CSSD
CSSD
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CENTRAL STERILE SUPPLY
DEPARTMENT
No. of Pages :
Date of Preparation 18/07/2024
Date of Implementation 25/07/2024
Approved By Name :
Dr.
Designation: Professor & HOD
Department of Anaesthesiology & Critical Care Signature:
Source
NABH guidelines
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INTRODUCTION
VISION
MISSION
QUALITY POLICY
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INTRODUCTION TO CSSD
OLMH is a multispecialty hospital located in Thanjavur with bed strength of 150 beds. The
Central Sterile and Supply Department (CSSD) forms the heart of the sterilization activities
carried out at our lady of health multispeciality hospital.
The CSSD provides and supplies sterile instruments, linen and other items used for operations
& sterile procedure.
It receives, Checks & Cleans the instruments & maintain inventory.
CSSD Monitors and ensures sterility necessary to prevent cross infection control policy.
It maintains record of all cycles & their sterility indicators daily.
LOCATION
We have good CSSD set up
CSSD is situating on the basement .
Receiving area
Instruments cleaning area
Assemble and packing area
Working area
Sterile storage area
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SCOPE
1. CSSD receives the instruments & linen which is required for the operation
theater & from various wards of hospital.
2. Cleaning is done with the prescribed solution before packing.
3. After cleaning the instruments, they are inspected for the good working
condition of the instruments before packing in the tray.
4. Instruments are assembled in trays according to the procedure set.
5. Packing of sets is done in double wrap as per the procedures.
6. Sterilization is done according to the procedure either autoclaving or ETO
sterilization.
7. Storage of sterile sets is done in a sterile storage room. The temperature of
sterile storage maintained & monitored periodically.
8. The respective trays are supplied to the respective departments on request.
RESOURCE AVAILABLE
MAN POWER
CSSD
CSSD supervisor 1
Technicians 1
EQUIPMENTS
CSSD
Steam sterilizer with Double door system 01
Ultrasonic Cleaner 01
Instruments Dryer 01
Ethylene oxide machine 01
Sealing machine (rolling) 01
Water gun & air gun 01
Assembling tables 02
Racks 04
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QUALITY OBJECTIVE
JOB DESCRIPTION
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CSSD TECHNICIANS:
JOB DESCRIPTION:
Keep records of all material receiving for sterilization from OT and Other Dept.
Sterilized instruments packs, linen, OT dresses etc issuing to OT and other Dept.
Keep Record of all material returned & issued.
Provide sterile packs on time to all surgeries.
Receiving and packing of instruments.
Ensure supply of sterile packs to OT, wards and other departments as per their
requirement.
Supervise cleaning of instruments.
Packing the instruments as per checklist.
Ensure and monitor that minimum stock is always maintained.
Monitor the condition of the instrument regularly and maintain it.
Help the CSSD supervisor in stock taking and any other job as per requirements.
Check all instruments meticulously before packing.
Ensure sterility indicators before loading the pack.
Ensure Bowie Dick’s test every day before the beginning of cycle, Time Steam
temperature (TST) for every load, Biological Indicators (BI) test once a week for steam
autoclave, and during each load for Ethylene Oxide sterilizer.
He should be trained for operating the autoclaved machine, ETO machine, Ultrasonic
cleaner & dryer.
Maintain all records & documents in prescribed registers & forms.
Ensure the CSSD area is always clean and daily surface cleaning is done as per protocol.
Maintenance of autoclave machine as per portal prescribed by the company.
Proper handing over and taking over after each shift.
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INDEX
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SOP 1 - CSSD FUNCTION AND LAYOUT
In order to meet the requirements of quality Health Care, Central Sterile Supply Department
(CSSD) has been set up to provide sterile goods to entire hospital.
This manual defines the Protocols, Standard Operating Procedures (SOP) and Quality system policies
for CSSD developed in conformance with the National and International CSSD Guidelines and the
CDC Guidelines for Prevention of Hospital Acquired Infections
OBJECTIVES OF CSSD
1. The CSSD provides support to all patient care services and responsible for :
a. Collection.
b. Decontamination.
c. Disinfection.
d. Inspection.
e. Assembly
f. Packaging.
g. Sterilization.
h. Storage.
6. Communicate with the end users to improve the quality of the service.
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8. Specifying criterion for quality control of all items produced by CSSD’s
9. Providing job training program, refreshment courses and continuous updating of
technical staff progress to increase awareness of technical staff about Quality
Systems.
