Version No: 1

CSSD MANUAL Date: 27/01/2024

Nayanakumar’sMultispeciality hospital

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Document Summary

Document Title CSSD MANUAL

Department Code CSSD Department Name CENTRAL STERILE SUPPLY DEPARTMENT

Classification Internal Storage Location Quality

Current Version 1.0 Date of Release 27/01/2024

Reference clauses addressed NABH/HIC

Document Id NK/NABH/CSSD/01

DOCUMENT APPROVER

Version No Name Designation Date

1.0 Mr.Kumar K B Facility Director 27/01/2024

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Contents
1 INTRODUCTION:.........................................................................................................................................4
1.1 RANGE OF ACTIVITIES INCLUDES:...................................................................................................4
2 QUALITY OBJECTIVES..................................................................................................................................5
3 JOB RESPONSIBILITIES:...............................................................................................................................5
3.1 JOB TITLE – CSSD IN-CHARGE.........................................................................................................5
3.2 JOB TITLE – CSSD TECHNICIAN........................................................................................................5
4 STANDARD OPERATING PROCEDURES:......................................................................................................6
4.1 INSTRUMENTS/ MATERIALS AVAILABLE:........................................................................................6
4.2 RECEIVING OF UNSTERILE ITEMS FROM THE OPERATION THEATERS:............................................7
4.3 RECEIVING OF UNSTERILE ITEMS FROM OTHER UNITS:.................................................................7
4.4 RECEIVING OF UNSTERILE ITEMS FROM CATH LAB........................................................................8
4.5 RECEIPT OF UNSTERILE ITEMS:.......................................................................................................9
4.6 CLEANING OF INSTRUMENTS.........................................................................................................9
4.7 VISUAL INSPECTION OF EQUIPMENT / INSTRUMENTS:................................................................10
4.8 FUNCTIONAL INSPECTIONS:..........................................................................................................10
4.9 PACKING OF MATERIALS FOR STERILIZATION:..............................................................................11
4.10 STEAM STERILIZATION:.................................................................................................................12
4.11 CONTROLS FOR THE STEAM STERILIZATION PROCESS:.................................................................13
1.1 Equipment Control...........................................................................................................................13
2.1 Exposure Control:.............................................................................................................................13
3.1 Pack Control:....................................................................................................................................13
4.1 Record Keeping Control:...................................................................................................................13
4.12 PROTOCOL FOR REPROCESSING OF SINGLE USED DEVICE...........................................................16
4.13 PRECAUTIONS, IF ANY:.................................................................................................................16

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5 NABH STANDARDS & MEASURES APPLICABLE TO THE DEPARTMENT:....................................................17

1 QUALITY MONITORING:...........................................................................................................................17
1 MANAGEMENT OF INFORMATION:..........................................................................................................18
1 COORDINATION WITH OTHER DEPARTMENTS.........................................................................................19
6 SAFETY MEASURES FOR CSSD...................................................................................................................20
6.1 HEALTH HAZARD- AVOID BODY CONTACT AND INHALATION.......................................................20
1.1 FIRE AND REACTIVITY HAZARD- DANGER! HIGHLY FLAMMABLE VIOLENTLY REACTIVE...............20
1.2 SPILLS & LEAKS HAZARD: GREAT DANGER OF FIRE AND EXPLOSION............................................20
Inhalation:....................................................................................................................................................21
1.3 STORAGE AND HANDLING............................................................................................................21
6.2 SPILLAGE.......................................................................................................................................22
6.3 DISPOSAL......................................................................................................................................22
6.4 PROTOCOLS FOR ENTRY IN THE STERILE STORAGE AREA.............................................................22
6.5 PROTOCOLS TO MAINTAIN THE STERILE AREA.............................................................................23
6.6 PROTOCOLS FOR CARBOLIZATION OF THE SURFACES..................................................................23
7 PROTOCOL FOR CSSD RECALL OF INSTRUMENTS IN CASE OF FAILURE OF BIOLOGICAL INDICATOR:......23
7.1 MOCK RECALL OF CSSD INSTRUMENTS........................................................................................24
8 PROTOCOL TO MAINTAIN STERILE AREA..................................................................................................24
9 ANNEXURE-I- OPERATING INSTRUCTION FOR ULTRASONIC CLEANER.....................................................24
10 ANNEXURE-II- PROCEDURE FOR MANUAL WASHING...........................................................................25
11 ANNEXURE-IV- SEQUENTIAL STEPS OF ENVELOPE FOLD WRAPPING TECHNIQUE.................................26
12 ANNEXURE-V- OPERATING INSTRUCTION FOR STEAM STERILIZER......................................................27
13 ANNEXURE VI- OPERATING INSTRUCTION FOR GAS (ETO) STERILIZER.................................................27
14 ANNEXURE VII- INSTRUCTIONS FOR CSSD PERSONNEL RECEIVING USED INSTRUMENTS...............28
15 ANNEXURE VIII – INSTRUCTIONS FOR CSSD PEROSNNEL WHILE WASHING INTRUMENTS...................28
16 ANNEXURE VIII- INCIDENT REPORTING................................................................................................29
1. Purpose................................................................................................................................................29
2. Scope....................................................................................................................................................29
3. Definitions............................................................................................................................................29

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4. Responsibility.......................................................................................................................................30
5. Description...........................................................................................................................................30
17 SHELF TIME FOR PACKING INSTRUMENTS:...........................................................................................31
1 CSSD RECALL REQUEST (FORMAT)...........................................................................................................31

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1 INTRODUCTION:

Central Sterile Supply Department provides sterilized materials to the Operation

Theaters, ICU s, Wards, and other areas of the hospital. In CSSD safe sterilization
is conducted under controlled conditions thus contributing to reduction in the
incidence of Hospital Infections. It plays an important role in the Implementation
of the plan of Hospital Infection Control Committee on Prevention & Control of
Infection.

