Central Sterile Services Department

CENTRAL STERILE SERVICES
DEPARTMENT
‫الدليل االرشادي ألقسام التعقيم المركزية‬

Guidelines for Central Sterile Processing
Version 1: January 2021
Version 1: January 2021
‫الدارة العامة لمكافحة عدوى المنشآت الصحية‬

General Directorate of Infection Prevention & Control (GDIPC)
In the name of ALLAH, Most -
Gracious, Most Merciful
1 | Guidelines for Central Sterile Services Department - Version 1: January 2021

MESSAGE FROM THE GENERAL DIRECTOR
It is with utmost enthusiasm that I would like to present the first version of CSSD manual for the
health care facilities. GDIPC team has succeeded in establishing a comprehensive manual that covers all
important domains of sterile processing to ensure a high quality end product that can be safely used for the
patients.
Central Sterile Services Department holds the key responsibility for reprocessing instrumentation and other
reusable medical devices. The process involves handling, collecting, transporting, sorting, disassembling,
cleaning, disinfecting, inspecting, packaging, sterilizing, storing, and distributing reprocessed items.
The ultimate goal of sterile services is to provide safe, functional, and sterile instruments and medical
devices and reduce the risk for healthcare associated infections.
We hope this manual will provide CSSD personnel with the information and skills needed to standardize the
work practices, thereby decreasing the risk of operator errors and improving patient outcomes.
In conclusion, I ask the Almighty Allah to accept these efforts & grant staff with required knowledge and
expertise for effective implementation.
Dr Khalid H. Alanazi -
Director General, -
General Directorate of Infection Prevention & Control (GDIPC) -
Ministry of Health -
Kingdom of Saudi Arabia -

CONTRIBUTORS
Ms. Aisha M Al Shehri Mr. Abbas M Al Qahtani

ashehrim@moh.gov.sa aalqahtani@moh.gov.sa
Ms. Arwa F Shesha Mr. Ibrahim M Al Dhuwaihi

ashesha@moh.gov.sa imaldhuwaihi@moh.gov.sa
Mr. Azeez H Saleh Mr. Bandar H Al Ruwaili

azizalsaleh36@yahoo.com Bal-rwaily@moh.gov.sa
Dr. Faiza Rasheed Mr. Majdi M Al Solumani

fshuja@moh.gov.sa Malsolumani@moh.gov.sa
Dr. Abdul Majid M Al Mutairi

aalmutairi53@moh.gov.sa
Ms. Amal A Almedaini
AAlmedaini@moh.gov.sa
Ms. Amani S Samman

sammana@moh.gov.sa

TABLE OF CONTENTS
---------------------------------------------------------------------------------------------------------------------------
1. Message from General Director----------------------------------------------------------------- 02

2. Definitions ---------------------------------------------------------------------------------------- 05
3. Introduction to Central Sterile Services Department (CSSD)----------------------------- 08
4. Chapter – I: Infection Prevention & Control in CSSD --------------------------------------- 09
a. Hand Hygiene (HH) ------------------------------------------------------------------- 10
b. Personal Protective Equipment (PPE) ---------------------------------------------- 10
c. Dress Code ---------------------------------------------------------------------------- 11
d. Environmental Hygiene -------------------------------------------------------------- 12
5. Chapter – II: CSSD Staff Qualification & Safety --------------------------------------------- 14
a. Training and Education -------------------------------------------------------------- 15
b. Staff Skills ---------------------------------------------------------------------------- 15
c. Occupational Healthcare and Safety ----------------------------------------------- 16
d. National Criteria for CSSD Staffing Level ----------------------------------------- 19
6. Chapter – III: CSSD Design / Infrastructure -------------------------------------------------- 20

a. Design Layout ------------------------------------------------------------------------- 21
b. Traffic Control and Workflow -------------------------------------------------------- 22
c. Environmental Control of CSSD Facilities ------------------------------------------ 24
7. Chapter – IV: CSSD Functions ------------------------------------------------------------------ 25
a. Point of Use/Pre-Cleaning ----------------------------------------------------------- 27
b. Transportation of Contaminated Reusable Medical Device to CSSD ----------- 27
c. Decontamination Area ---------------------------------------------------------------- 30
d. Inspection, Assembly & Packaging Area ------------------------------------------- 41
e. Sterilization of Reusable Medical Devices (RMD) -------------------------------- 49
f. Sterilization Area / Steam Sterilizers ---------------------------------------------- 51
g. Sterile Process Monitoring & Recalls ----------------------------------------------- 52
h. Plasma Sterilizers ------------------------------------------------------------------- 57
i. Sterilizers Maintenance -------------------------------------------------------------- 59
j. Sterile Storage Area ------------------------------------------------------------------ 60
k. Distribution of Sterile Items --------------------------------------------------------- 62
l. Documentation & Record Keeping ------------------------------------------------- 63
8. References --------------------------------------------------------------------------------------- 64

DEFINITIONS
Bactericidal Agent that kills bacteria.

Accumulated mass of bacteria and extracellular material that is
Biofilm tightly adhered to a surface and cannot be easily removed.
Diagnostic test of a sterilizer's ability to remove air from the

Bowie-Dick Test chamber of a steam sterilizer with dynamic air removal. The air-
removal or Bowie-Dick test is not a test of sterilization.
A non-biological indictor test system designed to respond with a

chemical or physical change to one or more of the conditions in the
sterilizing chamber. CI is categorized according to their intended
Chemical Indicator
use; i.e., Differentiation between unprocessed and processed items,
(CI)
specific tests and or procedures; assess the attainment of the
process parameters. CIs are expressed in six types and categories
(see section on Routine Monitoring for further information)
Cleaning agent that makes no antimicrobial claims on the label.

They comprise a hydrophilic component and a lipophilic component
Detergent
and can be divided into four types: anionic, cationic, amphoteric,
and non-ionic detergents.
Usually a chemical agent (but sometimes a physical agent) that

Disinfectant destroys disease-causing pathogens. It refers to substances applied
to inanimate objects.
Thermal or chemical destruction of pathogenic and other types of

microorganisms. Disinfection is less lethal than sterilization because
Disinfection it destroys most recognized pathogenic microorganisms but not
necessarily all microbial forms (e.g., bacterial spores).
A cleaning agent that contains enzymes (e.g., protease, amylase,

lipase) that break down proteins such as blood, body fluids,
Enzymatic secretions and excretions from surfaces and equipment. They are
Detergent used to loosen and dissolve organic substances prior to cleaning.
The agent may use a single enzyme or multiple types of enzymes.

Period in a disinfection or sterilization process during which items
are exposed to the disinfectant or sterilant at the specified use
Exposure Time parameters. For example, in a steam sterilization process, exposure
time is the period during which items are exposed to saturated
steam at the specified temperature.
High-level Destruction of vegetative bacteria, viruses, fungi and mycobacteria in

Disinfection (HLD) or on devices, except for small numbers of bacterial spores.
Level of disinfection that destroys all vegetative bacteria (except

Low-level tubercle bacilli), lipid viruses, some non-lipid viruses, and some
Disinfection (LLD) fungi, but not bacterial spores.
Specialized clothing or equipment worn by a healthcare worker

(HCWs) for protection against a hazard. General work clothes (e.g.,
Personal Protective uniforms, pants, shirts) not intended to function as protection
Equipment (PPE) against a hazard is not considered to be PPE. PPE includes thick
general-purpose gloves, fluid resistant covering with long sleeves,
fluid resistant mask, eye protection and hair covering.
Physical Use of a mechanical device to monitor the physical conditions of the

Monitoring sterilization process (e.g., graphs, gauges, printouts).
Transmissible pathogenic agents that cause a variety of

neurodegenerative diseases of humans and animals, including sheep
and goats, bovine spongiform encephalopathy in cattle, and
Creutzfeldt-Jakob disease in humans. They are unlike any other
Prions
infectious pathogens because they are composed of an abnormal
conformational isoform of a normal cellular protein, the prion protein
(PrP). Prions are extremely resistant to inactivation by sterilization
processes and disinfecting agents.
Reusable Medical Devices intended for repeated use on different patients with
Device (RMD) appropriate decontamination and other processing between uses.

Length of time a stored or in-use product/solution can remain active
Shelf life and effective. Also refers to the length of time a sterilized product
(e.g., sterile instrument set) is expected to remain sterile
Strategy for reprocessing contaminated medical devices. The system

classifies a medical device as critical, semi-critical, or non-critical on
the basis of risk to patient safety from contamination on a device.
Spaulding
The system also established three levels of germicidal activity
Classification
(sterilization, high-level disinfection, and low-level disinfection) for
strategies with the three classes of medical devices (critical, semi-
critical, and non-critical).
Relatively water-poor round or elliptical resting cell consisting of

condensed cytoplasm and nucleus surrounded by an impervious cell
Spore wall or coat. Spores are relatively resistant to disinfectant and
sterilant activity and drying conditions.
State of being free from all viable microorganisms. In practice,

usually described as a probability function, e.g., as the probability of
Sterile or Sterility
a viable microorganism surviving sterilization being one in one
million.
Level of reprocessing required when processing critical medical

Sterilization devices. It results in the destruction of all forms of microbial life
including bacteria, viruses, spores and fungi.
Type of steam sterilizer that depends on one or more pressure and

vacuum excursions at the beginning of the cycle to remove air.3 This
method of operation results in shorter cycle times for wrapped items
because of the rapid removal of air from the chamber and the load
Sterilizer, Pre-
by the vacuum system and because of the usually higher operating
Vacuum Type
temperature (132–135oC). This type of sterilizer generally provides
for shorter exposure time and accelerated drying of drape and
packaged loads by pulling a vacuum during the exhaust (drying)
phase.

Central Sterile Supply Department - An Introduction
C entral sterile supply department is an area responsible for reprocessing instruments and other
reusable medical devices (RMD) The process involves handling, collecting, transporting, sorting,
disassembling, cleaning, disinfecting, inspecting, packaging, sterilizing, storing, and distributing
reprocessed items. The goal is to provide safe, functional, and sterile instruments and medical devices and
reduce the risk for healthcare associated infections.
GENERAL PRINCIPLES OF CSSD BEST PRACTICES:
A centralized area for reprocessing Central Sterile Supplies Department (CSSD).

