Housekeeping

 Mobiles off
 Fire exits
 Please visit the Exhibition Hall
 Please come back promptly after breaks

1
Professor Nick Bosanquet

2
 Biomed engineers
Biomed engineers have communed with
the machines in workshops at the end
of corridors. As long as the machines
had a tick on their box all was right with
their world.

3
Key Changes in Health Environment
 Funding Pressure .Trusts -5% p.a.
 NHS England –coming of Specialist
Commissioning.
 143 Specialist Services. Budgets
 Costs—benchmark on reasonable
providers.
 CCGs –in the mist.

4
Dispersed Technology
 Greater access by more people.
 Lower cost
 Medium ticket technology.
 Concerns about quality
 From feudal system to pluralism.
 The story of the hard working African toad
(Xenopus laevis)

5
Challenges after the Francis Report

 NHS Challenges after Francis Report.

 Immediate funding pressures. Make every
£ count.
 Competitive pressures on Trusts
Pressures to rise activity—use equipment
more intensively.
 Concerns about quality/patient experience

6
 RAISING PRODUCTIVITY
 Health Service Workforce Issue
 Shortage of problem solvers. Biomed
service for leaders of local teams.
 Involve local product champions in
design/lay outs.
 BIOMED LEAD IN RAISING PRODUCTIVITY.

i 7
 Customer focus
 What would customer focus be for Biomed?
 What is important to the customer(s)—health
professionals and managers?
 Raise capability to give patient care.

 Quality. Francis Report.

 Care integration—hospital to service closer to

patients. Service redesign.
 Improving process and outcomes.

 Reduce cost per item of quality service.

8
 Biomeds can deliver results
 Biomeds can deliver results in terms of
care improvement.
 Equipment design /layout to increase ease
of use and raise reliability.
 Monitor process including speed of service
and patient experience.
 Monitor impact on outcomes.

9
 Staff Training
 Staff Training.
 StaffTraining—more intensive.
 Central to professional mission/capability
 More than half day induction.
 Rigorous training and testing.
 The Grantham approach.(WW 1 training—
assemble a machine gun on a dark night in 2
minutes). RAF training.

10
 Entering an entrepreneurial future

 .NHS “entering an entrepreneurial

future”.(Tim Kelsey National Director for
Patients and Information. )
 Biomed key area for public /private
partnership.
 Access to capital and expertise .

11
 Thank you.

12
 Linking Technology to
Medical Device
compliance

Joe Emmerson
Head of Medical Devices / Divisional Business Manager
University Hospitals of Morecambe Bay NHS Trust
1- Information Overload!
 Habitual over-engineering or under-optimisation
• Nature - Human nature to store, save just in case
• Fear - litigation through lack of evidence
• Knowledge - Lack of knowledge in a subject
• Requirements - Failure to look at the requirements for compliance
• Misinterpretation - of the written word
• Detachment- from operations / enthusiasm

Do we tidy the bathroom whilst brushing

our teeth?
1- Information Overload! Compliance Cost

 Hidden and visible pitfalls Time

• Cost – we are often under the impression

that compliance costs money but often it’s
our own industries and inefficiencies that
create overhead.
• Time - Degradation of core business – not
enough time to complete what we should
be doing
• Compliance - Missing the obvious signs
for basic compliance due to the above
1- Information Overload!
 Back to basics
• Scoping – Undertake a scoping exercise to see
if what you capture is relevant.
• Fresh Eyes – Take a fresh eyed view of what is
going on, ask the obvious questions, get
involved!
• Control process – Ensure that you document
the process or method / write into a quality
system
2- Setting up your medical device inventory to capture the
RIGHT information
 Establish your organisations
MANDATORY Dataset
• Inventory
• Maintenance
• Repair
• Replacement
• Disposal
• Documentation
 2- Setting up your medical device inventory to capture the
RIGHT information
 Establish your organisations MANDATORY Dataset
• Inventory
• We need to have an inventory of all diagnostic and
therapeutic devices
• This database needs to be able to identify diagnostic
and therapeutic devices
• Maintenance
• Repair
• Replacement
• Disposal
• Documentation
2- Setting up your medical device inventory to capture the
RIGHT information
 Establish your organisations MANDATORY
Dataset
• Inventory
• Maintenance
• Documented process & system for the
maintenance of Medical Devices
• Repair
• Replacement
• Disposal
• Documentation
 2- Setting up your medical device inventory to capture the
RIGHT information

 Establish your organisations

MANDATORY Dataset
• Inventory
• Maintenance
• Repair
• Documented process & system for the repair of Medical Devices
• Linked to ‘sufficient quantity’ and ‘availability’
• Replacement
• Disposal
• Documentation
 2- Setting up your medical device inventory to capture the
RIGHT information

 Establish your organisations

MANDATORY Dataset
• Inventory
• Maintenance
• Repair
• Replacement
• Devices should be renewed under a recorded programme
• Capital replacement process/programme
• Revenue replacement process/programme
• Disposal
• Documentation
 2- Setting up your medical device inventory to
capture the RIGHT information

