Presentation on theme: "Easi-Sterilise Information session for Clinicians"— Presentation transcript:
1 Easi-Sterilise Information session for Clinicians “Getting it right, every step of the way”
2 Why are we here? Patient and staff safety Directives from QH EMT for rapid implementation of education and training following incidentsImplementing a continuous quality improvement programAcknowledge an absence in effective communication when changes are madeTo build on current level of knowledge in light of ever changing technology, standards, guidelines, advisories and legislation
3 Aim of this workshopProvide participants with an overview of the Easi Sterilise Standard Operating Procedures and outline the responsibility of the clinician in ensuring that items have been through the correct reprocessing and are able to be used safely for patient care.
4 QH Commitment Is to: Appropriately train and skill staff Provide information and resources so that step-by-step quality processes are consistently followedAssist in identifying gaps in knowledge and provide opportunities for improvement
5 SOPs & WSAsTo assist Oral Health facilities operationalise QH policy and guidelinesA resource for staffUpdate and supersede the OH Critical Instrument Tracking (2003)A framework to assist staff identify competence and areas where education and improvement may be neededA resource to identify opportunities for improvement within the department that will require further education and training
7 1.1 Standard PrecautionsStandard precautions are applied as a first-line approach to infection control. These form the basis for your decision-making and practice. Standard precautions are a set of guidelines based on the assumption that all blood and body fluids are potentially infectious.
8 1.1 Standard Precautions Hand Hygiene In the context of sterilising practice and ALL the Standard Operating Procedures, standard precautions include:Hand HygieneHand cream – approved by infection control – not in packing area or handling of sterile stockPersonal Protective EquipmentGlovesFace shields, hair protection, safety glasses and masksFluid resistant gowns/apronsOHS Requirements
9 1.2 Soiled Pickup Collection Standard Precautions - PPEContaminated items - dedicated collection trolley/containerKeep instrument sets togetherSecure sharpsCollection containers are:puncture-resistantleak-proof and made of either plastic or metalwith a lid or liner that can be closed
10 1.3 Sorting Prior To Cleaning Instruments and items sorted by;TypeMethod of cleaning e.g. Manual , ultrasonic,Instruments and items are checked for;CompletenessDefectsSharps or blades that have not been removedHeavily soiled itemsSingle use only items must not be returned for reprocessingReport concerns to supervisor
11 CleaningCleaning removes organic and inorganic soil, blood, fats etc which contain pathogenic micro-organismsGross Debris should be removed chairsideCleaning minimises contamination levels of bioburden (number of micro-organisms) prior to sterilisationFor sterilisation to occur the aim is to have a low number of micro-organisms present on instruments
12 Cleaning Steam will not penetrate contamination left on instruments If the item is not clean it won’t be sterilised
13 1.5 Pre CleaningPre cleaning (initial cleaning) allows for the removal of visible blood, body fluids and debris from items prior to cleaning (definitive cleaning). Pre cleaning shall be undertaken as soon as possible (e.g. during and post procedure chairside).If blood, proteins and other debris are allowed to dry or remain in crevices and joints, the instruments become very difficult to clean and are prone to stiffness and accelerated corrosion.Pre cleaning (initial cleaning) allows for the removal of visible blood, body fluids and debris from items prior to cleaning (definitive cleaning). Pre cleaning shall be undertaken as soon as possible (e.g. during and post procedure chairside).If blood, proteins and other debris are allowed to dry or remain in crevices and joints, the instruments become very difficult to clean and are prone to stiffness and accelerated corrosion.Application of standard precautionsPre cleaning can be performed by methods such as dry wiping, damp wiping or use of a commercially available single use only instrument spongePlace the dry wipe, damp wipe or sponge on the bracket table and carefully wipe the instrument across the material
14 1.5 Pre CleaningPre cleaning can be performed by methods such as dry wiping, damp wiping or use of a commercially available single use only instrument spongePlace the dry wipe, damp wipe or sponge on the bracket table and carefully wipe the instrument across the material
15 1.6 Hand Cleaning For Immersible Items Drying – As per manufacturer’s instructionsDrying cabinetDisposable low-lint cloth for hose, battery and external partsAir pressure gun (for removal of excess moisture)Disposable syringeDRYING - As per the manufacturer’s instructionsDrying cabinetDisposable low-lint clothAir pressure gun - to be regulated to a low pressureDisposable syringe15
16 1.6 Hand Cleaning For Immersible Items Problems associated with incorrect dryingItems should NOT be air dried/ dripped dryGood conditions micro-organisms multiply in minutesWet packaging result in unsterile itemCan cause rusting, corrosion, pitting to the item
17 Handpieces handpieces slow speed motors outside surfaces cleaned using detergent wipe,rinsed by wipingdriedslow speed motorsrinsed by wiping,lubricated (manually or automatic) may need special adaptorsDried, wrapped & processed in a wrapped cycle17
19 Special adaptors may be needed Special adaptors may be needed to connect your handpiece or head or motor to the lubricating device to allow sufficient cleaning and lubricants to enter the handpiece, head or motor.If in doubt “shout” check with your device manufacturer. When obtaining new instruments or makes and models always obtain the cleaning and reprocessing instructions for the device.Ideally, handpieces and slow speed motors are cleaned and lubricated using mechanised cleaning equipment19
21 1.8 Ultrasonic CleanerPurpose Ultrasonic cleaning is a form of mechanical cleaning that uses high frequency ultrasonic waves (cavitation) that dislodges fine particles from the surfaces of instruments.21
22 1.8 Ultrasonic cleanerUltrasonic cleaning is an effective cleaning method for instruments prior to the reprocessing
23 1.9 Washer Disinfector Machines Batch and continuous type washer disinfectors clean and remove bio burden/micro-organisms (blood and debris)Thermal (high level) disinfection using time at temperature – final rinseMeans the cleaning process is verifiableLumened items still require Flush brush FlushUnlock and open itemsUse appropriate washer baskets/insertsKeep sets together
24 1.9 Washer Disinfector Machines REPORT IMMEDIATELY:Cycle parameters not meeting set requirements or variations to cycle parameters – failed cyclesItems that appear dirty or stained are returned to the cleaning area for recleaning/destainingExcess water – check the following: the machine temperature, amount of rinse aid going into the machine or the way in which the machine was loadedDamaged instruments24
25 1.9 Washer Disinfector Machines Releasing the load and unloading the washer disinfectorAuthorising release of the load occurs on completion of washer disinfector cycle and prior to opening the door.Check cycle parameters have been met and print out/log (or equivalent) is signedCare opening the doors due to heat and moistureInspect load not become dislodged or displacedAvoid injury and damaging the equipment/instruments25
27 Packaging and Wrapping Procedures Section 2Packaging and Wrapping Procedures27
28 2.1 Organisation Of Packing Area Organised packing area ensures a clean, safe work working area that reduces the risk of equipment damage/loss and unsafe work practices.
