CSSD

Standard Operating
Procedures
MTI-BKMC/GKMC, Swabi

Prepared by:
Dr Amina Tariq
HOD Anesthesia

Mr. Ishfaq
CSSD Incharge
SOP No. 1 CSSD function and layout
SOP No. 2 Safety awareness in CSSD
SOP No. 3 Job description
SOP No. 4 Department cleaning procedure
SOP No. 5 Departmental dress code
SOP No. 6 Water quality
SOP No. 7 Collection of soiled/ contaminated equipment
SOP No. 8 Dealing with known infectious cases (soiled  instrumentation with labeled infectious)
SOP No. 9 Manual decontamination of medical devices
SOP No. 10 Prepare, Load and Operate Automated Decontamination Equipment
SOP No. 11 Packing area operation
SOP No. 12 Steam Sterilization procedure
SOP No. 13 Ethylene oxide sterilization
SOP No. 14 Low temperature sterilization
SOP No. 15 The delivery and distribution of processed items
SOP No. 16 Planned Scheduled Equipment maintenance
SOP No. 17 Sterile packaging
SOP No. 18 Decontamination of Textiles/Linen for sterilization
SOP No. 19 Recall Procedure
SOP No. 20 Sterile storage
SOP No. 21 Tracking system and validation of equipment
SOP No. 22 Reprocessing Endoscopes
SOP No. 23 Decontamination and management of laryngoscopes
SOP No. 24 Waste management

General Information:
1. Guidelines can be processes, procedures, flowchart, steps to follow, instructions, patient education.
2. Guidelines are applicable to MTI-BKMC/GKMC.
3. Guidelines needs to be revised at least every eighteen months and/or if anything changes. If a Guideline is
reviewed, but have no changes, it is indicated on the original cover page as "revised guideline without
changes (thus it has to re-signed again)”
4. Attachments (e.g. documents, flowcharts etc. can be added as is (i.e. not necessary to be on a page
with a header)
5. Indicate the total number of pages.
6. SOP Number: Obtain from Director Operation & Admin

PURPOSE:
THE PURPOSE OF THE PROCEDURE IS TO ENSURE THE AVAILABILITY OF CSSD SERVICES TO ALL PATIENTS AT
MTI-BKMC/GKMC.
SCOPE:
This SOP is applicable to all CSSD staff (full time, part time, contract employees, interne).

RESPONSIBILITY:
It is the responsibility of all staff to follow this procedure.
It is the responsibility of Head of Department and In-Charge CSSD to ensure that staff is familiar with the
procedure and to monitor the compliance.

Standard Operation Procedure Policy Title:

SOP No. 1 CSSD function and layout

Prepared by: Section:

Dr Amina Tariq Central Sterilized Supply Department (CSSD)
Mr. Ishfaq

Area of application:
CSSD

Objective/ Purpose:
To establish the functions and design layout of the CSSD

Procedure:
I- Functions of CSSD:
1. CSSD provide services for patient care and its main responsibilities are ;
a. collection
b. decontamination
c. disinfection
d. inspection
e. assembly
f. packaging
g. Sterilization
h. storing
i. distribution of all instruments and medical devices.

2. Provide sterile supplies to all hospital departments where it is required.

3. Provide policies and procedures and their implementation.

4. Technical supervision of the CSSD

5. Communication with end users to improve quality of service.

6. Specify criteria for quality control of all items produced by CSSD.

7. Training of technical staff, refreshment courses and continuous update of knowledge.

II- Layout
1. The CSSD department design should be physically separated from all other work areas in the hospital.
2. It should be designed to have a unidirectional flow from ‘dirty’ area to ‘clean’ area.
3. It should have a changing area for workers including toilet facilities and lockers for keeping belongings
along with hand hygiene facilities.
4. The designated area for CSSD should be free from opening windows.
5. All the rooms in CSSD should be mechanically ventilated and controlled to provide a comfortable
working environment (temperature should be controlled between 18-22 degree Celsius and relative
humidity should be controlled within the range of 35-60%).
6. There should be no staff movement between dirty and clean areas of CSSD without passing through
wash-up area and clothing change.
7. Storage facilities for bulk items should be provided external to clean room.

Standard Operation Procedure Policy title:

SOP No. 2 Safety awareness in CSSD

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Staff involved:
All personnel that are assigned or engaged in Sterile service operation.

Objective / Purpose:
To establish an overview of guidelines and safety awareness procedures in the Sterile service
department.

Relevant / Related documents

Infection Control Policy

Equipment:
Personal protective equipment

Procedure:
I- General Guidelines
1. All personnel must follow established work and traffic flow patterns.
2. Material Safety Data Sheets (MSDS) for all chemicals used in the sterile service department must be
available in a binder index.
3. Employee must be trained in a safe work procedure and be aware of any relevant procedures, policies.
4. All employees must be trained in appropriate personnel protective equipment designated for each
area.
5. Employees must adhere to dress code and policies before entering and when leaving the area.
6. Employees must follow and practice hand washing guidelines (before and after each tasks) in
accordance with WHO guidelines.
7. Eating and drinking is prohibited in all workspaces including supply storage, processing and
decontamination sections.
8. Work spaces must be free from clutter and have un-obstructed entrances and exits.
9. Visitors are prohibited from entering CPD spaces without permission.
10. If visitors must enter restricted areas, appropriate attire is required and they should be escorted by
CSSD staff.

II- Patient Safety

1. Ensure that all items are processed according to established guidelines (manufacturer’s instructions).
2. All CSSD personnel should be trained in Decontamination and Sterilization Practices.
3. Safe keeping of all items by ensuring that storage areas are kept clean, storage cupboards are locked,
equipment is covered and preventive maintenance is performed on all equipment.
4. Assure there is no contamination of patient care areas during collection and transportation of
contaminated items.

III- Employee Safety

1. Prevent burn injuries when loading or unloading steam sterilizers and washer disinfectors by following
procedure and wearing appropriate PPE.
2. Employees must use proper body mechanics when carrying or handling heavy items. • Use care and
caution when handling sharps.
3. Maintain “line of light “when handling medical devices.
4. In the decontamination area, employees must wear proper personal protective equipment (PPE) to
prevent direct exposure from contaminants and injury that could result when handling contaminated
and sharp instruments.
4. Appropriate PPE must be worn when handling chemicals used for cleaning and decontamination.
5. When receiving or handling contaminated items, always wear the correct PPE for the task.

Standard Operation Procedure Policy Title:

SOP No. 3 Job description
Prepared by: Section:
Dr Amina Tariq CSSD
Mr. Ishfaq

Applicable to:
All staff working in CSSD.

Objective/ Purpose:
To establish job responsibilities of the CSSD incharge and the sterilization technicians and assistants.

I- Responsibilities of CSSD Incharge:

1. Run CSSD according to the goals and objectives of infection control.
2. Directorate and ensure its implementation and follow up.
3. Supervise, direct follow up of CSSD staff, and suggesting the best motivational approach .
4. Ensure to cover entire sterile supply of hospital.
5. Yearly assessment of the employee.
6. Prepare and write reports for infection control directorate.
7. Keep accurate records for all CSSD activities including the repair programs for CSSD equipment.
8. Taking part in emergency plan for CSSD and regular checkup.
9. Participate in training the staff by giving lectures during courses or scientific days.
10. Prepare operating instructions manuals for the CSSD equipment.
11. Performing other tasks entrusted by infection control manager.

II- Sterilization technician

1. Follow the correct procedure in the decontamination area of reception ,segregation and loading the
soiled instruments in the trays
2. Assembly & packing of the instruments is performed according to operation manual.
3. Packaging of single use packages according to the planned program.
4. Regular performance of validation tests of the instruments
5. Operating all the equipment & devices in CSSD according to operating manual.
6. Arranging the packages in the sterile store according to the expiry date, preparing the orders for
hospital wards
7. Should have enough knowledge regard quality assurance in each area of the CSSD and participate in
the statistics collection.
8. Using the electrical cutter to cut sterilization papers and gauze.
9. Committed to work in the holidays according to planned time table.
10. Performing other tasks entrusted by head of CSSD.