Written policies and procedures for reprocessing each type of reusable medical device (RMD).
Training of all staff who perform reprocessing at initiation of employment and at least yearly.
Verification of cleanliness, decontamination or sterility and function of the reprocessed equipment
and device.
Continual monitoring of reprocessing procedures to ensure their quality.
Management and reporting of medical incidents and safety-related accidents.
Complete and proper documentation of all reprocessed items for traceability, recall of improperly
reprocessed devices and legal purposes.
Procedures to be followed in emergencies (e.g., utilities shutdowns, compromised packaging,
biological indicator testing failures).

CHAPTER - I
Infection Prevention and Control in CSSD
Hand Hygiene (HH)

Infection Prevention and
Personal Protective Equipment

Control in CSSD
(PPE)
Dress Code
Environmental Hygiene

Implementation of infection prevention protocols for patients undergoing invasive surgical
procedures is extremely important in preventing surgical site infections (SSIs). These are initiated in Central
processing department by maintaining a hygienic environment and achieving adequate sterility of Reusable
Medical Devices (RMD).
In order to achieve this goal, we need to apply the following:
1: HAND HYGIENE (HH):

Hand washing stations including hand washing sinks with hands-free controls, Soap, hand sanitizer
dispensers, and paper towels should be located in or near all work areas including changing rooms
and in the entrance of the Decontamination Area and IAP Area etc.
Staff must perform Hand hygiene before entering of the CSSD areas & starting the work shift.
In case of gloves tear with accumulation of fluid inside the gloves or visible contamination on hands
during the decontamination process, CSSD staff must immediately remove gloves and perform
Hand washing with antiseptic soap & water.
CSSD technician and HCWs should keep fingernails short and clean at all time.
For female staff, nail polish or acrylic nails are not allowed during the duty hours.
2: PERSONAL PROTECTIVE EQUIPMENT (PPE):
In CSSD department, wearing the PPE should be strictly followed based on infection and prevention
control standards which are as following;
- Sufficient and appropriate PPE are available in adequate amount, types, and sizes with proper
qualities & easily accessible to the staff. (Heavy duty gloves, face shields /eye goggles,
impermeable gowns/aprons etc).
- Full PPE should be worn in the Decontamination area.
- CSSD technician must be trained on the correct Donning and Doffing practices including
sequence, technique, safety & disposal.
- In the Inspection, Assembly, Packaging Area and Sterile storage, Head cover and clean scrub
suite are required.

When choosing PPE, the following points need to be considered:
- Gloves should be long enough to cover wrists and forearms, sufficient weight to be highly tear-
resistant, and allow adequate dexterity of the fingers.
- Gown should protect skin and clothing from the hazardous chemicals. Secured gown that cover
torso, neck to knee, and arm to the end of wrists must be used.
- Mask should be fit covering mouth, nose, chin properly and N95 Respirator should be fit tested
every 2 years according to MOH requirements.
- Face shield / goggles must fit properly, face shield should cover the eye, forehead and extend
below the chin. Must possess features of anti-fog to help maintain clarity of vision.
- Dedicated shoes with appropriate fit must be used to serve as a barrier against accidental
splashes.
All Personal Protective Equipment (PPE) must be of high quality material to ensure protection against
potential contact with respiratory secretions, chemicals fumes and vapors, and blood or body fluids etc.
CSSD staff should never touch face or adjust PPE with contaminated gloves and minimize unnecessary
touching of items & surfaces.
PPE is removed on completion of the task for which it was indicated before leaving the reprocessing
area followed by hand hygiene.
3: DRESS CODE:
- CSSD technicians should wear clean surgical attire (Scrubs), dedicated shoes, head & facial hair
cover (except eyebrows and eyelashes).
- Attire should be changed daily or as needed if visibly contaminated with blood or other potentially
infectious material.
- Scrubs should be laundered appropriately after each use in a healthcare-accredited laundry facility.
- CSSD Personnel should not wear jewelry (Rings, bracelets, watches etc.) during duty hours.
- CSSD staff should must change their surgical attire upon leaving the department.

4: ENVIRONMENTAL HYGIENE:
- Environmental services department should consult IPC department & CSSD to establish policies
and procedures for cleaning practices and cleaning frequency.
- Environmental cleaning and disinfectant agents must be approved by MOH to be used in the
healthcare facilities.
- Environmental cleaning is not allowed during sterilization process due to possibility of spread
dust to Reusable Medical Devices (RMD).
1. Environmental Cleaning Methods:

- Floor are swept & wet mopped at least after each decontamination procedure in the
decontamination area.
- Floor are swept and wet mopped at least after each shift in the cleaning area.
- All areas must be free of dust, and insects etc.
- The Process of cleaning should be from clean areas to dirty areas, from high areas to low areas
(i.e., top of walls to floor) and from least contaminated to most contaminated.
- In case of hazardous chemicals spill etc. disinfection must be performed immediately using the
spill kit according to the steps of spill management.
- High touch horizontal surfaces must be cleaned and disinfected at the beginning and end of
each shift & more frequently during the shifts e.g. tabletops, counter tops etc.
- Decontamination sink should be cleaned after each shift and more frequently as needed.
- Work tables preferably cleaned before starting the sorting process in the decontamination area
& Inspection process in the IAP area.
- Shelves, cabinets, racks, wall, and ceiling are cleaned based on regular cleaning schedule using
a checklist
- Offices. Changing /locker room etc are cleaned at least daily.
- Light fixtures, and air vent should be cleaned at least every six months or as necessary (by
Environmental Service or Maintenance department)

2. Environmental Cleaning Equipment:
- Cleaning equipment's are separate and dedicated for each area. (e.g. mops and bucket)
- Cleaning equipment must be kept clean and dry & are appropriately stored after use.
- Mop heads must be appropriately laundered after each use or disposed of if single use.
3. Environmental Cleaning Schedule:
- All cleaning activities must be performed according to the approved cleaning schedule with specified
frequency for each area.
- Cleaning activities must be documented using a checklist that include cleaning frequency,
responsible worker, used agents, methods & environmental surfaces intended to be cleaned.
- Quality of the cleaning activities should be regularly monitored by CSSD supervisor, Infection control
Team & environmental services supervisor.

CHAPTER - II
CSSD STAFF QUALIFICATION & SAFETY
Training and Education

CSSD STAFF QUALIFICATION & SAFETY
CSSD Staff Skills
Occupational Healthcare and Safety
National Criteria for CSSD staffing

level

1: TRAINING AND EDUCATION:
CSSD technicians must be qualified by owning certain certifications, training or experience and have
comprehensive knowledge in all aspects of sterile processing.
CSSD staff must be well trained on all infection prevention & control protocols including aseptic
technique during biohazard transportation, decontamination, inspection, packaging, sterilization &
storage.
CSSD staff must be knowledgeable about updated infection prevention & control standards to be
followed during all stages of sterile processing.
Functional analysis, risk factors, and best practices will achieve successful productivity.
CSSD staff must fully understand their roles and responsibilities with efficient implementation of all
policies and procedures in order produce a high quality sterile equipment for patient use.
Infection Preventionists (IPs) should be a part of the interdisciplinary team that collaborates to
provide safe, efficient, cost-effective, and high-quality reprocessing.
2: STAFF SKILLS:
CSSD personnel must be able to apply active listening skills using reflection, re-statement, and
clarification techniques when communicating with other departments staff.
CSSD staff must have collaborative approach since reprocessing of medical devices requires a
collaborative association between them and the clinical staff who use the devices, especially in
surgical settings.
Practice team skills such as cooperation, leadership, and anticipation of co-worker's needs.
Use analytical skills to solve problems and make decisions.
In addition to the multi-dimensional tasks, technicians must always take responsibility and Practice
personal integrity and honesty.
Be respectful and interact kindly with peers, superiors, subordinates, and customers.
Respect interdisciplinary differences among team members.
Demonstrate professionalism at all times.
Never disclose confidential information about a patient.

3: OCCUPATIONAL HEALTH AND STAFF SAFETY:
An Occupational health and safety review is recommended for all protocols for reprocessing of medical
equipment / devices to verify that staff safety measures are followed and are in compliance with the
local Occupational Health and Safety Act. This review will verify the following:
2.1: Fire Safety:

- Attention must be paid on the fire safety guide inside the CSSD for the electrical and chemical
hazards that may occur during sterilization processes.
- CSSD technicians should be trained to deal with fire incident plan by knowing the fire alarm,
emergency code, and the emergency exits.
- CSSD technicians should be trained to use the fire disregarder that belong to the CSSD.
2.2: CSSD Staff Health:
- According to the Occupational Safety and Health Administration (OSHA) regulations, all
employees who are dealing with potentially contaminated items should receive hepatitis B
immunization.
- Employee Health Care Clinic should offer certain vaccines for HCWs including CSSD technician
for the purpose of diseases prevention as per institutional policy (mumps-measles-rubella,
varicella, influenza, tetanus-diphtheria, etc.).
2.3: Sharp Injury:
- All sharp injuries from sharp instruments including sharp skin hook, broken metal instruments
ETC must be reported.
- Sharp needles and blades should not be received in CSSD; If incidentally have been sent, so
they need to be placed in sharps container.
- Take care when handling glass and other fragile objects.

