.

INSTITUTE OF MANAGEMENT STUDIES

Study and analyse the service quality management

and perform the audit of Central Sterile Supply
Department of INDEX hospital

SUBMITTED BY- SUBMITTED TO-

POORVI HARDIA DR. MEGHA JOSHI

MA’AM

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 CERTIFICATE

This is to certify that POORVI HARDIA student of Hospital Administration BBA (HA) – VIth
SEM of Institute of Management Studies, Devi Ahilya University, Indore has undergone his
training on project entitled “To study and analyse the service quality management and perform
the audit of Central Sterile Supply Department of INDEX hospital and determine strategy for
further improvement at INDEX MEDICAL COLLEGE HOSPITAL AND RESEARCH
CENTER , INDORE.” She has successfully completed the project, his study and performance
during the period of 45 days has been found to be satisfactory.
I wish her all success in his future endeavours.
MR. SANJEEV MISHRA (SIR)
Date:
Place: INDEX MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER , INDORE

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 ACKNOWLEDGEMENT

I would like to sincerely acknowledge my deep thanks to Dr. SURESH SINGH BHADORIYA
(Chairman sir) and Mr. Nishikant Waikar (Training and Placement Officer).
I express my feeling of gratitude to Dr.PAVAN BAMBANI (Medical Director, INDEX
MEDICAL College and Hospital) for granting me the opportunity to undergo departmental
training from their renowned hospital.
I am thankful to Mr. SANJEEV MISHRA SIR and Dr MEGHA JOSHI MA'AM who guided
me at every step and has motivated me to put sincere efforts despite various constraints without
which, this project could not have been completed.
I convey my sincere thanks to the staff of the hospital that supported me in routine activities
required for completion of project and spared their precious time for guiding me in respective
field of concern.
Last but not the least I would like to thank all those who have directly or indirectly helped me in
completing this project.
POORVI HARDIA

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 DECLARATION

I, POORVI HARDIA, student of BBA (Hospital Administration) VIth SEM, Institute of

Management Studies DAVV University, Indore hereby declare that this project has been
completed by me and is a part of my Research Project. This report has not been submitted
anywhere else to the best of my knowledge.

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 Table of Contents
INTRODUCTION ......................................................................................................................................... 8
LOCATION.................................................................................................................................................. 9
AT A GLANCE : ........................................................................................................................................... 9
FACILITIES ................................................................................................................................................ 10
VISION AND MISSION.................................................................................................................................. 10
VISION ..................................................................................................................................................... 10
MISSION .................................................................................................................................................. 10
CORE VALUES .......................................................................................................................................... 10
LITERATURE REVIEW ................................................................................................................................... 11
INTRODUCTION ....................................................................................................................................... 11
Purpose ................................................................................................................................................... 12
Functions of CSSD ................................................................................................................................... 12
INFRASTRUCTURE REQUIREMENTS ............................................................................................................ 12
PLANNING OF CSSD................................................................................................................................. 13
Layout...................................................................................................................................................... 13
Area for cleaning and decontamination of materials ( dirty area) ......................................................... 14
Area for conditioning, packaging, preparation and sterilization of material (clean area). .................... 15
Area storage of material (sterile area) .................................................................................................... 15
Administrative area................................................................................................................................. 16
Support area ........................................................................................................................................... 16
Space ....................................................................................................................................................... 16
Mechanical systems ................................................................................................................................ 17
Floor and walls ........................................................................................................................................ 17
Ceilings .................................................................................................................................................... 17
Ventilation............................................................................................................................................... 17
Temperature and moisture ..................................................................................................................... 18
Sinks for washing instruments ................................................................................................................ 18
Fire extinguishing systems ...................................................................................................................... 18
STAFFING . ................................................................................................................................................... 19
Hospital personnel .................................................................................................................................. 19
Control and registration of the materials on the CSSD........................................................................... 20
EQUIPMENTS .............................................................................................................................................. 21

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 Cleaning of materials .............................................................................................................................. 22
Manual washing and rinsing of the material .......................................................................................... 23
STERILIZATION............................................................................................................................................. 23
Sterilization methods .............................................................................................................................. 23
PHYSICAL METHODS ............................................................................................................................... 23
Stages of sterilization by ETO .................................................................................................................. 26
Ultrasonic Cleaner....................................................................................................................................... 28
Quality Control: Sterilisation Checks ...................................................................................................... 29
Sterility Indicators in CSSD department .................................................................................................. 29
HANDLING ............................................................................................................................................... 29
TRANSPORT ............................................................................................................................................. 30
STORAGE ................................................................................................................................................. 30
POLICIES AND PROCEDURES ....................................................................................................................... 31
Responsibility .......................................................................................................................................... 32
Disposables ............................................................................................................................................. 32
Segregation of Sterile and Unsterile Supplies ......................................................................................... 32
Standardisations of Packs ....................................................................................................................... 32
Packing Procedures ................................................................................................................................ 33
Manual of Operations ............................................................................................................................. 33
Packing Material ..................................................................................................................................... 33
Shelf-life .................................................................................................................................................. 34
Sterilisation Process ................................................................................................................................ 34
CSSD Distribution System ........................................................................................................................... 34
STANDARD OF POLICY ................................................................................................................................. 35
1.General consideration.......................................................................................................................... 35
2.General cleaning of the department: .................................................................................................. 36
a.Packing area ..................................................................................................................................... 36
b. Sterile packs storing ........................................................................................................................ 36
c. Decontamination area and sluice room .......................................................................................... 36
3.Generation of items to sterilize ........................................................................................................... 36
Process: ............................................................................................................................................... 36
b. Return of unutilized packs .............................................................................................................. 38
c. Maintenance and calibration of equipment ................................................................................... 38

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 d.Recall procedure .............................................................................................................................. 38
4. POLICY FOR............................................................................................................................................. 39
NORMAL CASES .............................................................................................................................. 39
INFECTED CASES (septic, HbsAg ,HIV) ..................................................................................................... 39
5. DOCUMENTS GENERATED: ..................................................................................................................... 39
6. PPE ( Personal Protective Equipments)................................................................................................... 40
PROJECT TITLE ............................................................................................................................................. 41
BACKGROUND ............................................................................................................................................. 41
AIM .............................................................................................................................................................. 41
OBJECTIVES ................................................................................................................................................. 41
METHODOLOGY .......................................................................................................................................... 42
DATA COLLECTION METHOD ...................................................................................................................... 42
RESULT ........................................................................................................................................................ 43
DISCUSSION................................................................................................................................................. 43
RECOMMENDATIONS ................................................................................................................................. 44
CONCLUSION............................................................................................................................................... 44
BIBLIOGRAPHY ............................................................................................................................................ 45