10. Quality Manual, Quality Procedures and Quality Control Records are prepared
and implemented.
II- LAYOUT
1. The department is designed so that it is physically separated from all other work areas.
2. The department is designed to facilitate a unidirectional flow from the ‘dirty’ area to the
‘clean’ area.
3. There is a changing area for workers including toilet facilities and lockers in proximity to the
decontamination area.
4. Access to the wash room and to the clean room is through dedicated passage provided with
hand hygiene facilities.
5. All rooms in the department are mechanically ventilated and controlled to provide a
comfortable working environment.
6. Staff movement between dirty and clean areas is not possible without passing through a
clothing change and wash-up area.
7. Storage facilities for bulk items is provided external to the clean room and the wash room.
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SOP 2 - CSSD HEALTH AND SAFETY
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SOP 3 - CLEANING AND DISINFECTION IN COVID 19 PANDEMIC
Corona virus disease 2019 (COVID-19) is an infectious disease caused by severe acute
respiratory syndrome corona virus 2 (SARS-CoV-2). The disease was first identified in December
2019 in Wuhan, the capital of China's Hubei province, as an outbreak of pneumonia of unknown
cause. The outbreak was declared public health emergency of international concern on 30 January
2020. It spread globally; involving many countries resulted in the ongoing 2019 - 20 corona virus
pandemic.
Healthcare personnel (HCP) are on the front lines for caring patients with confirmed or possible
infection with Corona virus disease 2019 (COVID-19) and therefore have an increased risk of
exposure to this virus. HCPs can minimize their risk of exposure when caring confirmed or possible
COVID-19 patients by following these guidelines.
PREVENTION
Cough or sneeze by covering your mouth and nose with tissues or into your upper sleeve or elbow,
not your hand
Wash your hands with soap and water often (for at least 20 seconds).
Don’t touch your eyes, nose or mouth if your hands are not clean.
Avoid personal contact, such as kissing, sharing cups or food with sick people.
Clean and disinfect frequently touched surfaces and objects, such as doorknobs.
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HAND HYGIENE
Hands are the most important vehicle of transmission of infection. So Hand hygiene is the most
important measure for the prevention and control of COVID19.
Use alcohol based hand rub, if hands are not visibly soiled (duration 20-30sec.).
Use soap and water, if hands are visibly soiled (duration 40-60sec), before having food and after
using wash room.
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SOCIAL DISTANCING
Keep in touch with friends and relatives using phone, internet, and social media.
Cover your mouth and nose with a tissue when coughing or sneezing;
Use the nearest waste receptacle to dispose of the tissue after use;
Perform hand hygiene (e.g., hand washing with soap and water or alcohol-based hand rub) after
having contact with respiratory secretions and contaminated objects/materials.
Healthcare facilities should ensure the availability of materials for adhering to Respiratory
Hygiene/Cough Etiquette in waiting areas for patients and visitors.
Provide conveniently located dispensers of alcohol-based hand rub. Where sinks are available,
ensure that supplies for hand washing (i.e., soap, disposable towels) are consistently available.
PPE should be used based on the risk of exposure; will vary according to the setting and type of
personnel and activity. The overuse/misuse of PPE will have a further impact on supply shortages. All
staff should be trained for proper use of PPE.
• Before putting on a mask, clean hands with alcohol-based hand rub or soap and water.
• Unfold the pleats; make sure that they are facing down.
• Place over nose, mouth and chin. Fit flexible nose piece over nose bridge.
• Secure with tie strings (upper string to be tied on top of head above the ears and lower string at the
back of the neck.)
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• Ensure there are no gaps on either side of the mask, adjust to fit.
• Avoid touching the mask while using it; if you do, clean your hands with alcohol based hand rub or
soap and water.
• Do not let the mask hanging from the neck.
• Change the mask after six hours or as soon as they become wet. Replace the mask with a new one as
soon as it is damp
• Disposable masks are never to be reused
• To remove the mask: remove it from behind (do not touch the front of mask); While removing the
mask, great care must be taken not to touch the potentially infected outer surface of the mask. To
remove mask, first untie the string below and then the string above and handle the mask using the
upper string.
• Disposal of used masks: Used mask should be considered as potentially infected medical waste.
Discard the mask in a closed bin immediately after use. Clean hands with alcohol-based hand rub or
soap and water.
