CSSD Namibia
CSSD Namibia
FIRST EDITION
2015
Ministry of Health and Social Services
FIRST EDITION
2015
Division: Quality Assurance
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iii
PREFACE
Surgery has become an integral part of global health care, with an estimated 234
million operations performed yearly. Surgical complications are common and often
preventable (New England Journal of Medicine). A major risk of all such procedures
is the introduction of pathogens that can lead to infection. Failure to properly disinfect
or sterilize equipment carries not only risk associated with breach of host barriers,
but also risk for person-to-person transmission (e.g. hepatitis B virus) and
transmission of environmental pathogens (e.g. Pseudomonas aeruginosa).
I would like to congratulate all who were involved in development of these guidelines.
All healthcare workers involved in preparing, processing, and distributing medical
and surgical supplies and equipment required for patient diagnosis, treatment and
ongoing care, are mandated to use these guidelines.
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ACKNOWLEDGEMENTS
These guidelines were developed through a widely consultative process and made
possible by the support, participation and valuable inputs given by individuals from
both the public and private health sectors and offices.
Ms. C.S. Gordon and Dr. A. Basenero from Division Quality Assurance in the
Ministry of Health and Social Services (MoHSS) head office who worked
tirelessly to develop the first draft document.
All healthcare managers who reviewed the document during a workshop that was
held at Ongwediva in October 2013.
Prof Shaheen Mehtar who supported the revision of these guidelines based on
technical expertise and evidence.
All health care workers and operating theatre managers from both the private and
public sectors who provided critical technical inputs during the finalization phase
of the guidelines at the workshop held in May 2014 in Windhoek.
Ms D. Witbooi and Ms L. Nisbet from Daab Consulting for technical inputs, final
editing and designing the printing layout of the final Manual.
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Table of Contents
PREFACE ....................................................................................................................................................... iv
ACKNOWLEDGEMENTS ................................................................................................................................. v
DEFINITION OF TERMS ................................................................................................................................. xi
CHAPTER 1: INTRODUCTION ......................................................................................................................... 1
1.1 Purpose of the Guidelines ..................................................................................................... 1
1.2 Objectives of the Guidelines ................................................................................................. 1
CHAPTER 2: OVERVIEW OF THE CENTRAL .................................................................................................... 2
STERILE SERVICES DEPARTMENT .................................................................................................................. 2
2.1 Scope of Work of CSSD.......................................................................................................... 2
2.2 Establishing a CSSD ............................................................................................................... 2
2.2.1 Essential Requirements of a CSSD Worker................................................................... 3
2.3 The Design of CSSD ................................................................................................................ 4
2.4 Preparing an Area for Processing Instruments and Other Items ................................ 5
2.4.1 Hand Washing Sinks.......................................................................................................... 5
2.4.2 Jet guns ............................................................................................................................... 6
2.5 Storage of Sterile Items .......................................................................................................... 6
2.6 Commercially Prepared Items .............................................................................................. 7
2.7 Release of Sterile Items .......................................................................................................... 7
2.8 Transportation of Contaminated Equipment and Sterile Supplies ............................. 7
2.8.1 General Design Features for Trolleys and Transport Containers ............................... 7
2.8.2 Transport of Sterile Supplies ............................................................................................ 8
2.9 Waste Management at CSSD ................................................................................................ 8
2.10 Quality Assurance and Monitoring...................................................................................... 9
2.10.1 Proper Care of Surgical Instruments ............................................................................... 9
2.10.2 Proper Care for CSSD Packs ........................................................................................... 9
2.11 Risk Management................................................................................................................... 10
2.12 Auditing and Validation ........................................................................................................ 10
CHAPTER 3: STANDARD PRECAUTIONS ...................................................................................................... 11
3.1 Personal Protective Equipment (PPE) .............................................................................. 11
3.2 The Role of Infection Control Teams ................................................................................ 11
3.3 Adverse Events....................................................................................................................... 12
CHAPTER 4: RISK OF INFECTION FROM MEDICAL EQUIPMENT ................................................................ 13
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4.1 Classification of the Risk from Medical Equipment ...................................................... 13
4.1.1 Low Risk (Noncritical Items) ........................................................................................... 13
4.1.2 Intermediate Risk (Semi-critical Items) ......................................................................... 14
4.1.3 High Risk (Critical Items) ................................................................................................. 14
4.1.4 Single Use Items .............................................................................................................. 14
CHAPTER 5: INSTRUMENT PROCESSING ............................................................................................... 16
5.1 Cleaning Process ................................................................................................................... 16