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 HOSPITAL PROFILE

INTRODUCTION

Index Medical College, Hospital & Research Centre is the latest avenue in Medical
advancements where young enthusiastic minds are taught the Science & art of Medicine. Index
Medical College, Hospital & Research Centre in built on empirical values & pragmatic approach
of dedication and commitment to excellence. Index Medical College, Hospital & Research
Centre in Collaboration with Mayank Welfare Society is dedicated to Excellence in Medical
Education research and Patient care. Woven throughout all these pursuits is a strong commitment
towards public service and a collaborative work ethics of providing care for our diverse
population. In the year 1996 the visionary promoters of this Institute committed to advancement
of Medical Education Health Care and Research set upon this great journey towards greater level
of excellence in all these fields.

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LOCATION

The Campus is situated at Gram Morodhat, Near Khudel Villege, Nemawar Road Indore. The
Campus is situated on 30 acres of land with four lush green garden and is soon going to be
connected with four lanes and sufficient numbers of sub-lanes.

Address: NH-59A, Nemawar Road, Post- Bavliya Khurd, Index City, Indore
Mobile: 9630098980, Landline: 0731 4013604
Email: deanmed@indexgroup.co.in

AT A GLANCE :
• Hospital Established in 2006 catering rural, suburban and urban populations with free
diagnostic and treatment modalities.

• 1st batch MBBS was admitted in 2007 & passes out in March 2012.

• Post graduate (MD/MS) courses started in 2011.

• GOI & MCI permitted PG degree programmes in Non clinical subjects in 2011 .

• GOI & MCI permitted PG degree programmes in clinical subjects in 2014. Ecologically
friendly lush green campus habitat.

• ISO certification 9001-2008.

• Recognized by Medical Council of India, New Delhi.

• Affiliated to DAVV University, Indore , MPMSU, Jabalpur, & Malwanchal University,

Indore

• Approved for 150 Admission per year in MBBS & 103 MD/MS admission per year in
various departments.

• Now IMCHRC is a constituent unit alongwith Dental, Nursing, Pharmacy & Paramedical
College of Malwanchal University.

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• Cater rural, suburban as well as urban area students as an opportunity for professional
growth.

• Create international standards of academic excellence in all fields.

Motivate students and working professionals to overcome barriers and move uphill towards
bright horizons.

FACILITIES

The building is built such that there is abundant fresh air and spacious complex designed to meet
all future expansions and requirements. The serene and healthy environment comprises of the
college building including lecture galleries block, separate hostel building for Boys & Girls,
Multi Gym & dedicated diet centre for Hostel inmates

VISION AND MISSION

VISION
To emerge as a pioneer in a quality healthcare and medical education centre.

MISSION
To take strides in revolutionizing the health care scenario as a tertiary care centre in Madhya
Pradesh.
To provide highest quality of medical education , training and services.
To conduct approved research related to patient management.

CORE VALUES
• Our existence depends on patient satisfaction.

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 • The most important person in our hospital is our customer

• Our chief aim is continuous improvement in medical knowledge and skill

• To safeguard and preserve patient/client right during the course of clinical care and other
services provided to the patients

• To inform all patients about their rights in a manner that they can understand.

LITERATURE REVIEW

INTRODUCTION

Ensuring a high standard of sterilisation and disinfection to minimise the incidence of hospital infection
has been uppermost in the minds of clinicians as well as hospital administrators. The advantages of
centralisation of all sterile supplies through one unit have been realised by all hospitals for ensuring
sterilisation safety and quality control. Sterilization activities in a hospital are better centralised in
one single department for efficiency and effectiveness. This department, called the central sterile
supply department (CSSD) becomes responsible for processing, sterilising and dispensing of
almost all items of sterile equipment, sets and dressings in the hospital.Sterilization plant services
are also responsible for collecting and receiving the object and devices used during patient care,
and for processing ,storing and the distributing them throughout the hospital and procedures that
have been developed to prevent hospital acquired infections inside and outside the sterilization
plant.

Centralisation of sterilising activities in one department has resulted in many advantages. The
chief among these are improved efficiency, sterile supplies available at all times of the day or
night, economy of trained manpower.

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Purpose

The purpose of the CSSD is to make reliable sterilize articles available at the required time and
place for any agreed purpose in the hospital as economically as possible, having regard to the
need to conserve the time of users .

Functions of CSSD
Broadly, the functions of the department are as follows:

1. To receive and process used and unsterile supplies and sets from nursing units, OPD,
operation theatres, labour rooms, etc.

2. To sterilise and dispense sterile articles to user units

3. To maintain an uninterrupted supply of bacteriologically safe supplies at all times

4. To undertake studies for improvement of sterilization practices and processing methods to

provide supplies economically

5. To impart training to hospital personnel in safe hospital practices

6. To participate in hospital infection control programme

7. To advice hospital administration on suitability of supplies and equipment from sterilisation

point of view.

INFRASTRUCTURE REQUIREMENTS

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PLANNING OF CSSD

The planning of CSSD must conform to the sequence of work starting from the reception of
materials to their despatch from the department. The sequence of events is as follows.

1. Materials are received into the department from various users (OT, wards, labour suite,
nursery, etc.)

2. All used materials are cleaned—preliminary cleaning to remove blood, pus and other
substances difficult to remove when dried up should have been done by the users before sending
the articles to CSSD

3. Clean materials are inspected, assembled and packed, ready for sterilisation

4. After sterilisation, they are either stored in a sterile storage area or distributed directly as
required.

Layout

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The location of CSSD should be convenient to its principal consumers. These are the nursing
units, labour suites and operation theatres. It should be so located that supplies and equipment
are brought to and taken away by the shortest route.

The department can conveniently be located as part of the main service core of the hospital.

The CSSD department of INDEX HOSPITAL is situated at second floor.It is in close

coordination with OT and DIALYSIS UNIT.