Remember: Masks are effective only when used in combination with frequent hand hygiene with
alcohol based hand rub or soap and water. Also use and dispose mask properly.
Wash your hands thoroughly before putting on and taking off the respirator.
Inspect the mask for damage. If your respirator appears damaged, DO NOT USE IT. Replace it
with a new one.
Do not allow facial hair, hair, jewelry, clothing, or anything else to prevent proper placement or
come between your face and the mask.
Position the respirator in your hands with the nose piece at your fingertips.
Cup the respirator in your hand allowing the headbands to hang below your hand. Hold the
respirator under your chin with the nosepiece up.
The top strap (on single or double strap respirators) goes over and rests at the top back of your
head. The bottom strap is positioned around the neck and below the ears. Do not crisscross straps.
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Leak Test
Place both hands over the respirator, take a quick breath in to check whether the respirator seals
tightly to the face.
Place both hands completely over the respirator and exhale. If you feel leakage, there is not a proper
seal.
If air leaks around the nose, readjust the nosepiece as described. If air leaks at the mask edges, re-
adjust the straps along the sides of your head until a proper seal is achieved.
Articles – cap, face shield, gloves, PPE kit (n-95 mask, goggles, gloves, gown, shoe cover)
Mirror Donning
Two chairs /stool – one dirty chair and one clean chair
Extra gloves
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STEPS FOR DONNING AND DOFFING
Hydrate well
Avoid personal things like jewelry including wedding ring, watch, mobile phone, etc.
Range of motion to be checked prior and do show yourself to a buddy before moving to the patient
side.
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Special instructions before doffing
If you are not feeling well call for a buddy/assistant to help in doffing. Buddy must be in full PPE
Do fold the gown inside out while removing and put it in the yellow bucket itself
N-95 respirator to be removed outside the doffing room in a separate bucket closed with lid
We have covid OT and covid wards in designated area. CSSD is adjacent to covid operation
theatre on second floor of building No 2.
There are two covid operation theatres. one for obstetric surgical procedures, other for general
surgery/orthpedics/other surgical procedures for all age groups and one labour room for covid
positive or suspect delivery.
Instrument used for surgical procedure should be soaked in freshly prepared 1%sodium hypochlorite
solution for 30 min at source of use.
After thorough cleaning of instruments, it should be dried well before assembling and packing in
procedure trey.
Cleaning, assembling and packing of instruments should be done by technician wearing complete PPE
in designated area.
Prepared trey should be handed over by same technician to cssd technician who have wear
nonpermeable gown, goggle, N95 mask and double gloves.
Disposable sterile drapes should be used for covid procedure and it should be disposed in yellow bin
according to biomedical waste guidelines.
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LAUNDRY
Soiled linen from covid OT, wards and ICU should be disinfected in freshly prepared 1% bleach for a
minimum of 20 minutes at point of use in designated area and then it should be transported to
laundry through assigned lift and corridor with signage.It should be transported in tightly sealed and
labeled plastic bag through leakproof trolley label as ‘COVID -19- LAUNDRY’
Laundry helper after wearing PPE will receive linen and it should be washed and dried in covid
assign washing machine.
After drying and labeling linen should be dispatch to respective unit.
IN CSSD
CSSD also receive cleaned, assembled, and packed tracheostomy and CVP tray from covid ICU for
sterilization.
Material received from Covid OT and ICU will be handled by assign technician after wearing
impermeable gown, goggles, N95 mask and double gloves.
External chemical indicator and standard label should be applied before loading in sterilizer.
Separate cycle should be run.
After cycle completion and cooling of load it should be stored in assign rack or cupboard in sterile
storage zone prior dispatch.
Separate register should be maintained for the same.
Hand wash strategy and social distancing should be strictly followed from receiving zone to dispatch
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SOP 4 - CLEANING OF CSSD
1. The CSSD should be cleaned on a daily basis at the beginning and at the
end of each shift.
2. Cleaning equipment’s like dry and wet mob and buckets should be stored in a designated
area and should be used for CSSD only.
3. Cleaning of the department must be undertaken by CSSD staff with the assistance of helper.
4. Daily cleaning includes damp mopping floors, storage shelves, other work surfaces and
empty trash containers. High cleaning is performed as required.
5. CSSD staff is responsible for ensuring that all surfaces are cleaned in accordance with the
cleaning schedule.