- In case of needle stick injuries incidents following procedure must be followed:
❖ Encourage the wound to gently bleed, ideally holding it under running water.
❖ Wash the wound using running water and plenty of soap.
❖ Don't scrub the wound whilst you are washing it, do not squeeze the puncture site.
❖ Dry the wound and cover it with a waterproof plaster or dressing.
❖ Seek urgent medical advice from your infection prevention and control team.
❖ Report the injury to your employer.
2.4: Chemical Hazards:

- Chemicals must be labeled, stored, and handled appropriately under the supervision of the
safety department.
- Use Safety Data Sheets (SDS), and keep it readily available.
- Use defined, written procedures and methods for handling and storage of process chemicals.
- Clearly identify chemicals that should not be stored together.
- Store chemicals below shoulder height and choose the correct size of safety cabinets.
- All personnel who handle detergents, rinse aids, disinfectants, or any chemical solutions must
be aware of the hazard classification of each chemical use and take a full training course on
this subject.
- Follow emergency procedures and protocols and manage hazardous materials for spill hazard
as per policies & procedures for spill management:
❖ Get help and put warning signs in place where the incident has occurred
❖ Collect the spill kit
❖ Follow protocol precisely
❖ Check the material safety data sheet if indicated
❖ Put on PPE and Assemble cleaning equipment
❖ Clean the spill
❖ Dispose of waste appropriately
❖ Replenish supplies
❖ Complete an incident or adverse occurrence report

2.5: Emergency Eyewash Station:
An eyewash station, separate from other cleaning facilities/sinks, is installed to prevent a potential
hazard to the eye due to contact with a biological or chemical agent.
It must be available with unobstructed access for immediate use within a travel time of 10 seconds,
or accessible within 30 meters of areas of potential chemical exposure.
The American National Standard Institute established a minimum standard for eyewash station:
- It should permit hand-free operation and have a stay-open feature to flush both eyes.
- It should be tepid, not too hot, or too cold to prevent burn to the eyes.
- It must be regularly tested and documented.
- Technicians must follow the SDS instructions for a chemical reaction.
If blood or blood products make contact with eyes, rinse the eyes gently but thoroughly (remove
contact lenses), for at least 30 seconds, with water or normal saline.
If blood or body fluids are sprayed into the mouth, spit out and then rinse the mouth with water
several times.
2.6: Waste Management:
Hazard yellow containers, sharp containers, and regular black container should be available in
sufficient numbers, and to be located in a place that is easy to reach and access.
All materials that have been used in the decontamination area are disposed in the yellow bag
All used PPE, BI vail, empty Plasma Cassettes should be disposed inside hazard waste container.
Waste should be segregated accurately that no medical waste inside the regular waste container or
regular waste inside the yellow medical waste container.
Medical waste bags and sharp boxes should not reach over filled (i.e., 3/4 filled).

4: NATIONAL CRITERIA FOR CSSD STAFFING LEVEL:
Hospital Bed Capacity Required Number of CSSD Staff
One CSSD workers for every 20 beds
Hospitals with bed capacity An additional CSSD worker per average of 100 Surgical
100 or less Procedures done per month
Minimum required number is 3 CSSD staff at least.
for example:
50 bed hospital with 20 surgical procedure per month = Minimum required number is 3 CSSD staff at least.
100 bed hospital with 80 surgical procedure per month = 100/20= 5 CSSD staff
One CSSD workers for every 50 beds
An additional CSSD worker per average of 100 Surgical

Hospitals with bed capacity
Procedures done per month
> 100 Beds
Minimum required number is 5 CSSD staff at least.
for example:
150 bed hospital with 80 surgical procedure per month = Minimum required number is 5 CSSD staff at least.
600 bed hospital with 800 surgical procedure per month = 600/50 + 800/100 = 20 CSSD staff
1000 bed hospital with 2500 surgical procedure per month = 1000/50 + 2500/100 = 45 CSSD staff
Hospitals without Operation

Rooms i.e. No Surgical producers
are done in the hospitals like At least 3 CSSD workers are required.
Psychiatric, rehabilitation & chest
diseases hospitals etc.

CHAPTER - III
CSSD DESIGN / INFRASTRUCTURE
Design Layout
CSSD DESIGN / INFRASTRUCTURE
Traffic Control and Workflow
Environmental Control Parameters

1. DESIGN LAYOUT:
CSSD construction requires an in-depth knowledge of operational CSSD experts, biomedical engineers,
Infection control expertise with collaboration & approval of infection control committee. CSSD
infrastructure should be developed under specific standards according to Facility Guidelines Institute
(FGI), and MOH-health care facility guidelines have to be reviewed before any planned CSSD
construction.
Sterilization services MUST be centralized in one UNIT/ Department and none of the sterilization
activities are carried out by individual departments outside CSSD. In general, there must be a
centralized area for reprocessing Reusable Medical Devices (RMD)
Adequate space in Sterile processing unit is critical to provide for a good workflow and efficient and
effective processes that promote staff safety, standardize procedures, minimize environmental
contamination, and maintain the sterility of processed items.
The size of the CSSD should be appropriate for the volume of work being performed, the processes
being conducted, the types of services provided, and the amount of equipment required to perform
the required tasks.
CSSD must have physical barriers with clear demarcation for clean and dirty areas. There must be
complete physical separation between the clean areas (i.e packaging, sterilization & storage areas)
and decontamination area with demarcation signs posted for each zone. . (2 or 3 zones)
Ideally, the decontamination area should have a three-section sink for cleaning (one section for
cleaning, one for initial rinsing, and one for final rinsing). The sinks should be approximately 36
inches from the floor and 8 to 10 inches deep. The sink should be large enough to place a tray or
container basket of instruments flat in the sink. AAMI states the area should have a source of critical
water for the final rinse.
Walls should be constructed of non-particulate, non-fiber shedding materials to withstand cleaning
& disinfection etc.
The ceiling in the restricted area should be constructed of enclosed fixtures hold all pipes and
ductwork.
The door should be made of a durable, smooth, and cleanable material.

Doors should open easily following the one-way directional workflow.
Floors should be level and constructed of non-particulate, non-fiber shedding materials to withstand
daily cleaning & disinfection activities.
The work surfaces should be covered with a nonporous material that can withstand frequent
cleaning with germicides.
Lighting fixtures should put into a selected position to facilitate the work.
2. TRAFFIC CONTROL AND WORKFLOW:
CSSD should be away from the main traffic pattern and restricted to the authorized personnel
identified ONLY based on the in the facility's policies and procedures of the department.
Visitors must be accompanied by authorized personnel should be allowed in the restricted areas
(e.g., decontamination, preparation, packaging, sterile processing, and sterile storage).
Anyone in these areas should wear surgical attire (scrubs) and dedicated shoes, and their head and
facial hair (except eyebrows and eyelashes) should be covered.
Visitors should wear dedicate shoes or shoe covers.
Areas, including locker rooms, break rooms, meeting rooms, offices, and sterilizer service access
rooms may be limited based on the facility's policies and procedures.
CSSD areas must be physically separated at least two zones to prevent cross-contamination.
This arrangement reduces the risk of cross contamination of areas and the items being sterilized,
which both improves safety and increases the efficiency of sterile processing operations. In
hospitals, the decontamination, packaging, sterilization, and sterile storage area/rooms should be
physically separate to eliminate environmental contamination.
The workflow processes allow items to move progressively from the dirty phase to the high
disinfection phase. Then from the safe handling phase to the final phase.
CSSD Technicians should be organized so that activities and objects flow in a unidirectional way &
sterilization process is never circumvented.

Figure 1: CSSD work flow, Design, and Areas pressure.
UNIDIRECTIONAL WORKFLOW

3: ENVIRONMENTAL CONTROL PARAMETERS:
AREAS IN CSSD TEMPERATURE PRESSURE HUMIDITY
18°C - 20°C Negative 03%-60%

Decontamination Area
Inspection, Assembly & 20°C – 23 °C Positive 30%-60%

Packaging Area
20°C – 23 °C Positive < 70 %

Sterile Storage Areas
Table1: CSSD Environmental Control Parameters

CHAPTER - III
CSSD FUNCTIONS
# FUNCTIONS PAGE #
01 Pre-Cleaning /Point of Use Cleaning 27
02 Transportation of Contaminated RMD to CSSD 27
03 Decontamination Area Procedures 31
04 Inspection / Assembly and Packaging 42
05 Sterilization of RMD 50
06 Sterile Storage & Item Distribution 60

CSSD procedure cycle distribute the sterile reused medical devices and supplying sterilized
products to various departments such as operation theatres, critical care departments, emergency
department and wards etc
Cleaning and
Disinfection
Inspection
Transport Assambly
Pachaging
Sterile Storage Sterlization
Figure 2: The CSSD procedure cycle

Safe and effective handling of Reusable Medical Devices (RMD) will ensure the following:
Prevent transmission of microorganisms to patients and health care workers.
Minimize damage to RMD from foreign material (e.g., blood, body fluids, saline and medications
etc) or inappropriate handling.
Protect health-care workers from injury during use of hazardous chemicals.
Produce high quality RMD/ end product to the required level of sterilization / disinfection for
safe reuse.
1. POINT OF USE CLEANING / PRE-CLEANING:
The reprocessing of contaminated equipment or instruments for sterilization begins at the point of
use. Assigned staff must separate instruments into reusable items to be sent for the CSSD, single-
use items to be disposed of in a proper waste container with a biohazard label.
The end user is responsible immediate pre-treatment by removing gross soil and debris by wiping
instruments with wiping with a sterile surgical sponge moistened with sterile water, wet towel or
spraying with transform gel in operation set to reduce the risk of dried gross soil including tissue,
body fat, blood, and other substances.
RMD that need repair should be identified by tag before sending it to the CSSD and notified.
Containers must be located in a soiled utility room that has controlled access, negative air pressure,
and clearly identified with biohazard labels to identify the risk associated with carrying dirty
instruments.
Before contaminated items are transported to CSSD, they should be placed in puncture-resistant,
leak proof sealable containers and visibly labeled as biohazardous.
2. TRANSPORTATION OF CONTAMINATED RMD TO CSSD:
All contaminated Items must be transported to the CSSD for reprocessing in a covered container or closed
cart with ideal characteristic such as:
- Transportation carts should be equipped with a secured lid to prevent spread of infection &
instruments from falling over.