5.1.1 Manual Cleaning ............................................................................................................... 17
5.1.2 Mechanical Cleaning........................................................................................................ 19
5.1.3 Proper Care of Surgical Instruments ............................................................................. 19
CHAPTER 6: DISINFECTION PROCESS .......................................................................................................... 21
6.1 High Level Disinfection (HLD) - Semi-critical Items ...................................................... 21
6.1.1 HLD by Boiling .................................................................................................................. 21
6.1.2 HLD by Mechanical - Thermal Disinfection .................................................................. 22
6.1.3 Chemical HLD ................................................................................................................... 22
CHAPTER 7: STERILIZATION PROCESS ......................................................................................................... 25
7.1 Pressure Steam Sterilization (Autoclaving) .................................................................... 25
7.1.1 Types of Steam Sterilizers .............................................................................................. 26
7.1.2 Sterilization Times ............................................................................................................ 27
7.1.3 Wrapping Instruments and Other Items for Autoclaving ............................................ 27
7.1.4 Steps for Pressure Steam Sterilization (Autoclaving) ................................................. 29
7.1.5 Advantages and Disadvantages of Steam Sterilization ............................................. 31
CHAPTER 8: MONITORING EFFECTIVENESS OF STERILIZATION AND AUTOCLAVE MAINTENANCE ...... 33
8.1 Monitoring the Effectiveness of Sterilization ................................................................. 33
8.1.1 Mechanical Indicators (Physical) ................................................................................... 33
8.1.2 Chemical Indicators.......................................................................................................... 33
8.1.3 Biological Indicators ......................................................................................................... 33
8.1.4 Recommended Ideal Monitoring System...................................................................... 34
8.1.5 Correcting Sterilization Failure ....................................................................................... 34
8.2 Contaminated Supplies ........................................................................................................ 35
8.3 Autoclave Maintenance ........................................................................................................ 35
8.3.1 Cleaning of the autoclave................................................................................................ 36
8.4 Record Keeping ...................................................................................................................... 36
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8.4.1 Types of Records ............................................................................................................. 36
CHAPTER 9: ENDOSCOPE CLEANING/ DISINFECTION AND MONITORING REPROCESSING ........................ 38
9.1 Endoscope Cleaning ............................................................................................................. 38
9.1.1 Cleaning and Disinfection of Flexible Endoscopes ..................................................... 39
9.1.2 Cleaning of Rigid Endoscopes ....................................................................................... 40
9.2 Endoscope Disinfection ....................................................................................................... 40
9.2.1 Disinfection of Flexible Endoscopes.............................................................................. 41
9.2.2 Disinfection of Rigid Endoscopes .................................................................................. 42
9.2.3 Post Disinfection Rinsing ................................................................................................ 42
9.3 Decontamination and Disinfection of Endoscopes ...................................................... 42
9.3.1 Decontamination of Flexible Endoscopes .................................................................... 42
9.3.2 Sterilization of Rigid Endoscopes .................................................................................. 42
9.4 Storage of Endoscopes ........................................................................................................ 43
9.4.1 Storage of Flexible Endoscopes .................................................................................... 43
9.4.2 Storage of Rigid Endoscopes ......................................................................................... 43
CHAPTER 10: LINKAGE WITH OTHER .......................................................................................................... 44
DEPARTMENTS ............................................................................................................................................ 44
10.1 Laundry Services ................................................................................................................... 44
10.1.1 Laundering Standards ..................................................................................................... 44
10.1.2 Cleaning and Sterilization of Theatre Linen ................................................................. 44
CHAPTER 11: DISASTER MANAGEMENT .................................................................................................... 46
11.1 Purpose..................................................................................................................................... 46
REFERENCES ................................................................................................................................................ 50
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Table of Figures
Table of Tables
Table 1: Spaulding's Classification of Medical Equipment/Devices and Required level of Processing ...... 13
Table 2: Steps to follow during the Cleaning Process ................................................................................. 18
Table 3: Different Types of Disinfectants, their Actions and Limitations ................................................... 24
Table 4: The Sterilization Times for the Different Types of Sterilizers ....................................................... 27
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ABBREVIATIONS
x
DEFINITION OF TERMS
Cleaning is the removal of visible soil (e.g. organic and inorganic material) from
objects and surfaces and normally is accomplished manually or mechanically using
water with detergents or enzymatic products. Thorough cleaning is essential before
high-level disinfection and sterilization because inorganic and organic materials that
remain on the surfaces of instruments interfere with the effectiveness of these
processes.
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CHAPTER 1: INTRODUCTION
The Central Sterile Services Department (CSSD) is responsible for preparing,
processing, and distributing safe sterile medical and surgical supplies and equipment
required for patient diagnosis, treatment and ongoing care.
Some medical equipment and surgical instruments are typically designed for reuse
and therefore can transmit infections including hepatitis B, C and HIV, if any of the
steps involved in reprocessing, cleaning, disinfection, or sterilization are inadequate
or experience failures. It is therefore essential that all CSSD staff is trained in all
aspects related to CSSD, to ensure that they have an in-depth knowledge regarding
sterile medical supplies.
Having this guideline in place, will guide staff to decide what decontamination
process (i.e. cleaning/disinfection/sterilization), should be used for which items or
equipment.
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CHAPTER 2: OVERVIEW OF THE CENTRAL
STERILE SERVICES DEPARTMENT
The Central Sterile Services Department (CSSD) is the area in the hospital where
medical devices and equipment both sterile and non-sterile, are cleaned, prepared,
processed, stored and issued for patient care.
The CSSD is vital for an effective Infection Control and Prevention program. The
expertise and knowledge of CSSD personnel is important to ensure high standards
of decontamination and reprocessing of medical devices. In the hospital or clinic, it is
important that all equipment and materials used for treating patients are safe for use.
It is essential that Sterilizing Services are included/ but not limited to being
consulted in the following instances:
OT scheduling
Procurement of reusable instruments and equipment
OT management meetings
Peri-operative education and training
Changes in models of care and processes across Peri-operative services
Plans for the redevelopment, refurbishment and/or redesign and commissioning
of new OT and sterilizing services
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Figure 1: Work flow diagram for reprocessing of medical devices
Note: when dirty items are received, they should be counted and recorded in a logbook – the same
applies to dispatch.
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The supervisor should have had a minimum of two years’ experience in Sterile
Services, and should have attended at least one training course where the basic
principles of decontamination and sterilization are explained and practically applied
to the place of work. It is best if the supervisors go towards a 6 month’s course in
sterile services so that they may be able to carry out their duties diligently.
The Manager should have a higher qualification in health and should have had at
least 5 years or more, experience in Sterile Services. They should have attended an
Advanced Course in Sterile Services, with skills in managing the CSSD, including
knowledge on financial, administrative and procurement. Further they should know
how to control flows of medical devices through the CSSD, know basics of the
processing equipment and how it works and most importantly, understand and apply
validation.
Ideally, the design of the CSSD must have physical barriers which separate dirty and
clean areas in the reprocessing room. However, if this is not possible, the same
room can be used, provided that:
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Soiled objects never cross paths with clean, sterilized, or high-level disinfected
instruments and other items
The doors are kept closed in the reprocessing rooms in order to minimize dust
contamination and to eliminate flies
There is separate reprocessing equipment for each area
The staff at CSSD should work in either clean or dirty areas and never in both
Note: In some Health Service Districts, the potential exists for centralizing the provision of
sterilizing services through one facility with a properly designed and equipped sterilizing
unit that is able to meet the sterilizing needs of a number of other facilities.
It is ideal to have separate rooms – one for receiving and cleaning medical
devices (the Wash room) and another for Inspection, Assembly and Packaging
(IAP) and for final processing (sterilization or high-level disinfection) followed by
a storage and dispatch area
When only one room is available, it should be arranged so that activities and
objects flow in an organized way with physical barriers to stop dirty and clean
medical devices from crossing over
Adequate counter top space for receiving dirty items and for drying and
packaging clean items
There must be at least one sink (two or more are preferable) and should be
deep enough to allow soaking of the medical devices
It is important to have good space for separation between soiled handling area
and the clean, packaging area
The high-level disinfection area has to be separated from the sterile area, must
preferably be in a separate room
5
given to the use of alcoholic hand gel in consultation with the Infection Control
coordinator.
- All sterilization parameters should be met, i.e. temperature, pressure, time based
on the batch documentation
- Evaluation of the chemical batch control
- Visual inspection of the integrity of packaging. Look for the following: holes or
tears, wetness or stains, broken seals, dust, evidence of crushing, labeling, and
indicators
- DO NOT release items where the indicator is missing or has not changed colour
Equipment must be dedicated for this purpose, i.e. separate equipment for the
transportation of contaminated and sterile items. The trolleys should have the
following characteristics:
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Puncture-resistant
Leak-proof
Made of either plastic or metal, with a lid or liner that can be closed and cleaned
and disinfected
Containers and trolleys used for the transportation of sterile goods should be
dedicated and must not be used for non-sterile goods, e.g. transportation of food
or garbage
Transport containers/systems must allow articles to be handled with care and be
inspected as necessary
Boxes or bags used should not be overloaded
All transportation equipment should be maintained in a clean, dry condition and
must be in good working order
All sterile items for distribution outside the health care facility must be securely
packed and protected against damage and contamination during transportation
There must be a regular cleaning program for all sterile storage areas, including
all containers and trolleys
During the decontamination cycle at CSSD, a wide range of waste may be produced.
The clinical waste commonly produced at CSSD will be in form of packaging from
returned medical devices and personal protective equipment (PPE).
Examples of the waste include; wrapping papers, gloves, aprons, masks, blood or
body fluids, used swabs, drugs and other pharmaceutical products, sharps like
needles and blades, and human tissue may also be present.
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Responsibility of CSSD staff in waste management:
i. Monitoring is carried out to ensure all systems are performing to the required
standards
ii. Records are produced and maintained to demonstrate that activities comply
with the stated requirements
iii. The correct protocols are in use
iv. The protocols are adhered to and there is documented evidence of adherence
v. Standard operating procedures (SOPs) are in place for the different activities
of CSSD
vi. Adequate supplies of satisfactory quality are available at all times
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Table surfaces: Check for rough, sharp edges
All these factors could tear the sterilization paper and therefore compromise
the sterility of the packs. In case of damages, report to the supervisors for the
necessary repairs and replacement.
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CHAPTER 3: STANDARD PRECAUTIONS
Standard precautions are safe work practices required to minimize the risk of
infection to both patients and staff. They include good hygiene practices, particularly
hand hygiene, the use of, appropriate handling and disposal of waste, adherence to
the principles of asepsis and maintenance of a clean environment. Refer to the
MOHSS Infection Prevention Control Guidelines 2nd Edition 2015 (Chapter 4)
for more details.
Ensure that the sterilizing service department is aware of local and nationwide
infection control policies that may affect the service they provide.
The CSSD should have a responsibility for achieving consistent production and
management standards in the reprocessing of reusable instruments and equipment.
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The following infection control measures should be observed by all CSSD
staff:
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CHAPTER 4: RISK OF INFECTION FROM
MEDICAL EQUIPMENT
4.1 Classification of the Risk from Medical Equipment
The classification system developed by Spaulding1 divides medical
equipment/devices into three categories based on the potential risk of infection
involved in their use:
Non critical (Low Equipment/device that touches only intact Cleaning followed by low
risk) skin and not mucous membranes, or does level
Equipment/device not directly touch the client / patient / disinfection (in some cases,
resident. cleaning alone is acceptable)
Placing instruments and equipment into one of the above categories can be helpful
in choosing the proper level of disinfection or sterilization needed in order to protect
the patients and the health care personnel.
1
Spaulding EH.: The Role of chemical disinfection in the prevention of nosocomial infections. In: PS Brachman and TC
Eickof (Ed):. Proceedings of International Conference on Nosocomial Infections, 1970. Chicago, IL: American Hospital
Association: 1971: 254-274.
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Cleaning with a detergent and drying is usually adequate. Stethoscopes are usually
cleaned and in rare cases they should be disinfected if used on an infectious patient
or highly susceptible patient.
Intermediate (Semi-critical) items are items that make contact directly or indirectly
with intact mucous membranes or non-intact skin. Examples include: endoscopes,
laryngoscopes, specula and endotracheal tubes.
Cleaning followed by high level disinfection (HLD) is usually adequate. They should
be well stored to protect from environmental contamination and stored for only up to
one week.
High risk (critical items) items are items entering sterile tissue, the body cavity, the
vascular system and non-intact mucous membranes. Examples include: surgical
instruments, intra-uterine devices, vascular catheters and implants. These items are
called critical items because of the high risk of infection if such an item is
contaminated with any microorganism before penetrating the tissue.
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Figure 2: Summary of Decontamination Process
Disposable Semi-critical
Non-critical Critical
Items: e.g. Items: e.g. Items: e.g. Items: e.g.
gloves, stethoscopes, endoscopes, surgical
needles, BP cuff, laryngoscope instruments
syringes. thermometer
s ants.
s
Dry and
Dry and Store
Store
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CHAPTER 5: INSTRUMENT PROCESSING
(CLEANING PROCESS)
There are several steps when reprocessing medical devices that are used during
clinical and surgical procedures which are summarized here (Fig. 3) of which
cleaning is the most important one. Once a medical device is thoroughly cleaned, it
can either be disinfected or sterilized depending on its resistance to heat.
16
If instruments and other items have not been cleaned, sterilization and disinfection
may not be effective because microorganisms trapped in organic material may
survive sterilization or disinfection.
Studies have shown that thorough cleaning alone can provide a major reduction in
contaminant microbes from endoscopes. Cleaning can be very effective in removing
microbial contaminants from surgical devices.
i. Manual
ii. Mechanical
17
Table 2 Steps to follow during the Cleaning Process
18
Things to remember when cleaning:
Do not use hand soap to clean instruments because fatty acids in the soap react
with hard water to leave a soap scum on the instruments. Only use a
recommended detergent for cleaning
Always wear utility gloves, a mask, eye protection and closed shoes when
cleaning instruments
Do not use abrasive materials that scratch or pit instruments. Scratches, pits, or
grooves can harbor microorganisms and promote corrosion (Don’t use metal
brushes)
Automatic washing machines are preferable to washing by hand
Washing machine: The washing machine gives a cold rinse followed by a hot
wash at ≥55°C. This is followed by a 10-second hot water rinse at 80-90°C and
then by drying at 50-75°C.
Washer/disinfector: The washer/disinfector is used for anesthetic equipment. It
runs a 45-minute cycle of washing with a detergent solution and cleaning plus a
2-minutes disinfection cycle with water at 80-100°C.
Ultrasonicator: the ultrasonicator is a sophisticated and expensive but extremely
efficient piece of equipment. It uses high-power output of 0.44 W/cm3 and
dislodges all organic matter on metallic surfaces. Do not use it on plastic items.
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CHAPTER 6: DISINFECTION PROCESS
Disinfection refers to inactivation of vegetative (non-sporing) organisms using either
heat or water (thermal) or by chemical means like glutaraldehyde 2%.
Organic matter (serum, blood, pus or fecal material) interferes with the antimicrobial
efficiency of the disinfectant. The larger the number of microbes present, the longer it
takes to disinfect. Thus thorough cleaning before disinfection is of greatest
importance.
When sterilization is not available, HLD is the only acceptable alternative for
instruments and other items that will come into contact with the bloodstream or
tissues under the skin. Flaming is not an effective method of HLD because it does
not effectively kill all microorganisms.
High-level disinfection is best achieved by moist heat such as boiling in water (100°C
for 10 minutes holding time), which kills all organisms except for a few bacterial
spores. However it cannot be adequately controlled and should not be used
instead of controlled validated sterilization.
It is important to note that boiling equipment items in water will not achieve
sterilization.
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Guidelines to follow during HLD by boiling:
The thorough initial rinsing and washing removes most of the microorganisms and
shortens disinfection times.
If machines are used they should be regularly maintained and checked for efficacy.
Low to high-level disinfection is achieved depending on the type of machine and the
complexity of the items.
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A limited number of disinfectants can be used for this purpose. These include:
- The object must be thoroughly rinsed with sterile water after disinfection
- If sterile water is not available, freshly boiled water can be used
- After rinsing, items must be dried thoroughly and stored properly
1. Clean and dry all items to be high-level disinfected. Water from wet instruments
and from other items dilutes the chemical solution, thereby reducing its
effectiveness
2. Fresh solution should be made each day (or sooner, if the solution becomes
cloudy).Follow the manufacturer’s instructions
3. If using a previously prepared solution, use an indicator strip to determine if the
solution is still effective. If preparing a new solution, put it in a clean container
with a lid and mark the container with the preparation date and expiration date
4. Disassemble items with multiple parts; the solution must contact all surfaces in
order for HLD to be achieved
5. Place all items in the solution so that they are completely submerged. Place
bowls and containers upright, not upside-down, so that they fill with the solution
6. Cover the container and allow items to soak for 20 minutes. During this period, do
not add or remove any items from the container. Monitor the time
7. Remove the items from the container using, dry, high-level disinfected pickups
(e.g. forceps)
8. Rinse thoroughly with boiled water to remove the chemical residue that is left on
items. This residue is toxic to skin and to tissues
9. Place items to air-dry on a high-level disinfected tray or in a high-level disinfected
container before use or storage. Use instruments and other items immediately or
keep them in a covered, dry, high-level disinfected container and use within one
week based on the manufacturer’s guidelines
Easy to use
Non-volatile (does not evaporate rapidly)
23
Not harmful to equipment, staff or patients
Free from unpleasant smells
Effective within a relatively short time
Peracetic acid 0.2 to Broad range of microbial activity. May be slightly corrosive or
o.35% Generally rapid acting including damaging.
mycobacterium and spores.
Alcohol 70% isopropyl Rapidly acting against most Since alcohol is flammable, it
alcohol or 60 to 80% bacteria and viruses. Main use is cannot be used in large
ethyl alcohol (ethanol) for rapidly disinfecting clean amounts. Soil prevents
surfaces. The alcohol penetration.
evaporates quickly to leave Not sporicidal and has poor
surfaces dry. penetration.
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CHAPTER 7: STERILIZATION PROCESS
Sterilization is a process which achieves the complete elimination or destruction of
all microorganisms, including bacterial spores.
Note:
- Boiling and flaming are not effective sterilization techniques because they do not
effectively kill all microorganisms.
- Large health care facilities should have more than one type of sterilization system in
case of power outage, equipment failure or shortage of supplies.
Autoclaves use steam as a carrier of thermal energy or heat. Steam is a much more
efficient carrier of heat than air. The steam softens the outer layer of
microorganisms, which permits the thermal energy or heat to enter the organism and
come in contact with the proteins in the organisms. The proteins are then denatured
thus become unable to do their normal function in the cell leading to cell death.
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7.1.1 Types of Steam Sterilizers
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7.1.2 Sterilization Times
Gravity Sterilizer
Unwrapped 121 ºC (1.036 Bar) 15 minutes
Note:
Sterilization time does not include the time it takes to reach the required temperature
or the time for exhaust and drying; therefore, it is shorter than the total cycle time.
The temperatures required for steam sterilization are lower than those for dry heat
sterilization because moist heat under pressure allows for more efficient destruction of
microorganisms.
Wrapping instruments and other items before steam sterilization helps to decrease
the likelihood that, after sterilization, they will be contaminated before use.
To wrap instruments and other items for steam sterilization, use two layers of
material such as paper or cotton fabric however paper is preferred to allow
steam penetration.
Make points in the wrapping material while wrapping the instruments and other items
so that the packs can be easily opened without contaminating their contents (see
Fig. 3 below).
27
The wrapping systems for sterile items should meet the following criteria:
Place the instrument or Fold the bottom Fold the left section Fold the right
other item in the center of section of the top to the center, and section to the
the top wrapper. Items wrapper to the fold back the point. center, and fold
should be positioned so center, and fold back the point.
that the points and not the back the point.
flat edges are at the top,
bottom, and sides.
Fold the top section to the Fold the bottom Fold the left section Fold the right
center, and fold back the section of the to the center, and section to the
point. bottom wrapper to fold back the point. center, and fold
the center, and fold back the point.
back the point.
28
Step 9 Step 10 Step 11
Fold the top section to the Tuck the point under the right left Fasten the folds
center, and fold back the sections. securely, using
point. autoclave tape, if
available.
29
o Packs of hollow-ware and trays of instruments should not be placed above
textile packs or soft goods in order to avoid wetting caused by condensation
from items above
o Do not load the heavier packs on the top shelf as it is easier to unload the
packs from the bottom shelf without dragging it
4. Wait until the pressure gauge reads “0” to open the autoclave. Open the lid or
door to allow remaining steam to escape. Leave all items in the autoclave until
they dry completely. It may take up to 30 minutes.
30
Things to remember:
Unwrapped items: use immediately after removal from the autoclave or keep
them in a covered, dry, sterile container for up to one week.
Wrapped items: The length of time (shelf life) that a wrapped, sterile item is
considered sterile depends on whether or not a contaminating event occurs, not
necessarily on how long an item has been stored. The shelf life depends on:
o Handling after sterilization
o Storage conditions
o Transport conditions and
o Amount of handling
A wrapped pack can be considered sterile as long as it remains intact and dry. It
is however recommended that items entering sterile organs should be stored for
a maximum of 3 months.
Instruments packed in steri-pouches remain sterile for up to a year as long as
these are not punctured.
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CHAPTER 8: MONITORING EFFECTIVENESS
OF STERILIZATION AND
AUTOCLAVE MAINTENANCE
8.1 Monitoring the Effectiveness of Sterilization
To ensure that sterilization has been successful, the process of sterilization (and not
the end product) is tested. Indicators have been developed to monitor the
effectiveness of sterilization by measuring various aspects of the process through
different indicators. These include mechanical, chemical and biological indicators.
The advantage is that chemical indicators are visible to the user. The
disadvantage is that some chemical indicators can change without going through a
complete sterilization process.
33
The disadvantage is that this indicator is not immediate, as are mechanical and
chemical indicators. Bacterial culture results are needed before sterilization
effectiveness can be determined.
34
8.2 Contaminated Supplies
Contaminated supplies are totally unsuitable for use. Items should be closely
monitored by visual inspection looking for contamination as part of a quality
management program.
Any contaminated or opened packaging should be considered unfit for use and
discarded or decontaminated if they are re-usable items.
35
To ensure that the autoclave is properly maintained, ensure the following:
Regardless of the type of sterilization methods used, several basic records must be
maintained for each sterilization cycle that is performed. These records will allow the
tracking of sterilized items to the patient.
a) Load control number: must be attached to any item intended for use as a
sterile product. It must identify the sterilization date, sterilizer equipment used;
cycle number and expiration date if applicable
b) General contents of the load in each sterilization cycle
c) Biological and chemical indicator test results
d) Exposure time and temperature and pressure (if applicable) of the sterilization
process
e) Name or initials of the sterilizer operator
36
The following autoclave maintenance records must be maintained for all
sterilization:
- Date of service
- Model and serial number
- Reason for maintenance
- Location
- Descriptions of replaced parts
- Biological testing records
- Name and signature of controller
- Scheduled date for re-testing
- Re-testing results
37
CHAPTER 9: ENDOSCOPE CLEANING/
DISINFECTION AND
MONITORING REPROCESSING
Endoscopes are medical devices used to examine the inside of the body. They are
made of a long thin tube that is passed into the body and are widely used in a
number of surgical specialties. There are two types, i.e. flexible and rigid
endoscopes.
They are problematic to clean, disinfect and sterilize because of the complexity of
their design (long narrow channels, complex internal design, etc.). They are also
expensive and easily damaged.
Processing of Endoscopes
- Cleaning
- Rinsing
- Disinfection or sterilization
- Rinsing if only disinfection was done
- Drying
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9.1.1 Cleaning and Disinfection of Flexible Endoscopes
The following is recommended:
Immediately on removal of the instrument from the patient, the endoscope should
be wiped from control head to distal tip using a clean cloth soaked in clean water
and enzymatic cleaning solution (diluted as per manufacturers’ instructions). It is
impossible to adequately disinfect or sterilize an endoscope when organic
material has been allowed to dry on the endoscope
The internal suction channel should be aspirated with enzymatic solution,
depressing and releasing suction button to promote debris dislodgement.
Depress and release air/water buttons to flush water through water channel and
air through air channel (where applicable use air/water cleaning adaptors as per
manufacturers’ instructions)
Prior to disassembly and further cleaning of the endoscope the leak test should
be performed as per manufacturer’s instructions. In the case of video
endoscopes the protective cap should be applied prior to leak test
The flexible endoscope and all reusable accessory items should be disassembled
as far as practicable
The components should be cleaned with an enzymatic solution (diluted as per
manufacturers’ instructions)
Any taps should be opened and the channels/lumens of the endoscope should be
brushed to remove any adherent debris
If the cleaning brush has obvious debris, it should be washed prior to being
withdrawn through the channel
Sites such as nozzles, flaps, hinges, crevices and joints of accessory items
should be cleaned with a soft brush to remove any adherent debris. This cleaning
process should continue until the endoscope, its channels, buttons and valves
and accessory equipment are completely clean
Accessory items, including buttons should be placed in an ultrasonic washer
according to manufacturers’ instructions. It is mandatory for spiral coiled
accessory equipment to be thoroughly cleaned in the ultrasonic washer
Thorough flush rinsing should be carried out to remove any traces of
enzyme/detergent from all channels
All channels should then be purged with medical air to expel as much water as
possible, and the external surface is dried with a lint free cloth prior to
disinfection.
Brushes used in the cleaning process for each endoscope shall be cleaned and
thermally disinfected after each use
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Note: Fibre optic endoscopes should only be subjected to ultrasonic cleaning in
accordance with manufacturers’ instructions. Some accessory instruments have
extremely small lumens or are too fine or difficult to dismantle for cleaning. In these
situations it is impossible to ensure thorough cleaning and decontamination has occurred,
in which case consideration should be given to using a single-use accessory.
Rigid endoscopes and accessories, which do not have any fibre-optic light
carriers or cables, may be dried in a drying cabinet
On completion of the cleaning, rinsing and drying process, the rigid endoscope
and associated instruments should be reassembled, inspected and checked to
ensure they are not damaged and are in working order, and then disassembled
prior to sterilization
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Manufacturer's recommendations on the management of glutaraldehyde
should be followed. The solution is at a 2% concentration initially. It is
undesirable for this to fall below 1.5%
Change of the glutaraldehyde solution will depend on usage
Where endoscopy is being performed infrequently, the glutaraldehyde solution
should be disposed of at the end of the day
Chemical indicators should be used to ascertain the concentration of
glutaraldehyde. These processes must be documented and monitored
The methods for the soaking and rinsing of the endoscope must be conducted
in an aseptic manner
Note: OPA is not to be used for processing of urological instruments due to a rare
risk of anaphylaxis noted in patients with a history of bladder cancer.
The endoscope is placed into and connected to the machine and the appropriate
disinfection cycle chosen in accordance with manufacturer’s instructions dependent
on the type of endoscope.
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9.2.2 Disinfection of Rigid Endoscopes
Disinfection is not a sterilizing process and shall not be used to prepare items
intended for entry into sterile body cavities, or which penetrate the mucosal barrier.
Rigid endoscopes are critical items and shall only be steam sterilized prior to reuse.
Note: If items used for surgery will not tolerate sterilization, consideration should be given
to the purchase of rigid scopes that can undergo a sterilization process, or single use
items.
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9.4 Storage of Endoscopes
9.4.1 Storage of Flexible Endoscopes
The endoscopes must be thoroughly dry before being stored. Sterile isopropyl
alcohol 70% or dry clean air should be used to assist forced air-drying of
channels. This reduces bacterial growth during storage
Denatured alcohol, e.g. Methylated spirit should not be used for drying as it can
damage components of flexible endoscopes. Some manufacturers do not
recommend the use of alcohol, in which case it should not be used
Endoscope storage is preferably, by hanging at full length with insertion tube as
straight as possible, on appropriate support structures, rather than coiled in a
case
The storage conditions should be as recommended in (Chapter 1) for sterile
items
After storage all endoscopes must be disinfected / sterilized prior to use
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CHAPTER 10: LINKAGE WITH OTHER
DEPARTMENTS
10.1 Laundry Services
See the IPC Manual for more details - the laundry services for the CSSD are
summarized here.
Laundering of OT linen
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Hot water washing at a temperature of at least 71oC, for a minimum of 25 minutes
is recommended. This provides an effective means of destroying vegetative
forms of bacteria but not spores
Addition of mild acid to neutralize any alkalinity in the water supply, soap or
detergent. This is the last action performed during the washing process. It helps
in decreasing skin irritation and further reduces the number of bacterial present
Hot air drying or drying in sunlight will also reduce the number of bacteria
present, as will ironing with a hot iron
Clean linen must be stored and transported in such a manner that cross
contamination is avoided
Linen to be sterilized must be properly wrapped before being sent to the sterile
processing department.
A function check of the sterilization machine must be performed before the
sterilization process
A validated process must be used to determine when reusable textiles have to be
withdrawn from use.
Note:
- Low linting fabrics are preferred since lint may impair wound healing because of
reactions to foreign bodies. Therefore non-woven fabrics are recommended.
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CHAPTER 11: DISASTER MANAGEMENT
11.1 Purpose
To provide an emergency plan for internal emergencies that will ensure the safety of
all staff, patients and visitors. All CSSD staff should be committed to a policy of
emergency preparedness for the benefit of all occupants and visitors.
Disaster Committee
All internal and external disasters will be coordinated by the Disaster Committee.
o Starvation
A fire can be starved by either removing the source (material
burning) or by moving the fire to a safe area.
o Cooling
Burning material can be cooled to below its combustion point.
Water is a suitable coolant.
Types of fire
o Class A
General fire of wood, paper, etc. and can be extinguished with
either water or foam.
o Class B
Burning, flammable liquid, that can be extinguished with dry
powder or foam.
o Class C
Fires where electricity is involved must be extinguished with dry
powder or foam.
o Class D
Gas fires that include products that release gasses when
burning must be extinguished with dry powder or foam.
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All staff must be aware of the position of the nearest fire-
fighting equipment.
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REFERENCES
1. Integrated Health Care Waste Management Plan. Namibia, Ministry of Health
and Social Services, 2010.
3. National Guidelines on Post Exposure Prophylaxis for HIV, HBV and Tetanus
after Workplace exposures and Sexual Assault. Namibia, Ministry of Health
and Social Services, 2010.
5. William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H. and the
Healthcare Infection Control Practices Advisory Committee (HICPAC).
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008.
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