References Standards Australia. AS/NZS 4187 : 20003 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities NHMRC (2010) Australian Guidelines for the Prevention and Control of Infection in Healthcare. Commonwealth of Australia http://www.nhmrc.gov.au/guidelines/publications/cd33 A LITTLE YELLOW INFECTION CONTROL BOOK THE CSSD BOOK Gardner Joan F & Peel Margaret M. Sterilization,Disinfection and Infection Control. Third Edition. Churchill Livingstone Resources For other booklets and resources visit the Grampians Region Health Collaborative Website Infection Control at: http://www.grhc.org.au/infection-control Cartoons in this booklet by: http://www.davegibb.com.au/index.htm 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 booklet 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. 64 Grampians Region Infection Control Group 2014 1
About this book: A Little yellow 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 texts. Concept and production by: Bruce Fowkes Original: 2005 Revisions: 2006, 2010, 2014 Mary Smith mary.smith@health.vic.gov.au Sue Atkins sue.e.atkins@health.vic.gov.au AS/NZS 4187:2003 is currently under review. This booklet will be updated in detail once the new standards are available, - current to date. State Government of Victoria, Australia Department of Health Grampians Region My Notes.................. 2 63
Equipment Australian Standard Pre vacuum Steriliser AS 1410 Sterilisers-Steam-Benchtop AS 2182 Sterilisers-Steam-Downward displacement Flushers/sanitisers for bedpans & urine bottles AS 2192 AS 2437 Dry heat sterilisers AS 2487 Drying cabinet for medical equipment Ultrasonic cleaner-non portable AS 2514 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 Table of Contents Definitions 4 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 Sealing packs 19 Sterilising equipment 20 Steam sterilisers 22 Loading steriliser 27 Unloading steriliser 28 Validation process 30 Quality management 32 Product recall 35 Monitoring steriliser 36 Tests for pre-vacuum steriliser 39 Storage and handling 41 Disinfection 44 Blood or body fluid spills 49 Care with sharps 51 Occupational exposure 53 Staff health and hygiene 55 Clinical waste disposal 61 My notes 63 References and resources 64 3
Definitions Bioburden the number and types of microorganisms present on an object or surface Management of Clinical Waste Biofilm Cleaning 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 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 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. 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) 4 61
Safety Margin extra time added to the holding time to ensure sterilisation is achieved 25% of holding time Spores Sterile 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 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 2. Performance Qualification The above is specific to Victoria. Refer to your state or territory Environmental Protection Authority (EPA) for local requirements 60 Includes Installation Qualification And Operational Qualification Includes Physical Qualification And Microbiological Qualification 5
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 CSSD staff These are: Diphtheria/ Tetanus A full course of three staged injections Polio A full course of three staged oral drops/injection Measles/Mumps/Rubella Two doses, if born after 1966 Chicken pox (Varicella Zoster virus) Immunisation if no definite history of the disease The CSSD 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. 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 6 59
Immunisation - Your extra protective umbrella 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. Other methods of achieving sterility include: Low temperature and low moisture Ethylene oxide sterilizers Hydrogen peroxide plasma sterilizers Low temperature Peracetic acid sterilizing equipment. 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? IF IT CANNOT BE CLEANED IT CANNOT BE DISINFECTED OR STERILISED 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 8 57
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 should be carried out. 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 Ranges ppm 0 75 ppm 76 140 ppm 141 240 ppm > 240 ppm 56 9
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 on duty 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 10 55
Initial Cleaning Gross soil should be removed as soon as possible after use, before equipment is returned to CSSD 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 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 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 Material Safety Data Sheet Do not routinely use enzymatic cleaners, use only for removal of congealed debris 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. 54 11
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 for at least Report exposure to Supervisor, Nursing Administration, ICP or Staff Clinic Complete and lodge accident report 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 Exposure to saline products Inadequate cleaning Malalignment These problems will not be fixed by lubrication. Undertake blood tests/counselling as organised by Nursing Administration, Infection Control Practitioner, General Practitioner or Staff Clinic 12 53
Your worst nightmare! 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 Non-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 Batch-type washer AS 2945 Rack conveyor washer tunnel washer AS 3836 Anaesthetic equipment washer AS 2945 Ultrasonic washer AS 2773 Washer/disinfectors must be routinely cleaned to prevent colonisation and formation of biofilms which could contaminate the instruments during the cycle. Detergent Biodegradable Non-abrasive Low foaming Free rinsing Mild alkali formulation. 52 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 Continually Monitor the Cleaning Process Used needles, blades and other sharp items inadvertently returned to CSSD must be placed into a sharps container that complies with AS 4031 or AS/NZS 4261 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 Tubing and anaesthetic equipment must be dried using a drying cabinet (AS/NZS 4187) Do not leave tubing hanging around to dry Use 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 (AS/NZS 4187 page 27). 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 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 solvent-based felt-tipped marking pens 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. 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 16 49
Packaging and Wrapping Requirement of packaging: Provide an effective barrier against contamination Maintain sterility under storage conditions Permit aseptic removal of contents. INFECTIOUS WASTE Precautions Launder all textile wraps prior to reuse Do not reuse single-sue wraps 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 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. 48 17
Chemical Disinfection Only 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 Concentration Contact time Temperature Correct ph Safety directions Residual soil Do not use methods that may compromise the packaging e.g. Staples String Pins Non-adhesive tape 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 Elastic bands Sticky tape TAKE EXTREME CARE WHEN USING INSTRUMENT GRADE DISINFECTANTS 18 47
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-critical (heat tolerant) Contact with intact nonsterile mucosa (or nonintact skin) Preferably steam sterilisation or A minimum of thermal disinfection Breathing circuits, vaginal speculae, instruments for routine dental procedures Semi-critical (heat sensitive) As above Low temperature automated chemical sterilant system or A minimum of high-level chemical disinfection Flexible endoscopes, fiberoptic scopes, gastroscopes, colonoscopes, bronchoscopes, invasive ultrasound probes Non-critical Contact with intact skin Clean as necessary with detergent and water If decontamination is required, disinfect with a low or intermediate level instrument TGA registered disinfectant after cleaning Stethoscopes, blood pressure cuffs, non invasive acupuncture devices and ultrasound probes, mercury thermometers 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 Note: 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. 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. Reference: NHMRC (2010) Australian Guidelines for the Prevention and Control of Infection in Healthcare. Commonwealth of Australia 46 19
Thermal disinfection Thermal disinfection uses heat and water at temperature to destroy pathogenic, vegetative microorganisms will not destroy bacterial spores Thermal disinfection can 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 cleaned before attempting thermal disinfection. 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 160 0 C for minimum of 120 minutes Surface Temperature ( o C) Minimum Disinfection Time (Minutes) 90 1 80 10 75 30 70 100 Powders, waxes, oils and ointments Not designed to sterilise liquids. 20 45
Disinfection Disinfection is a process that inactivates nonsporing infectious agents, using either thermal (moist or dry heat) or chemical means Thermal disinfection 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 are not clean cannot be disinfected 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 Ethylene oxide gaseous chemical used to sterilise heat and moisture sensitive items < 60 0 C Hydrogen peroxide plasma low temperature, low moisture sterilisation Sterrad System Peracetic acid low temperature sterilisation system for immersible devices Steris System. 44 21
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 Ref: Gardner and Peel, Sterilisation, Disinfection & Infection Control. Third Edition. Cover only when item is cool Cover within 2 hours of sterilisation otherwise do not plastic wrap Seal cover completely heat sealing recommended. 22 43
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 2 o 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? Temp o C Pressure kpa Pressure psi Holding Time Contamination of sterile stock is event-related not time related 121 103 15 15 Contamination can occur at any time and is related to: 126 138 20 10 Efficiency of packaging 132 186 27 4 Amount of handling 134 203 30 3 Conditions of transport Conditions of storage Processing/Cycle Time = Penetration Time + Holding Time (Includes safety margin) Avoid prolonged storage by ensuring sensible stock levels and efficient rotation of stock The cycle time must reflect the type of load and packaging material being processed 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. 42 A penetration time must be established and added to the holding time. 23
Storage and Handling 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. To prevent contamination and damage to the packaging sterile stock should be stored in a dedicated area with restricted access this applies to the wards and general store as well as CSSD Critical Medical Items unwrapped Clean and sterilise before being stored, clean and resterilise 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 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. 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 Temperature range 18 o C 22 o C Relative humidity range 35% - 68% Overhead lighting should be fitted to avoid dust entrapment. 24 41
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 must be used immediately after flash sterilisation. 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 Bowie Dick test Daily test that provides evidence of complete removal of air from pack 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. 26 39
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 Flash Steriliser Items must not be wrapped or bagged. 38 27
Reprocess items if: Item dropped on floor Item compressed Placed on dirty surface Seals are broken Torn Items are wet 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. 28 37
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 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 presterilisation viability of the batch of BI s Clean and maintain incubator as directed by manufacturer. Where applicable, change ultraviolet light as directed. 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 sterilisers For sterile set-up, staff must wear a surgical face mask and sterile attire when transferring items from steriliser to point of use. 36 29
Monitoring of Sterilising Equipment (Commissioning) 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 Purchasing equipment should comply with relevant Standard where available (see page 46 AS/NZ 4187) Validation Process Inspection Packaging Sterilising cycle Monitoring Unloading Distribution 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. Product Recall 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 Victoria: Adults only treated at your agency 7 years Paediatrics only 18 years Combined adult and paediatric 25 years. 30 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 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 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 34 31
Quality Management The manager requires specific qualifications and experience in sterilising technology must be able to understand process failures and be able to take corrective action Must be actively involved in day-to-day activities Must report directly to director of clinical services to ensure neutrality of service The level and extent of documentation should reflect the activity of the sterilising facility A formal orientation program should be in place to assist new workers All staff members should be encouraged to participate in external education courses 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 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 have a batch control label Steriliser ID number or code Date of sterilisation Cycle load or number You should be able to link the batch information to the patient this should be regularly audited to ensure the process works. 32 33