64

1

THE CSSD BOOK

A Little Yellow Infection Control Book

Grampians Region Infection Control Group

2

About this book: The CSSD Book is designed to provide beginning knowledge on important concepts of sterilising for workers.

Because of its simple nature this booklet will oversimplify some of the complex processes used in the CSSD setting.

Workers requiring detailed information should consult AS/NZS 4187:2003 and other relevant text. Office based practice consult AS/NZS 4815:2006

June 2005, Updated Dec 2006, Sept 2008

Concept and production by: Bruce Fowkes Mary Smith Modified by Jackie Moody AGPAL May 2009 with the kind permission

of the authors. It has been adapted for use in office based practice.

For other publications visit:

h t t p : / / w w w . g r a m p i a n s h e a l t h . o r g . a u /Regional_Groups/Infection_Control/index.aspx DISCLAIMER: Every effort has been taken to confirm the accuracy of the information presented in this booklet, however, the authors, are not responsible for errors or omissions or for any consequences from application of the information in the guide and make no warranty, express or implied, with respect to the contents of the publication. In view of ongoing research, changes in government regulations and the flow of other information, the information is provided on the basis that all persons undertake responsibility for assessing the relevance and accuracy of its content.

Department of Human Services

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Equipment Australian Standard

Pre vacuum Steriliser AS 1410

Sterilisers-Steam-Benchtop AS 2182

Sterilisers-Steam-Downward displacement

AS 2192

Flushers/sanitisers for bedpans & urine bottles

AS 2437

Dry heat sterilisers AS 2487

Drying cabinet for medical equipment

AS 2514

Ultrasonic cleaner-non portable

AS 2773.1

Ultrasonic cleaner-benchtop AS 2773.2

Drying cabinet for respiratory equipment

AS 2774

Batch-type washer/disinfector AS 2945

Rack conveyor washers AS 3836

62

References 1. Standards Australia. AS/NZS 4187 : 2003

Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities

2. Australian Government. Department of Health and Aging. Infection Control Guidelines for the Prevention of Transmission of Infectious Diseases in the Health Care Setting . Canberra 2004

3. Gardner Joan F & Peel Margaret M. Sterilization, Disinfection and Infection Control. Third Edition. Churchill Livingstone

Note: AS/NZS4187 is currently under review, this booklet will be updated when new version of standard is available (Sept 2008)

3

Table of Contents

Definitions 4-5

Reprocessing reusable items 7

Cleaning and handling used items 9

Water quality 9

Initial cleaning 11

Cleaning precautions 11

Cleaning equipment 13

Drying of items 15

Monitoring cleaning process 15

Packaging and wrapping 16-17

Sealing packs 19

Sterilising equipment 20-21

Steam sterilisers 22-25

Loading steriliser 27

Unloading steriliser 28-29

Validation process 30-31

Quality management 32-33

Product recall 35

Monitoring steriliser 36-37

Tests for pre-vacuum steriliser 39

Storage and handling 41-43

Disinfection 44-47

Blood or body fluid spills 49

Care with sharps 51

Occupational exposure 53

Staff health and hygiene 55-59

Clinical waste disposal 61

References 63

4

Definitions Bioburden the number and types of microorganisms

present on an object or surface Biofilm a layer of material on the surface of an

instrument or device which contains biological materials and in which microorganisms are imbedded

Cleaning the removal of soil and reduction of

microorganisms from a surface Disinfection a process intended to kill or remove

pathogenic microorganisms but which cannot usually kill bacterial spores

Holding Time the time for which all of the articles in a

steriliser must be held at the selected sterilising temperature, the time established to destroy all microorganisms in the load

Penetration Time time required for every part of a

load to reach the selected sterilising temperature

Processing Time the total time of the sterilising stage

after the load in the chamber has reached sterilising conditions

Processing Time = penetration time + holding time

(Includes safety margin)

61

Management of Clinical Waste

Medical waste can cause injury and infection transmission if improperly handled.

• Appropriate disposal of sharps

• Appropriate safe organisation of medical waste to facilitate appropriate containment and disposal

• Containerised liquid wastes (disposable suction receptacles, placentas) are surrounded by impervious plastic, or absorbent materials

• Tie off/staple bags when 2/3 full

• Persons handling waste bags to wear protective clothing and gloves

• Medical waste when bagged is kept under refrigerated, secure conditions.

60 From Infection Control in the Health Care Setting, January 2004

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5

Safety Margin extra time added to the holding time to ensure sterilisation is achieved — 25% of holding time

Spores thick walled resting cells formed by certain

Gram-positive bacteria, capable of survival in unfavourable environments and often highly resistant to heat and chemicals

Sterile Free from living microorganisms Sterility Assurance Level the probability of a viable

microorganism being present on an item after sterilisation — SAL for medical equipment = 10-6 or one in a million chance

Sterilisation validated process used to render a

product free of all forms of viable microorganisms, with an acceptably low SAL

Validation documented procedure obtaining, recording

and interpreting the results required to establish that a process will consistently yield a product complying with predetermined specifications

Validation

1. Commissioning

Includes Installation Qualification

And Operational Qualification

2. Performance Qualification

Includes Physical Qualification

And Microbiological Qualification

6

The reprocessing area should include separate designated areas for cleaning, packing and sterilising and for storage of sterile stock Workflow should reduce risk of contamination of clean and sterile items Walls, floors and other surfaces should be easy to clean

Image sourced from AS/NZS 4815:2006 — Office–based health care facilities not involved in complex patient procedures and processes—Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of the associated environment

59

Staff Immunisation The National Health and Medical Research Council recommends

specific immunisations for health care workers who have significant

patient contact. Hepatitis B vaccination is essential for staff who process items. Practices must document and advise staff of the risks

and recommend staff be covered for vaccine preventable diseases

These are: Diphtheria/ Tetanus A full course of three staged injections

Polio A full course of three staged injections

Measles/Mumps/Rubella Two doses, if born after 1966

Chicken pox (Varicella Zoster virus) Immunisation if no definite history of the disease

Hepatitis B A full course of three staged injections, followed by

a blood check to check antibody production. It is absolutely essential to know that you have developed antibodies as a result of the immunisation!

Influenza Annual injection of the current viral strains

TB Skin Test (possibly at induction and exit) Not an immunisation, but useful to know your

status.

58

Immunisation - Your extra protective umbrella

7

Reprocessing Reusable Instruments and Equipment

Reprocessing refers to cleaning, disinfection and/or sterilisation

The most efficient and reliable form of sterilising of reusable medical articles in hospitals is sterilisation by steam under pressure.

The level of reprocessing required depends on the body sites where the instruments will be used

Critical: Entry or penetration into sterile tissue, cavity or blood stream

All items must be sterile

Semi critical: Contact with intact mucosa (or non-intact skin

Sterilisation preferred where possible, if not possible use high level disinfection or thermal disinfection

Non critical: Contact with intact skin

Clean as necessary with detergent and water

8

IF IT CANNOT BE CLEANED IT CANNOT BE DISINFECTED OR STERILISED

57

Should You Be At Work?

Infectious diseases in staff can be readily transmitted to susceptible patients and other staff

Respiratory infections eg. the “flu”, can be transmitted to patients and staff by respiratory secretions shed by coughing/sneezing/your hands

Infections on your skin or eyes can be transmitted to patients or contaminate equipment handled by your hands

Dermatitis, skin infections or infected lesions should be inspected by a doctor—open lesions increase risk of occupational exposure and of contaminating equipment

Superficial skin lesions must be covered with on occlusive dressing

Diarrhoeal infections can be transmitted to patients and other staff by your hands, on articles you have touched, on food you have handled. A period of 48 hours free of diarrhoea/vomiting is usually required before return to work

IF YOU ARE ILL PLEASE CONSULT YOUR DOCTOR OR STAFF CLINIC

56 9

Cleaning and Handling of Used Items Cleaning is an essential part of reprocessing reusable equipment. If it is not cleaned adequately organic matter can prevent the disinfectant or sterilant from contacting the item therefore reducing or inhibiting the efficiency of the process. Water Quality

• Water must be clean and of good quality • Water suitable for drinking is usually suitable for

cleaning • Weekly water hardness tests may be carried

out. (AS 4187 - Required in hospitals.) High water hardness will:

• Leave a residue • Shorten live of instruments • Affect activity of detergent • May damage mechanical equipment

(Note: ppm is equivalent to ug/g — as shown in AS/NSZ 4187 — 2003)

Water Hardness Ranges—ppm

Soft to medium 0—75 ppm

Medium to hard 76—140 ppm

Hard to very hard 141—240 ppm

Very hard to extreme > 240 ppm

10

55

Staff Health and Hygiene

A high level of personal health, appropriate immunisations and good personal hygiene provides good baseline protection for health care workers Hand Hygiene

Staff hands are the most common vehicle for infection transmission in health care.

Staff hands must be washed and dried: • On commencement and completion of duty • Before and after using the toilet • After working in a ‘dirty’ area • Before working in a ‘clean’ area • Before and following meal breaks • Following any action that may contaminate hands • On removal of gloves

Liquid soap is recommended if hands are visibly soiled—never ‘top-up’ handwash solutions as there is a danger of contamination

Hand creams should be used liberally when off duty but hand creams and moisturisers add to the potential contamination of instruments and can compromise the integrity of the packaging and should not be used whilst reprocessing instruments and handling sterile packs.

Fingernails should be kept short and clean. Artificial fingernails and nail polish have been implicated in infection transmission and should not be worn

Jewellery - hand and wrist jewellery has been found to carry pathogenic micro-organisms - hand and wrist jewellery including wedding bands should not be worn

54

Hand Hygiene is using an alcoholic /chlorhexidine hand rub to remove and reduce the number of micro-organisms on the hands or using soap and water

11

Initial Cleaning

Gross soil on equipment should be removed as soon as possibleafter use, by:

• Dry wiping • Damp wiping • Rinsing in warm water—cold water will

congeal fats, hot water will coagulate blood and body fluids

Dried blood or exudate is difficult to remove and may need to be soaked in enzymatic detergent—these should not be used for routine cleaning

Cleaning Precautions

Always use standard precautions when cleaning and handling used items

Wear appropriate personal protection, such as gloves, eye protection and fluid-resistant aprons or gowns

Avoid generation of aerosols when manual cleaning

Use detergents and disinfected strictly as directly by manufacturer—read and have Material Safety Data Sheets

Do not routinely use enzymatic cleaners, may present an increased risk of sensitivity and OH&S issues

Ultrasonic cleaners: • Emission of aerosols—use with lid closed • High frequency sound could cause damage

to hearing—operate with lid closed • Do not immerse any part of body inot water

tank as this is thought to cause arthritic conditions

12

Lubrication

Only use when required—routine lubrication can lead to heavy contamination of instruments

Lubricants must be: • Water miscible • Compatible with sterilising agent • Used according to manufacturers instructions

Stiffness of joints may be caused by: • ‘Flash’ sterilisation (This should only occur in an emergency) • Exposure to saline products • Inadequate cleaning • Malalignment

These problems will not be fixed by lubrication

53

OCCUPATIONAL EXPOSURE

Needle stick injury or splashes with body fluids require: • Immediate washing of area with detergent

wash or antimicrobial wash • Eye splashes should be rinsed well with

water • Report exposure to Supervisor/Manager

immediately. • Complete and lodge accident report • Undertake blood tests/counselling as

organised by a General Practitioner or Infection Control Practitioner

52

Your worst nightmare!

13

Cleaning Equipment—Manual cleaning

• Two sinks—one for washing, one for rinsing • Small brushes for cleaning fine equipment • Light grade nylon or similar scouring pad • Non abrasive • Wire dental burr brush - used by dental practices • Non-linting cloths or disposable low-linting cloths

• Maintain cleaning equipment in good condition • Thermally disinfect or sterilise re-usable cleaning

equipment at the end of the cleaning session • Store clean and dry

Mechanical Cleaning — manufacturers’ instructions must be followed at all times to ensure correct operation (Mostly found in hospitals and day surgery facilities - the exception is Ultrasonic washers)

• Batch-type washer AS 2945 • Rack conveyor washer—tunnel washer AS 3836 • Anaesthetic equipment washer— AS 2945 • Ultrasonic washer— AS 2773 available for practices

Washer/disinfectors must be routinely cleaned to prevent colonisation and formation of biofilms which could contaminate the instruments during the cycle Instrument Grade Detergent

• Biodegradable • Non-abrasive, non-corrosive, non-toxic • Low foaming • Free rinsing • Preferably liquid and of Mild alkali formulation

14

Continually Monitor the Cleaning Process

51

Care with Sharps A sharp is any item capable of penetrating human tissue

All sharps used on people have the potential to transmit blood-borne infections

Inappropriate handling of sharps is the major cause of incidents involving potential exposure to bloodborne infections

Used sharps must be:

• Immediately placed in a sharps bin after use • Not handed to other staff • Used injection needles must not be removed

from syringe • Must not be recapped (except by single-

handed system) • Ensure sharps bins are securely locked when

2/3 full and safely transported to secure storage area

• Butterfly needles are ONLY handled by both wings

Used needles, blades and other sharp items inadvertently returned to the reprocessing area, mustbe placed into a ‘sharps’ container that complieswith AS 4031 or AS/NZS 4261

50 15

Drying of Items

• Dry items quickly to avoid corrosion and stains

• Do not leave items to dry in ambient air as heavy contamination may occur while items are sitting on bench drying

• Use a mechanical drying cabinet where ever possible (usually found in hospitals/day surgeries)

• Use disposable low-linting cloths and/or

• Lint-free cloths for all manual drying

• If not, lint may be left on equipment used for invasive surgery and can cause a foreign body reaction

Monitoring Cleaning Process

Visually inspect items before and after each part of the cleaning process

Use a magnified light to accurately inspect items

Commercially available soil tests are available for mechanical washers

Record results of all soil tests

For mechanical washers, check for detergent or rinse additive residue daily by measuring pH of the rinse water

16

Labelling

• Use non toxic, water resistant felt-tipped markingpens or rubber stamps

• Do not use sharp-tipped, water based or ball point pens—these may damage the packaging

• Always label before sterilisation as marking after sterilisation may compromise the integrity of packaging

Monitor size of packs— for occupational health and safety purposes ensure they do not exceed 5 kgs. Actual size needs to be established via the validation process

49

Blood or Body Fluid Spill

• Assess the volume of spill to be removed • Prevent access to the spill area • Don protective apparel • Soak up spill with paper towel/absorbent

granules • Dispose of absorbent material into infectious

waste bag • Clean area of spill using neutral detergent/

hot water • A chlorine compound (sodium hypochlorite

5000ppm) MAY be necessary for benchtop spills following cleaning) - consult your infection control manual

(Diversol 5000 sachet—1 sachet to 1 litre of water)

(Household bleach 125ml to 1 litre of water) • Place all used disposable protective apparel

into the infectious waste bag and tie securely • Wash hands

48

INFECTIOUS WASTE

17

Packaging and Wrapping

Requirement of packaging:

• Provide an effective barrier against contamination

• Maintain sterility under storage conditions

• Permit aseptic removal of contents

Precautions

• Do not reuse single-use wraps, bags or pouches

• Combinations of hollowware, instruments, dressing and drapes must not be incorporated into a single pack—may not dry adequately

• Sharp instrument tips should be covered to allow exposure to sterilising agent but prevent damage to packaging

• Hinges and ratchets must remain open and unlocked

• Disassemble or loosen multi-part instruments prior to packaging to ensure overall exposure to sterilant (e.g. steam)

• Use perforated trays

• Hollowware:

− All openings to face same direction

− Should not be able to move in pack

− Ensure items separated when nested

− Steripeel—place opening against the paper and not the plastic

18

• Staples • Pins

• String • Non-adhesive tape

• Elastic bands • Sticky tape

Do not use methods that may compromise the packaging e.g.

47

TAKE EXTREME CARE WHEN USING INSTRUMENT GRADE DISINFECTANTS

CHEMICAL DISINFECTION - DUE TO OH&S ISSUES THIS ISNOT USUALLY ABLE TO BE DONE IN OFFICE BASED PRACTICEOnly use chemical disinfection when thermal disinfection is unsuitable

Pre-cleaning is vital—soil left on the instruments can shield microorganisms from the action of the chemical disinfectant

Disinfectants need a minimum contact time to kill or inactivate microorganisms—always follow the manufacturers instructions when using chemical disinfectants

Material Safety Data Sheets must be available, read and understood by all staff using the chemicals

Chemical disinfectants used to process reusable instruments and equipment in hospitals must be registered with the Therapeutic Goods Administration in Australia—TGA

• Sterilant— chemical agent that may be used to sterilise critical medical devices

• Instrument grade disinfectant

• Concentration • Contact time

• Temperature • Correct pH

• Safety directions • Residual soil

46

Level of Risk Application Process

Critical Entry or penetration into sterile tissue, cavity or blood stream

• Sterilisation by steam or

• A minimum of a low temperature automated chemical sterilant—must be sterile

Instruments, endoscopes and accessories used in invasive surgical and dental procedures

Semi-c r i t i ca l (heat tolerant)

Contact with intact non-sterile mucosa (or non-intact skin)

• Preferably steam sterilisation or

• A minimum of thermal disinfection

Breathing circuits, vaginal speculae, instruments for routine dental procedures

Semi-c r i t i ca l (heat sensitive)

As above • Low temperature automated chemical sterilant system or

• A minimum of high-level chemical disinfection

Non-critical Contact with intact skin • Clean as necessary with detergent and water

• I f decontaminat ion i s required, disinfect with a low o r i n te rmed ia te l eve l instrument grade disinfectant after cleaning

Stethoscopes, blood pressure cuffs, non invasive acupuncture devices and ultrasound probes, thermometers

Flexible endoscopes, fiberoptic scopes, gastroscopes, colonoscopes, bronchoscopes, invasive ultrasound probes

Reference: Infection Control in the Health Care Setting. January 2004

19

Sealing Packs

Heat Sealer

• Check all seals to ensure seal is complete

• Have a regular preventative maintenance program in place

Sterilising Indicator Tape

• Select tape specific to mode of sterilisation

• Colour change after exposure should be clear, distinct and uniform

• Bags and pouches should be sealed with a heat sealer—only use tape in the event of a breakdown of heat sealing equipment

− Fold bag over 2-3 times

− Tape across entire folded edge

− Use one continuous piece of tape

− Extend tape at least 25 mm around back of bag

Note:

Sterilising tape is a Class 1 chemical indicator and only indicates that the item has been exposed to a sterilising process—it distinguishes between processes and unprocessed items

20

Dry Heat Sterilisers—AS 2487

• Air removal not part of process • Chamber, air in chamber and the load is

heated to high temperatures

For items that cannot stand steam under pressure but can withstand high temperatures for a long time—1600 C for minimum of 120 minutes

Dry Heat Sterilisers are rarely found in office basedpractices as this process takes too long.

45

Thermal disinfection

Thermal disinfection uses heat and water at temperature to destroy pathogenic, vegetative microorganisms—will not destroy bacterial spores

Thermal disinfection can be ONLY be achievedusing an automated thermal washer-disinfectorusing the appropriate cycle.

Where practical and possible, thermal disinfection is preferable to chemical disinfection

Items must be thoroughly cleaned before attempting thermal disinfection

Surface Temperature (oC)

Minimum Disinfection Time (Minutes)

90 1

80 10

75 30

70 100

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Disinfection

Disinfection is a process that inactivates non-sporing infectious agents, using either thermal (moist or dry heat) or chemical means

Thermal disinfection (requires special equipment) andis not suitable for instruments that are to be used in critical sites, as these instruments must be sterile.

Where instruments and equipment can withstand the process, sterilisation is the preferred process for reusable items

Do not use disinfection as a substitute for sterilisation

Do not store items in disinfectant before or after any form of processing

Items intended for critical, invasive procedures should be sterilised before use

Items that are not clean cannot be disinfected

21

Sterilising Equipment

Methods used in health care facilities:

• Low temperature sterilisation • Dry heat • Steam under pressure

The method chosen must be suitable for the items being processed

The manufacturers written instructions must be followed at all times

The operators manual should be in the vicinity of the steriliser at all times

Caution:

Heat bed devices, microwave ovens, pressure cookers, incubators, ultraviolet cabinets, boiling water units, ultrasonic washers and similar appliances will not sterilise and must not be used for the purpose of sterilising medical equipment

Low Temperature Sterilisation - (Not usually in OBP due to OHS)

• Ethylene oxide—gaseous chemical used to sterilise heat and moisture sensitive items < 600C

• Hydrogen peroxide plasma—low temperature, low moisture sterilisation—Sterrad System

• Peracetic acid—low temperature sterilisation system for immersible devices—Steris System

22

Ref: Gardner and Peel, Sterilisation, Disinfection & Infection Control. Third Edition

Temperature/Pressure Relationship

43

Storage Surfaces

Surfaces should be: • Non-porous • Smooth • Capable of being easily cleaned • No wood concrete or chipboard as these are allow

dust and lint collection and are difficult to clean • Storage containers should comply with the same

requirements

Storage Precautions • Wipe dust from store boxes before opening • Do not accept grossly damaged or soiled boxes • Remove items from store box before bringing into

clean area • Do not reuse cardboard boxes for storage

containers • Do not top-up commercial dispenser boxes • Do not squash packages into small containers • Do not use elastic bands around packages

Plastic Dust Covers

Plastic dust covers can be used to protect sterilised articles from dust and other contamination during prolonged storage

• Cover only when item is cool • Cover within 2 hours of sterilisation otherwise do

not plastic wrap • Seal cover completely—heat sealing recommended

42

Stock Life

How long can an item be stored?

Contamination of sterile stock is event-related not time–related

Contamination can occur at any time and is related to:

• Efficiency of packaging • Amount of handling

• Conditions of transport • Conditions of storage

Avoid prolonged storage by ensuring sensible stock levels and efficient rotation of stock

Plastic wrap emergency equipment that is used infrequently and stored for prolonged periods of time

Ensure storage conditions for all sterile stock meet AS standards

23

Steam Sterilisers

A combination of heat and moisture at a pre-set temperature-pressure-time relationship—coagulates cell protein killing the microorganism, just like boiling an egg

Economic, fast, non toxic

The process is dependent on air removal and steam penetration In order for steam to be effective it must have a:

• Dryness fraction of 97% and above • Not be superheated beyond 2o C

The presence of wet steam or superheated (dry) steam may lead to sterilisation failure

Time-pressure-temperature relationship:

Processing/Cycle Time = Penetration Time + Holding Time (Includes safety margin)

The cycle time must reflect the type of load and packaging material being processed

A penetration time must be established and added to the holding time

Temp oC

Pressure kPa

Pressure psi

Holding Time

121 103 15 15

126 138 20 10

132 186 27 4

134 203 30 3

24

Pre-vacuum Steriliser — AS 1410

• Air is eliminated from the chamber and load by mechanical means—vacuum pump

• More effective method of air removal

• Suitable for cannulated and complex items

• Faster steam penetration

• Increased efficiency of drying cycle Portable Steam Steriliser (Benchtop) - AS 2182

• May not have a drying cycle—unwrapped only

• Air removal inefficient, air is displaced by steam

• Suitable for small quantities of small items

Pre-vacuum portable sterilisers are available—many of the requirements of AS 1410 apply to this type of steriliser

41

Storage and Handling

To prevent contamination and damage to the packaging sterile stock should be stored in a dedicated area with restricted access.

Critical Medical Items—unwrapped

Clean and sterilise before being stored, clean and resterilise wrapped immediately prior to use

Semi-critical and Non-critical—unwrapped

After processing, store in a clean, dry, dust-free, dedicated container or drawer to protect from environmental contamination. Reprocess prior to use if necessary

Storage of Wrapped Sterile Items

Sterile goods of commercial, or CSSD origin must be stored in the following conditions to maintain sterility:

• Dust free • Insect and vermin free • Moisture free • Not in strong sunlight • Store items at least 220 mm from floor • Store items 440 mm from ceiling • Aim for temperature range 18oC—22oC • Aim for relative humidity range 35% - 68%

Overhead lighting should be fitted to avoid dust entrapment

40 25

Types of Steam Sterilisers

Downward Displacement—Jacketed— AS 2192

• Drying capacity

• Wrapped items

• Air removal inefficient, air is displaced by steam

• Difficult to achieve sterilization of cannulated items

• Time for drying needs to be determined by the size and density of packs to be sterilized

Downward Displacement— ‘Flash’

• Unwrapped, non-porous items only

• Single instruments only

• Cannulated, complex instruments and other tubing shall not be processed by this method

• No drying cycle

• Textiles and papers must not be used

• Instruments required to be sterile must be used immediately after ‘flash’ sterilisation and only in an emergency.

26

39

Tests for Pre-vacuum Sterilisers

Leak rate test— demonstrates that the quantity of air leaking into the chamber during vacuum stage does not exceed a level that may inhibit the sterilising process

Daily if no air detector fitted (weekly where there is an air detector)

When done daily it should be done before the Bowie Dick test/Helix test

Bowie Dick test/ Helix test — are tests that provide

evidence of complete removal of air and/or steam penetration using a test pack/card/helix device.Checking Packaging After Sterilisation

When the load is cool it is important to check packages as they are taken off trolley ready for use or storage.

Check for:

• Integrity of outer wrap • Integrity of seals • Correct labelling • Correct colour change on external chemical

indicators

Evaluation

To ensure a quality service it is important to evaluate the sterilising processes and procedures, regularly audit activities and make adjustments to service provision as required

38

27

Loading the Steriliser

Correct loading is essential to ensure: • Efficient air removal from chamber and load • Adequate steam penetration • Proper drainage of condensate • Reduced damage to packs and their content • Maximum efficient use of steriliser

Commence sterilisation cycle immediately after loading Do not preheat loads—risk altering the physical characteristics of packaging, dehydration of textiles can lead to superheating Hollowware

• Tilt on edge to assist drainage of condensate and efficient air removal and steam penetration

Drapes • Place layers vertically to assist rapid air removal

Flexible packaging • Load on edge or flat with paper side down • Rack may be used to assist this process • Place hollowware with opening against paper

Loading Sterilising Trolley • Items must not touch chamber walls • Do not place hollowware above textile packs as

condensate from hollowware can cause wetting of textiles if placed below

• Loosely load to capacity • Single layer of packs on each shelf

Steriliser without a drying stage (Flash)• Items must not be wrapped or bagged

28

Reprocess items if:

• Item dropped on floor • Seals are broken

• Item compressed • Torn

• Placed on dirty surface • Items are wet

37

Monitoring Sterilisers

Physical Monitoring

Time, temperature and, where applicable, pressure must be monitored for every load.

This should be done by with a continuous automatic permanent monitoring system:

• Process recorder • Printout • Internal and external data logger

Where there is no permanent data recorder the readings from the gauges should be documented for every cycle at intervals of:

• 10 seconds for steam sterilisation • 10 minutes for dry heat sterilisation

Existing sterilisers without permanent recorders need to be upgraded or replaced to ensure automatic monitoring

Chemical Indicators

Designed to monitor one or more sterilisation process parameters for the purpose of detecting malfunction or failures (or both)

• External indicators—tape or labels placed on the outside of the pack to denote that the item has been exposed to a sterilising process

• Internal indicators—multi-parameter chemical indicators can be used inside each pack to indicate a sterilisation process failure

Chemical indicators do not verify sterility but allow detection of potential sterilisation failures

36

Biological / Enzymatic Indicators

A standardised preparation of bacterial spores/enzymes which challenges the sterilisation process and demonstrates whether sterilisation conditions have been met— should be capable of providing a sterility assurance level of 10-6

BI’s must be incubated according to the manufactures instructions

One additional unexposed control indicator must be used each day BI’s are used to verify the pre-sterilisation viability of the batch of BI’s

Clean and maintain incubator as directed by manufacturer. Where applicable, change ultraviolet light as directed

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Unloading the Steriliser

Items are very vulnerable to contamination by moisture and improper handling directly after the sterilising process

• Remove load from steriliser immediately after completion of cycle

• Visually inspect to ensure load is dry • Check sterilising indicators have made the

required colour change

On Removal of Load

• Check recording chart/printout and sign-off that required sterilising parameters have been met

• Notify supervisor if any problems are detected • Keep cooling load away from high activity

areas • Do not use fans or boosted air conditioning to

cool loads • Do not place cooling items on a solid surface,

as condensation may result

Flash Sterilisation - Only to be used in emergencies, eg dropped single item no sterile replacement .

• For sterile ‘set-up’, staff must wear a surgical face mask and sterile attire when transferring items from steriliser to point of use.

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Monitoring of Sterilising Equipment

All stages of the sterilising process: • Must be developed and documented • Must be able to be reliably reproduced • Must be routinely monitored

Purchasing — equipment should comply with relevant Australian Standard where available

Validation Process

Installation qualification is done during installation and ensures that the area in which the steriliser is to be installed is suitable and that the measurement systems on the steriliser are within specified limits

Operation qualification is also done at time of installation and confirms that when operated empty the steriliser performs correctly

Performance qualification demonstrates that the steriliser is capable of sterilising the types of loads used by a particular organisation and that the process is reproducible—a minimum of three consecutive replicate cycles is required for each ‘challenge’ load

− Cleaning − Inspection

− Assembly − Packaging

− Loading − Sterilising cycle

− Calibration − Monitoring

− Record keeping − Unloading

− Storage − Distribution

− Validation

(Co m

mis

sion

ing)

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Product Recall - This is what happens in a hospital (Important for those practices who use a hospital to perform their sterilising)

In the event of evidence a sterilisation process failure, after items have been released, a recall procedure should be in place to enable rapid recall of all items suspected to be non-sterile

A recall notice should:

• Identify the persons or department for which the notice is intended

• State the batch information being recalled • Include an area to record products and quantity

of products to be returned in recall • Include the action to be taken by persons

receiving notice - e.g. return or hold for collection by CSSD staff

A report should be completed defining:

• The reason for recall, • The total number of products recalled • The actual number located • Number of patients potentially exposed • The actions taken re. patient involved • Where applicable, the actions taken to prevent

this happening again

Sterilising department records must be kept for a period of time not less that that defined by state or local regulations or policy. Check with your medical defence organisation.

Victoria: Adults only treated at your agency—7 years Paediatrics only—18 years Combined adult and paediatric —25 years

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Recommissioning needs to be done if changes or engineering work are carried out on equipment which could affect the performance of the steriliser or review of records indicate a problem

Performance Requalification needs to be done annually and if a change is made to the steriliser load which is outside the limits specified in the PQ

Calibration checks that the measuring devices, timers, gauges and displays on the steriliser are accurate and reliable—NATA certified

• If these devices are not functioning correctly then the monitoring and validation processes are unreliable and a fault in the steriliser may not be detected

Monitoring and maintenance of the sterilisers and associated equipment needs to be conducted in accordance with Table 7.1 and Table 7.2 of AS/NZS 4187 and 4815

Preventative maintenance programs must be established and maintained for all equipment

RECORDS MUST BE KEPT OF ALL MONITORING AND MAINTENANCE ACTIVITIES

Validation

1. Commissioning

Includes Installation Qualification

And Operational Qualification

2. Performance Qualification

Includes Physical Qualification

And Microbiological Qualification

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Sterilising Cycle Records

• Date of cycle • Steriliser code or number • Cycle or load number • Exposure time, temperature and pressure • Name/ID of loading operator • Name/ID of person authorising release • Specific content of load and • Read out results of indicators used

− Physical − Chemical − Biological/enzymatic

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Quality Management

The staff member with the designated responsibility requires education and training in sterilising and reprocessing - must be able to understand processfailures and be able to take corrective action

• Must be actively involved in day-to-day activities

The level and extent of documentation should reflect the activity of the sterilising facility

A formal orientation program must be in place to

assist new workers and a competency assessment undertaken

for all staff perfoming any part of the sterilising or reprocesing.All staff members should be encouraged to participate in external education courses

• National and state registered courses in sterilisation are available

Material Management

Stock levels must be managed to ensure maintenance of service provided by health care facility

• Monitor and forecast stock use • Avoid situations where sterile stock is not

available

Each pack must be labelled with • Steriliser ID number or code • Date of sterilisation • Cycle load or number and contents of pack if not visible.

You should be able to link the information to the patient—this should be regularly audited to ensure the process works