 Establish your organisations

MANDATORY Dataset
• Inventory
• Maintenance
• Repair
• Replacement
• Disposal
• Disposed of or recycled, safely and securely
• Documentation
 2- Setting up your medical device inventory to
capture the RIGHT information

 Establish your organisations

MANDATORY Dataset
• Inventory
• Maintenance
• Repair
• Replacement
• Disposal
• Documentation
• Supplied with the necessary information to minimise the risk of
using them incorrectly
 3- Developing information systems

 Three basic components are required:

• Policy
• Documented Process / Quality Procedures
• Medical Device Management System

Management

Policy Process
 3- Developing information systems

 Three basic components are required:

• Policy
• Should be a Medical Device Management policy, written to
comply with current NHSLA and CQC documentation.
• Should take reference to the guidance in DB2006(05)
• Documented Process / Quality Procedures
• Medical Device Management System
 3- Developing information systems

 Three basic components are required:

• Policy
• Documented Process / Quality Procedures
• Ensure that the policy is operationally implemented
• Repeatability & consistency
• Medical Device Management System
 3- Developing information systems

 Three basic components are required:

• Policy
• Documented Process / Quality Procedures
• Medical Device Management System
• Typically at a minimum a computerised database system to record
information however modern, more established systems extend
the scope to become a fully fledged Management Information
System (MIS)
• Compliment / guide workflows and processes
• Automatic gathering of evidence
• Manage evidence / documentation
• Task Management
 4- What technologies or partnerships can
support us?

 Designing the right systems:

• Who designed this system? I’d never have done it this way
• Mechanics and their tools
• Systemic review
 4- What technologies or partnerships can
support us?
 Investment and return:
• Individual Development
• Internal Solution: Where the site develops the skills and expertise to
create an automated system or process in order to improve.
• Partnership development
• Quick Fix: Where the site(s) work closely with the developer of the
system to partly automate as much as possible to compliment generic
working processes
• Developer
• Full Solution: Where the site(s) work closely with the developer of the
system to undertake some major revision to their software to re-engineer
or add new functionality.
 4- What technologies or partnerships can support
us?

Case Studies:
• Individual Development – Locally devised automated systems
• “Trust Website Updater”
Capital & revenue replacement programme
•

• Risk based user training needs analysis

• “PPM Reporting System” ****

• Pre and post visit notification and recording
• “Contracts Notification”
• Automated notifications regarding support agreement
• Auto attachments to database with mailbox recording
• “Customer Feedback Tool” ****
• Automated feedback tool to customers
 4- What technologies or partnerships can support
us?
Case Studies:
• Individual Development
• “PPM Reporting System”
 4- What technologies or partnerships can support us?

Case Studies:
• Individual Development
• “Customer Feedback Tool”
 4- What technologies or partnerships can support us?

Case Studies:
• Partnership Development
• “Capital Replacement & Inheritance”
• “Risk based training needs & Inheritance”

4- What technologies or partnerships can support us?

Case Studies:
• Developer
• “Auto attach” - Automatic attachment of documentation (evidence) to:
• Inventory / Devices
• Work orders / Jobs
• Suppliers/Contracts

• “Job status process mapping” - Re-engineering of common processes

• Letters – Quotations, notifications, consignment notes, shipping

• “Bulk operations”
• Acceptance testing
• Disposal of equipment


5- Next Steps?
Proactive practical steps to follow:
• Cut the excess
• Re-engineer your processes
• Challenge
• Slim down
• Converge
• Automate
• Engage with your stakeholders, ensure they listen to your needs
• Peer group / networking forum
• Product user or developer group
• Management product provider
 Thank you for listening

Any questions?

Joe Emmerson
Head of Medical Devices / Divisional Business Manager
University Hospitals of Morecambe Bay NHS Trust
1100 to 1130 Refreshments
 Please be back promptly at 1130

 Thank you

37
 Wayne Moore MCMI

Innovations in Integrated Care

38
 The Current Situation
 Acute Care
 High Technology Level
 Move to regional centres of excellence

 Greater need for post surgery consultations

 Determined cost constraints

 Primary Care
 Lower Technology Level
 State of change with move to CCG

 Government drive to improve technology usage

 Funding shift to self-determination

39
 The Current Situation
 Social Care
 Low Technology Level
 Moving closer to healthcare in operation

 Completely different funding criteria

 Tele-care / Tele-health
 Focussed on assisted living
 Disjointed in approach

 Now has renewed government drive

 3 million lives
 GP technology funding

40
 Why Integration?
 Care path based services allow greater
resource planning and innovative condition
management
 Allows for recycling of equipment and
devices
 Allows funding to follow the service user
 Opportunity for innovative funding
solutions for organisations
41
 How does this affect the
Service User?
 Improved equipment allocation
 Single point of contact for support
 Outcome based, Care Pathway service
delivery
 Improved chronic condition management