Standard Operation Procedure Policy Title:

SOP no. 4 Department cleaning procedure.
Prepared by: Section:
Dr Amina Tariq CSSD
Mr. Ishfaq

Area of Application:
All areas of the facility

Staff Involved:
Only staff trained in decontamination process

Objective/Purpose:
To ensure an acceptable level of hygiene and cleanliness throughout the CSSD area

Relevant/Related Documents:
Procedure Manual
Standard Precautions

Equipment/Supplies:
All surfaces and equipment in CSSD
All new equipment prior to introduction for use
Cleaning materials

Procedure:
1. The CSSD will be cleaned in accordance with the cleaning schedule
2. Cleaning will be undertaken between times to be agreed that will enable any aerosol particles to settle
prior to commencement of work.
3. Cleaning will take place before work commences or after work is completed, in the case of a 24 hour
facility cleaning will be rotated through areas when work is not in progress
4. The cleaning schedule will specify frequency of cleaning
5. A departmental cleaning inspection report will be prepared each month (at random times) by the
Sterile Services Manager or Senior Staff
6. Designated cleaning equipment will be stored in a designated area for that area’s use only.
7. Cleaning work will only be undertaken by Staff trained to work in that area
8. CSSD staffs are responsible for making sure that all surfaces are clean
9. All cleaning procedures and cleaning chemicals used in the department will be in line with
Departmental recommendations
10. The use of brooms is discouraged

Standard Operation Procedure Policy Title:

SOP No. 5 Departmental dress code
Prepared by: Section:
Dr Amina Tariq CSSD
Mr. Ishfaq

Area of Application:
All areas of the facility

Staff Involved:
All

Objective/Purpose:
To ensure that staff are properly attired according to the requirements of their work area

Relevant/Related Documents:
Procedure Manual
Standard Precautions

Equipment/Supplies:
PPE

Procedure:
1. On entering the Sterile Service Department, all staff will change into departmental uniform provided
in the changing area
2. Staff moving into the wash area, who will be engaged in the handling and processing of incoming
equipment, will put on an extra protection gown, gloves and protective goggles (when splashing is
anticipated) in addition to the departmental uniform
3. When leaving the wash area staff will remove and discard the gown and gloves and wash their hands
4. Prior to entering the preparation area all staff and visitors will wash and dry their hands and put on
the relevant PPE
5. Staff visiting from other areas will wear the departmental uniform and must comply with the dress
code when moving to other areas of the department.

Standard Operation Procedure Policy Title:

SOP No. 6 Water quality

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
CSSD
Objective/ Purpose:
To ensure clean and quality water supply to CSSD for cleaning of instruments and equipment.

Staff Involved:
All staff in CSSD

Procedure:
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. Hardness can affect the activity of the detergent used for cleaning and may require increased
concentrations of detergent.
6. Water testing can either be conducted by biomedical engineering department or by chemical
distribution representative from the public health authority.
7. Ph. levels, water quality and chemical compatibility tests are carried out and recorded
8. Report any residue left on instruments to the supervisor and biomedical engineering department.

Standard Operation Procedure Policy Title:

SOP No. 7 Collection of soiled/ contaminated equipment

Prepared by: Section:

Dr Amina Tariq CSSD
Mr Ishfaq

Area of application:
Theatres/wards/clinics

Staff involved:
Trained CSSD personnel

Objective/ Purpose:
To ensure the safe collection, handling and transportation of contaminated equipment from the clinical
setting to the Central Service Facility in a safe manner.

Relevant / Related Documents:

Standard Precaution Guidelines
Managing of Heavy Equipment
Infection Prevention Control Policy

Equipment/Supplies:
Puncture proof and leak resistant trolleys with removable bins, dedicated instrument trolleys. Protective
attire: i.e. clothing, masks, gloves, eye protection, safety footwear.

Procedure:
1. Non-sterile gauntlet gloves must be worn for the collection of instruments and be discarded into the
medical waste container at each collection point.
2. Wash hands in accordance with departmental procedures.
3. Wear protective clothing / attire in compliance with standard precaution guidelines.
4. Use allocated trolleys.
5. Follow designated collection routine and time table in accordance with department guidelines.
6. Linen and waste must be separated from reusable medical devices at the point of use.
7. Gross contaminants such as large amount of blood, feces, urine, etc. must be removed at the point of
use, in accordance with safety procedures.
8. Collect used items in puncture resistant containers; do not overload.
9. Place heavy instrument containers at the bottom of trolleys.
10. Secure contaminated items and cover prior to transportation.
11. Do not leave contaminated goods unattended during transportation.
12. Transport / Deliver used items and equipment to the cleaning area • Unload and sort items in the
receiving area.
13. Clean and disinfect collection trolleys and bins and store appropriately.
14. Remove gloves and wash hands according to Policy.

Standard Operation Procedure Policy Title:

SOP No. 8 Dealing with known infectious cases (soiled
instrumentation  with  labeled   infectious)
Prepared by: Section:
Dr Amina Tariq CSSD
Mr. Ishfaq

Area of Application:
CSSD, theatre, ward

Objective/ Purpose:
To ensure safe handling of infected instruments and equipment.
Relevant / Related Documents:
Standard Precaution Guidelines
Infection Prevention Control Policy

Equipment/Supplies:
Puncture proof and leak resistant trolleys with removable bins, dedicated instrument trolleys. Protective
attire: i.e. clothing, masks, gloves, eye protection, safety footwear.

Procedure:
1. Consider every item collected and received to C.S.S.D infectious either labeled or not .(some patients
don’t inform / virus incubation period with no symptoms )
2. Ensure proper handling for instruments with complete P.P.E.
3. Avoid Manual wash or Ultrasonic.
4. Use washer disinfector with load/ recommendation to use lower shelf
5. Run the cycle according to temperature recommended.( 90 C or 85 C )
6. The specification of the washer includes self-disinfection cycle therefore no need to run the washer
twice.
7. Most viruses can be killed in the temperature selected, no need to run the washer twice
8. Report the instruments with detailed
9. Report any injury – incident report
10. Disinfect the transport container using washer disinfector or trolley washer if available (bottom shelf)

Standard Operation Procedure Policy Title:

SOP No. 9 Manual decontamination of medical devices

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Objective/ Purpose:
To ensure that all soiled equipment returned to the CSSD is cleaned to an acceptable standard.

Scope:
All instruments and equipment returned to CSSD.
All new equipment prior to introduction for use
All damaged equipment prior to sending for repair.

Area of Application:
Decontamination Area of CSSD
Staff Involved:
Only staff trained in the decontamination process

Relevant/Related Documents:
Procedure Manual
Standard Precautions
Manufacturers’ Instructions

Equipment:
Gauntlet gloves, Full plastic apron, face mask, eye protection, hair protection
Double sinks with plugs
Marked sinks or measuring jugs
Hot and Cold running water
Elbow taps
High pressure cleaner
Selection of cleaning Brushes
Drying area
Non-linting Drying clothes
Hand cleaning facilities