CSSD located at the ground floor has access to the OT Complex for sterile
material. Other areas are served through the ramps. It sterilizes instruments for
various procedures, clean ups, tubing’s, linen, etc. in Steam as well as ETO
sterilizers.

1.1 RANGE OF ACTIVITIES INCLUDES:

 Transportation and receiving of un-sterile items from OT’s and other units.

 Receipt of non-sterile items.

 Cleaning.

 Drying

 Visual inspection of equipment's / instruments.

 Functional inspection.

 Packing of material for sterilization.

 Sterilization of the items.

 Storage of packs & items.

 Machine maintenance.

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2 QUALITY OBJECTIVES
 100 % sterilization of material supplied from the CSSD.

 Zero delay in the supply of the material to various department

 First-in First–out (FIFO) supply always maintained.

 Quality of the sterilization monitored regularly and documented.

3 JOB RESPONSIBILITIES:

3.1 JOB TITLE – CSSD IN-CHARGE

JOB SPECIFICATION

Qualification: BSC in Microbiology or any other equivalent graduate or

Diploma in CSSD or GNM or Nursing Degree.

Experience: Min. of 5 years of

experience in relevant field Skills:

Leadership skills, analytical skills,

computer skills JOB DESCRIPTION

 Supervises the overall activities of the department.

 Periodically inspect the processes.

 Responsible for training of technicians in all the sterilization activities

 CSSD In-Charge is authorized to approve the sterilization and issue of

sterilized materials/ instruments.
3.2 JOB TITLE – CSSD TECHNICIAN

JOB SPECIFICATION

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Qualification: Diploma in CSSD or GNM or Nursing Degree.

Experience: 0-1 year of

relevant Experience Skills:

Ability to learn & Aptitude

for Learning JOB

DESCRIPTION:

 Transport and receive unsterile items from the OT’s and other units to the CSSD
department.

 Responsible for receipt of non-sterile items and cleaning of the same.

 Involved in preliminary investigation of the equipment's / instruments

and recording the same in the register.

 Washing and cleaning the materials

 Packing the materials and loading for sterilization

 Issuing the materials for all the departments

4 STANDARD OPERATING PROCEDURES:

4.1 INSTRUMENTS/ MATERIALS AVAILABLE:

 Machine Fabric steam sterilizer- 840 L-1No

 Machine Fabric steam sterilizer- 640 L-1No

 P C I ETO sterilizer -08CF-225 L-1Nos

 Ultra-Sonic Cleaner – 120 L – 1 Nos

 Ultra-Sonic Cleaner - 100 L - 1 Nos

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 Hand Sealer – 1 Nos

 Automated Sealer – 2 No.

 Flash sterilizer- 2 No.

4.2 RECEIVING OF UNSTERILE ITEMS FROM THE OPERATION THEATERS:

 Receive the unsterile instruments in covered trolleys from Operation theaters.
 Procedure sets will be received only after the user has given a pre-wash
& Disinfection to the instruments immediately after use.
 The user will discard used consumables immediately after use.
 All the instruments will be checked for any blood or soil at the receipt
counter by the CSSD personnel.
 Number of instruments in the pack will be counted while receiving the set
according to the standard list available at the counter.
 In case of any missing instruments, the set will not be received till the loss
is confirmed by the concerned authority (OT in charge / In charge CSSD)
 Transport the unsterile items in covered trolleys to avoid accidental
spilling and reduce possibility of injury to transporting and receiving
personnel.
 Document the details of unsterile materials received from the user units in
the CSSD receiving Book. This will include the date and time of receipt,
description of the unsterile materials, number of instruments in each set
and the signature.
 Sets will be handed over for decontamination.

4.3 RECEIVING OF UNSTERILE ITEMS FROM OTHER UNITS:

 Receive the unsterile instruments in covered trolleys from ICUs, wards and other
departments.
 Transport the unsterile supplies from the various patient care and
diagnostic units once in a day from 8am -10am.
 Procedure sets will be received only after the user has given a pre-wash
& Disinfection to the instruments immediately after use.
 The user will discard used consumables immediately after use.
 All the instruments will be checked for any blood or soil at the receipt

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counter by the CSSD personnel and will be handed over for ultrasonic
cleaning.
 Number of instruments in the pack will be counted while receiving
the set according to the standard list available at the counter.
 In case of any missing instruments, the set will not be received till the
loss is confirmed by the concerned authority (Nursing in charge / In
charge CSSD)
 Sets will be handed over for decontamination.
 Transport the unsterile items in covered trolleys to avoid accidental
spilling and reduce possibility of injury to transporting and receiving
personnel.
 Document the details of unsterile materials received from the user units in
the CSSD receiving Book. This will include the date and time of receipt,
description of the unsterile materials, number of instruments in each set
and the signature of technician receiving and staff issuing the unsterile
items.