42
Improved Service User
Experience
The patient: offering a process
 The components
management solution

43
Service Data Architecture
Service User Portal Clinician portal
Ventilator

NIBP

Monitoring Data
CCG

SpO2
Medical Device Management Software

Medical Information Software

Business
Maintenance and Condition Data

Enterprise

Patient Information Integration

Group
ECG

Data Transfer

Data Transfer
Alarms and

Alarms and
Acute
Scales Care

Call Assist Social

Care
Call Handling and Alarm Software
Alarm Data

Environment Care
Alarms Homes

Location
Monitoring Service User
Clinical Team TBS GB Integrated Care Services
Specialist
Carers
Information Handling Model
Family & Friends 1 Apr 2013

44
 How does this affect EBME?
 Product Tracking
 Asset Management
 Training Requirements
 Remote Site PPM
 Resource Planning
 More involvement with external agencies

45
 Barriers to Integration

 If you keep on doing what you’ve always

done. You’ll only get what you’ve always
got….

46
Thank You

47
John Sandham IEng MIHEEM MIET
Deleivering real improvements in device
management practice

48
 Managing medical devices

 What should the NHS do to improve

practice in the procurement, use, and
maintenance of their medical
equipment management ?

49
Poor practice is harmful and expensive

 Poor acquisition leads to variation and ultimately

higher risk to the patient, and higher costs
 Poor training leads to patients’ being harmed,
litigation, and ultimately higher costs
 Poor maintenance leads to patient being harmed,
litigation, and ultimately higher costs
 Poor governance leads to non-compliance, and
ultimately patient being harmed, litigation, and
ultimately higher costs

50
 Problems that effective medical equipment
management could avoid
 30–50% additional cost for extra spare parts and extra
maintenance workload
 20–40% of equipment remains underutilized or unused
 extra modifications or additions required for 10–30% of
equipment
 10–30% additional unplanned costs
 loss of 30–80% of the potential lifetime of equipment
 25–35% of equipment out of service

 (Lenel, Temple-Bird, Kawohl, & Kaur, How to organise a system of Healthcare Technology Management, 2005, p. 31)

51
In 1999, the NAO said...
 Our survey showed however that only 12 per cent of
trusts had a documented policy on standardisation of
medical equipment. Furthermore, for the 70 per cent of
trusts that had purchasing advisory committees, only a
half of them had responsibility for the formulation of
policy on medical equipment standardisation.
(National Audit Office, 1999, p. 34)

52
In 2004, the NPSA said...
 A National Patient Safety Agency project report
across multiple NHS sites identified links
between purchasing and clinical incidents:
 ‘The project identified that uncontrolled
purchasing and device management, in the
absence of competency-based training, were
contributing factors in causing incidents’
(National Patient Safety Agency, 2004, p. 2)

53
In 2004 the NPSA also said...
 These findings reflected an inefficient system
in which infusion devices are purchased,
managed and used. This is probably a national
issue supported by the fact that 93 Trusts
initially expressed an interest in participating in
this pilot work (implying that they needed help).’
(National Patient Safety Agency, 2004, p. 6)

54
In 2006, The MHRA said...
 device management policy should cover the:
 selection, acquisition, acceptance and disposal of all medical
devices
 training of all those who will use them
 decontamination, maintenance, repair, monitoring, traceability,
 record keeping and replacement of reusable medical devices.
 (MHRA, Managing Medical Devices: Guidance for healthcare and
social services organisations, 2006, p. 8)

55
In 2011, The World Health Organisation
said...
 ‘A number of studies have shown that between 39% and 46% of
adverse events resulting from misuse of medical devices take place
in the OR (86–89). In most of these studies, the cause is only
indicated as (device) operation related.
 …Variation in medical devices between hospitals (and even within
the same hospital) is one of the causes of these accidents.’ (World
Health Organisation, 2010, p. 14)
 Three facts emerged: 1) the devices are often not well designed for
the medical environment in which they are used; 2) the user is often
not trained properly to use these devices; and 3) the (new)
procedures often result in long learning curves for health
professionals. These three facts influence outcome of care.

56
In 2013...
 From the Robert Francis Inquiry into failures at Mid
Staffordshire NHS Trust:
 Patient Safety Alerts; ...'as at December 2011, the
evidence was that there was no routine follow up of
compliance, unless the information suggested
non-compliance with an essential standard. The CQC
attributed this in part to their not having relevant
expertise, particularly in relation to the safety of
equipment. It (THE TRUST) argued that to take on such
a role would deflect it from its core activities'

57
The issue is not going away...
 ‘The medical technology market is estimated to be worth
£150-170bn worldwide with growth rates forecast at 10%
per annum over the next 5-6 years and a market size
approaching £300bn by 2015. This growth is driven by
the ageing of the world’s population and the per capita
income increases in healthcare expenditure across
developed countries’. (HM Government, 2011, p. 10)

58
Medical Devices Management
Policy needs to reflect...
How do
we buy?

How do Medical
Devices How do
we
we use?
manage?
Policy

How do
we
maintain?