Area for cleaning and decontamination of materials ( dirty area)

In the cleaning and the contamination area, the microbial load and organic matter of instruments
and medical devices that enter for later processing a reduced. This area is separated by physical
barrier from the other areas of CSSD and is easily accessible from an exterior corridor. The
importance of physical separation is based on the need to avoid the transport of aerosols, droplets
and dust particles from the dirty to the clean area through air currents. This is key given that this
sector generate a large quantity of aerosols. The floors, walls and ceilings and work surfaces
should be constructed with non porous materials that can tolerate frequent cleaning and humidity
conditions. All air from this sector should be expelled to the exterior without recirculation, thus
preventing the introduction of contaminants there that endanger with the patient and personnel in
to clean areas. The circulation of people is restricted and controlled and only adequately dress
personnel can enter . This areas should have a compressed air terminal for drying elements with
the lumen. Air should arrive clean and dry to the sector, which means that it should be treated

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appropriately with silica gel air dryer or oil filtrate . Oxygen is also used for drying and is
superior to other options since it does not present the moisture problems derived from
compressed air.
It should have negative air pressure relative to adjustment areas and should have an air extractor
that functions continuously while working in the area..
Fans should not be used within the area and window should be closed permanently. If it is not
possible to close the windows due to the heat produced by the washing Machine , ultrasound
devices and hot water used to wash materials, windows should have a metal screen to avoid the
entry of insects. The environmental relative humidity should be between 35% and 50%.
Minimum necessary physical structure : washable floors and walls .Two Deep Sinks. Bench
made of washable material. It cannot be wooden.

Area for conditioning, packaging, preparation and sterilization of material (clean

area).

The area for conditioning, packaging, preparation and sterilization of material should admit
completely clean, dry objects. Here, instruments and devices are checked in order to safeguard
their cleaning, integrity and functionality. Transit of people should be strictly control and only
adequately dress personal should enter the area .Here, medical devices, boxes of instruments,
clothing etc. are prepared for the sterilization process. Minimum necessary physical structure
include
washable floors and walls

Bench made of washable material.

Magnifying glasses for confirmation of the cleaning

Sink for personnel.

Exit for compressed air

.Cabinets with doors to store non sterile and materials and supplies.

Area storage of material (sterile area)

for The area for students sterile material should admit only wrapped sterile devices or
instruments, which should be placed on open shelves or in close cabinets .This area should be
ventilated with at least two air changes per hour, with a temperature from 18’C to 25’C and
environmental relative humidity between 35% -50%. All sterile packages should be stored at a
minimum of 30 cm from the floor. The transit of people is prohibited and only authorized,,
adequately dress personal should enter the area. Minimum necessary physical structure:

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• washable floors and walls

• cabinets to store materials after the sterilization process

• prior to entry a sink for personnel.

Administrative area

The CSSD should have an administrative area for carrying out administrative activities related to
personnel and supplies that is adjacent to but separated from the technical area. Furthermore, all
documentation generated by the CSSD should be kept in this area, such as

• controls of sterilization cycles ;

• controls of the number of materials,;
• devices and supplies;
• personal functions;

and all the other administrative processes of CSSD

Support area
 The support area should be made up of, at a minimum
A dressing area for changing out of street clothes and showing both clothes and personal
objects.
 A deposit area for chemical products, detergents and cleaning products. This area should
have any additional sink to wash the accessories used to clean environment.

Space
A minimum of 7 sq. ft. on a per bed basis (with 100 sq ft. for the smallest hospital) is considered
essential for planning a CSSD with scope for future expansion and growth. The following area is
recommended :

The area will be divided into receiving and cleaning, clean work and processing, sterilisation,
syringes and glove processing, sterile storage, and issue. Needs for space for each of these differ
by availability of mechanical devices and modern facilities.

These activities comprise of the following.

1. Receipt of used supplies

2. Accounting

3. Washing, cleaning and drying

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4. Sorting

5. Gauze cutting and assembling

6. Packing

7. Sterilisation

8. Sterile storage

9. Issue.

The direction of work flow and economy of labour determines the layout of the physical
facilities. Articles should move only in one direction through receipt, washing and cleaning,
drying, sorting, reassembling and packing, sterilisation and storage. The following areas will be
essentially required in the department. Although they cover most of the requirements, special
requirements of a particular hospital should be kept in mind during the planning process .

Mechanical systems

In addition to mechanical, energy, water and steam requirements, sterilization processes

habitually require pressurized systems such as compressed air, nitrogen and vacuum systems .A
system for water distillation or demineralisation which will be used both for cleaning and for
filling the steam autoclaves, is recommended.

Floor and walls

Floors and walls should be constructed with washable materials that do not released fibres or
particles and that are not affected by the chemical agents that are habitually used for cleaning.

Ceilings
Ceiling should be constructed so that there are no expose angles and only one surface in order to
avoid condensation by moisture, does or other possible causes of contamination.

Ventilation
Ventilation system should be design so that air flows from the clean to the dirty areas and is then
released into the exterior or into a filter recirculation system. There should be no less than 10 air
changes per hour. Fan should we not allowed in the CSSD since they generate high turbulence of
dust in the air and micro organisms that are projected from the floor to the word tables.

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Temperature and moisture
The ideal environment will maintain a stable temperature from 18°C - 25 °C and relative
humidity of 35% - 50% . Higher temperature and moisture favour microbial growth and lower
levels can affect given sterilization parameters, such as penetration of the sterilizing agent.

Sinks for washing instruments

The sinks should be deep, in order to avoid splatters during the task and permit the correct
immersion of the elements, a key factor for the correct cleaning of instruments.

Fire extinguishing systems

The service should have at least two fire extinguishers based on CO2 or ABC chemical powder
in a visible, accessible location.

Inputs for planning should be provided by a committee which should include representatives
from administration, surgical staff, anaesthesiology, pathology and nursing. This committee
should develop a written programme covering:

i. the overall scope of the department,

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ii. departments to be served,

iii. extent of services to be rendered,

iv. process equipment to be procured,

v. preparation of procedure manual, and

vi. organisational and administrative structure of the department.

STAFFING .

There should be a properly qualified supervisor in charge of the department. The chief of the
department, the CSSD supervisor, has traditionally been a senior nurse.

The routine work in the CSSD is of a repetitive nature. The other staff required are usually in-
service trained CSSD attendants, semiskilled workers who can be called CSSD assistants, CSSD
technicians and sweeper (safaiwalla).