- Carts should be Leak-proof to prevent accidental spillage of contaminated fluids.
- Transportation carts should be easily cleaned, disinfected, and dried to prevent recontamination in
the second rotation.
- Contaminated instruments should be transported on a rotational basis by direct routes far from
public traffic or through dedicated elevators.
- Transportation staff must consider the risk associated with hazardous items & wear the proper PPE.
- PPEs and biohazards material spill kits should be available in the vehicle, and if only one vehicle is
available, it must be decontaminated before using again to transport clean or sterile items.
- Keep the cart closed at all times except during loading and unloading.
- During transportation, never leave the trolley or transportation cart unattended.
2.1: The Transportation Policy and Procedures for transportation of Reusable Medical
Devices (RMD) out-Side the Hospital:
Transportation of reusable medical device (RMD) from CSSD facility to another CSSD facility out of hospital,
need to be monitored and controlled under strict conditions to prevent cross contamination and to assure
that items are securely contained without spillage or damage. CSSD worker must consistently follow safe
transportation procedures. A Clear MEMO should be announced to all hospitals facility to clarify the situation
and notify the frequency of collection and transportation.
a) Protocols for outside Transportation of soiled RMD are as following:
From the point of use to the planned holding area, transportation can be done in two ways:
- Hand transport in a puncture-resistant, leak-proof, biohazard sign, and sealed containers that
should be carried in a position parallel to the floor.
- Cart /Trolley transport that can prevent falling over during transport, Secured and closed, easy and
smooth wheels, and withstand frequent disinfection.
Place containers in the planed holding area organized and secured for the pick-up.
Transporters must wear gloves, protective gown and mask at soiled utility room while handling the
containers to load it in the transportation cart.
Responsible staff must wear appropriate PPE & perform hand hygiene.

Count the number of items that are being transferred.
At the time of transfer of contaminated RMD, a biohazard label sign should be tagged on the cart.
Transporter should use the service corridors or service elevators (avoid use the patients and visitor
hallway) to reach the vehicle.
Place contaminated containers and packages in an organized secure way in the transportation vehicle with
strict adherence to the safe handling precautions (glove, mask) & perform hand hygiene subsequently.
Driver must be instructed to drive gently and carefully to avoid spillage or damage to the RMD.
b) Protocols for outside Transportation of STERILE RMD are as following:
The transporter must perform hand hygiene before handling sterile items.
After sterilization process assigned technician should minimize the handling to maintain sterility of
sterile packs and containers/
Transporter must disinfect the trolley before transporting the sterile packages and sets.
During transportation outside, possible negative impact of environmental temperature and humidity
that may compromise the integrity of the packages MUST be considered.
For small packs it is recommended to cover it with dust cover and for big packs it is prefer to put the
RMD inside designated bin or closed trolley.
In case of any negative impact including wet pack the entire packs/sets must be returned back to the
reprocessing area (decontamination room).
c) Vehicles Specifications:
Provide complete separation of contaminated items from sterile items.

Allow for ease of loading and unloading items.
Allow for easy cleaning and disinfection after use with no seats.
Remain closed at all times except during loading and unloading and should not be left unattended in
unsecured areas.

DECONTAMINATION AREA
PROCEDURES
# FUNCTIONS
01 Receiving of Contaminated Items
02 Manual Cleaning of RMD
03 Disinfection of RMD
04 Automatic Cleaning and Disinfection

DECONTAMINATION AREA
1: RECEIVING CONTAMINATED INSTRUMENTS:
Once the CSSD technician receives the instrument following must be ensured:
❖ All items/instruments must be clearly identified with a label stating name the of sending
department/s.
❖ Quantity needs to be documented manually or by the tracking system.
❖ Manual or electronic system is available for all received items. Information MUST include:
Sender / Receiver ID, department's name, RMD sets and packages names, Date, Time &
quantities etc
❖ Sort disassemble, and segregate the RMD.
❖ Report any damage, missing, or defected RMD. Accidental sharp objects must be reported &
safely disposed of in sharp containers.
2: MANUAL CLEANING:
2.1: Cleaning Technique:
Cleaning is the removal of foreign material from objects and is normally accomplished using water with
detergents or enzymatic products. First and the most important step in reprocessing reusable medical
devices is thorough cleaning and rinsing.
Cleaning must be performed immediately once the instruments are received to reduce the
formation of biofilm that adheres to surfaces of the instruments and presoaking if applicable.
All Inorganic and organic soil that adheres to the surfaces of instruments interfere with the
effectiveness of disinfection and sterilization if not cleaned.
Manual cleaning must be done before any mechanical cleaning to remove all visible soil for
effective disinfection and sterilization.

Manual cleaning is necessary when:
- Mechanical cleaning is not available.

- Delicate instruments that may be manually cleaned include ophthalmology equipment,
microsurgical instruments, lensed instruments, flexible and semi-rigid endoscopes etc
- In some cases, the instrument manufacturer’s written IFU may require manually cleaning
before instruments are placed in mechanical cleaning equipment.
- Complex instruments needing manual cleaning based on the instrument manufacturer’s
written IFU.
- Items with narrow lumens cannot fit in the automatic washer.
Cleaning solution and water must be change when it is visibly soiled, which might be after one use
to prevent soil particles from re-depositing on instruments.
For all powered surgical devices, including Electric-Powered, Pneumatic-Powered, Battery-Powered,
and other complex instruments including lumen and reamers, delicate eye devices, lenses, and fiber
optic devices, it is critical to follow exactly the specific manufacturer’s IFU.
Similar devices may require very different processing procedures for cleaning.
A technician should separate general operating instruments and utensils from delicate instruments
that require special handling.
Disassemble all complex devices and open all jointed instruments.
Whether done manually or mechanically, it must involve friction to physically remove debris through
wiping, brushing, spraying, or flushing the items.
Use soft bristle brushes to clean serrations and box locks.
Cleaning should be under the surface of the water to reduce the risk of aerosol production and in to
and fro motion.
Ideally, the decontamination area should have a three-section sink for cleaning (one section for
cleaning, one for initial rinsing, and one for final rinsing).
- The first sink for cleaning. Sink should be filled with water having temperature range of 27°C -
44°C, enzymatic detergent solution.
- The second sink for initial rinsing with plain or softened (de-ionized) water that should be
changed frequently

- Third sink for the final rinsing that should be with de-ionized or reverse osmosis (RO) water to
allow instrument spotting.
2.2: Sink Features:

Cleaning sinks should:
- Be designed and arranged to facilitate soaking, washing and rinsing of RMD with minimal movement
or delay between steps.
- The sinks should be approximately 36 inches from the floor and 8 to 10 inches deep.
- Drain freely and not have an overflow.
- Be at a height that allows workers to use them without bending or straining.
- Be large enough to accommodate trays or baskets of instruments.
- Be deep enough to allow complete immersion of larger devices and instruments so
that aerosols are not generated during cleaning.
- Be equipped with water ports for the flushing of instruments with lumens, if appropriate.
- Have three compartments for soaking, cleaning and rinsing.
- Not be used for hand washing.
2.2: Cleaning Tools:

- Brushes with various shapes and sizes are available in the area & used appropriately.
- Cleaning tools (e.g., brushes) should be capable of thermal disinfection or be single use only.
- Inspect brushes and other cleaning equipment for damage, discard if necessary.
- Adequate supplies should be available for frequent changing.
- Cleaning tools should be cleaned, disinfected and stored dry.
2.3: Cleaning Detergents

There are six different types of cleaning detergents:
Multi-enzymatic detergents which contain protease to break down proteins in blood, mucous,
feces and albumins, lipase to break down fat, bone marrow and tissue, and amylase to change
the structure of soil from reforming can clean all type of soil.

Alkaline detergents Known as cleaning detergent agents contain Emulsifiers to dissolve the
uncombined substances, Surfactants to increase the solubility of organic substance, and
chelating agents to hold hard water minerals.
Pre-cleaning agent commonly contain: enzymatic detergent, and combination enzyme-
germicide detergent to keep soil moist and loosen dried soil.
Stain and rust removers contain acid-based compounds to remove hard water deposits, rust
scale, and discoloration from RMD.
Lubricants for instrument maintenance for RMD integrity and good function, used after
cleaning as final step of mechanical wash or can be applied manually.
Descaler to remove substances appears on the wall of equipment, washer, or sinks due to the
scale interfere with the cleaning abilities.
- For choosing an effective agent, some criteria and features should be present long with the
machines and instruments like manufacturer’s instruction & compatibility.
- Agents must be environment friendly, rapidly dissolve soil, nontoxic, low-foaming, non-abrasive,
free-rinsing.
- Factors affect the level of cleaning purity of the surgical instruments which should be highly
considered are:
Cleanliness of the surface of the RMD.
Characteristics or the design of RMD.
Type and concentration of the cleaning product.
Contact time (Duration) and temperature of exposure to the cleaning product.
Physical properties of the Mechanical Action.
The device manufacturer’s written instruction for use (IFU).
Water Quality including Water Hardness, and water PH
2.4: Water Quality:
- Water used in all phases must be purified for high-quality instruments outcome.
- Poor water that contains minerals, dissolved soil, particles, bacteria, algae, and parasites will
shorten the life of instruments by harming their finish and rusting them, and lead to corrosion.

- Purified water in the final rinsing phase releases the instruments from the high PH of many
chemicals used for cleaning and disinfecting.
- CSSD personal must be acknowledged of the water quality that supplies their department.
- There are three types of purified water used in CSSD: Distilled, Deionized, Reverse osmosis (RO).
- A regular water quality test should be done with the collaboration with hospital infection control
department.
- Since water is an effective factor in the cleaning process, some criteria should be followed:
Correct dilution is required for affective cleaning - more water is not always better
Specific water quality hardness and PH
Correct concentration, the correct volume of concentrated detergent must add to the correct
volume of water at the correct temperature.
The following calculation can be used for right concentration:
CONCENTRATION REQUIRED X CAPACITY OF THE SINK/BOWL IN ML

VOLUME OF DETERGENT = --------------------------------------------------------------------------------------------
CONCENTRATION SUPPLIED
3. DISINFECTION OF RMD:
The disinfection process kills and destroys the majority of remaining microbes except for spores, some
mycobacteria, and prions, which may not be inactivated by the disinfection process.
3.1: Disinfection Methods:

Thermal by using of moist heat at 70°C -100°C in the automatic washer disinfector.
Chemical by using of chemical disinfectant the Low /Intermediate level disinfectant for minimum
treatment recommended for reprocessing non-invasive medical devices, and the High-level
disinfectant (HLD) for maximum treatment recommended for reprocessing invasive medical devices
for use in critical site.