Procedure:
1. When washing Instruments manually standard/universal precaution must be applied at all times
2. Only staff trained in decontamination should manually clean medical devices
3. Maintain segregation of designated clean and other areas within the department
4. Identify the correct process for the items to be decontaminated according to manufacturers
instructions
5. Staff working in this area will wear protective clothing at all times in compliance with the standard
precautions dress. PPE is additional to the uniform code for your specific working environment and may
include: a) Gloves b) Aprons, gowns, overalls (single-use, fluid- repellent, disposable) c) Masks d) Face
and eye protection e) Footwear
6. Apply standard precautions for infection control and other relevant health and safety measures
7. Use and store all equipment chemicals and materials in accordance with manufacturer’s instructions
and organisational policies and procedures.
8. Ensure that stock of chemicals and materials that are being accommodated is rotated so that oldest is
used first.
9. Keep work areas safe and free from hazards during work activities and report any situations where
risks arise that prevent work going ahead or continuing, restricting access to risk area until the area has
been assessed as safe by a line manager
10. Place waste containers in positions that will minimise hazards to staff and visitors and dispose of full
waste containers promptly and in accordance with departmental procedures
11. Comply with manufacturers' and organisation specifications when processing of medical devices.
12. Handle contaminated devices as little as possible. All equipment is transferred from the trolley to the
work surface.
13. Check instruments off against the checklist returned with the set and take notice of any comments
made on the check list by the theatre team/user
14. Identify if the medical devices can be decontaminated in the washer and identify items requiring
special attention and handle in accordance with documented manufacturers’ instructions
15. Each instrument will be prepared for decontamination as follows
a) Remove the protective outer wraps
b) Wearing gloves and using a Cheatle Forcep discard any disposable materials into the appropriate
containers. Clinical waste in red plastic bags, domestic waste into black bags, sharps into sharps
container taking special care to dispose of sharp objects safely.
c) Avoid contaminating hands with soilage.
d) Separate baskets, container and instruments.
e) Check degree of soil, sort and discard any disposable material.
f) If needles/blades are found, the instrument set should be set aside and the end user contacted to
come and remove the sharps (if this is possible).
g) Sort Cannulated and solid devices and open all hinged instruments
h) Flush all Cannulated instruments with the pressure jet gun / syringe before and after brushing
i) Loosen all instrument pins and separate instruments
j) Disassemble all multi part instruments and handle and process all devices in accordance with the
manufacturers’ instructions.
k) If an instrument is broken, any broken piece is located immediately, or a report made following the
missing instrument procedure. It is vital to identify any missing screws or broken part as a matter of
urgency, as the sooner it is identified the better chance there is of locating it.
l) Set the tray aside until the instrument is replaced or repaired
16. Two dedicated deep sinks must be available with a dedicated drying surface
17. Sinks and accessories must be cleaned at each water change
18. When cleaning manually, a pre-rinse, wash, rinse and drying process must be followed.
19. The water temperature should be according to detergent manufacturers’ instructions.
20. Water and detergent should be measured according to manufacturers’ instructions and have the
correct chemical mixture.
21. The dedicated sinks should only be used for washing instruments, not for hand washing or anything
else
22. The sink should have water measurement marks, to assist with the detergent concentration.
23. Use the cleaning equipment, materials and agents in a manner that minimises risk to yourself and
others taking appropriate action when problems arise during cleaning
24. If the water, is visibly stained at any stage it must be replaced
25. All devices being manually cleaned must be fully immersed in the washing water while being
scrubbed. This is to ensure that any aerosols being generated are in the main, contained.
26. Special attention must be paid to the joints of any jointed instrument and meticulous attention paid
to the tips or crevices.
27. A clean soft brush or soft cloth /Sponge is required to clean the surfaces.
28. If the water, is visibly stained during the rinsing stage. The cleaning stage should be repeated. It is
important that all soil and chemical is removed prior to, or during the rinsing stage.
29. After decontamination, all devices must be visually inspected for soil, damage and functionality.
30. Place clean, functioning items on a drainage area that should be kept clean at all times.
31. Dry items using a non-linting cloth
32. Clean items should be stored and transported in such a manner that cross contamination is avoided
33. Ensure that cleaning equipment is cleaned disinfected and dried before being stored.
34. Return cleaning equipment and cleaning materials in good working order and condition to the
appropriate place after use

Standard Operation Procedure Policy Title:

SOP No. 10 Prepare, Load and Operate Automated
Decontamination Equipment
Prepared by: Section:
Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
Cleaning Area of Theatre/CSSD

Staff involved:
Only staff trained in decontamination process

Objective/Purpose:
To ensure that medical devices/equipment are correctly prepared and loaded for decontamination

Relevant/Related Documents
ISO 15883:2006
Procedure Manual
Standard Precautions
Equipment guidelines
Manufacturers’ guidelines

Equipment/Supplies:
Personal Protective Equipment
Washer
Disinfector
Ultrasonic Cleaner
Detergent Stain Remover

Procedure:
1. Maintain segregation of designated clean and other areas within the department
2. Identify the correct process for the items to be decontaminated following manufacturer’s instructions
3. Staff working in this area will wear protective clothing at all times in compliance with the standard
precautions dress. PPE is additional to the uniform code for your specific working environment and may
include: a) gloves b) aprons, gowns, overalls (single-use, fluid- repellent, disposable) c) masks d) face
and eye protection e) footwear
4. Apply standard precautions for infection control and other relevant health and safety measures
5. Use and store all equipment chemicals and materials in accordance with manufacturer’s instructions
and organization policies and procedures.
6. Keep work areas safe and free from hazards during work activities and report any situations where
risks arise that prevent work going ahead or continuing, restricting access to risk area until the area has
been assessed as safe by a line manager.
7. Place waste containers in positions that will minimize hazards to staff and visitors and dispose of full
waste containers promptly and in accordance with departmental procedures
8. Comply with manufacturers' and organization specifications when using all appliances and processing
of medical devices.
9. Handle contaminated devices as little as possible.
10. Washer disinfectors will be prepared for use as described in the Working Instructions
11. All equipment is transferred from the trolley to the work surface.
12. Identify if the medical devices can be decontaminated in the washer
13. Identify items requiring special attention and handle in accordance with documented manufacturers’
instructions
14. Each instrument will be prepared for decontamination as follows
a) Remove the protective outer wraps
b) Wearing gloves and using a Cheatle Forcep discard any disposable materials into the appropriate
containers. Clinical waste in red plastic bags, domestic waste into black bags, sharps into sharps
container taking special care to dispose of sharp objects safely.
c) Avoid contaminating hands with soilage.
d) Check degree of soil, sort and discard any disposable material.
e) Sort Cannulated and solid devices, open the hinged devices and flush all cannulated instruments with
the pressure jet gun / syringe before placing in the tray.
f) Disassemble all multi part instruments and handle and process all devices in accordance with the
manufacturers’ instructions.
g) If an instrument is broken, any broken piece is located immediately, or a report made following the
missing instrument procedure. It is vital to identify any missing screws or broken part as a matter of
urgency, as the sooner it is identified the better chance there is of locating it. Be aware that small items
may become lodged in the drainage system
h) Check instruments off against the checklist returned with the set and take notice of any comments
made on the check list by the theatre team/user
i) Manually clean items that are too large or unsuitable for mechanical washer/disinfector in accordance
with the manual cleaning protocol
j) Place instruments into a wash basket and check to ensure all items and parts are present.
k) Load items to be decontaminated in the correct position in baskets so that maximum exposure to the
decontamination process is achieved on all surfaces of the instrument .
l) Place heavier items at the bottom making sure that all surfaces can be reached by the spray jets
m) Do not pack too densely or over-pack trays, all surfaces must be reached by the spray jets. Make sure
that instruments do not stick out of baskets as they may affect the washer operation
n) A full-automated process should be used including pre rinsing, washing at 60°C minimum (if
recommended by manufacturer), rinsing and drying.
o) Where more than one chemical is used in the automated washer disinfector, the tubing should be
marked to indicate which chemical it
p) Check that all daily tests are completed satisfactorily and results recorded in appropriate log books
accurately and legibly before using cleaning equipment, report any abnormal performance of the
cleaning equipment promptly to the appropriate member of staff
q) Chamber self-disinfection should be carried out each week as per manufacturer’s recommendations
and documented.
r) Maintain records of all items received and prepared for processing
s) Record data correctly as per departmental procedure using log books

Standard Operation Procedure Policy Title:

SOP No. 11 Packing Area Operation

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
Packing Area

Staff involved:
Only staff trained in CSSD/Theatre

Objective/Purpose:
To describe the operation and procedure controls in the Packing Room

Relevant/Related Documents:
Quality Manual
Working Instructions Manual
Missing Instrument Form

Equipment/Supplies:
N/A

Procedure:
1. Senior Staff will ensure the order of production meets immediate customer priority where
appropriate.
2. After decontamination, all clean items are received into the packing area
3. Any item that is rejected due to evidence of residual blood, body fluid, stains or water are placed in a
plastic bag and identified before being returned for washroom staff to action
4. Any item that is damaged or broken is sent for repair
5. Bio-burden tests will be performed on the washer disinfectors regularly, according to policy, ensure
that items being processed are safely disinfected.