59
 Who is responsible?

 The NHS executive expects us to operate

in accordance with best practice.
 As experts in medical equipment
management what should we be doing to
improve the situation?

60
1.Acquisition
• BUYING (LOAN/RENT)
• Need identified, funding agreed
• Devices evaluated
• PPQ Form completed
• Supplier selected
• Order placed
2. Training
• USING
• User training delivered
• Training records updated
• Device put into operational use
3. Maintenance 4. Governance
• MAINTAINING • MANAGING
• Call EBME • adherence to policy.
• Decontaminate device • Training monitored to ensure safety
• Request maintenance/repair by (NHSLA requirement)
phone • HR keep staff records up to date
• EBME collect • Devices monitored for clinical
• EBMEmaintain effectiveness/need.
• EBME return device • Regular monitoring is carried out on
cost profiles
• EBME keep inventory records
61
Thank you

62
 PANEL DEBATE
 Who is responsible for medical equipment
management?
 What does that mean to you?
 Does it mean management of
maintenance? ..or more....
 Management of policy, procurement, use
and maintenance?

63
 Lunch
 Back at 2pm prompt please

64
 Justin McCarthy
Changes in standards and guidelines
for electrical safety testing

65
 Summary
• Why do we do EST?
• When should we do it?
• What Standards exist?
• BS EN 60601-1
• BS EN 62353
• What changes have there been or are coming?
• Guidance documents
• IPEM Report 97
• IET Code of Practice
• HSE Guide HSG 107
• HSE Guide INDG 236(rev2)

66
Why do Electrical Safety Testing?

• To ensure patients and staff are not at risk

from electric shock – macroshock or
microshock

• To meet legal obligations

67
 Legal Context

• Electricity at Work Regulations 1989:

Regulation 4(2)

• Provision and Use of Work Equipment

Regulations: Regulation 5

68
 Electricity at Work Regs
4(1) All systems shall at all times be of such
construction as to prevent, so far as is reasonably
practicable, danger.

4(2) As may be necessary to prevent danger, all

systems shall be maintained so as to prevent …
such danger.
See also
• Memorandum of Guidance paragraphs 4.7 and 4.8
• Maintaining portable and transportable electrical
equipment at
http://www.hse.gov.uk/pubns/priced/hsg107.pdf
69
What EWR does & does not say
• Does NOT say what testing has to be done
• Does NOT say how often
Guidance says
• Regular inspection an essential part of any
preventive maintenance programme
• Practical experience may indicate an
adjustment to the frequency
• A matter for the judgement of the duty holder

70
 PUWER
Regarding Maintenance, PUWER is stricter
than EWR, but is covering all aspects
5(1) Every employer shall ensure that work
equipment is maintained in an efficient
state, in efficient working order and in
good repair.
5(2) Every employer shall ensure that where
any machinery has a maintenance log, the
log is kept up to date.

71
 When should we do it
• At commissioning of new equipment –
reference values

• After repair – assurance of safety

• In service, maybe linked to PPM or PPC –

BUT based on experience and risk
assessment

72
 Standards – 60601-1
• BS EN 60601-1:2006 Medical Electrical
Equipment – Part 1: General requirements for
safety and essential performance [Ed. 3.0]
revised to
• IEC 60601-1:2005 + A1:2012 [Ed. 3.1]

• This is a TYPE TEST standard

• We DO NOT test TO 60601-1
• but we can derive routine tests from it
73
 Derived tests
• Protective Earthing of Class I equipment
• 0.1 Ω internal and 0.2 Ω to plug top
• Earth leakage of Class 1 equipment
• 500 µA for plugged-in equipment but < 5 mA if
no exposed earthed parts
• Touch current
• SFC: 500 µA from exposed conductive parts
Class I & II
• Patient leakage current
• SFC: 500 µA, Types B & BF; 50 µA for Type CF
74
 So what’s new (of relevance) in Ed. 3.1
Protective Earth Resistance (PER)
• Now a clear requirement for 0.2 Ω to the plug
top earth for fixed and detachable mains leads
• Previously, only specified for fixed mains leads

NOTE: 60601-1 does not address Insulation

Resistance tests.

75
So what’s new (of relevance) in Ed. 3.1

Earthing of Medical Electrical Systems (MES)

• Ed 3.0 sub-clause 16.9.2.1c) allows 0.4 Ω
PER if an MES uses a Multi Socket Outlet
• Ed. 3.1 sub-clause 16.9.2.2 modifies this to
0.2 Ω [same as for an individual equipment]

76
 Standards – 62353
BS EN 62353:2008 Medical electrical
equipment – Recurrent test and test after
repair of medical electrical equipment
• Based on an Austrian/German standard
• UK did not vote in favour and did not
formally contribute to it
• Read the UK National Forward