3.2: Disinfectant Types:
Low / Intermediate level disinfectant:
Alcohol 70% (isopropyl): Rapidly acting against most bacteria and viruses, but it cannot be used
in large amounts due to its flammability.
Chlorine (Hypochlorite): Useful in decontaminating blood and body fluid spills, but it can cause
damage, bleach and pitting of metal. Inactivated by organic soil.
Quaternary Ammonium (Quats): Kills some bacteria, fungi, and viruses unless Super quats mix
use, but it can absorb by cotton, surface must be wet for 10 min to disinfect
Phenolic: Kills bacteria, fungi, and lipophilic viruses, but it can cause skin burn if not rinse, and
damage plastic instruments.
High-level Disinfectant:
Glutaraldehyde 2%: Easily kills bacteria, fungi and viruses, but it is slow in killing spores,
dangerous, toxic and irritant.
Hydrogen peroxide 6%-7.5%: Fast viricidal and bactericidal, but it causes corrosive to some
metals, and slow in killing fungi and spores.
rtho-phthalaldehyde (OPA): Broad range of microbial activity, generally rapid, no odor, but it is
poor sporicidal agent, Expensive. Skin irritant
Peracetic acid 0.2% - 0.35%: Kill wide range of microbe, mycobacterium, spores, but it may
cause slight corrosive or damage.
The approved disinfectant in the hospital environment must be:
Easy to use with a light scent smell.

Does not evaporate rapidly.
Not harmful on RMD, staff, or patients.
Disinfect within a relatively short time.
Disinfectants should never be stored in direct light or excessive heat .

For instruments that are heat-labile, manual high-level disinfectant processes must be followed:
Clean and dry all items to be high-level disinfected .

Prevent dilution of chemical solution that may occur from wet instruments.
Fresh solution should be made each day and must change whenever visibly dirty.
Change solution if did not pass the minimum effective concentration test (MEC) to determine if the
solution is still effective .
Add the solution in a clean container with a lid and mark the container with the preparation date and
expiration date .
The technician must cover the container and allow items to be soaked for the exact duration stated
in the disinfectant manufacturer's instruction .
Rinse thoroughly with purified water to remove the chemical residue.
AUTOMATIC CLEANERS AND DISINFECTORS:
1: WASHER DISINFECTOR:
Washer disinfector allows instruments to be cleaned and disinfected by exposing them to spray force and
thermal action during several stages:
First step is a cool pre-rinse to wet the instruments and prevent the coagulation of proteins; the
chamber is filled with cold water.
Second step is a detergent cycle with water and is heated to about 60°C to maximize the
effectiveness of the detergent action.
Third step is rinsing, followed by a pure rinse cycle to remove any remaining detergents.
Some washers also provide a lubrication cycle during the rinse cycles.
The disinfection step allows the chamber to filled for a final time again with filtered or RO water
but this time, the temperature is raised to 80°C - 93°C and held for a predetermined time
(usually 90°C for 5 minutes) to ensure effective disinfection.
Final step will allow instruments to dry.

Manufacturers design different cycles to serve the instrument material without damaging.
Technician should use anesthesia rack for the anesthesia cycle.
Washer racks should never be overloaded, and spray arms should move freely during operation.
Trays or sets with multiple levels should be opened, and each tray should be placed separately
on the washer’s rack; keep them together to avoid missing.
Hinged instruments should be opened to permit direct contact of the water and detergent.
Trays with lids/covers should be opened so contents may be exposed to the washer spray.
Delicate and small instruments may be dislodged from the racks due to the blunt force of the
spray action so, should be confined in small perforated baskets with approved lids.
Instrument washer racks and conveyor systems should be inspected daily.
Routine cleaning of washers should include inspection and cleaning of spray arms, washer jets,
strainers, and surface.
Washer detergent levels should be frequently monitored. If detergent drums are allowed to run
dry, feed lines can deliver air instead of detergent.
Document all maintenance schedules and visits for all machines.
It is important to put an identification password for each washer settings dashboard to avoid
changes in the parameters after repair or maintenance by manufacturers.
To verify that the washer-disinfector cycle process parameters met including time, temp, spray
coverage, chemistry in all phases of the cleaning cycle use mechanical test and recorded result
in a logbook (protein check, water PH, water hardness, water temperature).
2: ULTRASONIC CLEANERS:
Ultrasonic cleaners are used for fine cleaning, not for disinfection or sterilization.
They are used to remove soil from joints, crevices, lumens, and other areas that are difficult to
clean by other methods.
Hospital sonic cleaners produce from 20,000 to 38,000 vibrations per second.
Bath temperatures for cleaning instruments should be between 80 F to 109 F (27°C to 43°C)
unless specified by the equipment or detergent manufacturer.
Temperatures above 140 F (60°C) will coagulate protein, making them difficult to remove.

Ensure that the manufacturer’s recommendations are followed regarding the ultrasonic cleaner
detergents are compatible.
Technicians should be using a suitable enzymatic detergent that is effective at low temperatures.
If the tank has a heater, set the temperature control to be comparable with the detergent
manufacturer’s recommendations.
An ultrasonic unit may have one, two, or three chambers: first chamber is for the detergent
bath, second is for rinsing, and third is for drying.
Some of the single-chamber ultrasonic have a raising and drying cycle so, a technician must be
aware of their machines IFU.
For cannulated instruments, it should be flushed and brushed before load in the ultrasonic.
Instruments should be placed in trays that are designed for use in the machine.
Typical trays should be in small wire construction with at least eight openings per inch to allow
the transmission of sonic energy.
Instruments must be submerged in the solution completely, so they are exposed to the
cavitation.
Hinged instruments placed in the sonic cleaner should be opened.
Trays must not be overloaded.
Check the ultrasonic IFU for load limitations.
There are some items that should not be placed in a sonic cleaner include: Chrome-plated
instruments, Plastic, Glass, Wood, Rubber, Fiber-optic instruments.
Ultrasonic energy can loosen the tiny screws of delicate instruments so, staff should inspect
RMD.
Maintenance for the sonic electrical part is always important as any other powered mechanics.
Water should be changed when it is visually soiled or at regularly scheduled intervals to prevent
soiled particles from re-depositing on instruments.
The unit's tank should be cleaned, and the drain should be checked for debris of each water
change.
Ultrasonic Water must be degassed daily and after changing sonic cleaner for 5 to 10 minutes.
De-gassing is the process of releasing dissolved air bubbles within the cleaning solution .
Ultrasonic check should be used daily and record the result for the machine verification.

3: CART WASHERS:
They are designed to clean carts used for transport of all devices and instruments.
Several manufactures provide accessories that help to process rigid containers and other
miscellaneous items.
It is operating in a manner similar to an automated washer disinfector but on a large scale.
Spray nozzles will deliver high-temperature water and detergents.
A high rainwater volume will remove the residue out of the cart's surface.
A hot air-drying cycle will then run as a final step.
Do not process instruments in the cart washer due to lost, and damage
Only use chemical cleaning detergents that are recommended by the manufacturers.
Regularly clean its strainers and surfaces with a descaler.
Cart washer also needs to documents all its maintenance reports.
Send HLD instrument through the hatch window to the IAP area.

Inspection Assembly and
Packaging Area PROCEDURES
# FUNCTIONS
01 Unloading of Reusable Medical Devices (RMD)
02 Inspection of Reusable Medical Devices (RMD)
03 Assembly of Reusable Medical Devices (RMD)
04 Packaging of Reusable Medical Devices (RMD)

INSPECTION ASSEMBLY AND PACKAGING AREA
1: UNLOADING OF RMD:
The cycle selection should be checked before unloading to ensure that correct cycle was used.
The printout should be saved for a year as per MOH recommendations.
Check that the chart record for the cycle confirms the information established during validation and that
all recorded variables are within the parameters permitted.
Allow items on rack to cool down before dragging in order to prevent CSSD from burn injury.
Reject load if:
- Visible soiling on instruments, and failure in the protein test.

- Any blockage in the spray arm.
- Incorrect cycle, and if cycle canceled for any mechanical issues.
Whether RMD received manually or unloaded out of the washer-disinfector, both must be dried to
prevent microbial growth, and reduce spotting.
Follow IFU for drying RMD.
Drying cabinets should be used unless not recommended by the instruments IFU so, air-dried using
compressed instrument grade air, or hand dried using a lint-free cloth.
2: INSPECTION OF REUSABLE MEDICAL DEVICES (RMD):
2.1: Instruments Inspection for Cleanliness:

Each set should be inspected separately.
Lighted magnifying should be available at workstations to assist with detailed inspections.
Box joints, serrations, and crevices should be critically inspected for cleanliness
Check/reject policy in the department.
Cannulated devices should be checked to ensure that the channels are patent and free of soil

2.2: Instruments Inspection for Function:
Hinges on devices, such as artery forceps and clamps, should be checked for ease of movement
Jaws and teeth should be checked for alignment.
Ratchets should be checked for security.
Multi-part instruments should be assembled to ensure that all parts are complete and working.
Multi-part instruments should be assembled as per IFU
Any damaged, incomplete, or malfunctioning devices should be reported immediately to the
supervisor and documented.
Cutting edges on devices should be checked for sharpness:
- For Scissors: Red test material thick for 4”
- For Scissors: Yellow test material thin for 4½” and larger.
- For Rongeurs /cutter: Index card
- For Chisels/ Curettes: Plastic dowel rod
Hinges on devices, such as artery forceps and clamps, should be checked for ease of movement
and lubricate the hinge box if necessary.
Each device should be checked to ensure free movement of all parts, and that joints do not stick, a
water-based lubricant may be used if required.
All screws on jointed devices are tight and have not become loose.
3: ASSEMBLY OF REUSABLE MEDICAL DEVICES (RMD):

Each device should be checked against the surgical list specific to the tray being assembled.
Any device missing in this phase from a tray should be reported to the supervisor.
Any extra devices found while assembling a tray should be reported to the supervisor for further
action, and non-conformance documented.
The purpose of assembly and checking is to ensure that :
- All devices are present in accordance with the surgical tray list .
- All devices are assembled correctly in accordance with the IFU.
- All devices are placed in the correct tray in a manner that ensures ease of use by the user.