Standard Operation Procedure Policy Title:

SOP No. 12 Steam sterilization procedure

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
Autoclave area/ specialized area in theatre

Staff involved:
Only trained personnel allocated to area and engineering/maintenance staff

Objective/ Purpose:
To ensure consistent sterilisation of items through quality control checks of the autoclave
To ensure that all reprocessed medical devices are sterilized to an acceptable standard and ready for use.

Safety Warning:
Protective Equipment: heat resistant leather gloves and appropriate footwear.
Sterilizer is hot, burns may occur!

Relevant / Related Documents:

Manufacturer’s Manual
Occupational Health and Safety Act, 85 of 1993
Standard Precautions

Equipment/Supplies:
Steam Sterilizer (Autoclave), Loading Trolleys, Log books
Testing products: Bowie & Dick test pack, Microbiology test vials

Procedure:
The steam sterilizer must be operated accordance with the manufacturer’s instructions.

Daily Preparation of the autoclave:

1. For an autoclave with a manual recording chart, replace chart identifying autoclave, date and initial in
place provided
2. For autoclaves with a computerised recording, check paper
3. Check to ensure printer, recorder is working properly
4. The first cycle will be a “warm up “cycle.
5. On the second cycle place a Bowie & Dick Test Pack, in the warm empty chamber above the drain, on a
pre-vacuum cycle, (first or second of the day depend on whether the sterilizer was shutdown). Run the
test according to manufacturers’ instructions
6. Once the cycle has run, record the Bowie & Dick according to procedure
7. If the Bowie Dick result is a fail repeat the test with a new Bowie Dick Test pack.
8. If the Bowie Dick is still a fail shut down the autoclave for repair and recall all sterile packs after the
last Positive Bowie Dick Test result
9. Run a daily Biological, according to manufacturers’ instructions, in the first full load of the day as well
as any load containing implants.
10. Record the result according to procedure
11. Complete test and record biological indicator ( BI ) Test according to procedure Operational
Guidelines
12. Record contents of load, information must be detailed enough to allow for tracking and recall if
necessary.
13. Label Package according to policy
14. Make sure each pack has a tracking label affixed
15. Packaging manufacturers must validate that the product contained can be satisfactorily sterilized
within the wrap, pouch, container etc.
16. Ensure that items being loaded are compatible with High Temperatures
17. Process full loads – not overloaded- to limit the number of cycles you need to run
18. Load the autoclave according to manufacturers’ instructions, make sure the door to the chamber is
locked, and the appropriate cycle is selected based on the types of devices being processed
19. Load items in a loose fashion to facilitate air removal, and steam penetration of all surfaces – do not
stack items one on top of the other.
20. Packages must not be in contact with walls or ceiling of chamber, package damage from heat or
moisture may occur
21. Load baskets and carts so hands won’t touch packs when removing the hot trolley
22. For approved rigid containers, follow manufacturer’s validated loading instructions.
23. Close and secure lock the autoclave door.
25. On completion of cycle, cycle complete indicator will appear, visually check the graph / printer to
determine that all parameters have been met.
26. Follow manufacturer’s directions for door opening and load transfer
27. In the event of a cycle failure / cycle aborted, the entire load will need to go through the full
reprocessing cycle
28. The person responsible for checking the load should sign their name on the printout before opening
the sterilizer door or scan in their data for tracking
29. Before opening the door, thoroughly wash hands according to Hospital Policy
30. Open the door while standing towards the side to avoid burns.
31. Put on heat resistant gloves and remove carrier from Autoclave.
32. Allow to cool for 10 – 20 minutes before storage or dispensing.
33. Do not touch hot packs
34. Inspect packages to ensure integrity and external chemical indicators have changed.
35. Record results in log book and file for each autoclave according to Procedure no:

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
Chemical Indicators
Chemical Indicators are used in combination with physical parameter to monitor the effectiveness of the
sterilizer
They monitor conditions in the sterilizer chamber or from within the load as part of a total system of
sterilization monitoring. The following main types of chemical indicators are available
- Process indicators
- In-Pack indicators
- Load controls or Process Challenge Devices

Standard Operation Procedure Policy Title:

SOP No. 13 Ethylene oxide sterilisation

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
ETO area

Staff involved:
Only trained personnel allocated to area and engineering staff.
Pregnant women should not be allocated to this area

Objective/ Purpose:
To ensure that all ETO sterilisers are functional and operated according to departmental policy.
To ensure that all reprocessed medical devices are sterilized to an acceptable standard and ready for use.
To ensure that the work environment is safe for employees

Safety Warning:
ETO is an odourless gas
Skin Contact with liquid EO - immediately wash affected area Eye contact with liquid EO - flush eyes with
copious amounts of water for at least 15 minutes
Ensure staff have been educated regarding safety precautions when working with ETO

Relevant / Related Documents:

Manufacturer’s Manual
Occupational Health and Safety Act, 85 of 1993
Standard Precautions
Sterilization policy and process
Environment requirements
Safe work practices
Emergency procedures
Logbooks

Equipment/Supplies:
ETO Sterilizer
ETO Cartridges
Aeration Cabinet
Monitoring equipment
Emergency equipment
Personal Protective equipment

Procedure:

Daily Preparation of ETO Sterilizer:

1. Ensure the work environment is safe for employees
2. Replace Load Control Slips Daily or computer printout paper
3. Identifying sterilizer, date and initial on load control slip
4. Check to ensure printer is working where applicable
5. Complete test and record biological indicator (BI) Test according to manufacturers instructions
6. It is important that all staff members are aware of the policy and procedures that relate to EtO
sterilization
7. Operators must know how to operate the ETO sterilizer safely as well as the importance of adequate
aeration
8. Operators need to understand the environment requirements and safe work practices
9. Operators must know what the emergency procedures are in case of a leak or accident
10. Operators must understand that regulations have to be followed
11. The ETO sterilizer must be operated accordance with the manufacturer’s instructions
12. 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 • Single-use cartridge delivers the appropriate volume/concentration of ETO
13. Check with gas manufacturer/supplier for storage recommendations and MSDS sheet.
14. ETO gas must be stored at the prescribed temperature in a well ventilated area in a cupboard marked
with Hazardous materials label
15. The cycle must be long enough to allow thorough ETO penetration to kill microorganisms
16. The sterilizer operating temperature is usually preset by the sterilizer manufacturer; there are usually
two options: 100F (cold cycle) 130F (warm cycle)
17. The manufacturer of a device is responsible for providing validated information regarding proper
sterilization and aeration of their products, usually between 1 to 6 hours, depending on the
concentration, humidity, temperature parameters, and the type of sterilizer
18. The ETO cartridge must be discarded in a safe manner according gas manufacturer/supplier and
hospital policies
19. Personnel exposure must be measured as a Time Weighted Average based on environmental
exposure. Average personnel exposure concentration should be measured over a specific period of time,
usually 8 hours
20. Employer must ensure that no employee is exposed to airborne concentrations of ETO in excess of
the concentration recommended by suppliers.
21. ETO won’t penetrate soil so proper cleaning and decontamination must be done for the items that
will be processed (See Cleaning SOP)
22. Soil and Liquids hinder sterilization efficacy and may result in harmful residuals being formed: Water
+ EO = Ethylene Glycol (Antifreeze); Saline + EO = Ethylene Chlorohydrins (Possible carcinogen)
23. Material compatibility with EtO must be validated by the device manufacturer
24. Aeration Cabinets are required to remove residual ETO before patient contact with the device
25. If plastic instrument containers/trays are used, make sure they can be sterilized with ETO and aerated
26. It is important that the ETO is aerated from the device within and from the plastic container itself
with no cumulative ETO absorption/residual into the plastic that cannot be satisfactorily removed by
each aeration cycle
27. Plastic, rubber or silicone mats must have been validated by the manufacturer for suitability in ETO
processing
28. Make sure that instrument tip protector manufacturers have validated their recommendations for
the application and use of ETO
29. Verify with the manufacturer if colour code tape can be used with ETO
30. 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
31. Do not use plastic coated baskets unless designed and validated for ETO sterilization and aeration •
Label Package according to policy
32. Load items in a loose fashion to facilitate air removal, humidification, ETO circulation and penetration
of all surfaces, and ETO removal during aeration
33. Packages must not contact walls or ceiling of chamber, package damage from heat or moisture may
occur
34. Process full loads to limit the number of cycles you need to run
35. Load the sterilizer according to manufacturer’s instructions, make sure the door to the chamber is
locked, and the appropriate cycle is selected based on the types of devices being processed
36. Group like products that need same aeration times to avoid exposure when opening the
sterilizer/aerator to retrieve items during the aeration process
37. Load baskets and carts so hands won’t touch packs if you need to transfer them to an aeration
cabinet.
38. For approved rigid containers, follow manufacturer’s validated loading instructions.
39. Follow manufacturer’s directions for door opening and load transfer
40. When unloading some sterilizer manufacturers recommend immediate removal if transferring items
to a freestanding aerator
41. Opening the door 2 inches for 15 minutes is recommended…obviously you would not remain in the
area
42. Load is transferred to separate aeration unit/area
43. Rolling carts should be PULLED (NOT pushed) to minimize Operator exposure to off-gassing ETO
vapors
44. Butyl rubber or Neoprene gloves should be worn if Operator will be in possible contact with ETO
residuals, touching wrappers before aeration
45. Aeration in the sterilizer doesn’t require transfer
46. Aerate until potentially toxic ETO residues are removed before storage and use of medical devices
47. Length of aeration depends on Composition/materials, thickness, design and weight of the device
and it’s wrapping, sterilization and aeration system used, temperature, ETO, concentration, duration of
gas exposure, rate of air exchange, and air flow pattern
48. Size and arrangement of packages in the sterilizer/aerator or aeration cabinet and the number of ETO
absorbent materials being aerated
49. Device manufacturer’s recommendations must be VALIDATED aeration parameters
(time/temperature)
50. Manufacturer recommended aeration times MUST BE FOLLOWED!!!
51. Preset temperature selections per the aerator manufacturer
52. The aeration time must be uninterrupted
53. 8 hours at 140° F (60°C), 10 hours at 130° F (54°C), 12 hours at 120°F (49°C), 20 hours at 100° F (38°C)
54. DO NOT remove prematurely, with premature removal, personnel and patients may be adversely
affected
55. Signing a waiver sheet DOES NOT relieve any liability for anyone
56. “Ambient air” aeration is not recommended as it greatly increases the risk of worker exposure to EO
and is not necessarily a reliable means of removing ETO from the items

Standard Operation Procedure Policy Title:

SOP No. 14 Low Temperature Sterilization

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq
Area of application:
Plasma sterilization area

Staff involved:
Only CSSD and theater staff trained for this task.

Objective/ Purpose:
To ensure that all heat sensitive medical devices are sterilized to an acceptable standard and ready for
use.

Safety Warning:
Always wear gloves recommended by manufacturer when handling Hydrogen Peroxide cassettes or
cartridges, and when removing items from the sterilizer if the cycle has been aborted.

Relevant / Related Documents:

Manufacturer’s Manual
Standard Precautions

Equipment/Supplies:
Sterilizer
Cassettes / cartridges
Tyvek
Wrap recommended by manufacturer
Cassette collection boxes
Printer paper
Instrument sterilization containers recommended by manufacturer
Personal Protective equipment

Procedure:
1. Used for heat sensitive items with specific diameter and tube length. A) Any item that is not
completely dry. B) Items or materials that absorb liquids. C) Items made from materials containing
cellulose e.g., Cotton, paper, cardboard, linens, gauze or items that contain wood pulp
2. Do not remove cassette from plastic wrapper if indicator strip is red (Sterrad) this indicates That the
cassette might have been damaged
3. Use manufacturer approved biological indicators ) biological monitoring is recommended to be
performed with every load.
4. Place biological monitor into a Tyvek pouch then put it with load in sterilizer as per manufacturer’s
recommendation (Sterrad: Back of the chamber on the bottom shelf with the opening toward the back
of the chamber).
5. Incubate Biological indicator at temperature as recommended by manufacturer.
6. Preparing Items for loading & Loading sterilizer.
7. All items must be thoroughly cleaned and dried before packaging.
8. Use packaging and containers recommended by the manufacture.
9. Place chemical indicator in each packaged item.
10. Arrange items in such a way as to ensure sterilant will come into contact with the surfaces.

Standard Operation Procedure Policy Title:

SOP No. 15 The Delivery and Distribution of Processed Items

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
All sterile storage and dispatch areas

Staff involved:
Only staff trained in CSSD/Theatre

Objective/Purpose:
To ensure customers receive sterile items in a safe condition and ready to use

Relevant/Related Documents:
Quality Manual
Dispatch Log

Equipment/Supplies:
Clean Trolleys

Procedure:
1. All items will be checked for sterility before they are released
2. The following should be checked when deciding if the pack is still sterile: - a) Holes or tears b) Wetness
or stains c) Broken seals d) Dust e) Evidence of crushing
3. All damage items are returned to the decontamination area
4. All items issued will be recorded so that a tracking system is effected
5. Various methods can be used in the transport of sterile packaged items to their point of use.
6. This can range from hand carriage (in particular where a decontamination area is located close or
adjacent to a point of use), to the use of trolley’s and other such transport systems for taking items to a
remote location (within a facility or at a different facility).
7. Sterile supplies should be transported in covered or enclosed trolleys with a solid bottom shelf. The
solid bottom shelf prevents microorganism on the floor being picked up by the wheels of the trolley and
then spun upwards onto the sterile packs.
8. If items are placed inside plastic or paper bags, they should be arranged to prevent them from being
crushed or damaged during transport. They all protect medical devices from damage
9. Items must be placed onto a clean trolley that can be covered
10. Trolleys must not be overloaded
11. Soiled items must NOT be loaded onto the same trolley
12. Loaded trolleys must not be left to stand

Standard Operation Procedure Policy Title:

SOP No. 16 Planned Scheduled Equipment maintenance

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of Application:
Sterile Service Department

Staff Involved:
Senior Staff
Maintenance Department

Objective/Purpose:
To ensure all plant and equipment is checked and maintained in good working order according to
manufacturer’s guidelines and departmental maintenance schedule

Relevant/Related Documents:
Quality manual
Working Instructions Manual
Planned Preventative Maintenance Schedules
Machine Log

Equipment/Supplies:
All machinery and equipment used in the Decontamination Department

Procedure:
1. A schedule of planned maintenance of all machinery and equipment used in the Decontamination
Department is documented.
2. Shutdown of equipment is planned according to schedule
3. The work to be carried out at each check is documented.
4. All maintenance carried out is recorded
5. Log Books will be examined at least on a monthly basis or as appropriate, and signed by the test
person, designated for all equipment, for completion and accuracy.
6. Task sheets for weekly and quarterly Planned Maintenance detail the work to be undertaken and work
order dockets are completed by the maintenance person responsible and a copy issued to the CSSD
manager for filing in the appropriate log after the service schedule has been updated
7. Senior staff will carry out daily checks on equipment in all Areas according to policy and as detailed in
the Working Instructions Manual
8. Testing will be carried out at prescribed frequencies (Daily, Weekly, Quarterly and Annually).
9. Results will be recorded on the Daily Test / Check Forms in the respective log books
10. Service Engineers will carry out inspections under the planned preventative maintenance program
according to the agreed schedule.
11. At the end of the visit the Service Engineer will complete a Preventative Maintenance Plan (PMP)
form for the equipment checked.
12. The Service Engineer must sign the report.