6. All counter surfaces and floors should be disinfected daily with freshly prepared 1% sodium
hypo chloride solution.
7. Alcohol 9e.g. isopropyl 70% or ethyl alcohol 70 % should be used to wipe down surfaces
where the use of bleach is not suitable like e.g. metals .
8. The disinfectant should be freshly prepared on a daily basis and discarded at the end of the
workday.
9. Outer packaging should be removed from raw material before it enters the
assembly and packaging area to avoid environmental contamination.
10. Vacuuming the air vents and cleaning out the light fixtures should be performed at least
twice per year to prevent buildup of dust and lint.
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SOP 5 - WATER QUALITY
1. Water used for the cleaning of instruments should meet specific quality it should
not cause damage to instruments and equipment.
2. Water hardness is determined by the amount of calcium and magnesium ions
present. High levels of mineral content will result in surface staining and shorten
surgical instruments life span.
3. Chlorides are the most corrosive of water contaminants.
4. Water with high mineral content is unsuitable for the final rinsing of instruments due
to mineral deposits permanently damaging and shortening the life span of the item.
High mineral content may also interfere with the efficacy of the cleaning agents.
5. High mineral content is unsuitable for the final rinsing of instruments due to mineral
deposits permanently damaging and shortening the life span of the item. High
mineral content may also interfere with the efficacy of the cleaning agents.
IN OUR HOSPITAL TAP WATER USED FOR ALL PUPOSE IS SOFT IN NATURE.
Ph levels, water quality and chemical compatibility tests should be carried out and
recorded.
Staffs should inform to the supervisor and
biomedical engineering department if any residue left on instruments
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SOP 6 - COLLECTION OF SOILED /CONTAMINATED EQUIPMENT
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SOP 7- DEALING WITH KNOWN INFECTIOUS CASES
1. Consider every item collected and received to C.S.S.D is infectious either labeled or not.
(some pt. don’t inform / virus incubation period with no symptoms )
2. Ensure proper handling for instruments with complete P.P.E.
3. Manual wash should be avoided.
4. In our setup, infected instruments are soaked in 1% sodium hypo chloride solution for 30
minutes after use at source.
7. The specification of the washer disinfector includes self-disinfection cycle therefore no need to
run the washer twice.
8. Most viruses are killed in the temperature selected. No need to run the washer twice.
9. Report the instruments with detailed.
11. Disinfection of the transport container should be done using washer disinfector or trolley
washer if available (bottom shelf).
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SOP 8 - INSTRUMENT SEGREGATION AND LOADING THE TRAYS
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SOP 9 - CLEANING OF MEDICAL DEVICES
1. Identify the correct process for the items to be decontaminated according to manufacturer’s
instructions. (with immersion /without immersion)
2. Staff working in this area should always wear protective clothing in compliance with the
standard precautions dress.
3. Two dedicated deep sinks should be available with a dedicated drying surface.
4. Sinks and accessories should be cleaned at each water change. The sink should be used only
for washing instruments, not for hand washing or anything else.
5. When cleaning manually, a pre-rinse, wash, rinse and drying process should be followed.
6. Water and detergent should be measured according to manufacturers’ instructions to have
the correct chemical mixture.
7. If the water is visibly stained at any stage it should be replaced.
8. All devices being manually cleaned must be fully immersed in the washing water while being
scrubbed.
9. Special attention should be paid to the joints of any jointed instrument and meticulous
attention paid to the tips or crevices.
10. A clean soft brush or soft cloth should be used to clean the surfaces.
11. After decontamination, all devices should be visually inspected for soil,
damage and Functioning should be tested.
12. Items should be dried using a lint free cloth or the dryer.
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SOP 10 - ASSEMBLING OF TRAY
1. After decontamination, all clean items should be received into the packing area.
2. Any item that is rejected due to evidence of residual blood, body fluid, stains or water
should be returned through dispatch window.
3. Any item that is damaged or broken should be documented
4. Make sure that all work surfaces are clean and disinfected.
5. Cleanliness & functional test should be performed every
week. (Settle plate examination by microbiology department)
6. Trays should be perforated to allow penetration of the sterilizing agent and efficient
drying.
7. Instruments should be laid out according to the order on the check list.
8. The contents of instrument sets are usually decided by the surgical team.
9. Ideally chemical indicator should be place inside every instrument or dressing set. In
our set up we are placing the chemical indicator outside each covered pack and inside
the implant pack.