Jointed instruments must be placed in an unlocked position to allowed sterilizer penetration.
Multi-part should be disassembled unless otherwise indicated by the IFU.
Devices with concave surfaces must be flipped upside down to prevent condensation .
Heavy items arrange at the bottom of the tray, so they will not damage delicate items.
Sharp instruments should be capped with tips protected without being too tight .
Devices with ratchets should be closed on the first ratchet only for steam penetration.
Similar devices should be kept together when placing them in the tray.
Tray liners should be placed at the base of the surgical tray .
Devices should be spread evenly by weight over the tray surface.
PACKAGING OF REUSABLE MEDICAL DEVICES (RMD):

The preparation and assembly of surgical instrumentation is a complex process, and various
packaging methods are used. Preparing instruments in the manner described helps ensure that
there will be adequate contact by the sterilizing agent with all surfaces and reduces the potential for
sterilizing residues (e.g., wet packs).
Delicate/sharp instruments are protected while being handled/ assembled for sterilization. Tip
protectors should be fit for purpose and permeable to the sterilizing process.
Instruments that open (e.g., scissors, haemostats) are held in unlocked, open positions.
Multi-part instruments are disassembled prior to sterilization, ensuring all parts are easily accessed
for aseptic assembly.
Lumened devices - Remove styles /plugs, such as catheters, needles, and tunings.
Complex instruments (e.g., air-powered, endoscopes, having lumens or channels) are prepared
according to written IFU from device manufacturers.
Tray liners are used to alleviate drying problems during steam sterilization.
Basins: Graduated basins should differ in diameter by one inch.
Follow the policy and procedure of wrapping, and pouching technique indicated by the department.
Every package should have a compatible external chemical indicator and compatible internal
chemical indicators.
Protect package contents from physical damage .

10.1: Packages Material Standard:
The type of material used must allow the sterilant to reach the contents of the packing.
The material must provide a good barrier to all types of microorganisms.
The pack must be able to be opened without contamination.
Withstand normal handling, resistant to tears, punctures, and proven tamperproof seal.
The packaging material must comply with the IFU recommendations of RMD.
10.2: Packaging Methods:

The choice and type of packing material will depend on the type of sterilization process used :
Packing Type for Steam Sterilizer
- Woven wraps (crape paper)
- Non-woven wraps (SMS)
- Paper-plastic pouch (peel pouch)
- Rigid Container System
Packing Type for Plasma Sterilizer
- Non-woven wraps (SMS)
- Spun-bond polyolefin- plastic pouch (Tyvek)
10.3: Paper–Plastic Pouch:

The paper–plastic pouch should be used, filled, and opened according to the pouch IFU.
Sealed smoothly without folds, bubbles, or wrinkles .
Double packaging in paper-plastic pouches should only be performed if the pouch manufacturer has
validated the product for this use.
If the item needs to be double-packaged, two sequentially sized pouches should be used .
The pouches should be positioned so that plastic faces plastic.
When pouching leave 1 inch after sealing and write in plastic side.

The use of paper–plastic pouches with heavy metal instruments could result in inadequate drying of
the package after sterilization.
Heat sealing or self-sealing should be used on their shelf life.
Each facility should evaluate what works best for its situation including ease of use by staff, and the
highest quality standard for patients.
The temperature is adjustable for the type of material being sealed, either for a paper-plastic pouch
or Tyvek pouch.
Shelf life is affected by sterilization and storage conditions, and time .
Follow the prepare packing, sealing, and visual inspection methods for avoiding any defects.
Recommended sealing temperatures and pressures and other technical advice should be followed
carefully .
Heat sealer should be safety tested annually by the biomedical departments.
10.4: Sterilization Wrap:

Sterilization wraps Sterilization wraps including:
- Crepe paper suitable only for steam sterilizer
- Non-woven wrap (SMS) is suitable for porous-load steam sterilization and plasma
There is two type of wrapping technique:
Sequential Wrapping refers to when two layers of wrap material are wrapped individually using a fold
technique. A single layer is folded completely and then sequentially followed with a second sheet of wrap
material and repeating the wrap sequence to form a package within a package.
Simultaneous Wrapping refers to when both layers of wrap material are wrapped together simultaneously.
Two single-layer wrappers or one bonded double-layer wrapper can be used.

There are also two techniques for wrapping packages and both are used with the sequential and
simultaneous wrap methods:
- Envelope Fold Technique The items to be wrapped are placed on the table in a diamond shape to
the wrapper. This method is frequently used for smaller items.
- Square Fold Technique The items to be wrapped are placed on the table parallel to the wrapper.
This method is generally preferred with heavier items.

10.6: Rigid Container System:
Containers vary in size and intended for use in various sterilization methods
Containers consist of a solid bottom, inner basket, silicone gaskets, latches, load cardholder with
engravable ID tags, and lid.
Filter retention plates and its valves should be checked for cleanliness, and function with no sign of
damage or leak.
10.7: Package labeling:

Packages should be labeled before sterilization.
Package labels should be visible and legible.
Consist of non-toxic materials and ink.
Write only on the non-porous side of the pouch.
Write on indicator tape or affixed labels.
Indicate a description list of the contents with identification of lot number, expiry date, and initials of
the operator.
10.8: Product Identification and Traceability:
Each package should be labeled with a lot-control identifier that lists the sterilizer identification
number, cycle and lot numbers, and date of processing.
10.9: Loading Considerations:

To achieve sterility of packages and containers, loading policy and procedure must be followed.
Technicians should be aware of their sterilizer's IFU loading considerations.

Documentation should be done manually or by printing an informative adhesive card out of the
tracking system including:
- Cycle parameters
- Tests results
- Loaded items and quantity
- Sterilizer cycle and load number
- Date of sterilization
The load control number must be attached to any item intended for use as a sterile product.
The name or initials of the sterilizer operator must be stated in the package or checklist.
Light items should be placed above, and heavy metal should be below if mixed load.
Items should be loaded within the boundaries of the loading tray, do not overload the chamber.
Ensure there is sufficient room between items to allow the circulation of steam.

STERILIZATION OF REUSABLE MEDICAL
DEVICES (RMD)
# FUNCTIONS
01 Steam Sterilizers
02 Plasma Sterilizers
03 Sterilization Process Monitoring & Recalls
04 Sterilizers Maintenance

STERILIZATION OF REUSABLE MEDICAL DEVICES (RMD)
Sterilization indicates all forms of microbial life including spores. Sterility assurance level considers sterile if
there is less than a one in a million chance of microorganism survival. Bacteria population decreases
Measured with log; sterility happened when 10ˉ 6
of bacteria population are killed. 1-log reduction means
that 90% of the spores have been killed. Each successive log reduction results in an additional 90% kill until
there is less than one microorganism surviving.
Spaulding Classification:
Sterilization of reusable medical devices depends on their instruction of use and subjected to the
Spaulding classification.
The minimum acceptable level of decontamination of surgical instruments based on the risk associated
with the procedures and the surgical sites.
Device Minimum Inactivation

Patient Contact
Classification Level
Sterilization RMD enters tissue or blood

Critical Items (Steam or Plasma) stream
RMD comes into contact with

High-level disinfection
Semi-Critical Items non-intact skin or mucous
(HLD)
membrane
RMD touch only intact skin

low-level disinfection
Non-Critical Items and does not directly touch
(LLD)
the patient
Table 2: Spaulding classification for processing the RMD

1: STEAM STERILIZERS:
1.1: The Components of Prevacuum Steam Sterilizers:

Jackets: heat the interior chamber wall.
Insulation: prevent condensation from forming around the jacket.
Door: has a safety locking and unlocked only when pressure is exhausted.
Door Gasket: maintain a tight seal that prevents steam from escaping and air from entering.
Chamber Drain: to release steam must be cleaned for effective steam flow.
Thermostatic Trap: automatically controlled by a senior to allow flow of air and steam.
Gauges and Controls: Gauges allow visual pressure which set at zero, and when steam injected
it must reach 14.7 pound per square inch (PSI) to start the exposure sterility time.
1.2: The Principles of Prevacuum cycle:
Conditioning:
Steam enters at the upper back portion with saturated steam which holds many tiny water droplets
in suspension, the relative humidity of the saturated steam is 97% to 100% r.h.
Air displaced through drain
Pressure and temperature begin to rise.
Exposure:
After temperature is reached and all air removed from the autoclave
Sterilizer’s control system begins timing the cycle’s exposure phase
Exhaust:
Chamber’s drain the steam through the discharge line.
Filtered air is gradually reintroduced into the chamber and chamber decrease to room pressure.
Drying
Drying the instruments for a specific time can be programmed.

1.4: Sterilization Process Monitoring:
Sterilization process monitoring includes the use of physical monitors, CIs, BIs, and documentation of
results. By monitoring every load for all sterilization processes, personnel can detect operator errors,
ensure that each cycle type and all implant loads are monitored, simply staff training, and provide a
universal standard of patient care.
This approach reduces the cost and other consequences of recalls, lowers the risk of HAIs, and
improves patient safety.
CSSD, OR, and infection prevention and control staff should be involved in determining the
sterilization process monitoring protocol for all sterilizers used in the healthcare system.
TYPES OF INDICATORS / QUALITY ASSURANCE TESTING

- Physical monitors are the visible monitors (time, temperature, and
pressure recorders, digital printouts, and gauges) on equipment that
enable the operator to promptly determine whether the correct sterilizing
parameters were met.
- They are the first monitoring tool used to detect a sterilization process
failure and initiate a recall. Sterilizers that do not have recording devices
PHYSICAL should not be used.
MONITORS - The SP staff should verify all sterilization parameters (e.g., time,
temperature, pressure, humidity, sterilant concentration) were met by
reading the results on the digital printouts, recording charts, displays, or
gauges at the end of the cycle and initial.
- CSSD staff should not release a load for use if the physical monitoring
results are incorrect for the load contents.
- A Bowie-Dick test is used to rapidly assess whether dynamic-air-removal

steam sterilizers properly remove air from the chamber and prevent air
reentrainment.
- Test should be done every day that the sterilizer is used, “before the first
processed load or at the same time each day, and during sterilizer
qualification testing.
- The Bowie-Dick test pack should be run in an empty preheated chamber
(run a shortened cycle by omitting the drying phase) and placed
BOWIE-DICK TEST horizontally on a cart or shelf (not on the floor), over/near the drain but
should not obstruct it.
- Following the Bowie-Dick test pack manufacturer’s IFU, the test
exposure time should be 3.5 to 4 minutes at 134°C (273°F).
- If sterilizer does not pass the Bowie-Dick test, personnel should remove
it from service and determine whether it should be retested, serviced, or
returned to service.