Standard Operation Procedure Policy Title:

SOP No. 17 Sterile packaging

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
Packing area

Staff involved:
Only CSSD and Theatre Staff trained in the task

Objective/ Purpose:
To ensure that the correct materials are used and that items are correctly packaged in order to maintain
sterility

Relevant / Related Documents:

Manufacturer’s information
Sterilization policy and process
Quality Manual

Equipment/Supplies:
Stainless steel packing tables
Packaging materials
Packaging Accessories e.g. Tape, sealers

Procedure:
1. Sterile packaging must provide protection against contamination during handling as well as providing
an effective barrier against microbial penetration.
2. Items classified as critical devices should be packaged for sterilization (with the exception of flash
sterilization methods)
3. An ideal packaging should have the ability to allow sterilization agents to penetrate and then provide a
barrier, which will maintain the sterility of the wrapped devices.
4. Use only medical grade SABS approved packaging
5. The type of packaging and the way you package the devices will determine if aseptic opening is
possible in the operating theatre or the ward.
6. The packaging should allow air that is in the pack to be driven out and the sterilizing agent to reach all
surfaces of its content.
7. The packaging should protect the contents against damage during handling and transport.
8. The packaging should be able to withstand the conditions during the sterilization process such as
pressure changes, high temperature and humidity
9. It is important that the following points are taken into consideration when choosing a tray/set and
packaging method:
a) The type of pack
b) The size and weight of items to be packed
c) The number of times the pack will be handled before use
d) The number and training of personnel who may handle the pack
e) The distances that packs will be transported
f) Whether the storage system is open or closed
g) The condition of the storage area (cleanliness, temperature, humidity)
h) If secondary packaging (e.g., aseptic bags or dust covers) will be used or are necessary
i) The method of sealing packs
10. The packaging should bear a clearly visible marking indicating whether or not the product has been
through a sterilization process.
11. There are many different types of packaging that can be used for different items
12. Packaging material used in steam sterilization must be able to withstand high temperatures, allow for
adequate air removal, be flexible considering changes in pressure during the process, permit steam
penetration to the pack's contents and allow for adequate drying.
13. Packaging materials used with low temperature sterilization processes (e.g., ethylene oxide and
gaseous hydrogen peroxide processes) must have similar properties, particularly being compatible with
the sterilization chemicals, moisture, pressure changes and temperature ranges.
14. The packaging system chosen should be appropriate for the items being sterilized and compatible
with the specific methods of sterilization being used.
15. Choose packaging to suit the dimensions of the instruments/tray and type of sterilization technique
to be used.
16. In addition to containers, individual devices and sets can be packaged with sterilization pouches or
wraps
17. The choice of packaging will generally depend on the sterilization method being used.
18. Packaging materials should only be used that have been tested to be compatible and safe for each
sterilization purpose.
19. Always follow manufacturer and hospital guidelines
Medical Grade single Use Disposable Sterilization Wrap:
1. Double wrapping creates a package within a package.
2. Two sheets of wraps are used providing multiple layers of protection of surgical instruments from
contamination. Double wrap = wrap and wrap
3. The use of two layers of wraps reinforces the strength of the packaging.
4. Folding the two wraps separately, one after the other makes the pack more secure, as the greater the
number of folds the more tortuous the path becomes for micro-organisms to penetrate into the
packaging.
5. The double wrap with two sequential folds also affords a two-step unwrapping process which assists in
aseptic presentation and creation of a sterile field for users in the operating theatre; the outer wrap is
removed before entering the operating room or by an assistant.
6. Do not re-use single use packaging
7. Use a hospital grade masking tape and autoclave tape when using wrap
8. Do not write on packaging

Disposable Peel-open Pouches and Reels:

1. Paper/Plastic peel-open packaging materials are suitable for steam, steam formaldehyde and low
temperature sterilization processes such as ethylene oxide. It is not suitable for use in hydrogen peroxide
gas and ozone sterilizers, again due to the paper (cellulose) content. Disposable peel-open pouches and
reels are designed to contain lightweight or small items and are available in various sizes, for single use
only.
2. Peel-open packaging should not be used for heavy or bulky items because the seals can become
stressed and rupture.
3. Pouches are available in many sizes.
4. The open end of the pouch is closed with a sealing device. It is essential that the heat sealer is
functioning effectively in order to get an adequate seal.
5. Both ready-made pouches and reels are available flat or with side gussets for packing bulkier objects.
6. The user can cut reels to any size needed, in which case both sides of the pack will need to be sealed
by the user.
7. Peel-open packaging is useful when visibility of the contents is important.
8. When packaging items, care must be taken to leave a minimum of 1 inch (2.5cm) of space between
the end of the item and the seal of the pouch or reel in order to facilitate aseptic opening.
9. When double pouching, the inner pouch should be at least a size smaller than the outer pouch to
prevent folding which may entrap air and inhibit the sterilization process. They must be packaged paper
against paper, plastic against plastic in order to enable sterilant penetration.
10. A felt-tip, indelible, non-toxic ink marker can be used on clear plastic side of the pouch to label.

Reusable rigid container systems :

1. Sterilization containers are a durable sterilization packaging system constructed of a rigid material
such as metal, or plastic.
2. A variety of sizes can accommodate a wide range of instrument sets. Containers need to be
disassembled and cleaned after each use, following the reprocessing instructions supplied by the
container manufacturer.
3. Remember! Containers are classified as devices themselves and as such should be reprocessed after
each use, not just wiped down. Containers must be cleaned in the same way as any other reusable
device.
4. Following reprocessing they should be checked to include: a) Checks of gaskets for fraying, cuts,
missing pieces, bubbling or compression b) Cleaning reusable filters and inspecting them for cracks or
chips. The number of uses also needs to be logged and the manufacturer’s recommendations not
exceeded.

Standard Operation Procedure Policy Title:

SOP No. 18 Decontamination of Textiles/Linen for sterilization

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
Laundry
Linen room, packing area

Staff involved:
Trained CSSD Staff

Objective/ Purpose:
To ensure that all contaminated textiles are cleaned, disinfected and inspected to an acceptable
standard.

Relevant / Related Documents:

Sterilization policy and process
Quality Manual

Equipment/Supplies:
Washing Machine
Drier
Ironing
Detergent
Stain Remover
Container bags

Procedure:
1. Standard precautions for linen and laundry must be adhered to when working with linen that may be
contaminated with secretions from patients
2. Staff should wear full PPE when dealing with contaminated textiles to protect themselves and to avoid
injuring or contaminating their hands with sharps and soilage. They should handle contaminated linen as
little as possible
3. Bags of soiled textiles should be taken to a dedicated soiled linen area i.e. a dirty area
4. All masking/autoclave tape must be removed from the textiles prior to returning them to the laundry.
5. Standardized validated washing and disinfecting processes should be used.
6. Moisten soiled textiles to prevent staining. Treat stains to prevent them setting.
7. Stains must be removed if possible, holes must be repaired with heat patches, foreign debris (hair, lint)
must be removed, labels etc. removed and tapes on gowns repaired.
8. Soiled textiles should be sorted before being loaded into washer, to prevent damage to machines from
sharps and instruments.
9. A validated written process must be used to determine when textiles, used in packing, need to be
withdrawn from use. (condemned)
10. A cold prewash rinse cycle will remove gross soilage preventing it from baking onto the fabric.
11. A hot detergent cycle of at least 91 degrees C will destroy microorganisms.
12. A minimum wash time of 25 minutes is commonly recommended. Soaps or detergents loosen soil
and also have some microbicidal properties, so it is crucial to use only recommended detergents that will
also not cause irritation to skin.
13. The addition of a mild acid to neutralize any alkalinity in the water supply, soap, or detergent
decreases skin irritation and further reduces the number of bacteria present • Clean textiles must be
stored in a clean storage area with slatted shelving and transported in a closed container to prevent
cross contamination.
14. Textiles that are to be returned to the Reprocessing Area for sterilization must pass through a
validated process and be appropriately transported to the sterile processing department
15. Textiles should be visually inspected between drying and packing, with the assistance of a light table,
for stains, physical defects, foreign debris, labels/tape, against written quality standards. The critical
zones of gowns, drapes, table covers, and sterilization wraps, as defined by ISO 13995, should be visually
inspected to determine if they meet the criteria.
16. If textiles are being processed and used as a ‘sterile items’ they become an integral part of the
Reprocessing Facility quality assurance program and need to have a system in place that enables
complete traceability.
17. Quality assurance measures need to be in place to ensure that every step in the process i.e.
collecting, cleaning, disinfecting, drying, function checks, storage and transporting of textiles meet
validated process specifications. Acceptable standards can be met if reusable textiles are treated as
medical devices and are professionally processed accordingly.
18. The drying cycle is an important part of the cleaning process as it assists in killing any remaining
microorganisms that may be left after the laundry machine has done its work. Drying in a dryer is
recommended, as the heat can be very efficient in killing microorganisms, air drying in direct sun-light is
also an option.
19. Linen to be sterilized must be appropriately wrapped before being sent to the sterile processing
department. Linen must not be placed or stored on the floor.
20. Linen must be stored in a dedicated clean storage area.
Standard Operation Procedure Policy Title:
SOP No. 19 Recall Procedure

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
CSSD, Wards, Clinics and Theatre

Staff involved:
All CSSD, wards, clinic and theatre personnel

Objective/Purpose:
To ensure that any product suspected of being substandard is identified, quarantined, collected,
investigated, and the findings recorded.

Relevant/ Related Documents:

Sterilization policy and process
Quality manual
Working instructions manual
Daily, weekly, quarterly and annual test record

Equipment/ Supplies:
N/A

Procedure:

 In the event of sterilization failure, such as positive biological indicators (BI)/failed load controls
or sterilizer malfunction, items from that test and previous loads after the last known good test
must be immediately recalled.
 All affected trays must be recalled in the event of failed quality management tests i.e. positive
biological indicator (BI), load control.
 Take the following steps after incubating and reading each BI that has been run through the
sterilizer.
1) If BI indicates “no growth”, (a negative BI) document the finding in the sterilization
log for that cycle.
2) If BI indicated “ growth of organism”, (a positive BI) then proceed as follows;
 A written recall procedure must be followed in the event of a sterilization failure.
 The sterilizer must be shut down and all the staff members must be made aware that it is out of
operation.
  The sterilization record sheets should be checked for a list of “sterilized items that need to be
recalled.
 The recall procedure should be documented on the sterilization record sheets listing what items
have been retrieved and reprocessed and which items had already be used and on whom. Note
items that may have already been used on the list.
 As it becomes apparent that items need to be recalled, reprocessing personnel will immediately
notify users and retrieve the supplies from the storage and from user as soon as possible.
 A recall is usually authorized by the most senior staff member on the shift.
 Other responsible persons i.e. infection control should be advised of the recall according to
hospital policy.
 Affected departments should be advised verbally as soon as possible with a followup written
confirmation advisory stipulating which items, trays from a particular batch are suspect and
should be returned.
 Departments should be requested to check their sterile stock as well as used stock for the
suspect batch.
 The following details will be given:
1) The name of the sets to be recalled.
2) The sterilizing date
3) Details of the action to be taken
4)Reasons for the recommended actions and any likely associated hazards
 Notify the local medical officer of health if medical equipment that has been reprocessed in a
failed cycle was used on the patient. The MOH with help from experts in Infection Prevention
and Control will assist in determining the risk of the disease transmission and the need for a
look-back of potentially affected patients.
 Sterile services staff will attempt to confirm that the check has been carried out.
 Any decontamination in the CSSD will be checked by the sterile services staff and any identified
suspect batch removed.
 Sterile services staff will arrange collection of any identified suspect stock on the premises.
 Recalled items should be labeled “Under Quarantine” whilst in transit to the cleaning area of the
reprocessing area where it will be reprocessed or be put into quarantine.
 All items retrieved from a Recall must be completely reprocessed.
 All items must be disassembled, processed with fresh linen, assembled, rewrapped and
sterilized.
 Once the sterilizer has been repaired all monitoring results will be checked before the sterilizer is
used.
 The cause of the recall should be investigated and a report written.

Standard Operation Procedure Policy Title:

SOP No. 20 Sterile Storage
Prepared by: Section:
Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
Storage area

Staff Involved:
CSSD staff

Objective/ Purpose:
To ensure safe storage of all the sterilized equipment and medical devices.

Relevant/ related documents:

Quality Manual
Logbook

Procedure:
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 are completely dry
- Integrity of the outer wrap
- Coloring of sterile indicator tape, date prepared, initialed
- Lot number labels
4. Any sterile item that has been dropped on the floor in 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 are 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 should be within the range of 35%-
50% to prevent drying out or premature breakdown of material of seal.

Standard Operation Procedure Policy Title:

SOP No. 21 Tracking System and validation of equipment

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
All equipment (present or new)

Staff Involved:
CSSD, clinic, ward, theater personnel

Objective/ Purpose:
To ensure that all equipment which can influence quality or safety is not used for processing until its
performance has been approved and can be tracked easily.

Relevant / Related Documents:

Manufacturers Instructions
Sterilization policy and process
Quality Manual
Relevant ISO Standards

Equipment/Supplies:
N/A

Procedure:
1. Ensure all new equipment ordered for CSSD is appropriate and safe to use
2. Copies of any relevant documentation relating to the equipment must be given to the manager
3. Equipment will not be used until it has been validated and an assurance is given that the equipment
will give an acceptable quality of product and is safe to operate
4. The installer / manufacturer should verify in writing that all is in order by way of a certificate.
5. This certificate is to be maintained with the log book for the equipment
6. Equipment will only be used after the necessary training is given to the staff
7. No new or replacement equipment will be used without the appropriate approval and training
8. Ensure that surgical instruments can be tracked through decontamination processes .
9. Labels are applied to the external packaging, prior to sterilization to allow ease of identification of the
contents of a package and the process
10. Packaging should be labeled prior to sterilization in a way that does not compromise the integrity of
the pack.
11. Labeling must not:
- Affect the sterility or integrity of the pack
- Transfer to pack content -Interfere with the decontamination process
- Become detached after sterilization or subsequent storage
12. An electronic system allows the items to be scanned by a hand held scanner with the information
downloaded to produce a batch report.
13. A common method involves the use of bar codes that are used to identify packs and device locations
by a scanning process
14. Packaging systems should be labeled with;
- a description of the package contents
- identification of the person receiving, cleaning, checking, assembling, sterilising, storing, dispatching
the package
- a lot control number
- any expiration date/shelf life statement applicable to the facility
- dispatch information
15. All affected trays can be recalled in the event of failed quality management or in the event of a
contagious disease or infection, if an effective tracking system is available.

Standard Operation Procedure Policy Title:

SOP No. 22 Reprocessing Endoscope

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Area of application:
Endoscopes

Staff involved:
CSSD staff trained for this task

Objective/ Purpose:
To ensure proper sterilisation of the endoscopes.

Relevant/ related documents:

Manufacturer Manual
Sterilization policy and process
Quality Manual
PPE

Procedure:
1. Endoscopes or accessories that contact sterile tissue (e.g.,laparoscopes, arthroscopes and other
scopes) should be sterilized and endoscopes that contact intact mucous membranes (e.g., the
respiratory and gastrointestinal tracts) undergo at least high-level disinfection before each use.
2. All heat-sensitive endoscopes (e.g.gastrointestinal endoscope, bronchoscope, nasopharygoscope)
must be at a minimum, subjected to high-level disinfection after each use.
3. Sterilization with a liquid chemical sterilant may not convey the same sterility assurance as sterilization
achieved using thermal or low temperature chemical gas/ plasma/vapor sterilization.
4. Personnel in the endoscopy suite should be trained in and adhere to standard precautions and safety
measures regarding the biological and chemical hazards.
5. Personnel assigned to reprocess endoscopes should receive device-specific reprocessing instructions
i.e. endoscope and/or automatic endoscope reprocessor (AER).
6. Personal protective equipment PPE (eg, gloves, gowns not water permeable, mask, eyewear,
respiratory protection devices) should be readily available and should be used during handling of the
endoscopes, as appropriate, to protect workers from exposure to chemicals and blood or other
potentially infectious material.
7. Pre-cleaning 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 .
8. Flush suction/biopsy and air/water channels with enzymatic detergent. Other channels should be
cleaned per manufacturer’s instructions.
9. Remove all detachable parts e.g., valves/buttons/caps and clean with enzymatic detergent.
10. Correctly dispose of parts designated as single use.
11, Transport the soiled endoscope and accessories to the reprocessing area immediately before
remaining soil dries.
12. An open container can suffice for transport to immediately adjacent reprocessing rooms, but fully
enclosed and labeled containers should be used for transportation to distant areas.
13. Select a liquid disinfectant or sterilization technology that is compatible with the endoscope. FDA
maintains a list of cleared liquid chemical sterilants and high-level disinfectants with the exposure time
and temperature that can be used
14. At this time, the FDA-cleared and marketed formulations include:
a) >2.4% glutaraldehyde at 25ºC range from 20-90 minutes (professional organizations support the
efficacy of >2% glutaraldehyde for 20 minutes at 20ºC),
b) 0.55% ortho-phthalaldehyde (OPA) for 12 minutes at 20ºC,
c) 0.95% glutaraldehyde with 1.64% phenol/phenate,
d) 7.35% hydrogen peroxide with 0.23% peracetic acid for 15 minutes at 20ºC,
e) 7.5% hydrogen peroxide .
15. Disinfectants that are not FDA-cleared and should be strongly discouraged because of lack of proven
efficacy against all microorganisms or materials incompatibility are:
- Iodophors
- alcohols
- chlorine solutions
- phenolic
- quaternary ammonium compounds
16. Visually inspect both endoscopes and reusable accessories frequently in the course of their use and
reprocessing, before, during and after use, as well after cleaning and before disinfection.
17. Damaged endoscopes and accessories should be removed from use for repair or disposal
18. When storing the disinfected endoscope, hang it in a vertical position to facilitate drying with caps,
valves and other detachable components removed, per manufacturer’s instructions.
19. Reuse of endoscopes within 10 to 14 days of high-level disinfection appears to be safe although
shorter period is recommended.
20. Sterilized endoscopes must be stored sealed in the container or packaging in which they were
sterilized

Standard Operation Procedure Policy Title:

SOP No. 23 Decontamination and Management of
Laryngoscopes
Prepared by: Section:
Dr Amina Tariq CSSD
Mr. Ishfaq

Objective/ Purpose:
To ensure that all laryngoscopes are decontaminated and fit for purpose.

Scope:
All laryngoscopes returned to CSSD.

Area of Application:
CSSD
Wards
Theatre

Staff Involved:
Only staff trained in decontamination of laryngoscopes

Relevant/Related Documents:
Procedure Manual
Standard Precautions

Equipment:
PPE C
Cleaning materials
Disinfectant

Procedure:
1. When washing Instruments manually standard/universal precaution must be applied at all times.
2. Only staff trained in decontamination should manually clean medical devices
3. Identify the correct process for the items to be decontaminated following manufacturers instructions.
4. Check laryngoscope for functionality.
5. Any laryngoscope found to be non-functional should be taken out of service and replaced or repaired
as soon as possible.
6. All instruments should be cleaned and sterilised according to department policy.
7. If the blade is disposable, dispose of it according to hospital policy
8. At point of use, immediately after use, the laryngoscope blade should have been rinsed in clean tap
water or wiped down to remove any residue.
9. Before cleaning check that the bulb in the laryngoscope is working.
10. Disconnect the blade from the handle.
12. Prior to removal of light carrier, allow the lamp to cool.
13. Prior to cleaning, remove any debris trapped between the carrier and the blade. Reassemble the
light carrier and blade.
14. Check that the lamp is sufficiently tightened before submerging in water.
15. NOTE: Submerging in water with lamp removed will result in damage to the electrical circuit.
Unscrew bottom cap of handle and remove batteries.
16. NOTE: Batteries will be damaged if submerged in water
17. External surfaces should then be gently scrubbed with a soft brush, to provide a thorough cleaning.
(using a medical grade detergent prepared as per the manufacturers instructions)
18. Either clean manually or in an automated cleaner according to manufacturers instructions
19. After cleaning, rinse blades thoroughly, and dry prior to disinfection/sterilization.
20. Inspect physical condition for: Foreign Substances, Damage or cracks, broken, loose or wear
WARNING: ultrasonic cleaning is not recommended
21. A minimum of High Level Disinfection is required.
22. If recommended by manufacture blades may be steam autoclaved NOTE: Autoclaving with lamp
removed will result in damage to the electrical circuit.
23. Standard battery handles are usually not compatible with steam autoclave sterilization
24. Autoclaveable handles can often be identified by the term ‘AUTOCLAVE’ written on the handle. If
they do not have the marking they ARE NOT autoclavable
25. Always wrap laryngoscope blades and handles unattached if autoclaving. NOTE: Do not exceed
temperature of 134°C
26. Flash and Hot air sterilisation is not recommended
27. If disinfecting refer to solution manufacturer’s instructions for recommended exposure times and
solution concentrations, NOTE: Disinfecting with lamp removed will result in damage to the electrical
circuit. Prior to immersion, ensure that the lamp is secure.
28. Rinse thoroughly in sterile water.
29. Dry with a non linting cloth

Test Procedure:
1. Once Disinfected/Autoclaved (unwrap pack) replace appropriate size batteries (as per manufacturers
instructions) into Laryngoscope handle and replace bottom cap. Stubby handle: insert battery pack with
tab side down.
2. Laryngoscope blades and handles should always be tested after cleaning/disinfection/sterilization and
prior to use.
3. To check, connect the laryngoscope blade to the handle and pull open to the “on” position. If the unit
fails to light or flickers, check the lamp/ batteries.
3. Be sure adequate supplies of spare lamps, batteries, and replacement parts are readily available.
4. Be sure the lamp’s glass envelope is clean and free of any fingerprints after assembly. If necessary, the
glass may be cleaned with a soft cloth or cotton ball moistened in alcohol.
5. Wrapping the reassembled laryngoscope should protect it from contamination until the item is to be
used
6. A re-sealable plastic bag or other impermeable wrap may be used as the covering because the
laryngoscope is clean not sterile. Wrapping the blades in sterilization wrap or a sterilization peel pack is
not recommended because this may lead the user to think that the blade is sterile.
7. Contamination may result from a clean blade coming into contact with a contaminated laryngoscope
handle.
8. The item should be clearly labelled as being high-level disinfected and not sterile. Labelling should also
contain some method to indicate the date when the high-level disinfection occurred and the person
responsible for completing the process.

Standard Operation Procedure Policy Title:

SOP No. 24 Waste Management

Prepared by: Section:

Dr Amina Tariq CSSD
Mr. Ishfaq

Objective/ Purpose: 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

Procedure:

Categories of health-care waste Descriptions and examples

Sharps waste Used or unused sharps (e.g. hypodermic,
intravenous or other needles; auto-disable
syringes; syringes with attached needles; infusion
sets; scalpels; pipettes; knives; blades; broken glass
Infectious waste Waste suspected to contain pathogens and that
poses a risk of disease transmission (e.g. waste
contaminated with blood and other body fluids;
laboratory cultures and microbiological stocks;
waste including excreta and other materials that
have been in contact with patients infected with
highly infectious diseases in isolation wards)
Non-hazardous or general health-care waste Waste that does not pose any particular biological,
chemical, radioactive or physical hazard
Colour code:

- Yellow bags : infectious waste, incineration

- Blue/ black bags : domestic waste
- Red bags : microbiological/solid waste