
regardless of solution, and could also investigate the effects of decontamination technique and
drying time. The primary outcome measure should be rates of VAD-related bacteraemia, rate of VAD
428
site infections, mortality, cost and quality of life. Secondary outcomes measures should include
Visual Infusion Phlebitis (VIP) score, insertion times and skin irritation.
It was recognised that decontamination of VAD hubs would be another important alternative to skin.
The GDG wanted to design the study to include these but concluded that this would probably
require another research study.
What is the clinical and cost effectiveness of 2%chlorhexidine in alcohol versus 0.5% chlorhexidine in alcohol versus 2% chlorhexidine in aqueous solution versus 0.5%
chlorhexidine in aqueous solution for cleansing skin (beforeinsertion of peripheral vascular access devices [VADs] and during dressing changes of all VADs) in reducing
PICO question Population: Patients in the community with a VAD.
Interventions: 2% chlorhexidine in alcohol vs. 0.5% chlorhexidine in alcohol vs. 2% chlorhexidine aqueous solution vs. 0.5% chlorhexidine
aqueous solution. The method and technique used for cleaning need to be clearly defined and reported in the protocol.
Comparison: Each other
Outcomes: VAD related bacteraemia and VAD site infection.
Importance to patients or the It is clinically easier to have one solution for everything. It is currently unknown which solution is best to use – knowing could help reduce
population VAD related bacteraemia and VAD site infections.
Relevance to NICE guidance This study would provide evidence with regard to the specificity of the recommendation of correct skin cleansing agent.
There would be potential to recommend a standard across skin cleansing for insertion and site care.
Relevance to the NHS It would be more cost effective buying a standard solution across the NHS (both secondary and primary care).
There would be greater compliance by staff where there is certainty in practice, inherent cost savings on treatment and additional service
delivery due to morbidity.
The minimisation of additional professional resources involved in unscheduled VAD changes, delayed treatment or treatment of acquired
infection, hospitalisation.
The minimisation of patient discomfort associated with VAD infections.
National priorities This study has a direct bearing on the prevention of infection agenda.
99
Saving Lives: reducing infection, delivering clean and safe care (Department of Health, 2007) .
Current evidence base There is no direct evidence looking at percentages of chlorhexidine in randomised controlled trials and little evidence looking at the use of
solutions for cleansing skin prior to insertion of peripheral VADs and during dressing changes of all VADs in the community.
Study design RCT. Power calculations should be conducted to establish the required sample size of the trial. It is important that the study is adequately
powered to detect a clinically important effect size.
Economic considerations The specific evidence base to inform practice would ensure that patients are properly protected against HCAI in relation to VAD insertion
thereby reducing both the risks and costs of acquiring an infection.
Feasibility Currently, all the proposed solutions are available and in use in practice, therefore it should be feasible to carry out the research in a
realistic timescale at a reasonable cost.
Equalities There are no specific equality issues.
Other comments An ongoing concern is the possibility of chlorhexidine resistant microorganisms.
What is the clinical and cost effectiveness of 2%chlorhexidine in alcohol versus 0.5% chlorhexidine in alcohol versus 2% chlorhexidine in aqueous solution versus 0.5%
chlorhexidine in aqueous solution for cleansing skin (beforeinsertion of peripheral vascular access devices [VADs] and during dressing changes of all VADs) in reducing
It was recognised that decontamination of VAD hubs would be another important alternative to skin decontamination. The GDG wanted to
design the study to include these but concluded that this would probably require a separate research study.
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Partial Update of NICE Clinical Guideline 2

Infection: prevention and

Commissioned by the National Institute for

Published by the National Clinical Guideline Centre at

First published 2003

© National Clinical Guideline Centre - 2012

Partial Update of NICE Clinical Guideline 2

Explaining the changes in the partial update

Partial Update of NICE Clinical Guideline 2

Partial Update of NICE Clinical Guideline 2

4.1.1 Standard principles – general advice ................................................................ 37

Partial Update of NICE Clinical Guideline 2

7.3.2 Do gloves leak? ................................................................................................ 85

Partial Update of NICE Clinical Guideline 2

10.10.1 Review question ............................................................................................ 149

Partial Update of NICE Clinical Guideline 2

12.8.3 Inline filters do not help prevent infections .................................................... 198

Partial Update of NICE Clinical Guideline 2

Guideline development group and project team

Guideline development group members (2003)

Partial Update of NICE Clinical Guideline 2

Guideline Development Group co-optees (2012)

Dr Paul Averley General Dental Practitioner

Ms Daphne Colpman Incontinence Specialist, St Helier Hospital, Epsom

Ms Joanna Ashe Senior Information Scientist

Ms Sarah Bermingham Health Economist

Dr Caroline Blaine Research Fellow (from January 2011)

Dr Lee-Yee Chong Senior Research Fellow

Dr Sarah Hodgkinson Senior Research Fellow and Project Manager

Dr Jennifer Hill Guidelines Operations Director (until March 2011)

Ms Susan Latchem Guidelines Operations Director (from March 2011)

Dr Smita Padhi Research Fellow (from January 2011)

Partial Update of NICE Clinical Guideline 2

Guideline Review Panel (2012)

Guidelines Advisory Committee (2003)

Miss Amanda Wilde Association of British Healthcare Industries (ABHI) representative

Mrs Joyce Cormie Lay representative

Mrs Judy Mead Head of Clinical Effectiveness, Chartered Society of Physiotherapy

Stakeholder List (2012)

Partial Update of NICE Clinical Guideline 2

Rationale for the update

This clinical guideline is a partial update of ‘Infection control: prevention of healthcare-associated

Healthcare settings covered by this guideline are:

1.2 Introduction (2003)

2 Development of the guideline

NICE clinical guidelines can:

We produce our guidelines using the following steps:

The NCGC and NICE produce a number of versions of this guideline:

2.3 Who developed this guideline?

2.4 What this guideline update covers

This guideline covers the following healthcare settings:

This guideline covers the following clinical issues:

Information and support for healthcare workers, patients and carers:

2.5 What this guideline update does not cover

2.6 Structure of the updated guideline

2.7 Relationships between the guideline and other NICE guidance

• Urinary incontinence. NICE clinical guideline 40 (2006). Available from

NICE Related Guidance currently in development:

2.8 Background and context to the Guidelines (2003)

2.9 Scope and Purpose of the Guidelines (2003)

These guidelines were developed to help prevent healthcare-associated infections (HAI) in

3.1.1 Amendments to 2003 text

3.1.2 Developing the review questions and outcomes

Chapter Review questions Outcomes