- CIs are devices used to detect potential sterilization process failures that
could result from incorrect packaging, incorrect loading of the sterilizer,
or malfunctions of the sterilizer
- These external CIs check whether a package has been processed or
EXTERNAL
exposed to the sterilization process.
CHEMICAL
- The external CI should be read when unloading the sterilizer, dispensing
INDICATORS
or issuing the item for use, and before the item is opened in the OR
- Personnel should not dispense or use a package whose external CI
indicates improper processing. If the package is dispensed, it should be
returned to SP unused with the load identification and the CI intact.
- At least one internal CI should be placed in each healthcare facility-

INTERNAL prepared package, tray, or containment device in the area considered
CHEMICAL the most challenging to sterilant penetration.
INDICATORS - These internal CIs are used for pack control to determine that the
sterilant penetrated each package, tray, or containment device.
- BIs are the only process indicators that directly monitor the lethality of a
given sterilization process.
- Compared with the bioburden found on medical devices or instruments,
the spores used as BIs demonstrate increased resistance to the
BIOLOGICAL sterilizing agent used in a sterilization process.
INDICATORS
- It is important to follow the BI manufacturer’s written IFU to determine
which BI PCD to use to monitor a specific sterilization process and cycle,
how to use positive controls, the correct incubation temperature and
time, how to interpret results, and optimal storage conditions.

Monitoring the Effectiveness of Steam Sterilization:
Monitor the sterilization process to detect equipment or operator errors or malfunctions that prevent
sterilization.
To ensure that sterilization has been successful, the process of sterilization is tested by measuring
various aspects of the process through different physical and mechanical indicators:
Written record of all conditions Date, time, type of cycle, temperature, dry time, exposure time,
pressure showed in the display screen are provided in print out paper or digital copy in the computer.
The printout should be saved for a year (MOH recommendation).
Vacuum leak test should be performed daily.
- Determine the air-tight integrity of a Prevacuum autoclave’s chamber and plumbing system.
- A typical Vacuum Leak Test Cycle will consist of three vacuum/pressure pulses
o followed by 15-minutes of dwell period at deep vacuum.
- leak rate will be displayed on the autoclave’s control screen in an average leak rate of 1mmHG/min
or less.
- Regularly perform a Vacuum Leak Test that allows greater confidence in the integrity of the chamber
and plumbing.
Bowie Dick Test should be used daily before any sterilization processes performed.
- The Bowie-Dick test pack should be placed in a preheated chamber on a cart or shelf, over the
drain and placed horizontally
- Select the cycle specified by the sterilizer manufacturer.
- The exposure time should be 3.5 to 4 minutes, not exceed 4 minutes at 134°C .
- At the conclusion of the cycle, open the test pack carefully because it might be hot.
- Fail results should be reported as defined in facility policy, and a determination made as to whether
the sterilizer should be retested, serviced, or remain in use.
- The test sheet should be saved for a year as per MOH recommendation.
External chemical indicator Process indicator should be present on the external surface of each package or
rigid container in the form of indicator tape, an indicator label, a container identification card, or a tamper-
evident device.

Internal chemical indicators: Type 6 indicator is preferable because the chemical indicator changed only at
specific parameters of the cycle.
It provides the user with more information on the critical steam sterilization parameters.
Internal CIs should be visible to the person opening the package and placed in the area considered
least accessible to steam penetration.
If the chemical indicator not pass:
- The contents of the package should not be used.
- At the point of use, the nurse should inform the CSSD supervisor and return the complete,
unused package including load identification and the CI, to the sterile processing area.
- The department head should then decide whether to recall that load or not.
- The results of internal CIs of another set in the same load can help.
Biological Indicators (BIs) should consist of spores of Geobacillus stearothermophilus comply with
ANSI/AAMI/ISO 11138-3 standard, as stated in both IFUs of the BI manufacturer and the sterilizer
manufacturer.
These indicators use the heat-resistant bacterial endospores (Geobacillus stearothermophilus) to

demonstrate whether or not sterilization has been achieved.
Various types of BIs are available, each with different response characteristics and incubation
requirements. The appropriate BI must be chosen for the steam sterilization cycle being run and
used correctly in accordance with the manufacturer’s written IFU.
Biological indicators should be used minimum weekly, preferably daily, and must use in each
implant load and after mechanical maintenance performed.
Self-contained BIs include incubation media with the spore carrier in a single vial .
Biological indicators then must place in its compatible incubator for periods of time depending on
the specific production time until it is determined whether the microorganisms grow or fail to grow,
which means killed by the sterilization process.
The test BI vial and a control BI vial should be from the same lot to ensure that the control will read
the appropriate time.
Biological indicators should be placed in an incubator at the IFU temperature, time .
The typical temperature is 55C to 60C.
If positive BI is indicated, a recall process must be followed.
The documentation of BI result should be saved for a year as (MOH recommendation)

RECALLS
A written procedure must be established for the recall and reprocessing of improperly reprocessed
medical instruments.
Protocols should be followed for necessary actions when BIs, CIs, or Physical Monitors Indicate a
Failure). Sometimes, a processing failure is confined to one load or one item in the load. For
example, a single load could fail if an operator ran the wrong sterilization cycle, or a single item
could fail because it had an unresponsive internal CI.
Reasons for recall can be as a result of improperly sterilized product being used in an event.
All RMD in each processed load must be recorded to enable tracking in the event of a recall.
The recall procedure should include:
- Outline the circumstances for issuing a recall.
- Designation of department and staff responsible for executing the recall.
- Identification of the medical instruments to be recalled; if recall is due to a failed BI, the
recall shall include the medical devices in the failed load as well as all other devices
processed in the sterilizer since the last negative growth BI.
- Assessment of patient safety risk.
- Procedure for subsequent notification of Infection Prevention and Control and Biomedical
Departments.
Actions to be carried out:
- Include all items processed back to the last negative BI.
- Identify the sterilization lot numbers and devices to be recalled.
- Recording of the items recalled and specify the action to be taken by the person receiving
the notification.
Following completion of the recall a report should be written that includes:
- The circumstances that prompted the recall.
- Specification of the corrective actions taken to prevent it happening again.
- Identification of the total number of devices intended to be recalled and the number actually
recalled.
- Verification that the recalled items were reprocessed appropriate.
- Surveillance of patients must be traced in case of nonsterile instruments used.

Steam Sterilizer Failure:
Contact Failure:
Inadequate cleaning before sterilization.
Sets are too dense.
Packages wrapped too tightly.
Crowded unorganized loads.
Mechanical Failure:
Defective steam traps.
Clogged exhaust lines.
Steam delivery system problems
Any mechanical malfunctions.
Parameters failure:
Inadequate exposure time.

Unsaturated steam.
2: PLASMA STERILIZERS:
Plasma sterilization is the process that is used to deactivate all microorganisms on devices / equipment
that are heat and moisture sensitive.
Hydrogen peroxide gas plasma sterilizes a wide range of instruments including single-channel flexible
endoscopes, rigid endoscopes, cameras, batteries, light cords, and power drills by using 59% sterilant
against a broad spectrum of pathogens include bacteria, mycobacteria, non-enveloped viruses,
enveloped viruses, fungi, and protozoa.
Hydrogen peroxide gas plasma depending on
- Concentration
- Contact time
- Process temperature.

The Principle of Plasma Cycle:
❖ Vacuum phase: air will remove from the chamber and pressure will reduce to below
atmospheric pressure.
❖ Injection phase: Hydrogen peroxide will be pumped from the cassette into vaporizer bowl to the
chamber.
❖ Diffusion phase: vapor into small crevices and lumens of devices.
❖ Plasma phase: a vacuum decreases the pressure and radio frequency energy which ionizes the
hydrogen peroxide creating hydrogen peroxide gas plasma, the injection and plasma phase are
repeated a second time.
❖ Vent phase: air vented into the chamber through bacterial high efficiency particulate air (HEPA)
filters, the chamber will return to the atmospheric pressure and the process byproducts are only
water vapor and oxygen.
The cycle time varies with the sterilizer model and the temperature varies from 113F, (45C) not exceed
131 F, (55C).
Sterilization should be monitored with suitable biological indicators at least daily, every load containing
implantable items.
Chemical indicators must be suitable for plasma and placed inside each package.
Physical indicators of each cycle .
Refer back to the recall section in case of CI, BI, and Physical Failure .
To minimize the hydrogen peroxide risk, be attention should be given to:
- Hazards associated with the sterilant.