10. Ensure that the tray checklist is dated and signed by the packer and checked.
11. The weight of packs must be taken into consideration when assembling
trays. (Max.8 kilos)
12. Overloaded and heavy trays/sets may remain wet.
13. A tray liner (where indicated) is placed on the bottom of the tray.
14. Instruments should be checked visually for cleanliness, missing parts if any and
functional test (tips, screws, free movement, sharpness, and overall condition).
15. Instruments with ratchets or hinges should be hold in an open and unlocked position.
16. Instruments should be left slightly open to allow for sterilant penetration and rings
should be slightly separated.
17. Tips of instruments should be facing the same direction. The use of tip protectors is often
advised by the manufacturer.
18. Always make sure that all parts of the instruments are present.
19. Items (bowl/basins/receivers) that could hold water during steam sterilization are placed
in a way that allows easy drainage.
20. Heavy instruments are placed at the bottom of the tray as the weight of heavy
instruments or retractors lying on top or over other instruments can cause the
instruments at the bottom to bend and become misaligned.
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SOP 11 - PACKING AND WRAPPING
1. Instruments and other items that are prepared for sterilization must be packaged so that
their sterility can be maintained to the point of use.
2. Collect clean and dry articles on clean trolleys and bring them to assembly tables.
3. Examine the instruments for cleanliness. Return dirty instruments for re-cleaning.
4. Check the instruments against the ‘Instruments Tray Master List’ which is kept updated at
all times.
5. Inspect the instruments for good condition. Segregate damaged instruments and replace
with good instruments from the stock.
6. Arrange the instruments in an orderly manner in the tray. Insert an Internal Chemical
Indicator.
9. Seal the pack with Chemical Indicator Adhesive tape carrying pack information.
10. Access to CSSD sterile packaging area is restricted.
11. All staffs are responsible for keeping the preparation room entry / exit neat and tidy.
12. Everybody entering the preparation area must be correctly dressed.
13. No personal possessions other than locker keys can be taken into the preparation area.
14. No jewelry is allowed other than stud like ear ring, and should be completely covered
with head wear.
15. Food or drinks of any kind should not be taken into any area of the department.
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SOP 12- STEAM STERILIZER
1. We have automatic steAm sterilizers. steam sterilizers are one is of HOSLAB Company.
2. The first cycle of a day should be a “warm up “cycle or empty cycle.
3. Next cycle should be of bowie dick test cycle. It should be done every day after first empty
cycle.
4. At the end of cycle record the Bowie & Dick according to procedure.
5. If the Bowie Dick result is a fail repeat the test with a new Bowie Dick Test pack. If the
Bowie Dick is still a fail shut down the autoclave for repair and recall all sterile packs.
6. After the last Positive Bowie Dick Test Result, run a daily Biological indicator, according to
manufacturers’ instructions
7. Detail records of load should be kept for easy tracking and recall if necessary.
8. Package should be labeled according to policy.
9. Process should be conducted with full loads but not overload.
10. Loading of autoclave is conducted according to manufacturers’ instructions, make sure
the door to the chamber should be locked, and the appropriate cycle should be selected
based on the types of devices being processed.
11. Load baskets and carts so that hands will not touch packs when removing the hot trolley.
12. On completion of cycle, cycle complete indicator will appear, visually check of the graph and
printer should be done to determine that all parameters have been met.
13. In the event of a cycle failure or cycle aborted, the entire load should be reprocessed.
14. Put on heat resistant gloves and remove carrier from steam sterilizer.
15. Cooling should be allowed for 10 – 20 minutes before storage or dispensing.
16. Inspect packages to ensure integrity and external chemical indicators have changed.
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PROTOCOLS TO BE FOLLOWED AND UNDERSTAND:
Monitoring includes all sterilizer components that track record time, temperature
and pressure during each cycle, Printouts, gauges, round charts, etc.
Documentation of critical cycle parameters permit the earliest detection of
equipment malfunctions since they can be evaluated when the cycle is in progress.
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IV. STERILIZATION FAILURE CAN BE IDENTIFIED AT A NUMBER OF STAGES:
Autoclave parameters are not met
Biological Test shows growth
Bowie Dick Test Failure
Process Challenge Device or Load Control Failure
External Process Indicator Failure
Internal Chemical Test Failure
Wet Packs
Quality is the consistent delivery of products and services according to established standards.