77
 IEC 62353:2007 Summary
• Recognises three situations for testing
• Adds 0.1 Ω to allowed PER 0.3 Ω
• Allows 0.5 Ω for ME System with MSO
• Introduces three new leakage current test
configurations
• Suggests that insulation testing [if required]
is done after leakage currents

78
 Alternative method Class I

• Similar to leakage current with N open

• Sort of ‘insulation test’ at 230 V ac

79
 Direct method Class I

• Equipment powered up
• All sources of leakage brought together
into one measurement – issues!
80
 Differential method Class I

• Equipment powered up
• All sources of leakage brought together
into one measurement
• Good if multiple earth points
81
 Applied Part leakage current
• Mains on the Applied Part tests
• Again, three alternative methods
• E.g. Direct method shown

82
 IEC 62353 2nd Edition

• Ed. 2 being worked on

• Currently at CDV stage
• CDV should be available as a DPC from
BSI in May
• UK has contributed to this revision
• Most of the UK issues addressed

83
 Changes in 62353 2nd Edition
• PER for ME Systems will be 0.3 Ω [0.5 Ω
only if RCD powered]
• Insulation testing comes after PER but
before leakage current tests
• Allows leakage current tests ‘derived from’
IEC 60601-1; diagrams provided
• Improved English
• Useful additional notes
84
Leakage current measurements
• Compare IEC 62353:2007 (1st Ed.)
“Measurements according to IEC 60601-1 (all
editions) may be performed, if protection of the
personnel and of the environment is guaranteed. ...”
• To 2nd Ed. CDV
“d) * Alternatively, for measurements of earth
leakage current, touch current and patient leakage
current, test configurations derived from IEC 60601-
1 (all editions) may be used. See figures A1, A2 and
A3. ...”
85
 Figure A.2

Key
For plugged-in CLASS I ME EQUIPMENT:
A = TOUCH CURRENT (SFC) from earthed ACCESSIBLE CONDUCTIVE PARTS of the enclosure:
500 µA
(A is equivalent to normal EARTH LEAKAGE CURRENT)
B = TOUCH CURRENT (SFC) from non-earthed ACCESSIBLE CONDUCTIVE PARTS of the
enclosure: 500 µA
C = PATIENT LEAKAGE CURRENT (SFC): TYPE B & BF 500 µA TYPE CF 50 µA
NOTE Closing SW1 will give Normal readings for B & C
86
 Other useful guidance
• IPEM Report 97: Guide to electrical safety testing
of medical electrical equipment: the why and the
how. 2009
• IET Code of practice for in-service inspection and
testing of electrical equipment. 4th Ed. 2012
• HSE Guide HSG107: Maintaining portable and
transportable electrical equipment. 2004
• HSE Guide INDG236(REV2): Maintaining
portable electric equipment in low-risk
environments. 2012

87
 Finally

Do enough
But not too much

Thank you

88
 Paul Musto
Endoscopes and their construction
 Types of Endoscopes

 Flexible instruments
 Rigid instruments
 Fibre optic imaging systems
 CCD imaging systems
 Medical Endoscopes
 Industrial Endoscopes
 History
 The first endoscope was invented by a German doctor, Kassmaul, at the
turn of the twentieth century, but being non-flexible, was not much use.
 A flexible device was made by another German, Rudolf Schindler, but it was
still not very flexible unless the patient was contorted to suit the instrument.
 The endoscope became a much more practical instrument in the 1960's
with the invention of the optical fibre.
 Latest generation all singing and dancing scopes

 Excellent picture quality with miniature CCD’s

at the tip
 Very efficient fibre optic light transmission
systems
 Improved mechanics with variable stiffness &
scope guide systems
Durability of an Endoscope
 Durability of an Endoscope
 Use on Patient / manual handling
 Pre cleaning / manual handling Storage
 Manual cleaning, brushing & flushing
 Decontamination process in an AER
 Storage
Decontamination

Cleaning

94
Flexible Endoscope Construction

 Light Transmission System

 Image Transmission System
 Mechanical Construction
Flexible Endoscope Construction

 Light Transmission System

 Image Transmission System
 Mechanical Construction
Light Transmission System
Light Transmission System
Flexible Endoscope Construction

 Light Transmission System

 Image Transmission System
 Mechanical Construction
Light Transmission System
Coherent Fibre Bundle
Image Transmission System
Charge Coupled Device
 Image Transmission System
Charge Coupled Device

All colours, especially green, carry luminance information

that the human visual system uses to discern and define
image detail. Recognizing the importance of green light,
manufacturers of colour CCDs dedicate 50% of the CCD to
capturing green light
 Image Transmission System
RGB SEQUENTIAL, MONOCHROME
RGB Filter
Light source

White Light

Video processor

Monitor

High resolution monochrome CCD

 Image Transmission System
Object
Light source

White Light

Video processor

Monitor

Color chip CCD

Image Transmission System

Incident Light

Micro-lens
Pixels
Dead Space
Image Transmission System

Charge coupled device

HDTV - 1080 LINES

Flexible Endoscope Construction

 NBI (Narrow Band Imaging)

 AFI (Auto Fluorescence Imaging)
 NBI
 What is the advantage of narrow band imaging?
 Surface disease can be treated but it can be difficult to spot
 NBI changes the contrast so diseased tissue stands out

 Need to change the contrast

 Blood = red
 Tissue = pink
 Contrast = poor!