- Storage, handling, and disposal of the sterilant cassettes.
- Handling canceled cycles.
- Adherence to standards and Safety Data Sheet (SDS( .
- Appropriate use of use of PPE

3: STERILIZERS MAINTENANCE:
The maintenance program may be in-house or contracted with the equipment manufacturer or other
qualified service company.
A validation test with a documented report must be provided for every installed machine.
Particular attention should be given to the inspection, maintenance, and replacement of components
such as filters, steam traps, drain pipes, valves, and door gaskets.
Scheduled maintenance including lubrication of appropriate parts and replacement of expendable
parts should be performed as needed by qualified personnel.
Certain maintenance tasks after warranty years that require special tools or calibration equipment
not available in the health care facility should be performed by the manufacturer’s representative or
another qualified service provider.
In the event of a sterilizer malfunction, repair, or replacement of any component affecting sterilizer
performance, appropriate recalibration should be performed.
A maintenance record, in either paper or electronic format, should be kept for each sterilizer
including:
- The date of the service request

- The model and serial number of the sterilizer
- The name of the requested service person
- The reason for the service request
- Description of the service performed
- The types and quantities of parts replaced
- Biological testing records
- Name and signature of the controller
- The scheduled date for re-testing
- Re-testing results

STERILE STORAGE AREA
1: UNLOADING AND RELEASE OF REUSABLE MEDICAL DEVICES (RMD):
Sterilized items should be allowed to cool to room temperature before handling In order to avoid
wet packs after unloading of sterilizers.
The time allowed for cooling should be taken into consideration:
- The type of sterilizer being used
- The design of the device being sterilized
- The temperature and humidity of the ambient environment
- The type of packaging used.
During cooling, the sterilizer cart should be placed in a low-traffic area and away from air-
conditioning or other cold-air vents, doors & windows etc
RMD Damage, no change of the external indicator, dust, debris, or moisture (wet packs) should be
returned to the decontamination area for reprocessing.
2: STORAGE AREA SPECIFICATIONS & MAINTAINING STERILITIES:
Sterile storage should be located adjacent to the sterilization area, preferably in a separate,
enclosed, limited-access area, the only function of which is to store sterile and clean supplies.
The sterile storage area is maintained under positive pressure, with 4 air changes per hour at least,
temperature ranges from 20°C to 23°C and relative humidity with limit of 70%.
The relative humidity in the sterile storage area should be maintained at the level recommended in
the instrument and packaging manufacturer’s IFU.
Storage Shelves: Must be designed to hold items safely, and ideally, the top and bottoms shelves
should be solid or covered to reduce or prevent dust accumulation.
Sterile storage shelves are clearly labelled, free from dust & away from sprinklers and air vents.
Items are arranged appropriately in the storage shelves with lighter items on the top shelves &
heavier items on bottom shelves.

Sterilized items should be stored far enough away from the floor, the ceiling, and outside walls to
allow adequate air circulation, ease of cleaning etc. Storage shelves are placed following appropriate
distance recommendations:
- Walls: packs/sets must be at least 5cm from walls to reduce condensation risks .
- Floors: packs/sets should be kept at least 25-30cm above the floor to prevent
contamination from floor cleaning, spills, and dust .
- Ceiling: packs/sets should be at least 45cm between the highest package and the ceiling
or fire sprinkler heads.
The products stored in the sterile storage area should be removed from shipping cartons or
processed on site prior to storage.
Correct handling: minimize touch with instruments and carefully pick it do not drag or push items
against surfaces causing friction or abrasion .
Use handling technique by lifting the front of the package underneath with one hand, place the other
hand midway under the package and lift the whole item free from the shelf.
3: STORAGE SHELF LIFE / EVENT- RELATED STERILITY:
Shelf life of facility sterilized items is event-related. CSSD personnel should follow policies and
procedures for shelf life of sterilized items based on:
- The quality of the packaging material

- The storage conditions
- The methods and conditions of transport
- The amount and conditions of handling.
With event-related sterility, items are considered sterile unless the integrity of the packaging is
compromised (e.g., torn, soiled, wet, or showing evidence of tampering).
Conditions that may alter the integrity of the packaging include the following:
- Environmental sources of contamination (e.g., moisture, vermin, and air movement associated
with traffic or transportation).

- The barrier properties of the packaging material (e.g., the integrity of its seals and its resistance
to tearing).
- Storage and distribution practices (e.g., open versus closed shelving and transport units)
- Stacking of sterile items that could result in packaging being torn etc
Use maintenance covers when needed.
Inspect package integrity and the external CI before the item is dispensed.
Document storage conditions that could result in contamination of sterile items.
4: DISTRIBUTION POLICY AND FIRST IN FIRST OUT (FIFO) CONSIDERATION:
Inventory should be rotated on a first-in-first-out (FIFO) basis. So the first item in is the first item out
(place newer items in the back part of the storage area to promote rotation of items).
To avoid contamination of sterile items, extreme care should be taken during transport to uncontrolled
environments.
A covered or enclosed cart with a solid bottom shelf should be used for transport, and packages should
not be dragged, slid, crushed, bent, compressed, or punctured.
Carts should be decontaminated before they are reused for transporting sterile supplies.
Follow the department's policies and procedures for transportation.
Tracing systems and documentation should be used for dispatching items either manually or by the
tracking system.

DOCUMENTATION / RECORD KEEPING
All cleaning, disinfection, and sterilization processes and monitoring results, as well as equipment
maintenance and repairs MUST be documented & records are kept where they can be retrieved easily
and when necessary.
Maintain thorough records that can be used if an infection needs to be traced. Records should cover
every step from the initial cleaning through high-level disinfection and sterilization processes, and
including patient use.
Implant sterilization and monitoring should be traceable to the specific patient. Scope disinfection or
sterilization monitoring should be traceable to the specific patient.
Verification Documents are kept for one year: sono check, protein test, water PH and hardness &
washers’ temperature test etc according to manufacturer's IFU.
Records for sterilization monitoring are kept for one year including: • Sterilization physical parameters
(print out from sterilizer / manual documentation of sterilization parameters by the operator)
Results of sterilization process monitoring should be documented & kept for 1 year. (Bowie dick test,
biological indictors (BI) etc
There should be a computerized system for tracking & tracing system (or at least manual process for
documentation & filing) with implemented policies & procedures for recall of unsterilized items.
Logbooks or implemented system is available for all received and dispatched items. Information
includes: Sender / Receiver ID, department's name, RMD sets and packages names, Date, Time &
quantities etc
Environmental Parameters monitoring documents should be available for one year: - Daily monitoring
record of each area for Temperature, Humidity, Pressure, and air exchange by CSSD staff & quarterly
monitoring record checked by maintenance department.

REFERENCES
1) Association for the Advancement of Medical Instrumentation: 1110 North Glebe Road, Suite 220,
Arlington, VA 22201-4795 703-525-4890 Fax: 703-276-0793 www.aami.org
2) APIC Text of infection control & epidemiology: Chapter 108, Sterile Processing, Published April
2019.
3) Association of perioperative Registered Nurses 2170 South Parker Road, Suite 300 Denver, CO
80231-5711 800-755-2676 www.aorn.org
4) Canadian Standards Association 5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA 800-
463-6727 Fax: (416) 747-2510 www.csa.ca
5) Certification Board for Sterile Processing & Distribution 2 Industrial Park, Suite 3 Alpha, NJ 08865
908-454-9555 www.sterileprocessing.org
6) International Association of Healthcare Central Service Materiel Management 213 W. Institute Place,
Suite 307 Chicago, IL 60610 312-440-0078 Fax: 312-440-9474 www.iahcsmm.org
7) World Health Organization and Pan American Health Organization ISBN 978 92 4 154985 1.
www.who.int

General Directorate of Infection Prevention and Control Ministry of Health
Ministry of Health, Kingdom of Saudi Arabia Preventive Health General Department
Email: gdipc@moh.gov.sa Prince Sultan Ibn Salman Ibn Abdul Aziz,
Visit us at : www.gdipc.org Ar Rahmaniyyah, Riyad

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CENTRAL STERILE SERVICES

‫الدليل االرشادي ألقسام التعقيم المركزية‬

Version 1: January 2021

‫الدارة العامة لمكافحة عدوى المنشآت الصحية‬

Gracious, Most Merciful

1 | Guidelines for Central Sterile Services Department - Version 1: January 2021

2 | Guidelines for Central Sterile Services Department - Version 1: January 2021

Ms. Aisha M Al Shehri Mr. Abbas M Al Qahtani

Ms. Arwa F Shesha Mr. Ibrahim M Al Dhuwaihi

Mr. Azeez H Saleh Mr. Bandar H Al Ruwaili

Dr. Faiza Rasheed Mr. Majdi M Al Solumani

Dr. Abdul Majid M Al Mutairi

Ms. Amani S Samman

3 | Guidelines for Central Sterile Services Department - Version 1: January 2021

1. Message from General Director----------------------------------------------------------------- 02

6. Chapter – III: CSSD Design / Infrastructure -------------------------------------------------- 20

4 | Guidelines for Central Sterile Services Department - Version 1: January 2021

Bactericidal Agent that kills bacteria.

Diagnostic test of a sterilizer's ability to remove air from the

A non-biological indictor test system designed to respond with a

Cleaning agent that makes no antimicrobial claims on the label.

Usually a chemical agent (but sometimes a physical agent) that

Thermal or chemical destruction of pathogenic and other types of

A cleaning agent that contains enzymes (e.g., protease, amylase,

5 | Guidelines for Central Sterile Services Department - Version 1: January 2021

High-level Destruction of vegetative bacteria, viruses, fungi and mycobacteria in

Level of disinfection that destroys all vegetative bacteria (except

Specialized clothing or equipment worn by a healthcare worker

Physical Use of a mechanical device to monitor the physical conditions of the

Transmissible pathogenic agents that cause a variety of

6 | Guidelines for Central Sterile Services Department - Version 1: January 2021

Strategy for reprocessing contaminated medical devices. The system

Relatively water-poor round or elliptical resting cell consisting of

State of being free from all viable microorganisms. In practice,

Level of reprocessing required when processing critical medical

Type of steam sterilizer that depends on one or more pressure and

7 | Guidelines for Central Sterile Services Department - Version 1: January 2021

GENERAL PRINCIPLES OF CSSD BEST PRACTICES:

A centralized area for reprocessing Central Sterile Supplies Department (CSSD).

8 | Guidelines for Central Sterile Services Department - Version 1: January 2021

Hand Hygiene (HH)

Personal Protective Equipment

9 | Guidelines for Central Sterile Services Department - Version 1: January 2021

1: HAND HYGIENE (HH):

2: PERSONAL PROTECTIVE EQUIPMENT (PPE):

10 | Guidelines for Central Sterile Services Department - Version 1: January 2021

11 | Guidelines for Central Sterile Services Department - Version 1: January 2021

1. Environmental Cleaning Methods:

12 | Guidelines for Central Sterile Services Department - Version 1: January 2021

3. Environmental Cleaning Schedule:

13 | Guidelines for Central Sterile Services Department - Version 1: January 2021

Training and Education

CSSD Staff Skills

Occupational Healthcare and Safety

National Criteria for CSSD staffing

14 | Guidelines for Central Sterile Services Department - Version 1: January 2021

15 | Guidelines for Central Sterile Services Department - Version 1: January 2021

2.1: Fire Safety:

2.2: CSSD Staff Health: