Modified for Office Based Practice - May 2009

THE CSSD BOOK

A Little Yellow Infection Control Book

Grampians Region Infection Control Group
64 1

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.

Equipment Pre vacuum Steriliser Sterilisers-Steam-Benchtop Sterilisers-Steam-Downward displacement Flushers/sanitisers for bedpans & urine bottles Dry heat sterilisers Drying cabinet for medical equipment Ultrasonic cleaner-non portable Ultrasonic cleaner-benchtop Drying cabinet for respiratory equipment Batch-type washer/disinfector Rack conveyor washers

Australian Standard AS 1410 AS 2182 AS 2192 AS 2437 AS 2487 AS 2514 AS 2773.1 AS 2773.2 AS 2774 AS 2945 AS 3836

For other publications visit:

http://www.grampianshealth.org.au/ 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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Table of Contents References 1. Standards Australia. AS/NZS 4187 : 2003

Definitions Reprocessing reusable items Cleaning and handling used items Water quality Initial cleaning Cleaning precautions Cleaning equipment Drying of items Monitoring cleaning process Packaging and wrapping Sealing packs Sterilising equipment Steam sterilisers Loading steriliser Unloading steriliser Validation process Quality management Product recall Monitoring steriliser Tests for pre-vacuum steriliser Storage and handling Disinfection Blood or body fluid spills Care with sharps Occupational exposure Staff health and hygiene Clinical waste disposal References 62 4-5 7 9 9 11 11 13 15 15 16-17 19 20-21 22-25 27 28-29 30-31 32-33 35 36-37 39 41-43 44-47 49 51 53 55-59 61 63 3

Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities
Australian Government. Department of Health and Aging. Infection Control Guidelines for

2.

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)

Definitions
Bioburden Biofilm the number and types of microorganisms present on an object or surface a layer of material on the surface of an instrument or device which contains biological materials and in which microorganisms are imbedded the removal of soil and reduction of microorganisms from a surface a process intended to kill or remove pathogenic microorganisms but which cannot usually kill bacterial spores Management of Clinical Waste Medical waste can cause injury and infection transmission if improperly handled.

Cleaning Disinfection

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.

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)

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Licensed contractor Incinerator: 1100oC (NHMRC 1999b)

Landfill Consider recycling (confidential waste to be shredded or incinerated

Incineration or validated steam sterilisation, then supervised landfill

Licensed contractor (for disposal by approved technologies

Sewer: local regulations must be followed

Safety Margin extra time added to the holding time to ensure sterilisation is achieved 25% of holding time
Licensed contractor (see guidelines for details)

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 Free from living microorganisms

Incineration

Disposal

Sterile

Black, buff, green, white

Yellow rigid container

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

Container Colour

Yellow bag

Purple

Clinical waste

Non-sharps

Radioactive

Cytotoxic

Sharps

General

Liquid

Waste

Validation documented procedure and interpreting the establish that a process a product complying specifications
Validation 1. Commissioning

obtaining, recording results required to will consistently yield with predetermined

Red

2. Performance Qualification
Includes Physical Qualification And Microbiological Qualification 5

Symbol

None

Includes Installation Qualification And Operational Qualification 60

From Infection Control in the Health Care Setting, January 2004

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

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
6

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.

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Immunisation Your extra protective umbrella

Reprocessing Reusable Instruments and Equipment Reprocessing sterilisation refers to cleaning, disinfection and/or

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
58 7

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 doctoropen 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 IT CANNOT BE CLEANED IT CANNOT BE DISINFECTED OR STERILISED IF YOU ARE ILL PLEASE CONSULT YOUR DOCTOR OR STAFF CLINIC

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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 Soft to medium Medium to hard Hard to very hard Very hard to extreme

Rangesppm 075 ppm 76140 ppm 141240 ppm > 240 ppm

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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
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Initial Cleaning
Gross soil on equipment should be removed as soon as possible after use, by:

Dry wiping Damp wiping Rinsing in warm watercold 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 detergentthese 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 manufacturerread and have Material Safety Data Sheets 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 Do not routinely use enzymatic cleaners, may present an increased risk of sensitivity and OH&S issues Ultrasonic cleaners: Emission of aerosolsuse with lid closed High frequency sound could cause damage to hearingoperate with lid closed Do not immerse any part of body inot water tank as this is thought to cause arthritic conditions
11

54

OCCUPATIONAL EXPOSURE Needle stick injury or splashes with body fluids require: Lubrication Only use when requiredroutine 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
12 53

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

Your worst nightmare!

Cleaning EquipmentManual cleaning

Two sinksone 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 washertunnel 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

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13

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 singlehanded 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, must be placed into a sharps container that complies with AS 4031 or AS/NZS 4261 Continually Monitor the Cleaning Process

14

51

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

50

15

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 sachet1 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

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 Labelling

Use non toxic, water resistant felt-tipped marking pens or rubber stamps Do not use sharp-tipped, water based or ball point pensthese may damage the packaging Always label before sterilisation as marking after sterilisation may compromise the integrity of packaging
16

49

Packaging and Wrapping Requirement of packaging:

Provide an contamination

effective

barrier

against

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 packmay 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:

INFECTIOUS WASTE

All openings to face same direction Should not be able to move in pack Ensure items separated when nested Steripeelplace opening against the paper and not the plastic
17

48

CHEMICAL DISINFECTION - DUE TO OH&S ISSUES THIS IS NOT USUALLY ABLE TO BE DONE IN OFFICE BASED PRACTICE

Only use chemical disinfection when thermal disinfection is unsuitable Pre-cleaning is vitalsoil left on the instruments can shield microorganisms from the action of the chemical disinfectant Disinfectants need a minimum contact time to kill or inactivate microorganismsalways follow the manufacturers instructions when using chemical disinfectants

Concentration Temperature

Contact time Correct pH

Safety directions Residual soil 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 AustraliaTGA
Staples String Elastic bands Pins Non-adhesive tape Sticky tape

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

Sterilant chemical agent that may be used to sterilise critical medical devices Instrument grade disinfectant

TAKE EXTREME CARE WHEN USING INSTRUMENT GRADE DISINFECTANTS

18 47

Level of Risk Critical

Application

Process

Entry or penetration Sterilisation by steam or into sterile tissue, cavity A minimum of a low or blood stream temperature automated chemical sterilantmust be sterile

Sealing Packs Heat Sealer

Check all seals to ensure seal is complete Have a regular preventative maintenance program in place

Instruments, endoscopes and accessories used in invasive surgical and dental procedures S e m i - c r i t i c a l Contact with intact non- Preferably steam sterilisation (heat tolerant) sterile mucosa (or nonor intact skin) A minimum of thermal disinfection

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 sealeronly use tape in the event of a breakdown of heat sealing equipment

Breathing circuits, vaginal speculae, instruments for routine dental procedures S e m i - c r i t i c a l As above (heat sensitive) Low temperature automated chemical sterilant system or A minimum of high-level chemical disinfection

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

Flexible endoscopes, fiberoptic scopes, bronchoscopes, invasive ultrasound probes Non-critical Contact with intact skin

gastroscopes,

colonoscopes,

Clean as necessary with detergent and water If decontamination is required, disinfect with a low or intermediate level instrument grade disinfectant after cleaning

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

Stethoscopes, blood pressure cuffs, non invasive acupuncture devices and ultrasound probes, thermometers
Reference: Infection Control in the Health Care Setting. January 2004

46

19

Thermal disinfection Thermal disinfection uses heat and water at temperature to destroy pathogenic, vegetative microorganismswill not destroy bacterial spores Thermal disinfection can be ONLY be achieved using an automated thermal washer-disinfector using the appropriate cycle. Where practical and possible, thermal disinfection is preferable to chemical disinfection Items must be thoroughly attempting thermal disinfection cleaned before

Dry Heat SterilisersAS 2487

Surface Temperature (oC) 90 80 75 70

Minimum Disinfection Time (Minutes) 1 10 30 100

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 time1600 C for minimum of 120 minutes Dry Heat Sterilisers are rarely found in office based practices as this process takes too long.

20

45

Disinfection Disinfection is a process that inactivates nonsporing infectious agents, using either thermal (moist or dry heat) or chemical means Thermal disinfection (requires special equipment) and is 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 disinfected are not clean cannot be

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 oxidegaseous chemical used to

sterilise heat and moisture sensitive items < 600C Hydrogen peroxide plasmalow temperature, low moisture sterilisation Sterrad System Peracetic acidlow temperature sterilisation system for immersible devicesSteris System

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Temperature/Pressure Relationship 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
Ref: Gardner and Peel, Sterilisation, Disinfection & Infection Control. Third Edition

not plastic wrap

Seal cover completelyheat sealing recommended 43

22

Steam Sterilisers A combination of heat and moisture at a pre-set temperature-pressure-time relationshipcoagulates 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 o Not be superheated beyond 2 C The presence of wet steam or superheated (dry) steam may lead to sterilisation failure Time-pressure-temperature relationship: Stock Life How long can an item be stored? Contamination of sterile stock is event-related not timerelated Contamination can occur at any time and is related to:
Temp o C 121 126 132 134 Pressure kPa 103 138 186 203 Pressure psi 15 20 27 30 Holding Time 15 10 4 3

Efficiency of packaging Amount of handling Conditions of transport Conditions of storage

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
42 23

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

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 Itemsunwrapped Clean and sterilise before being stored, clean and resterilise wrapped immediately prior to use Semi-critical and Non-criticalunwrapped 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 Portable Steam Steriliser (Benchtop) AS 2182
May not have a drying cycleunwrapped only Air removal inefficient, air is displaced by

Pre-vacuum Steriliser AS 1410

Air is eliminated from the chamber and load

by mechanical meansvacuum pump

More effective method of air removal Suitable for cannulated and complex items Faster steam penetration Increased efficiency of drying cycle

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

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

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 18oC22oC Aim for relative humidity range 35% - 68%

Overhead lighting should be fitted to avoid dust entrapment

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41

Types of Steam Sterilisers Downward DisplacementJacketed 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.

40

25

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

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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 loadsrisk 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
38 27

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 indicatorstape or labels placed on the outside of the pack to denote that the item has been exposed to a sterilising process Internal indicatorsmulti-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
28 37

Reprocess items if:

Item dropped on floor Item compressed Placed on dirty surface Seals are broken Torn Items are wet

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

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 BIs must be incubated manufactures instructions according to the

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 .

One additional unexposed control indicator must be used each day BIs are used to verify the presterilisation viability of the batch of BIs Clean and maintain incubator as directed by manufacturer. Where applicable, change ultraviolet light as directed
36

For sterile set-up, staff must wear a surgical

face mask and sterile attire when transferring items from steriliser to point of use.

29

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
Cleaning Assembly Loading Calibration Record keeping Storage Validation Inspection Packaging Sterilising cycle Monitoring Unloading Distribution

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 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

Purchasing equipment should comply with relevant Australian Standard where available Validation Process
(Commissioning)

A report should be completed defining:

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 reproduciblea minimum of three consecutive replicate cycles is required for each challenge load
30

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 agency7 years Paediatrics only18 years Combined adult and paediatric 25 years
35

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 reliableNATA 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 34

2. Performance Qualification
Includes Physical Qualification And Microbiological Qualification 31

Quality Management The staff member with the designated responsibility requires education and training in sterilising and reprocessing - must be able to understand process failures 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

Sterilising Cycle Records

National and state registered courses in sterilisation are available

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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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 patientthis should be regularly audited to ensure the process works
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