4.4 RECEIVING OF UNSTERILE ITEMS FROM CATH LAB

 Instruments and reusable medical devices meant for sterilization will be
received from OT duly packed and sealed through the CSSD trolley.
 Packs will be checked for following information:
 Name and contents of the pack.
 Total number of instruments
 Mode of sterilization required.
 When required for use.
 Check that all the devices for ETO sterilization should be packed in medical grade
paper.
 Check whether the packing is sealed at both the ends properly and is not torn from
anywhere.
 In case not packed properly, repack the item.
 Items requiring steam sterilization will be packed in linen wrapper or medical grade
paper.
 In case linen is used as packing material, check whether double wrapping
has been done. If not, then double wrap it.
 Segregate the items requiring steam sterilization and those requiring ETO
sterilization.

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 Before sterilization, packs will be labeled for following information:

 Date & time of sterilization.
 Date of expiry
 Signatures of the packer
 Hand over the packs for sterilization

4.5 RECEIPT OF UNSTERILE ITEMS:

 CSSD personnel will receive the non-sterile materials and record the details
in the CSSD
Receiving Book with the countersign of the staff giving the materials.

 Examine the non-sterile items received and record if any items are missing
from the pack/trays or if any of the items are damaged.
 Wear aprons, gowns and thick gloves while receiving and moving the non-
sterile items to avoid possible injury and body contact with the soils like
blood, body fluids and other infected materials.

4.6 CLEANING OF INSTRUMENTS

 Quick Cleaning after Use: Cleaning of the instruments as soon as possible

after the use is done at the user level. This is to reduce organic soils such
as blood, tissues, etc. from adhering to the instrument surfaces too
strongly making their removal difficult.
 Initial Cleaning: The initial cleaning of all instruments will be done using
the ultrasound cleaner. The ultrasound cleaning machines must be
operated as per the Operating Instructions for Ultrasonic Cleaner (Refer
Annexure -I). The ultrasound bath will be prepared by adding the cleaning
agent as per the Instruction for Preparation of Ultrasonic Cleaning. (Refer
Annexure -I).
 Sorting of Instruments for Manual and Machine Cleaning: Remove the
disposable materials from the trays if not already removed at the user
end. Segregate the instruments that cannot be machine-washed from the
ones that has to be manual wash.
 Machine Cleaning: Machine cleaning is done on a daily basis.
 Manual Cleaning: Do the manual cleaning of the instruments using
cleaning aids like brushes (internal and external), sponges, towels, spray

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guns, hand showers and instrument flushers.

 Verification of Cleaning and Drying: Inspect all the instruments for dryness
and accuracy of cleanliness. Pay Special attention to areas like lumens,
pivots and serrations.

4.7 VISUAL INSPECTION OF EQUIPMENT / INSTRUMENTS:

 Check that the instruments reaching the processing table after cleaning
are macroscopically clean. They should be free from visible protein residue
and other soils. Sort out the worn, damaged or porous instruments, since
they no longer can be considered to be in good working condition.
 Separate the corroded instruments immediately to prevent contact
corrosion with other instruments.
 Inspect the delicate and easy to damage instruments carefully. Use aids
like magnifying glasses where necessary.
 Inspect the instruments with teething carefully and if necessary subject
them to further cleaning and disinfection.
 Inspect the instruments for staining and discolorations. The reasons for
staining and discolorations may be insufficient cleaning, residues of
cleaning, disinfecting or rare agents, poor water quality, water soluble
residues like washing agents, residues from medications, contrast media.
 Investigate the cause of persistent staining and discoloration if any and
undertake corrective measures at the earliest.
 Seropositive instruments are cleaned and sterilized as separate batch.

4.8 FUNCTIONAL INSPECTIONS:

 Device functional tests for each type of instrument and equipment since
each surgical instrument are designed for a specific purpose.
 Allow the surgical instruments with movable parts to cool down before
their functional inspection to avoid metal friction, which may lead to
corrosion.
 Lubricate the hinged and threaded instrument before functional inspection.
 Replace the worn parts and defective components of the equipment before steam
sterilization.

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4.9 PACKING OF MATERIALS FOR STERILIZATION:

 Check all the instruments for proper cleaning. There should be no residues
of blood, tissues or soil.
 In case not cleaned properly, send the instruments back to the
decontamination area for another cycle of decontamination.
 Check whether the instruments are 100% dry. If not, dry them with a clean sponge.
 Count the number of the instruments according to the standard list.
 Check the instruments for their functionality (sharpness, movement etc.) or any
other defects.
 Replace the instruments in case not working properly.
 Place Class V Indicator inside the sets in OT instruments.
 Put chemical indicator along with the signatures of the packer inside the packs.
 Ink side of the chemical indicator should not come in contact with the instruments.
 Arrange the instruments and consumables in the tray according to the standard list.
 Hand over the set for sterilization.
 Wrapping Techniques for Packaging using sheets: Develop the wrapping
techniques for trays and sets with a view to ensure opening of the same.
Use the two wrapping techniques: envelope fold for packing of trays and
sets. Refer the Step wise Instructions for Envelope Fold Wrapping (Refer
Annexure -IV).
 Sterilizer operator will put the chemical indicator label over the pack.
 Following information will be written over the chemical indicator:
 Sterilizer name
 Batch or cycle number
 Date of sterilization
 Expiry date of the pack
 Signatures of the sterilizer operator.
 General Guidelines for Packaging: Inspect the reusable materials that have
to be re- sterilized (expiry date of pack, damaged, improper packing) to
check if it is cleaned and repacked. Recondition the textile. Consider the
content of a pack, which was opened, by mistake as non- sterile. Make it
evident that only removing or damaging the packaging material can open
the pack. Inspect the contents of such packs whether properly cleaned and
repacked and sterilized.