 How can we improve the contrast without loss of image detail?

 We need natural wave lengths of light to interact with human tissue
 Blue and green light interact with tissue in slightly different ways,
they penetrate to different depths
 Blue penetrates slightly deeper than green
 Red light is completely reflected by haemoglobin which the CCD is
picking up from blood
 Principles of Narrow Band Imaging

Normal white light consists of colour overlapping each other and reproduces a natural
colour image

Conventional

400 500 600 700 nm

NBI
B = 415nm @ FWHM30nm
G = 540nm @ FWHM20nm

400 500 600 700 nm

 Narrow Band Imaging

Conventional Imaging Narrow Band Imaging

 AFI (Auto Fluorescence Imaging)

 Substances in the body give of fluorescence (glow in the dark)

when excited by blue light

 Collagen fluoresces and anything that is in the way of the signal

being returned (e.g. cancer) will be displayed in a different
colour due to weakening of fluorescence coming back

 Normal tissue – bright green

 Diseased tissue – magenta in colour
AFI (Auto Fluorescence Imaging)

Conventional AFI
AFI (Auto Fluorescence Imaging)

AFI
CCD
Lens
Standard cleaning
CCD jets

Light guides
Instrument
channel
Flexible Endoscope Construction

 Light Transmission System

 Image Transmission System
 Mechanical Construction
Scope Eyepiece (Fiberscope)
Control body/piston chambers
 Air/Water & Aspiration Channel system
Suction Valve
Air/Water Valve
Biopsy Valve Insertion Tube
Nozzle

Water Bottle Tube

Water Bottle Light Source

Connection LIGHT SOURCE
Universal Cord Connector

Air
Biopsy/Suction Channel Water Channel Suction Pump
Connection
Air Channel
WATER
BOTTLE
Manual flushing of air/water & suction
channel system/connections
Proximal end of patient tube
Distal end of patient tube
Proximal end of light guide tube
Typical Damage to distal tip
Poor Packaging
Thank you for your time
1500 – 1530 Refreshments
 Please return promptly at 1530 for the final
presentation and prize draw.

125
 Increasing patient safety
,,/
with etCO2 monitoring
Jacob Castiel

Capnography and Ventilation training manager

 Why monitor etCO2?

 CO2 is a compound molecule

 2 elements of oxygen and 1 element of carbon
 colorless and heavier than air
 a natural waste product of cellular Energy production
 green plants clean up after our exhaled CO2

 Capnography comes from the Greek word Kapinos

(καπνίζω) - “smoke”
 smoke from the “fire” of metabolism
 So What is Capnography?
 Noninvasive, continuous measurement of exhaled
carbon dioxide (EtCO2) concentration over time
 A numerical value of the EtCO2
 A distinctive graphic representation of the EtCO2 concentration
 Respiratory rate detected from the actual airflow
 Physiology of Energy Production

Ventilation: Oxygenation:
SpO2
Factors affecting etCO2 values

CO2 produced by CO2 Carried by blood

Metabolizing tissues to the lungs

Production Delivery Elimination

Normal Capnography values

35 - 45 mmHg / 4.7 - 6 kPa

A-B: Baseline - no CO2 in breath, end of inhalation
B-C: Rapid rise in CO2 - Expiration
C-D: Alveolar Plateau
D: End expiration (ETCO2)
D-E: Inhalation

D
Capnography waveforms
45

0
Normal
45

RR EtCO2
0
Hyperventilation
45

0 RR EtCO2
Hypoventilation
CO2 Measurement Methods
Measurement of CO2

Blood Gas Transcutaneous

Breath Gas
Analysis Methods
Analysis

Chemical Infrared Light

Detectors Absorption

Sidestream Mainstream
Mainstream Capnography

Electronic Cable

EtCO2 IR Sensor
Arterial Blood Gas analysis (ABG)
 ABG is one of the most common tests performed on patients in
intensive care units (ICUs).
 An arterial blood gas (ABG) is a blood test that is performed
using blood from an artery. It involves puncturing an artery with a
thin needle and syringe and drawing a small volume of blood.
 The test is used to determine the pH of the blood, the partial
pressure of carbon dioxide and oxygen, and the bicarbonate
level.