Access for technical areas of the CSSD should be strictly for personnel that work in each area .
Visits, technical personnel from the other areas and supplier should be received in the
administrative area of the CSSD. In order to have access to the processing area, every visitor or
supplier should be dressed appropriately according to the standards, including use of gown, boots
and cap, and accompanied by the person responsible for the CSSD.

Hospital personnel
Only authorized personnel should have access to the area for processing and sterilizing materials.
No individuals from outside of the service can enter the clean and sterile areas, unless the person
has authorization from the Head of the CSSD and its appropriately dress according to the
standards.

Despite technological innovations in the arena of disinfection and sterilization with automated
equipment, this equipment required trained operators that should be informed about the
sterilization process they are performing . The centralization of cleaning and sterilization

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services from the entire hospital in the CSSD guarantees the quality of the processes, in addition
to optimizing and economizing human resources and materials. The number of CSSD Employees
depend on the volume of the work carried out, but there should always be minimum of stable
employees. The area for the cleaning and decontamination of material (dirty area) should have
an exclusive professional. Each remaining area should have one or more professionals that can
perform activities in a different cleaning areas. There should be an ongoing training program for
all CSSD staff that includes:.

• Notions of microbiology

• operations of equipment’s
• principles of cleansing,

• disinfection and sterilization;

• selection and packaging of instruments

• preparation of textile materials;

• loading of autoclaves;

• control of processes;

• Storage of sterile materials;

• Collection and distributions of material;
• and use of personal protective equipment( PPE)

Control and registration of the materials on the CSSD

All medical requirements and instrument should be registered in order to control the process of
reserve, maintenance and preventive substitution. Furthermore, certain characteristics of the
material that enters or leaves the CSSD should be registered : type, quantity, conditions of
conservation. Boxes with surgical instruments should contain a description of the content in
order to facilitate the work of organizing the boxes in the CSSD. They should be counted or
reviewed in the operating room, before and after each procedure.

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 EQUIPMENTS

The main item of equipment in the CSSD of Index hospital is the autoclave. Various type of
autoclaves are available.

CSSD of Index hospital have 3 autoclave machines.

Manufacturer’s instruction for installation and operation must be clearly understood. Most
modern electric autoclaves are designed to achieve a vacuum in the sterilisation chamber
followed by injection of steam under controlled pressure to achieve desired temperatures for
varying periods, and have recording devices. Walk-in type of autoclaves are available which are
suitable for the requirements of very large hospitals.

Other equipment in the CSSD of hospital includes

• Dry oven

• Gauze cutter

• Ultrasound washer

• Autoclaves

• Ethylene oxide steriliser

• Work benches with marble or stainless steel top

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• Storage cupboards and racks
• Linen folding table
• Soaking sinks
• High pressure water jets.

Cleaning of materials
Cleaning is an essential component in the reprocessing of medical devices and sterilization can
never be achieved without a complete cleaning.

Steps in the process for cleaning materials

•Reception
•Classification

•Pre washing or soaking

•Manual washing

•Mechanical cleaning

•Rinse with water

•Rinse with alcohol

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•Lubrication

Mechanical cleaning

Some centers may have the assistance of machines for mechanical cleaning . This could include

•Ultrasonic washer

•Washer disinfector

Manual washing and rinsing of the material

Washing machine should be in a perfect state of hygiene for their use, to be determined by
declining standards of the institution for each type of equipment. This is important since these
machines often act as contamination vectors for the elements being washed. Both ultrasonic
washer and the washer disinfector carry out the complete process within the chamber of the
machine on in successive modules. This process can be considered safer since it avoids cuts and
scrapes to personnel, water splatters in the washing area, etc.

STERILIZATION

Sterilization refers to the set of operations that are developed to eliminate or kill all forms of
living beings that are contained in an object or every critical article should undergo some type of
sterilization method according to every critical article should undergo some type of sterilization
method according to its compatibility.

Sterilization methods
Physical method: dry heat and moist heat

chemical methods: liquids and gases (ethylene oxide)

PHYSICAL METHODS

Dry heat
It is important to always take into account the micro bicycle action of feeders condition by the
presence of organic matter audit on the materials. This applies, for example, to all of advocates is
in which the microorganisms are protected from heat based action.
Dry heat penetrates slowly in materials, which means that long exposure periods are required.
Hot air is not corrosive but the process is slow. It is usually at 170°Cfor 60 minutes of 150 °C for
150 minutes. this system eliminates microorganism through coagulation of the proteins in the

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microorganisms.
This process depends on:

•The diffusion of the heat

•The quantity of heat available and

•The levels of heat loss

Instructions for use:

•It can only be applied when material do not support the action of moist heat
•It’s recommended use for the sterilization of certain materials derives from its facility to
penetrate solids non-aqueous liquids and close cavities.
•Its behavior which metal is less corrosive but more oxidant.
•It does not Erode glass, as is the case with steam, Sharp stainless steel instruments( scissors and
tweezers)
•Needles coma crystal syringes, tubes, glass pipettes, heat stable powders.

•Liquids and substances that are liposoluble and water-resistant such as oils, silicon, paraffin,
Vaseline, creams and talcum powder
Sterilizing agent: Hot air

Mechanism of action:
•microbial death occurs as a consequence of energy transfer and oxidation mechanism.

Conditions for process

•Institutional procedure manual should established working conditions sterilization according to

the load, volume, weight and thermal resistance of the material. It is indispensable to respect the
parameters obtained during the validation of a procedure
•The temperature of sterilization by dry heat should stay between 160°C to 170°C.
•the total exposure time of the material is determined through the corresponding validation of the
cycle.
•It is important to point out that exposure time should be recorded of the required temperature is
reached and not from the time that the sterilizer is charged in the bronze time could be required
to reach the sterilization temperature

MOIST HEAT OR STEAM STERILIZATION

Steam sterilization is the most common sterilization procedure. The equipment used is called an
autoclave. The action mechanism for moist heat is the denaturation of proteins. It has the
advantages of rapidly producing elevated temperatures, having short sterilization times, and not
leaving toxic waste in the material.

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The efficiency of steam as a sterilizing agent depends on:
•Moisture
•heat
•penetration
• the mixture of steam and pure air

In index hospital three machines are available for autoclaving.

Autoclaved instruments can be valid and sterilize for 7 days.

CHEMICAL STERILIZATION BY ETHYLENE OXIDE

Ethylene oxide (EO) is a gas which is now commonly used as sterilising agent for heat-sensitive
and moisture-sensitive materials like rubber, plastics and
fibreglass.
Sterilizing agent: Ethylene oxide, or ether 1-2 epoxy-ethane, is an alkyl ting agent. Its
presentation is liquid and it volatizes gases two forms a gaseous compound. Pure ETO is
inflammable and explosive. ETO gas is colorless, heavier than air, has an ethereal odour, is
detectable between 230 to 700 PPM, and the soluble in water and in majority of solvents. It is
only considered effective if the equipment used guarantees the parameters necessary for
sterilization such as temperature, moisture, exposure time, pressure and concentration of the
agent.

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Stages of sterilization by ETO

•Conditioning and humidification

•Entrance of the gas
•Exposure to the gas
•Evacuation
•Aeration

In index hospital 1 ATM machine is available. Sterilization temperature ranges from 35°C to
55°C and exposure times range from 1 hour 20 minutes and 4 hours
The aeration process that should be implemented is carried out at 40°C to 60 °C for 6 to 12
hours.

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 This results in a total duration for the entire process of 8 to 16 hours. Automatic machine
uses 100 grams of EtO gas cartridge Thermal paper roll for printer are used and it gives
printed details of each cycle.

One year validity is there for idiots sterilize instruments

Label over sterilize items contains sterilization date and expiry date with sign of the head

Concentration of gas:

450 mg/litre or higher is essential for complete sterilisation.

Temperature:

Exposure time can be reduced by increasing the temperature. Two temperature ranges are
generally provided in the EO sterilisers 49° to 63°C and 30° to 37.8°C.

Humidity:

In automatic sterilisers, steam is injected under vacuum before admitting the gas. In some a wet
gauze or sponge is required to be placed. Other sterilisers depend on ambient humidity, and
compensate for lower moisture by a higher exposure time.

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 Ultrasonic Cleaner

One of the essential items of equipment in CSSD is the ultrasound cleaner. Ultrasonic cleaner
cleans by bombarding the item with sound waves. These waves while passing through the
detergent solution produce sub microscopic bubbles which collapse on themselves, generating
tiny shock waves that knock debris off nooks and corners of instruments that are not easy to
reach. An effective programme of preventive maintenance should be in place to minimise the
chances of machine breakdown. If it is not possible to carry out such preventive maintenance by
the hospital’s own staff, there should be a maintenance contract with the manufacturers.
Preventive maintenance should cause minimal disruption to the CSSD.
Effective sterilisation by EO depends upon the following.

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Quality Control: Sterilisation Checks

In spite of the process instruments fitted on autoclaves which give a graphic record of
temperature and pressure, routine methods of check for sterilisation must be incorporated. Colour
index strips available for this purpose should be kept in each pack being autoclaved.
Manufacturer’s instructions must be followed scrupulously regarding loading of autoclaves,
temperature and pressure levels and timings.

Sterility Indicators in CSSD department

Mechanical indicators which are monitoring instruments record time, temperature, humidity and
pressure during the sterilisation cycle.

Chemical indicators are devices with a sensitive chemical or dye to monitor one or more
parameters of a sterilisation cycle.

Biological indicators employ the principle of inhibition of growth of microorganism of high

resistance to the mode of sterilisation. Subsequent failure of growth of microorganisms indicates
adequacy of sterilisation.

Articles should not be considered properly treated unless the time, temperature and pressure
indicators indicate that the required time, temperature and pressure were reached during the
autoclaving process. If not, the entire load of articles must be autoclaved again, until the required
temperature pressure and residual time are achieved again. Recording instruments on the
autoclave which give a progressive graphic record of temperature, pressure, etc. can be
inspected immediately after a load has been autoclaved. In addition, chemical indicators change
colour when conditions necessary for sterilisation have been met.
These are available as tapes and strips, and are attached or implanted inside the packing material.
This should be supplemented with periodical use of biological indicators to detect (which may
take several days) failure of the autoclave. To achieve a high degree of certainty that the
autoclave is functioning properly, biological indicators should be placed in the most inaccessible
location in the load and then cultured. They provide positive assurance, albeit retrospectively,
that each package has been subjected to proper sterilising conditions.

HANDLING

Product handling begins from the time that the material comes out of the sterilizer. Handling
should always be kept at the minimum amount necessary. Before touching containers that
contain sterile products, it is important to take the following into account:

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•Allow them to cool prior to removing them from sterilizer in order to avoid condensation.
•Hand should be clean and dry.
•If the operator carried out another activity prior to the current 1, carry out exhaustive
hand washing.
•Take off gloves used for the other activity and wash hands.
•Transport materials and cards, the volume requires it, and never resting against work clothes.
•Work clothes should be cleaned.

TRANSPORT

Material should never be taken directly by hand to the shelves. For their transport, cards that are
easily cleaned, have smooth surfaces and a preferably made of heat resistant plastic polymers
should be used. This type of cards produces less temperature difference in materials then
stainless steel parts and the possibility of condensation is also lower.

Depending on the route that the cart would need to follow, the following can be used:

• Open carts

• Protected carts

• Close carts

In any of these cases, carts should be taken directly from the CSSD to the destination area.

STORAGE

Although the storage of sterile product is carried out in different areas of the health center’s the
condition should always be the same.

General considerations

•Access to the area should be restricted

•It should be clearly separated from the dirty area and semi sterile area
•Packages should be placed on shelves or in cabinets. It is recommended that the storage
containers should not be wooden.
•They should be located at the minimum distance of 30 cm from the floor, 45cm from the ceiling
and 5cm from the floor.
•The material should be far from sources of moisture or heat.
•The presence of steam plumbing, portable water or wastewater should not be permitted in this
area.
•Air exchange should be carried out in such a way that it meets 10 changes per hour.
•They should be an adequate level of illumination.
•They should be identified, well differentiated and whenever possible, placed vertically.

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•The material should be placed in a position that makes it simple to label and visualize the
expiration date indicated on the container.

Requirements that the storage location should fulfill

•It should be large enough for the amount of material that needs to be stored there.
•The walls should be smooth and easy to clean.
•It's not adequate in my mental condition in terms of both temperature and moisture.
•Open shelving should be made of racks in order to avoid condensation of moisture and
concentration of dust.
•When the content is heavy or has a protruding edges, cardboard containers on a plastic interior,
protection with the double bag is suggested.

POLICIES AND PROCEDURES

Central sterile supply is most effective when it provides limited basic range of articles for the
greatest possible number of users. A periodical review should be made of the items processed by
the CSSD to assess which ones can be modified to meet a wider range of needs and whether any
can be dispensed with altogether. Once this basic need is catered for, any additional need can be
met by providing supplementary packs containing particular dressings or materials.

The list of items and special trays commonly processed in the CSSD are as follows.

• Instruments
• Appliances
• Dressings
• Sponges
• OT linen
• Special packs
• Gauze and cotton materials
• Gloves
• Bowls and trays.

CSSD is one department where policies and procedures must be unambiguous and scrupulously
followed in letter and sprit. The smallest mistake or carelessness on part of the staff can have
serious repercussions elsewhere in the hospital. The policies should cover the following:

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Responsibility
The CSSD technician is responsible for the results obtained from the biological indicators in
each slot, both and autoclaves by seem and by ethylene oxide. If the biological indicator suggest
a deficiency in the sterilizer, the technician should report this immediately to the department
supervisor and take the sterilizer out of the service.

• The department supervisor should notify the maintenance service about the repair of the
sterilizer. This cannot be placed in service again until the verification procedures are carried out.
All hospital staff should review the sterile packages routinely and organised them on the cells
according to their expiration date. Objects with an earlier expiration date should be placed
upfront. If expiration date has passed, the package should be removed from the service and send
to the CSSD for reprocessing. This is the responsibility of its department.

Disposables

The advantages and disadvantages of using disposables should be fully taken into account when
considering the replacement of traditional materials by their disposable equivalents,
remembering that some disposables give more value for money, while as some others have no
specific advantages.

Segregation of Sterile and Unsterile Supplies

Sterile supplies and packs and contaminated articles should never be carried on the same trolley
or by the same staff. The term “sterile supplies “covers all articles which have either been
sterilised in CSSD or disposable sterile packs distributed through CSSD.

Standardisations of Packs

Special trays and sets to be processed by CSSD should be standardised by the hospital. Surgical
instruments and other related items needed for commonly practised surgical procedures
generally do not vary from surgeon-to-surgeon. Such operations are appendectomies,
cholecystectomies, exploratory laparotomy, cataract surgery, nasal surgery, ear surgery,
hysterectomies, tubal ligations, etc. We should develop a composite pack for each surgical
procedure, such a pack should contain all items the surgeon and nurses require for a procedure.
In standardising, the aim is to have a standard surgical pack containing all the items required for
that procedure by the operating surgeon. This system has the advantage of having standardised
sets ready at hand even for emergency operations, irrespective of special preferences of a
particular surgeon. Besides these, the other commonly used sets (or packs) of sterile instruments
and materials in various other procedures that are generally standardised are as follows.

• Cut-down set

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• Lumbar puncture set
• Sternal puncture set
• Catheterisation set
• Bladder wash set
• Liver biopsy set
• Fine-needle aspiration cytology (FNAC) set
• Paracentesis set
• Suturing set
• Thoracic aspiration set
• Incision and drainage set
• Tracheostomy set.

In order that the most economic method of providing the packs can be established, cost
comparisons should take place from time-to-time, between packs available from commercial
sources and those prepared in the CSSD. The possibility of purchasing a standard range of
dressing packs and materials from trade sources should also be kept under review.

Packing Procedures

Step by step packing procedure for each pack should be determined, and should specify:

i. the quantities of materials required and their arrangement on the workbench, and
ii. the sequence of the packing operation.

Fifteen sq ft of packing space is necessary on each workbench for assembly of simple packs with
a high throughput, with some storage space above the bench. Workbenches should be so
designed to keep packing movements to minimum, with storage of materials either on shelves or
above the bench within easy reach of the packer.

Manual of Operations

A procedure manual listing all procedures followed in the CSSD for each process and their
correct sequence is essential for effective operation of the department. It must be realised that
more costly and sophisticated the equipment, more training and precision is required to operate
it.

Packing Material
Packing material used as wraps for articles for sterilisation differs with the process of
autoclaving or hot air oven. Linen and Kraft paper are commonly used, paper being a better
bacterial barrier. In case of paper, it is desirable to have a double paper wrapping. Although kraft

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paper is usually used, but even newspaper have been effectively used. The wrap should be easy
to open without spilling the inside items. If paper is used, it may be finally wrapped with linen or
placed in a cardboard box for autoclaving. Articles for hot air sterilisation can be kept in suitable
stainless steel containers. Syringes and needles are packed in paper wrappers. Gloves can be
packed either in paper or linen.

Shelf-life
The shelf-life of sterilised packs, i.e. the time for which it can be stored safely before use, should
be determined by a committee of experts including a bacteriologist. If the pack is not used,
during its shelf-life, it should be again put through the autoclaving process without being opened.
Although a pack can remain sterile for up to four weeks on the CSSD shelf, experts are of the
opinion that it should be reautoclaved without opening after one week.

Sterilisation Process

After the steriliser chamber is sealed and the controls set, sterilisation process goes through the
following phases:
1. Warming the chamber
2. Evacuating residual air to partial vacuum
3. Introduction of moisture to ensure that it penetrates
wrappings and material
4. Introduction of EO
5. Raising the temperature (if required)
6. Exposure for the required time
7. Release of chamber pressure
8. Removal of the gas under vacuum (called the “Purgecycle”)
9. Reestablishment of atmospheric pressure by introduction of filtered air into chamber.

CSSD Distribution System

• The sterilized medical use product should be distributed by preventing, dropping and
unnecessary manipulation.

• The discharge of the production be documented in the discharge registry

• Clean bags or container should be used to distribute the sterilize medical use product to
different sectors of the institution

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• Once distribution is completed the necessary mechanism for the rapid replenishment of
stock should be implemented.

• Proper documentation must be maintained

Distribution system for sterile article should also be decided at the planning stage itself. The
following four systems are in use. The last two are door deliveries.

Clean for dirty-exchange: A sterilised articles is issued at the CSSD issue counter on return of a
used one at any time.

Requisition system: Articles needed are requisitioned by users on a daily or regular basis and
collected by them at CSSD counter.

Grocery system: Each user’s requirements for all items for a specific period are delivered at
suitable interval irrespective of whether the contents have been used or not and the previous
basket or container withdrawn.

Quota system: Predetermined stock levels (quota) of various items for each user unit are
maintained by delivery personnel from CSSD through regular deliveries.
The choice of system will ultimately be dependent on local circumstances. A combination of the
systems may be more appropriate in most hospitals. Depending upon the size and requirement of
each hospital, the department may have to work in more than one shift. If the department works
on only one full shift, then provision for issues of required packs outside of normal working hour
will have to be made. In smaller hospitals, this task may be assigned to the casualty or
emergency department who would then be stocked at levels over and above its own requirement

STANDARD OF POLICY

1.General consideration

a.Dress code: all staff of the central sterile supply department is required to follow strict dress
code, no staff is allowed to enter the department with their normal clothes. Prior to the entry of
the staff to the department, each and every staff of the central sterile supply department is
required to change into appropriate departmental dress code with the required personal protective
equipment’s.

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b.Receipt and issue of packs: receipt of items on various points of generation: from 9.00 a.m. to
1.00 p.m.

Issue of sterile packs from the CSSD : from 3.00 p.m. to 6.00 p.m.

However in department like OT, ICU, emergency department it is exempted from the above
mentioned time dimension since it is difficult to restrict the activity within specific time limit due
to the emergency nature of care provided by them.

2.General cleaning of the department:

To prepare a clean environment for preparing items for sterilization, to maintain the cleanliness
in CSSD and to reduce and minimize source of infection. The general working of the CSSD is
mopped everyday including the following area within the CSSD environment.

a.Packing area
•Wipe working table, shelves and trolleys with the recommended disinfectant.
•Wipe the machines with damp cloth.

b. Sterile packs storing

•Wipe the shelves and walls with recommended disinfectant weekly.
•Mop the floor twice daily and ensure that the mop that is used is only meant for the sterile store.

c. Decontamination area and sluice room

Wipe the trolleys with recommended disinfectant daily.
•Wipe the machines with a damp cloth daily
•Mop twice and as and when required with the recommended disinfectant.
•The floors are cleaned truly and polished whenever required.

3.Generation of items to sterilize

The items to be sterilizer the central sterile supply department are washed (with detergent or
chemical as applicable), sorted and pet at the respective point of generation ( wards, ICUs,
emergency department, OTs, OPDs etc.) The housekeeping staff is responsible for transporting
the prepared packs from the point of generation to the central sterile supply department.OT linen
are send directly to the laundry for cleaning. The laundry washed linen are received packed and
forwarded to the CSSD for sterilization.

Process:

The CSSD technician receives the unsterile packs, inspect them to check the status of the item
(torn, punctured, cracked etc.) and places them at the unsterile pack storing platform. Entry is

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made in CSSD receipt register including date, time, type of instrument in the pack, its source,
procedure used for, and case infected or not, name and signature of person handing over, and
name and signature of person receiving it.The autoclave indicator is pasted in the packs by the
CSSD technician and the packs are taken to the main sterilizing area where the sterilizing units
are placed. The CSSD technician places the unsterile packs under appropriate temperature and
pressure specifications in the sterilizing units. The temperature, pressure specification and
accordingly the temperature period are as follows

Temperature Pressure Sterilizing period

Normal sterilization 121°C 15 lb 30 minutes
Rapid sterilization 140°C 20 lb 20 minutes

At the end of the sterilization period the packs are removed from the sterilizing units, autoclave
indicator are checked to confirm adequate sterilization of the packs, in case the sterilization is not
adequate the process is repeated. Packs which are adequately sterilized are stored in the sterile
packs storing area. The following procedure is followed for storing the sterile packs:

1. Packs are pushed directly to the sterile Store to maintain sterility.

2.Sterility of the pack is checked as follows:
i.Packs are not torn.
ii.No attempts at opening the pack have been made.
iii.Packs are not wet or dirty.
iv.The chemical indicator tape colour changes
v.If any of the above is detected, the instruments are clean, dried and re packed again.
3.The sterile packs are kept over trolleys to allow them to get cool prior to their arrangement in
the shelved. Sterile packs are always handled wearing gloves.
4.Inventory of sterile packs are checked everyday to ensure that they are stored without being
distributed to the respective user department.
5.Once the temperature of the sterile packs fall they are stored in appropriate racks in the sterile
packs storing area.

Thereafter the sterile packs are issued to the user department and an entry of the same is entered
in the packs issue register.

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b. Return of unutilized packs

In case the packs which are sterilized in the CSSD remains un utilized in the respective user
departments for a period of 72 hours, the same are returned to the CSSD department for re
sterilization.

c. Maintenance and calibration of equipment

Maintenance of the equipment’s are done as per the annual maintenance contract entered into
with the vendor of the respective CSSD equipments.all details in this regard and maintained by
the biomedical equipments engineer and maintenance department of the hospital. All
equipment’s used in the department of appropriately calibrated at periodic intervals to ascertain
whether they are performing at the expected level and a record of the same is documented in a
department as well as with the concerned clerk in the administrative department of the hospital.

d.Recall procedure

Whenever a breakdown in the sterilization system is noted all packs sterilized by the faulty
machine is immediately called back from the respective area where the sterile packs has been
supplied. The packs called back are sent for re sterilization using a proper machine.

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4. POLICY FOR

NORMAL CASES
1. Wash in OT
2. Received in CSSD in yellow bag
3. Check instruments with the CSSD instrument checklist
4. Keep for 20 minutes in 10 ml rapid solution in 1 litre water
5. Rinse thoroughly in R.O. water
6. Dry with clean cloth
7. Prepare set
8. Sterilize in general autoclave machine
9. Storage in aseptic storage

INFECTED CASES (septic, HbsAg ,HIV)

1. Wash in O.T.
2. Received by CSSD in red bag.
3. Check instruments with the checklist.
4. Keep four hours in 30 ml multi enzyme cleaner solution in 1 litre water.
5. Rinse thoroughly in R.O. water in separate basin and dry with cloth.
6. Autoclave in separate machine without wrap
7. Again wash with multi enzyme cleaner solution like normal cases
8. Resterilize in general autoclave machine
9. Storage in aseptic storage

5. DOCUMENTS GENERATED:

 CSSD ward requisition record

 CSSD ward supplier register record
 Equipment stock and maintenance record
 CSSD drum autoclaving record
 CSSD set autoclaving record
 CSSD draping and tray autoclaving record
 CSSD sterilize OT material record
 CSSD linen record
CSSD recall record
Linen stock record
Set stock record
Instruments stock record

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 IN CSSD of index hospital ,they are maintaining three registers regarding duties allotment
and technicians register. CSSD register is implemented with CSSD reference number and
maintained well from each and every department before sterilization of the sterlization so
record procedure can be done easily in case of problem in sterilization.

6. PPE ( Personal Protective Equipments)

1- When handling contaminated items, wearing personal protective equipment (PPE) is required.
2- PPE’s include: eye protection, gloves, surgical mask, moisture resistant gown, shoe covers and
hair covering. After task is completed, remove
and discard all PPE’s and thoroughly wash hands
3- All head and facial hair should be completely covered with surgical cap in re-stricted areas.
4-Finger nails must be kept short, clean and healthy, nail polish is not allowed.
5- Hand jewelry and wrist watch is not allowed to wear in decontamination area.
6- Vaccination is mandatory for hepatitis B for workers .

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NAME OF ORGANISATION: INDEX MEDICAL COLLEGE, HOSPITAL AND
RESEARCH CENTRE

PROJECT TITLE : CLINICAL AUDIT OF CENTRAL STERILE SUPPLY

DEPARTMENT
PROJECT MADE BY: MS POORVI HARDIA

BACKGROUND
The sterilization plant plays a very important role in the prevention of hospital acquired
infections. The purpose of Central sterile supply department is to make reliable sterilize articles
available at the required time and place for any agreed purpose in the hospital as economically as
possible, having regard to the need to conserve the time of users.

AIM
To study and analyse the service quality management and perform the clinical audit of Central
sterile supply department of index hospital and determine strategy for further improvement.

OBJECTIVES
 To provide sterilize material from a central department where sterilizing practices is
conducted under conditions, which are controlled, thereby contributing to a reduction in
the incidence of hospital infection
 To observe the current practices in implementation and analyse the gap
 To maintain inventory of supplies and equipment
 To stay updated regarding development in the field in the interest of efficiency ,
economy, accuracy and provision of better care
 To provide a safe environment for the patients and staff
 To monitor and in force controls necessary to prevent cross infection according to
infection control policy
 To maintain record of effectiveness of cleaning disinfection and sterilization process

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  To assess the effectiveness of sterility procedure
 To recommend rectification and development in the function of Central sterile supply
department

METHODOLOGY
A study among selected group of CSSD staff including CSSD in charge, CSSD technician,
CSSD assistants was carried out during a period of 45 days.
Monitoring of CSSD is done to oversee the use of different sterilization methods and capturing
indicators to monitor sterilization process and ensure technical maintenance of the equipment
according to National standards and manufacturer’s recommendation .
Each sterilization cycle give the printout of the temperature and pressure under which the cycle
is processed.
Any defect regarding the administration, maintenance of instruments, lapses in infection control
are recorded.

DATA COLLECTION METHOD

Based on a point prevalence study, a checklist was framed having eight sections, which covers
different aspects of the audit.
Each section contain some listed questions with options available
Points has been allotted following the criteria given below
 Completely satisfactory result is equal to 10 points
 Partially satisfactory result is equal to five points
 Unsatisfactory result or not evident result is equal to zero point
The section included in the checklist are:
Sections Name of the section Total number of questions
SECTION -A Handling, collection and 10 questions
transport of contaminated
Instruments
SECTION-B Cleaning and 10 questions
decontamination Processes
SECTION- C Instrumentation, Inspection, 14 questions
preparation and Packaging
SECTION-D Sterilization and monitoring 15 questions

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SECTION- E Sterile storage and 10 questions
distribution
SECTION- F Documentation 7 questions
SECTION G Facility design 15 questions
SECTION H Considerations 10 questions

RESULT

Sections Total points Points obtained

SECTION- A 100 90
SECTION-B 100 90
SECTION- C 140 130
SECTION -D 150 130
SECTION- E 100 90
SECTION- F 70 60
SECTION -G 150 130
SECTION -H 100 100

Graphical Representation of Result

105
RESULTS ( PERCENTAGE)

100

95

90

85

80

75
SEC. A SEC. B SEC. C SEC. D SEC. E SEC. F SEC. G SEC. H

DISCUSSION

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Every step in Central sterile supply department has a direct impact on infection control, patient
care and safety, therefore lack of quality can have dramatic consequences on the health and
safety of personnel and patients.
The audit result shows that the major areas of the central sterile supply department is effectively
managed, though there are few points which can be rectified.
 Different zones of the central sterile supply department are distinguished from each other.
 Floors of the semi sterile zone as well as sterile zone are epoxy coated.
 Secured and educated containers are provided for soiled items and reusable items are
separated from waste at the point of use.
 Written policies and procedures are place for cleaning and decontamination processes.
personal protective equipments are used by employees however it was found that
instruments are handled without using gloves which needs to be corrected
 There are proper guidelines displayed for the cleaning agent to be used with different
medical devices.
 It is ensure that instruments are clean and dry before packaging with proper labelling.
 Physical and chemical indicators are used to ensure the sterility of the instruments.
 Documentation regarding the sterilisation processes, instrument stock register CSSD
record register are maintained.
 Temperature ,pressure and humidity of the CSSD is maintained and monitored regularly
 Timely training programs are organised for continuous education of the personnel.

RECOMMENDATIONS

 Flash sterilizers must be available for emergency cases

 Storage room must also be epoxy coated
 Gloves must be used by the step of CSSD for handling of instruments
 Routine sterilizer efficacy testing with BI PCD should be done daily
 Bowie- dick testing must be done in pre vacuum sterilizers before first processed load
 Doors must close freely and should not have threshold
 Electronic instrument tracking system can be used
 Periodic educational interventions and training should be conducted for CSSD staff.

CONCLUSION

In most healthcare facilities the central sterile supply department plays a key role in providing
the items required to deliver quality patient care. A well plant, well managed and well staff CSE

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Central sterile supply department can ensure an infection free environment of hospital and save
valuable life and money.

BIBLIOGRAPHY

• www.choithramhospital.org

• TEXTBOOK – BM SAKHARKAR’S PRINCIPLES OF HOSPITAL

ADMNISTRATION

• www.wikipedia.org

• www.google.com

• Images are taken from Google.

• http://nabh.co/

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