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4.10 STEAM STERILIZATION:

 Operate the steam sterilizers as per the Operating Instructions for
Steam Sterilizers
 The physical and time parameters set for the process of steam
Sterilization is 134 0 C at 30 lb for 10 minutes.
 The entire cycle takes around 1hr 10 minutes.
 The physical and time parameters set for the process of steam
Sterilization is 121 0 C at 30 lb for 20 minutes.
 The entire cycle takes around 1hr 30 minutes.
 Log the Steam Sterilization with time of starting the cycle, number
of loads, and the packs sterilized in the load and technician
performing Sterilization, in the Steam Cycle Logbook.
 Linen and instrument packs will preferably be loaded and sterilized separately.
 In case, instrument packs and linen packs are required to be sterilized in
the same sterilizer at the same time, then place instrument packs on the
bottom shelf and linen packs up.
 In the loading car, place linen packs in vertical position, on edges rather
than the flat side up to permit steam to pass from the top of the
chamber through multiple folds in the packs towards bottom.
 Place instrument packs flat on the loading car shelf.
 Arrange the packs in loose contact with each other so that the steam can
easily pass through every corner of the load. There should be a gap of
minimum 3 inches between the packs and the chamber walls.
 Do not allow wrapped instrument packs to come in contact with the chamber
ceiling.
 Do not place the packs on the floor of the sterilizer chamber.
 Place the loading car on the trolley.
 Transfer the loading car into the sterilizer chamber.
 Lock the door of the sterilizer.
 Start the cycle.
 After the completion of the sterilization cycle, open the door of the sterilizer in the
sterile area.
 Wear gloves for safety and to avoid cross contamination.
 Unload the sterilizer only when steam has escaped from the chamber
and sterilized packs have undergone initial cooling.

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 Visually check the outside wrappers for dryness. Reject the packs
in case there are water droplets or visible moisture on the exterior
of the pack.
 To prevent entry of moisture and micro-organisms into the packs, do
not handle sterilized items before they are entirely cool.
 Do not place the sterilized items during cooling on cold metal surfaces as
moisture will condense onto the items and contaminate them.
 Sterile load to be kept on wire mesh racks till it cools down.

4.11 CONTROLS FOR THE STEAM STERILIZATION PROCESS:

1.1 Equipment Control
 Ensure the equipment control through the physical monitoring process.
 Verify from the sterilization printout that the cycle parameters are met.
 The verifying person will identify and sign the printout and staple it to the
Steam Sterilizer Load Record (Machine printouts stored for 3 months).
2.1 Exposure Control:
 Ensure exposure control through the use of chemical indicators.

3.1 Pack Control:

 Ensure the pack control through the placement of a multi parameter
chemical indicator capable of verifying critical parameters of steam
sterilization (temperature, pressure and time).
4.1 Record Keeping Control:
 Ensure the Record-keeping control through documentation of the steam
sterilization process including lot control numbers on the product, expiry
date statements and load records for steam sterilization.

5 6.13 CONTROLS FOR THE ETHYLENE STERILIZATION PROCESS:

6 Equipment Control: • Ensure the equipment control through the physical
monitoring process. • Verify from the sterilization printout that the cycle
parameters are met. • The verifying person must identify and sign the printout and
staple it to the ETO Sterilizer Load Record.
7 Exposure Control: • Ensure the exposure control through the use of a chemical
indicator.

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8 Pack Control: • Ensure the pack control through the placement of a multi-
parameter chemical indicator capable of verifying critical parameters of ethylene
oxide sterilization (temperature, pressure, humidity, and time).
9 Load Control: • Load control ensures an entire load is monitored and released
based on the results of a Biological Indicator in an appropriate test pack. • Place the
Biological Indicator in a test pack that creates a challenge to the Ethylene Oxide
sterilization process.
10 Record Keeping Control: • Ensure the record-keeping control through
documentation of the Ethylene Oxide sterilization process including lot control
numbers on the product, expiry date statements, and load records for ethylene
oxide sterilization.
11

12 6.14 CONTROL FOR FLASH STERILIZER PROCESS: • Switch on the main power. •
Open the condensate valve and drain the condensate. • Fill the water in level and
switch on the sterilizer. • Open the door and load the chamber. • Close the door. •
Start the cycle. • Total cycle finishing time is 45 minutes (10 min preconditioning,
10 min sterilization, 25 min drying). • After the cycle is complete, unload the
sterilizer. • Issue the things with taking MRD number and entry in record.
13

14 6.15 STERILE SUPPLIES STORE: • The Sterile Supplies Store is in the clean zone of
the CSSD near the OT to ensure the unidirectional flow of the sterile packs. • Sterile
supplies stores are provided with adequate racks and storage bins to ensure the
proper storage of the sterile packs. • Sterile supplies store is provided with
temperature and humidity gauges and adequate fire extinguishers.
15