Quality control procedures are laid down to provide a technical, statistical sampling method to
measure the quality of production.
The purpose of sterilization is to provide the end user with a sterile product. The only way of
ensuring sterility is to test every pack microbiologically, which would require opening the sterile pack.
To avoid this alternate method is to employ monitors to assure that the parameters of sterilization
have been met. Technical quality control indicators in the form of mechanical, chemical, and
biological indicators have to be incorporated into the Sterility Assurance Program (SAP).
1. Pressure Gauges: In jacketed sterilizers there are two main gauges, to determine pressure in the
jacket and chamber.
2. Temperature and pressure graphs and recording charts: These describe temperature and pressure
inside the sterilizer and various phases of sterilization can be known from the pattern.
3. Check the gauges and print out for every cycle to match with standard for the machine. Keep a
copy of the print out in the register.
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II CHEMICAL INDICATORS (CI)
Chemical Indicators are substances which change colour when exposed to specified conditions
through chemical reaction with the sterilant. They monitor one or more parameters of the
sterilization process. They are internal and external process indicators.
1. External process indicators inform the user that the pack has been exposed to the sterilization
process and may be used also for sealing and labeling of packs.
2. Every steam pack should be affixed with Autoclave indicator tape or label and every EtO pack
should be affixed with ETO indicator tape.
Internal indicators show proper penetration of the sterilant into the pack.
Multi parameter indicator strips or integrators should be used inside every steam
and ETO pack.
Bowie and Dick test is mandatory for pre-vacuum steam sterilizers. It is used to monitor vacuum level
and detect air leak.
For the second cycle, keep the Bowie and Dick Test Pack on the shelf above the drain, in empty
chamber.
Run the second cycle for 3 1/2 - 4-minute exposure time (As recommended by manufacturer).
If the Vacuum is perfect the entire indicator sheet changes color uniformly. If there is a lighter
or white patch in the sheet the sterilizer needs to be repaired.
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Biological Indicators (BI – Load Control)
Standardized and certified biological indicators are used to monitor sterilization process. They
contain a challenge number of spores (about 1 million) of a micro-organism most resistant to the
specific sterilization process.
Description:
1. Biological indicators consist of a spore strip or disc packed in a vial with a sealed ampoule of
growth medium. These are activated by crushing the ampoule, allowing microorganisms to come
in contact with the growth media.
3. The spore strips have a population of 10 5-106 spores to present a challenge to the sterilization
process.
Method of testing:
1. Use two ampoules per test, the load indicator and the control indicator.
2. The load indicator is packed in a paper packet and placed into the sterilizer at the center of the
load and the sterilization cycle is run.
3. After the cycle pull out the ampoule, crush the inner glass ampoule to mix the growth medium
with spore strip.
4. Incubate the ampoule at 56°C for steam and at 37°C for ETO.
5. The control indicator is not put in the sterilizer, but incubated after crushing the glass ampoule
along with the one that underwent sterilization.
6. The control indicator is expected to grow by showing a color change of the medium over 48 hours
but not the load indicator.
7. If the load indicator BI shows a color change this indicates failure of sterilization cycle. Recall all
packs processed from the last cycle that showed negative BI test.
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Frequency of testing:
Unloading:
1. After the cycle is over, only items that are visibly dry should be taken out once the door is opened.
2. Packs cannot be allowed to dry in the sterilizer after the cycle is over or outside.
3. Wait till the packages are cool before they are unloaded.
4. Do not stack the items which are just taken out of the sterilizer, one on top of the other, or else
condensation may occur.
SHELF LIFE
1. Shelf life of a sterile pack depends on the quality of the wrapper, storage conditions, and
conditions during transport and amount of handling.
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SOP 13 ETHYLENE OXIDE STERILIZER
Instructions
1. It is important that all staff members are aware of the policy and procedures that relate to
ETO sterilization (refer to room specification).
2. Operators must know how to operate the ETO sterilizer safely as well as the importance of
adequate aeration.
3. Operators need to understand the environment requirements and safe work practices.
4. Operators must know what the emergency procedures are in case of a leak or accident.
5. The ETO sterilizer must be operated accordance with the manufacturer’s instructions.
6. The ETO sterilizer must be used in a well ventilated controlled room with dedicated
exhausts, emission control, enclosed ETO sterilizer/aerator room, ventilation, air exchanges
and environmental monitoring provided.
7. Single-use cartridge delivers the appropriate volume/concentration of ETO.
8. Check with gas manufacturer/supplier for storage recommendations and
MSDS sheet.
9. ETO gas is stored at the prescribed temperature in a well-ventilated area in a cupboard
marked with Hazardous materials label.
10. The sterilizer operating temperature is usually preset by the sterilizer manufacturer; there
are usually two options: 37° C (cold cycle) and 55°C (warm cycle).
11. The manufacturer of a device is responsible for providing validated
information regarding proper sterilization and aeration of their products,
depending on
the concentration, humidity, temperature parameters, and the type of sterilizer.
12. The ETO cartridge must be discarded in a safe manner according gas
manufacturer/supplier and hospital policies.
13. Packaging manufacturers must validate that the product contained can be satisfactorily
sterilized within the wrap, pouch, container etc. and can release EO upon aeration in a
reasonable amount of time; not only from the device but the
packaging material too.
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SOP 14 STORAGE OF STERILE GOODS
1. All sterile must be cooled before storing and shall be stored in a secure location. This
maintains the Integrity of the sterile item.
2. All storage areas shall be clean, dry, protected from moisture.
3. Before storage, all sterile items shall be checked for the following:
Items should be completely dry
Integrity of the outer wrap
Coloring of sterile indicator tape, date prepared and Lot number labels for sterilizer
4. Any sterile item that has been dropped on the floor are considered unsterile.
5. Stock sterile items on shelves 8-10 cm from the floor and 20 -25 cm from ceiling.
6. Unauthorized personnel, patients, or visitors should be prohibited to enter the sterile storage
area. Ensure the proper signs and labels are posted in the storage shelves.
7. Items will be labeled (Sterile unless package is opened or damaged and checked Before use).
8. Damage of sterile items includes: Hole or torn wrapper, broken seal in peel Pouches, items
dropped, securing tape or lock that shows sign of tempering or having been removed,
exposure to contaminate of unsafe environment and exposure to any type of moisture will be
considered un-sterile.
9. Temperature should be controlled in range of Relative humidity 35%-50% to prevent
drying out or premature breakdown of material of seal.
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SOP 15 DELIVERIES AND DISTRIBUTION OF PROCESSED ITEMS
a. Holes or tears
b. Wetness or stains
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SOP 16 EQUIPMENT MAINTENANCE
MAINTENANCE OF STERILIZERS
General
Each manufacturer provides a manual that includes comprehensive care and maintenance
instructions about sterilizer .
Routine maintenance: daily inspections and cleaning of gaskets, chart pens, chamber drain
screens and internal/external surfaces.
Calibration: periodic calibration of items such as pressure and temperature gauges, timers,
recording and control devices must be carried out by qualified personnel as specified in the
manufacturer's instruction manual.
Daily
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SOP 17 TRACKING SYSTEMS
1. To ensure the effective tracking system proper labeling of pack and record keeping is very
important.
2. Labels should be applied to the external packaging, prior to sterilization to allow
ease of identification of the contents of a package and the process.
3. Packaging should be labeled prior to sterilization in a way that does not compromise the
integrity of the pack.
4. A common method involves the use of bar codes that are used to identify packs and device
locations by a scanning process.
5. Packaging systems should be labeled with,
A description of the package contents
Identification of the person receiving, cleaning, checking, assembling, sterilizing,
storing, dispatching the package
A lot control number
Any expiration date/shelf life statement applicable to the facility
Dispatch information
6. All affected trays should be recalled in the event of failed quality management or in the
event of a contagious disease or infection. Hence effective tracking system should be
available.
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SOP 18 RECORD KEEPING
At the beginning of the cycle, the date, time, sterilizer operator and cycle identification
should be marked on the record.
At the end of the cycle, the response of Chemical Indicator should be recorded.
4 . Re-call register
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SOP 19 RECALL POLICIES FOR STERILIZATION
1. Recall policy describe as sterilization process failure and to enable rapid recall of all items
suspected to be non-sterile.
2. The biological indicator is sent to microbiology department for testing the efficacy of sterilization
procedures.
In case of the failure of all cycle (biological or mechanical) the CSSD staff informs to all concerned
department to return the sterile material issued from the CSSD for Re-autoclaving. If trays are used,
then information are given to Infection control Nurse by sister In charge to monitor the patient
condition and follow up.
The recall procedures include:
• Sending a recall notice to all concern departments
• Identification of persons or department for which the notice is intended.
• Includes an area to record products and quantity of products to be returned in recall.
• Includes the action to be taken by persons receiving notice –e.g. return or hold for collection by
CSSD staff.
Report should be prepared and completed defining
• The reason for recall
• The total number of products recalled
• The actual number located
• Number of patients potentially exposed
• The actions taken regarding patient involved
• The action should be taken to prevent this happening again
• Sterilizing cycle records includes
a) Date of cycle
b) Sterilizer code or number
c) Cycle or load number
d) Exposure time, temperature, and pressure
e) Name / ID of loading operator
f) Name/ID of person authorizing release
g) Specific content of load and
h) Read out results of indicators used
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• Physical
• Chemical
• Biological enzymatic
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SOP 20 – SHELF LIFE FOR STERILIZED ITEMS
Use of autoclaved and ETO sterilized items should be done according to the shelf life of the
trey or pack.
SHELF LIFE
1. Shelf life of a sterile pack depends on the quality of the wrapper, storage conditions and
conditions during transport and amount of handling.
2. Shelf life is given as follows:
CSSD technician should check for the expiry date every day in sterile storage room. They should also
check for the packs to be intact for the sterility. All those set are then sent back to CSSD for
resterilisation if evidence of expiry or breach in package.
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SOP 21 ENDOSCOPE REPROCESSING
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• Disinfectants that are not FDA-cleared , should be strongly discouraged because of lack
of proven efficacy against all microorganisms or materials incompatibility. They are:
Iodophors - alcohols
Step 1: Precleaning
• Precleaning should be performed at the point of use by wiping the exterior of the endoscope with soft
cloth/sponge soaked in freshly prepared enzymatic detergent.
• Suction/biopsy and air/water channels should be flushed with enzymatic detergent. Other channels
should be cleaned per manufacturer’s instructions.
• All detachable parts should be removed e.g., valves/buttons/caps and clean with enzymatic detergent.
• Correctly dispose of parts designated as single use.
Step 2: transportation
• Transport the soiled endoscope and accessories to the reprocessing area immediately before
remaining soil dries.
• An open container can suffice for transport to immediately adjacent reprocessing rooms, but fully
enclosed and labelled containers should be used for transportation to distant areas.
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Step 3: Leak testing
• Pressure/leak test should be performed after each use and before reprocessing, according to
manufacturer guidelines to verify the integrity of the endoscope.
• If leak detected, send for repair.
• Disassemble removable parts e.g. all buttons/valves/caps. Ultrasonic cleaning of reusable endoscopic
accessories should be performed to remove soil and organic material from hard-to-clean areas.
• Completely immerse the Endoscope in enzymatic detergent solution. Wipe exterior of the endoscope
with a soft brush.
• Brush all channels until there is no debris visible. Discard brush appropriately after use.
• Drain water from the sink.
• Curl endoscope for transfer to a separate sink.
• Immerse endoscope in another sink full of water for rinsing to remove residual detergent.
• Flush all channels with water.
• Discard enzymatic detergents after each use.
Step 6: Drying
Compressed air should be blown into each channel to remove the water inside
Surface of endoscope should be mopped with a soft fabric, and 70% to 90%ethyl
alcohol should be poured into all its channels before drying with compressed air
All detachable parts such as air/water valves, suction valves, and waterproof cap should
be kept disassembled in storage.
Cabinet should be mopped with 70%alcohol daily.
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Step 7: Storage
• When storing the disinfected endoscope, hang it in a vertical position to facilitate drying with caps,
valves and other detachable components should be removed, as per manufacturer’s instructions.
• Reuse of endoscopes within 10 to 14 days of high-level disinfection appears to be safe although
shorter period is recommended.
• Sterilized endoscopes must be stored sealed in the container or packaging in which they were
sterilized.
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SOP 22 BIO-MEDICAL WASTE
1. The arrangements for the handling and temporary storage of waste awaiting collection within the
CSSD should be part of the hospital’s waste management programme and should conform to current
legislation and guidance.
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CSSD IMAGES
THE WASHING AREA WITH AIR DRYER
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ULTRASONIC WASHER DISINFECTOR
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AUTOMATIC WASHER DISINFECTOR
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ASSEMBLY AND PACKING AREA
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MODI STEAM STERILIZER
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ETO STERILIZER
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