Covidien Respiratory and Monitoring

Solutions | May 2, 2013 |
Confidential 135 |
Sidestream Technology
CO2 Measurement Methods
Measurement of CO2

Blood Gas Transcutaneous

Breath Gas
Analysis Methods
Analysis

Chemical Infrared Light

Detectors Absorption

Sidestream Mainstream

Oridion Microstream®
Technology
Microstream® Capnography - Technology Overview
Detection Technology:
Easiest to Use
Plug and Play:
No user intervention needed
Automatically corrects for pressure,
temperature changes; automatic zero
Always Accurate
Only CO2 specific IR Technology
Does not compete with
neonatal tidal volume
Low sample flow rate (50 ml/min)
Neonatal airway adapter 0.5 cc dead space
15 Microliter sample cell provides a fast
response time
Patient Interfaces: Smart Algorithms:
Crispest, cleanest sampling Reduce risk and cost
Specialty sampling lines for every clinical Smart Breath Detection: Eliminates
need artifact enabling OR quality monitoring on
Tailored for specific populations and non intubated general floor patients
procedures in EMS, Critical Care, Cath Lab, Smart Alarm for Respiratory Analysis
Endoscopy (SARA™)
Gen. Floor
Recognizes and suppresses most nuisance
alarms without missing real events.
Integrated Pulmonary Index™ (IPI™)
The first and only index that simplifies
measurement of the adequacy of
Smart Capnoline Plus:
ventilation making it accessale to the least
 Accurate CO2 and respiration rate sampling trained clinician.
from patients who are nasal or oral
Apnea Index / Oxygen Desaturation Index
breathers
Screen sleep disorders in patients in bed so
 Accurate in NIV they can be treated safely and referred for
 Unique O2 delivery revenue generating sleep studies.
 Oral prong for effective breath capture HFOV Monitoring Mode
even in shallow breathing Break-through technology that allows
monitoring of ventilation of patients on
HFOV
Market-leading OEM partners
Pain Management &
Emergency Medicine Procedural Sedation & Critical Care General Floor

Respiratory Care
 Capnography indications and patient safety

Intubated Patient
• Recognized misplaced or dislodged endotracheal tube
• Assess sufficient ventilatory support
• Assess effectiveness of resuscitation efforts

Non-Intubated Patient
• Monitors adequacy of respiration
• Detects Hypo/Hyperventilation from:
• Drug overdose: prescription or abuse
• Drug induced sedation & analgesia
• Ineffective ventilation support / failure to prevent respiratory failure
• COPD, asthma, CHF, etc.
• NPPV (CPAP, BiPAP)
The Arterial to End Tidal CO2 Gradient

• EtCO2 = concentration of CO2 exhaled in

each breath -35-45 mmHg
• PaCO2 = concentration of CO2 present in
arteries- 35-45 mmHg
• Normal delta around 2-5 mmHg Difference

PaCO2 > EtCO2

Ventilation-perfusion matching
 Ventilation-perfusion mismatching
Perfusion Problems:

• Pulmonary embolism

• Cardiac arrest

• Hypovelmia
 Ventilation-perfusion matching

Ventilatory Problems:

• Bronchial intubation

• Increased bronchial & alveolar

secretions

• Mucus plugging

• Bronchospasm

• Atelectasis

All values in the examples below are for

illustrative purposes only.
 Capnography Guidelines (Oct, 2010 – Mar, 2013)

ECRI
British Howard ASA AAAHC
RCoA//
RCoA Snitzer - IHI 2011 - IQI
DAS Mayo Standard 2013 Top
VHA for Mod-
Mod- CAS Narcotics 10 Hazards OSA AAGBI
Airway 96-Minute
96- Deep & Ambul..
Ambul
PCA (NAP4) Resuscitation Sedation Sedation Sedatives PCA Surgery PACU

Oct Mar May/ Jan Jan

Nov Apr July Aug Feb April June Aug Nov Dec Mar
2010 2011 June 2012 2013

AHA/ERC/ AARC / AAGBI/ APSF Intensive AAOMS JCAHO CMS

HSFC AHRQ EBA Care SEA Proposed
Guidelines Post-op
Post- Society Sedation Quality
ACLS/ PALS Sedation Opioids (UK) Hospital Measure
Guidelines CPG during and ICU Opioids
MV ICU PCA

17 Statements from 20 Societies in 2 ½ years (~ 7 per year)

March 2011 British Royal College of Anaesthetists and Difficult
Airway Society – Airway Complications

NAP4 BJA March 2011 - Major complications of airway management in the UK:
results of the Fourth National Audit Project of the Royal College of Anaesthetists
and the Difficult Airway Society:
“Capnography, or rather the failure to use it, likely contributed to 17
outcomes of death or brain damage on ICU, including four esophageal
intubations and 14 inadvertent tube displacements: these account for 82%
of events leading to death or brain damage in ICU.”

“The single most important change that would save lives is the use of a
[capnograph], which would have identified or prevented most of the
events that were reported. We recommend that a capnograph is used for
all patients receiving help with breathing on ICU; current evidence
suggests it is used for only a quarter of such patients.”

“Greater use of this device will save lives.”