16 6.16 STORAGE OF PACKS AND ITEMS: • Store the sterile packs and trays in an
organized, uncluttered manner ensuring the integrity of the packs and trays. •
Organize the storage areas/bins/racks and label according to the type of
packs/trays. • Store the sterile packs of flexible items like catheters and guide wires
in a manner preventing damage to their shape and flexibility. • Store all the items
in a manner facilitating the use of the First In First Out (FIFO) stock issue principle. •
Do not store the sterile pack/trays on the floor or in close contact with the walls of
the storage area. • Inspect and document the sterile storage area weekly for the
removal of damaged and expired packs/trays.
17

18 6.17 MACHINE MAINTENANCE:

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19 Routine Maintenance: • Perform routine maintenance and daily inspections of

ultrasound cleaners and steam sterilizers per the manufacturer’s
recommendations.
20 Preventive Maintenance: • Perform periodic preventive maintenance of the
machines according to the manufacturer’s instructions, and record activities in the
machine history.
21 Calibration: • Calibrate the pressure gauge, temperature gauge, and timer of the
sterilizers once a year and maintain the documents.
22 Controls for Machines: • Ultrasound Cleaning Machine: Check the performance of
the ultrasound machine using a cleaning indicator every cycle. • Test the steam
sterilizers daily for steam penetration and vacuum using the Bowie-Dick Test.
Record the results. If unsatisfactory, inform management and withdraw the
sterilizer from service.
23

24 6.18 QUALITY CONTROL FOR STERILIZATION PROCESS:

25 Electronic Controls: • Monitor each sterilization cycle closely for satisfactory
conditions. Verify the system parameters for each cycle from the printouts. •
Document the details of each sterilization cycle/load in the Steam Sterilizer
Logbook.
26 Chemical Indicators: • Use multi-parameter chemical indicators for validation of
each steam sterilization cycle. Place the test pack for each cycle in the area least
favorable to sterilization. The cycle load will not be approved unless satisfactory
color change is achieved. • Tag each pack with a chemical indicator at the primary
packing level to verify adequate steam penetration. Inspect the indicator for color
change at the time of pack opening. If inadequate, return the pack to CSSD.
Maintain a record of all rejected packs.
27

28 6.19 PROTOCOL FOR RECALLING STERILIZED ITEMS: • Once the sterilization cycle is
completed, CSSD personnel check the PCD, which is placed with the load. Once the
PCD passes, the load is transferred to the sterile area and the end user. If the PCD
fails, all the loaded materials are re-sterilized, and the delay is communicated to
the end user. • If the end user finds that the indicator inside the pack does not
show evidence of sterilization, they must inform CSSD immediately. CSSD In Charge
will check all sets sterilized in the same load. The sets where the indicator hasn’t
changed will be sterilized again. • If validation test results show improper
sterilization, all distributed sets must be recalled by CSSD and re-sterilized.
29

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30 6.20 PROTOCOL FOR STORAGE AND DISPATCH OF STERILE ITEMS IN CSSD: • After
sterilization, the loads are shifted to the designated sterile area for storage and
dispatch. • Loads are stored in racks based on the sterilization date. • Sterile
instrument and linen packs are distributed through the issue counter located in the
sterile area of CSSD. • The sterile area is cleaned twice a day, and the document is
kept at the entrance of the sterile area. • Loads are stored for up to 15 days for
machine fabric steam sterilized items and 6 months for ETO sterilized items. • The
user department is responsible for transporting sterile goods. • Instrument packs
are issued on an exchange basis. • Linen packs are issued on a requisition basis. •
Sterile packs are issued once a day from 3 pm to 5 pm. • Requests for sterile packs
are received through the phone.
31 The following information is received from the nursing in charge: • Name of the
packs • Quantity of packs required • When required for use
32 The following is checked before dispatching packs to OT: • Name and quantity of
packs • Date and time of sterilization • Expiry date of the pack (expired packs are
sent for reprocessing) • Chemical indicator in place (color change from white to
black)

4.12 PROTOCOL FOR REPROCESSING OF SINGLE USED DEVICE

List of Single Use Devices (SUD) which are re-used in NK, Mysore.

Formulated separately as Reprocessing of Single Use Devices

4.13 PRECAUTIONS, IF ANY:

 Test and document the performance of the ultrasound cleaner on a
weekly basis as per the operating instructions.
 While sorting out the instruments for manual and automated cleaning,
wear protective gear of apron, gown Safety face shield and gloves which
are a must.
 Open all hinged instruments while rinse & placing in the ultrasound cleaner.
 Do not overload trays of the ultrasound cleaner.
 Do not pour the instruments from one tray to another, but rather keep
them one by one to prevent damage to delicate instruments.
 Never store flawless surgical instruments with those defective instruments.

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5 NABH STANDARDS & MEASURES APPLICABLE TO THE DEPARTMENT:

Standard Measures taken by the Department

Std No

HIC.7 There are documented procedures There is an established CSSD on the ground floor
for sterilization activities in the to cater to the sterilization needs of the hospital.
organization.
Regular validation tests for sterilization are
carried out as mentioned in the departmental
manual.

The department takes all measures to avoid

recall of sterilized items.

1 QUALITY MONITORING:
Quality monitoring is done through various validation tests such as using
chemical indicators and other controls). The other validation tests conducted
include:

Test Interval/ Periodicity

Bowie Dick Test Daily

Biological Indicator Control for Validation Weekly

PCD Control Test Each Load

Class V Indicator (OT Steam Thinks) Each Set

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Class 1V Indicator (OT ETO Thinks) Each Pack

1 MANAGEMENT OF INFORMATION:

REGISTERS:

SL. Retention
Title Record Number
No. Period

CSSD Receiving & Issue Register

01 OT Un sterile Receiving REG/NK/CSSD/01 6 month

02 OT Sterile Issuing Register REG/NK/CSSD/02 6 month
03 ICU & Ward Un sterile Receiving REG/NK/CSSD/03 6 month
04 ICU &Ward sterile Issuing Register REG/NK/CSSD/04 6 month

Other Register

05 Steam Sterilization Register REG/NK/CSSD/05 6 month

06 ETO sterilization REG/NK/CSSD/06 6 month
07 Recall Register REG/NK/CSSD/07 6 month
08 Flash sterilization Register REG/NK/CSSD/08 6 month
09 Break down Register REG/NK/CSSD/09 6 month
10 Broken Instruments Register REG/NK/CSSD/10 6 month
11 Washing Register REG/NK/CSSD/11 6 month
12 SUD Discard Register REG/NK/CSSD/12 6 month
13 Department meeting minutes REG/NK/CSSD/13 6 month
14 Shift Hand Over register REG/NK/CSSD/13 6 month

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1 COORDINATION WITH OTHER DEPARTMENTS

OPERATION THEATRES ICUs

CENTRAL STERILE
WARDS & EMERGENCY
SUPPLY
DIALYSIS
DEPARTMENT
DEPARTMENT

OUT PATIENT DEPARTMENT MICROBIOLOGY

DEPARTMENT

6 SAFETY MEASURES FOR CSSD

Ethylene oxide
 Identity-
 Abbreviations: EO, ETO
 Common Name: Ethylene Oxide
 Chemical Formula: C2H4O
6.1 HEALTH HAZARD- AVOID BODY CONTACT AND INHALATION
 Liquid and vapor cause irritation and burns.
 Causes cancer.
 Liquid can be absorbed through the skin and can damage internal organs.
 Do not depend upon your sense of smell for warning. If you smell EO you are

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overexposed.
 Leave the area at once
 Inform your supervisor immediately.

1.1 FIRE AND REACTIVITY HAZARD- DANGER! HIGHLY FLAMMABLE

VIOLENTLY REACTIVE
 Keep away from sparks, flames and heat.
 If the fire spreads, use alcohol foam type fire extinguisher.
 Be prepared for re-ignition.
 Shut off the supply if possible and safe to do so.

1.2 SPILLS & LEAKS HAZARD: GREAT DANGER OF FIRE AND EXPLOSION
 Eliminate sparks, flames and all sources of ignition.
 Shut off leaks if possible and safe to do so.
 In case, the area must be entered before high concentrations are reduced,
following protective clothing and equipment will be used.
 EO impermeable clothing provides complete body coverage to prevent skin contact.
 Splash proof safety goggles and face shield.
 Work shoes impermeable to EO. Leather shoes will not be used.
 Butyl rubber gloves will be used.
 An air supplied positive pressure, full-face piece with a respirator.

FIRST AID

Inhalation:

 Ventilate the area by increasing the local exhaust in order to decrease the
concentration of EO by dilution with air.
 Remove the victim to fresh air.
 Give him artificial respiration if he is not breathing.

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Skin Contact:

 Wash with plenty of water and soap.

 Remove contaminated clothing. Wrap the victim in a blanket to keep him warm.

IN ALL CASES RUSH FOR MEDICAL HELP

1.3 STORAGE AND HANDLING

 Ethylene oxide should be stored in a cool, well-labeled, well-ventilated,
fireproof area, preferably away from other chemicals and outdoors. The
storage area should be surrounded by a retaining wall or a sill.

 Keep away all sources of ignition and heat as well as incompatible

materials. Containers for ethylene oxide can be made of stainless steel,
aluminum, zinc, nickel, copper, Teflon, ceramics, or glass.
 Storage vessels should contain a positive pressure layer of inert nitrogen.
A pressure vessel check programme should be made.
 Storage pressure and temperature ranges are 240-410 kPa and 10 – 15 oC
respectively. When long storage times are anticipated, a lower
temperature range is recommended to minimize polymerization.
 Prolonged storage in small containers where there is a high surface to
volume ratio should be avoided, because the polymerization rate is
increased by the presence of any metal.
 Never use the EO cartridge under following conditions:
 EO cartridge is below normal weight.
 EO cartridge when handled is cold.
 Liquid EO is leaking from the cartridge.
 Never puncture or incinerate cartridges.
 Mixtures of ethylene oxide and water should not be left dormant for any

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length of time, and the temperature and pressure of vessels containing

these mixtures should be carefully monitored.

6.2 SPILLAGE
 Remove all ignition sources and evacuate the danger area. Provide
optimum ventilation which should be explosion-proof. Spilled liquid
should be washed away with water. Avoid run-off into drains or sewers
(explosion hazard). Ensure personal protection by use of self-contained
breathing apparatus and full protective clothing.
6.3 DISPOSAL
 Ethylene oxide cartridges are discarded in red bag for biomedical waste
treatment.

6.4 PROTOCOLS FOR ENTRY IN THE STERILE STORAGE AREA.

 Only the person on duty in sterile area will be authorized to enter the area.
 Wash your hands with soap and water.
 Change your clothes and wear the scrub suite.
 Change the slippers.
 Enter the clean area.
 Enter the corridor leading to the sterile area.
 Wear a sterile gown.
 Wear gloves, head cap and mask.
 Wear slippers before entry into the sterile area.
 Enter the sterile area.

6.5 PROTOCOLS TO MAINTAIN THE STERILE AREA

 Following temperature and humidity conditions will be maintained in the sterile
area.
 Temperature – 18°-22°C
 Relative Humidity – 30-70%
 The person on duty in the sterile area will check air pressure every morning.
 All the surfaces (storage racks, work counter, issue counter) will be carbolyzed
every morning.
 Only one glass door will be opened at a time for the issue of material.
 Person on duty in the sterile area will maintain the principle of minimum
movement and no talking.

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6.6 PROTOCOLS FOR CARBOLIZATION OF THE SURFACES

 The person on duty in the respective areas will be responsible for the carbolization
of that area.
 Prepare a 10% solution of carbolic acid in water.
 Use a clean sponge for wiping the surfaces with this solution.
 All the work surfaces will be carbolized every morning by the person on
duty in the respective areas.
 False ceiling, fittings, and fixtures in all the areas will be carbolized
once a week by the housekeeping personnel.
 All the outside surfaces of the sterilizers and trolleys will be carbolized every
morning.

7 PROTOCOL FOR CSSD RECALL OF INSTRUMENTS IN CASE OF FAILURE OF

BIOLOGICAL INDICATOR:
1. In case of failure of Biological Indicator, The Microbiologist shall inform the CSSD In-
charge.
2. The In-charge shall immediately inform the respective departments.
3. During the recall of instruments, In-charge shall check for the Batch
number of the instruments, which must be returned to the CSSD.
4. In case the instruments are already used for the patient, in charge shall
note down the patient details form the user department tracking register
and informed to infection control team to raise the Incident report.
5. The returned instruments from the user department shall be re-sterilized using
biological indicator.

7.1 MOCK RECALL OF CSSD INSTRUMENTS

 Mock recall shall be performed once in a month.

8 PROTOCOL TO MAINTAIN STERILE AREA

 Following temperature and Humidity conditions shall be maintained in the sterile
area:
 Temperature: 18°-22°C
 Relative Humidity: 30-70%
 The above details shall be checked thrice a day – Morning, afternoon & evening and
noted.

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 All surfaces (Storage racks, work counter, Issue counter) will be carbolized every
morning.
 Only one glass door of the issuing door shall be opened at a time for the issue of
the items.
 Person duty in the sterile area will maintain the principle of minimum movement \
and no talking.
 Daily cleaning shall be done twice a day (Morning & evening)
 Fumigation will be done once in a week (Saturday night)
 Culture swabs shall be taken from the area once in a month.

9 ANNEXURE-I- OPERATING INSTRUCTION FOR ULTRASONIC CLEANER

 Fill the ultra-sonic cleaner tank up to the saturation mark.

 Add 1000ml of multi-enzymatic cleaner solution.

 (Liquizme 400ml & Hydrogen Peroxide 600 ml)

 The dilution factor is 1:10

 Switch on the ultrasonic cleaner.

 Place all the prewashed instruments into the mesh tray.

 Place the washing Indicator to each load.

 Set the time and temperature.

 Parameters for pre-rinsed instruments.

o Temperature - 40-55 deg C
o Time - 15 minutes
 Press on/off once to activate ultrasonics. Do not stir.

 When the items are clean, press on/off once to deactivate the ultrasonics.

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 Check for color change of the indicator (Cleaning indicator: Green to white)

 Slowly remove the items from the cleaner.

 Take the instruments out of the tray.

 Rinse clean items with clean water.

 Dry the instruments with a clean sponge.

10 ANNEXURE-II- PROCEDURE FOR MANUAL WASHING

1. Manual cleaning will be done as a standby method in case of urgency.

2. Table with sink will be used for manual cleaning.

3. Water reservoir will be filled with 10 liters of water.

4. Temperature of the water will be maintained in the range of 50-65 deg C.

5. Prescribed amount of disinfectant will be added to the water. (e.g. to

prepare 10% solution of disinfectant Liquizme, add 100 ml in 10 liters of
water)

6. Disassemble or unlock all the instruments.

7. Immerse and soak the instrument tray in water for 20 minutes.

8. Immerse only one instrument tray at a time to avoid mixing of instruments.

9. Clean the instruments with clean non-abrasive nylon brush to prevent damage to
the instruments.

10. Devices with lumen or holes will be cleaned with the brushes of
appropriate diameter. (Brushes to be disinfected daily.)

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11. Cleaning will be done under water to prevent aerosolization.

12. Instruments will be rinsed with abundant amount of running tap water
to remove the traces of disinfectant.

13. Dry the instruments with a clean sponge.

14. Hand over the set for packing

11 ANNEXURE-IV- SEQUENTIAL STEPS OF ENVELOPE FOLD WRAPPING

TECHNIQUE

 Step 1: Spread the linen sheet on the table.

 Step 2: Place the items in the center of the sheet or wrapper

 Step 3: Fold the section nearest to you to the center and fold back point.

 Step 4: Fold the left section to the center and fold back point.

 Step 5: Fold the right section to the center and fold back point.

 Step 6: Fold the top section to the center and fold back point.

 Step 7: Repeat all the steps for the second layer of wrapping.

 Step 8: Secure the closure with adhesive tape.

12 ANNEXURE-V- OPERATING INSTRUCTION FOR STEAM STERILIZER

 Switch on the main power.

 Open the condensate valve and drain the condensate.

 Check the water level and switch on the sterilizer.

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 Check the steam pressure gauge, minimum pressure 30 psi.

 Open the door and load the chamber.

 Place the steam integrator chart or PCD.

 Close the door, wait for chamber pressure.

 Start the cycle.

 After the cycle complete, unload the sterilizer.

 Check the steam integrator chart or PCD to pass the load.

13 ANNEXURE VI- OPERATING INSTRUCTION FOR GAS (ETO) STERILIZER

 Switch on the main power.

 Open the compressed air line condensate valve and drain the condensate.

 Switch on the sterilizer.

 Insert the gas cartridge into the slot.

 Load the sterilizer and select the cycle temperature- Cool cycle (370C) or Warm
cycle (550C).

 Place the integrator and close the sterilizer door.

 Press the start button.

 Check the integrator and unload the sterilizer after the cycle complete

14 ANNEXURE VII- INSTRUCTIONS FOR CSSD PERSONNEL RECEIVING USED

INSTRUMENTS

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 All CSSD personnel receiving used instruments must wear appropriate

personal protective equipment (PPE) – Aprons and thick gloves to avoid
possible injury and body contact with the soils like blood, body fluids and
other infected materials.

 The instruments are to be received after checking the list accompanying the same.

 If any instruments are found to be damaged at the time of receipt, the

same is informed to the end users and mentioned in the instrument
condemn register.

 If any instruments get damaged during washing or processing in the CSSD,

the details are entered in the instrument condemn register, informed, and
returned to the end user.

 The instruments received by the CSSD personnel are to be processed

according to the washing instructions.

15 ANNEXURE VIII – INSTRUCTIONS FOR CSSD PEROSNNEL WHILE WASHING

INTRUMENTS

 All CSSD personnel washing instruments must wear appropriate personal

protective equipment (PPE) – Aprons, Glove, Mask, Face shield, Ear plug
and Gum boot.

 Instruments shall be unclamped, pre-washed and placed in Ultrasonic

vibrating machine for 15 minutes.
 After removing from Ultrasonic machine, instruments are again washed
manually suing brush and running tap water.

 Later air-dried using air gun and finally wiped with clean cloth if any water persists.

 Rusted instruments are washed using Surgi stain (Mild acid solution)

 For smooth lubrication of instruments, lubricating solution is used.

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16 ANNEXURE VIII- INCIDENT REPORTING

1. Purpose
This document gives guidance to be followed for investigating the
complaints and suggestions and instituting corrective & preventive
actions.

2. Scope
This procedure is defined and developed to implement the corrective and
preventive actions based on the complaints and suggestions. The
corrective & preventive actions are taken in terms of control of non-
conforming work, internal & external audits, management reviews,
feedback & complaints from the customer, etc.

3. Definitions
 Corrective Action: It is a reactive process for the correction of problems or
complaints.
 Preventive Action: It is pro-active process to identify opportunities
for improvement rather than a reaction to the problems or
complaints.

4. Responsibility
The HOD/CSSD In charge shall be responsible for overall monitoring and
supervising the corrective and preventive actions.

5. Description
a. Cause Analysis
 For any kind of non-conformance from the quality system,
the root cause analysis shall be conducted.

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 The cause analysis shall be done retrospectively by

analyzing the prevailing conditions and the actual process.
b. Selections and Implementation of Corrective Actions
 The HOD/CSSD In charge shall identify the non-conformities
for which corrective actions to be taken.
 The HOD/CSSD In charge shall identify potential corrective actions.
 The selection of the corrective action shall be done based on
the magnitude & risk of the problem and the efficiency to
eliminate the problem and to prevent recurrence.
c. Monitoring of Corrective Actions
 The HOD/CSSD In charge shall monitor that the corrective
actions are implemented and monitor the effectiveness of the
actions with respect to the results.

d. Preventive Action
 The non-conformance, which can be avoided by appropriate
preventive action, shall be identified. The action plan shall be
developed.
 The implementation of the action plan shall be monitored.
 The effectiveness of the preventive action shall be evaluated
by the effectiveness with respect to the result.

17 SHELF TIME FOR PACKING INSTRUMENTS:

Types of packing Shelf time

Wrapping sheet packing 15 days
Steri-pouch packet (Steam item) 1 month
Steri-pouch packet (ETO) 6 months

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1 CSSD RECALL REQUEST (FORMAT)

Subject: Protocol for recalling of

sterilized items Name of

Department: ..........................

In charge sign: ............................

Protocol for recalling of sterilized items.

Dear all user Department staff: Please re-send the autoclaved set, given
from the CSSD on.......the batch number

is ...........................................................................................

All sets of this batch must be re-sterilized because of the failure of the biological
indicator validation test result (color change to yellow) so all set must be re-
sterilized again.

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