 May / June 2011
Association of Anaesthetists of Great Britain & Ireland (AAGBI)

 The AAGBI recommends that:

 Continuous capnography should be used in all anaesthetised patients,
regardless of the airway device used or the location of the patient.
 Continuous capnography should be used for all patients whose trachea is
intubated, regardless of the location of the patient.
 Continuous capnography should be used for all patients undergoing
moderate or deep sedation, and should be available wherever any patients
undergoing anaesthesia or moderate or deep sedation are recovered.”
 Continuous capnography should be used for all
patients undergoing advanced life support.
May / June 2011 European Board of Anaesthesiology

EBA Recommends:
• All intubated patients should be monitored with continuous capnography, be
they in the operating theatres, intensive care units, emergency departments
or outside hospital e.g. undergoing CPR
• All patients undergoing moderate or deep sedation should be monitored
with continuous capnography.
August 2011 Anesthesia Patient Safety Foundation - Postoperative
Monitoring With Opioid Use

 “Continuous electronic monitoring of oxygenation and ventilation should

be available and considered for all patients and would reduce the
likelihood of unrecognized clinically significant opioid-induced
depression of ventilation in the postoperative period.“
 “Capnography or other monitoring modalities that measure the
adequacy of ventilation and airflow is indicated when supplemental
oxygen is needed to maintain acceptable oxygen saturations.”
 “APSF is aware of hospital system experiences that support the
effectiveness of alternative continuous respiratory monitoring
technologies, such as Capnography, in lieu of pulse oximetry.”
 February 2012 Intensive Care Society (UK) Guidelines –
Procedural Sedation
Standards for Capnography in Critical Care

• Capnography during the procedures of tracheostomy or

endotracheal intubation in the ICU.
• “Capnography should be used for all intubated and
ventilated patients in the ICU.”
• Capnography for patients who require
mechanical ventilation during
hospital or intra-hospital transfer.

5/2/2013
March 2013 Association of Anaesthetists of Great
Britain and Ireland
Guidelines: Immediate Post-Anaesthesia Recovery 2013

In the PACU, if patients’ tracheas remain intubated or they have

their airways maintained with a supraglottic or other similar airway
device, they should be monitored with continuous capnography.

Authored with representatives from:

• Scottish Multiprofessional Anaesthetic Assistants Development
Group
• British Anaesthetic and Recovery Nurses Association
• College of Operating Department Practitioners
• Royal College of Anaesthetists

5/2/2013
NAP4 follow-up in Scotland March 2011
 BJA Volume 110, Issue 4 Pp. 662-663.
 Survey of airway management in scotsland C. Wallace*, B.
McGuire and S. Cole
 In our initial survey, 54% of units were using continuous
waveform capnography on all intubated and ventilator-
dependent patients. This figure is very close to the 56%
reported by Astin and colleagues across the UK in the same
period. At the time, this represented 64% of all such patients.
 By 2012, 74% of units reported use on all patients, representing
93% of all ventilator-dependent patients on Scottish ICUs. All
but one of the units in Scotland where monitoring equipment
was limited or unavailable had plans to introduce capnography
at all bed spaces in the future.
 while others are working towards this. The layout of these
trolleys in many of these trusts is now consistent across the
country.

152
 “Continuous Capnography Decreases the Utilization of Blood Gases
Society of Critical Care Medicine” (abstract 340).

Rowan, Courtney et al Riley Hospital for Children; Indianapolis USA

Methods:
 Standard continuous capnography was implemented for all
mechanically ventilated patients in March 2011. Prior, it was available,
but was not routinely used.
 The utilization of blood gas measurement in the paediatric intensive
care unit was retrospectively analysed.
 The time period of April 2010 to July 2010 was compared to April 2011
to July 2011.
 Parameters collected included total number of blood gases analysed,

cost of blood gas analysis, ventilator days, and patient days.

Covidien Respiratory and Monitoring

Solutions | May 2, 2013 |
Confidential 153 |
Continuous Capnography Decreases the Utilization of
Blood Gases

Results:
 The total number of blood gases in the time period after the institution of end-
tidal CO2 monitoring compared to the year prior decreased from 8667 to 3738.
 The total blood gas charge decreased from $1,487,886 to $717,006 for a total
cost savings of $770,880.
 Adjusting for the increased cost of the blood gas analysis and the cost of the
ETCO2 monitoring, the total savings over a 4 month period was $835,791.
Future months will still be analysed.
Conclusions:
 Continuous scenography resulted in a significant cost savings over a 4 month
period by decreasing the utilization of blood gas measurements. Decreasing
the number of blood gases analysed may also have other cost savings
advantages such as decreased blood transfusions and decreased catheter
associated blood stream infections.

Covidien Respiratory and Monitoring

Solutions | May 2, 2013 |
Confidential 154 |
 Future of Capnography

“Time for Capnography, everywhere.”

 Critical care
 Resuscitation
 Patient transport
 Post operative recovery
 Procedural sedation
 Neonatal resuscitation
 Emergency medicine and respiratory disease

D. K. Whitaker
Consultant Anaesthetist
Manchester Royal Infirmary
Manchester, UK
Thank you
Prize Draw

157
 Speakers, delegates,
Exhibitors.

 Thank you all, for participating.

158