29 2.2 Assembly Of Instrument Trays And Hollowware Prepare equipment for sterilization:Check multi-part equipment / instrumentscan be assembled and functioningthen disassembled or loosely assembled for sterilisation as per manufacturers instructionsHinged or ratchet instruments are opened and unlockedSharp items protected with a tip protector or enclosed in a cassette29
30 2.2 Assembly Of Instrument Trays And Hollowware When packaging hollowware sets:Openings are to face in the same direction,Hollowware should not be able to move, andIf hollowware is nestled - insert separatorsIndividual packs do not include combinations of hollowware, instruments, gauze dressings, drapes or tubing30
31 2.3 Wrapping and Packaging Provides a protective barrier against sources of potential contamination. Wrapping/packaging methods must facilitate aseptic removal of contents
32 2.3 Wrapping, Packaging & Labelling Wrapped itemsThe method shall be envelope fold or square fold techniqueThe type and method of wrapping and packaging is facility specificCheck prior to use the wrapping material is not damaged or expiredThe class 1 chemical indicator tape used for sealing will be specific to the mode of sterilisation (pressure sensitive, non-toxic and adhere to clean surface)Ensure tape is adhered to wrapping/packaging material 32
33 2.3 Wrapping, Packaging & Labelling Flexible packaging materialsCheck for damage and expiry dateCorrect size pouch for contentsHollowware openings are against non-laminate surfaceAny writing required should be done on the outer parameter of the flexible packaging material.Self sealing pouches must be sealed by folding the flap along perforation/dotted line as indicated by the manufacturer.Pouches shall only be filled up to ¾ of the overall space, allowing approximately 5 cm seal areaPouches shall only be filled up to ¾ of the overall space, allowing approximately 5 cm seal areaChoose correct size of pouch for contents as per validated process, refer to OH fact sheet Validation of Benchtop Sterilisers33
34 2.3 Wrapping, Packaging & Labelling Labelling of packs:All packs, bags, pouches and wrapped items must be labelled if contents are not visibleUse a non-toxic, water resistant, felt tipped marking pens and rubber stamps using similar ink or pre-printed tapeWriting on wrapping could damage the integrity of the materialPouches shall only be filled up to ¾ of the overall space, allowing approximately 5 cm seal areaChoose correct size of pouch for contents as per validated process, refer to OH fact sheet Validation of Benchtop SterilisersLabelling shall include name of item if items are not visible through packing material34
35 2.3 Labelling To occur prior to the sterilizing process utilising: Batch labels (piggyback)Details on the batch label gun must be checked and updated for each sterilizer cycle. The minimum information required on each label must include;Date of sterilizationSterilizer numberSterilizer cycle number 35
38 2.4 Using and Reloading Batch Label Gun Upper adjustable print display - Setting the date and the steriliser numberDate must appear as DD(space)MM(space)YY starting from the far leftThe sterilizer number must be positioned to the far right
39 White mark(R) Side - Steriliser number(L) SideDate - dd mm yySteriliser cycle numberWhite mark
40 Chemical IndicatorsClass 1 – Process indicator – exposure to a sterilisation process – shows processed/unprocessed e.g sterilising tape, external chemical indicators.Class 2 – Specific tests e.g Bowie Dick type testClass 3 – Single parameter – critical parameter e.g. dry heatClass 4 – Multi parameter eg. Time at Temp.Class 5 – Integrating indicator – time temp and moistureClass 6 – Emulating indicator (cycle verification) – eg. 3.5 min
42 Chemical Indicators do not indicate sterilization Written information about the indicators shall be obtained from the supplier covering:(a) How to interpret indicator results.(b) The factors affecting end-point colour change during storage of sterilized items.(c) The sterilization conditions that the indicator will detect.(d) The storage requirements and shelf-life of the indicator itself.
43 Packaging Instruments & Class 1 Chemical Indicators
48 3.1 Batching & Recording of a load prior to sterilisation MUST HAVE DOCUMENTED EVIDENCE OF ALL ITEMS of a sterilising process = tracking/tracing proofAssists in the recall of an item/loadRecording of load contents assists in compiling of statistical data on production volume
49 Warning: Do Not Store Unprocessed Items In The Sterilizer The sterilization cycle shall be commenced immediately after loading.Warm, moist atmosphere of the chamber can lead to—(a) release of unprocessed items for use;(b) contamination of packaging by condensate;(c) an increase in bioburden on unprocessed items; and(d) the deterioration of:(i) chemical indicators, packaging and labelling; and(ii) adhesive of self seal pouches, labelling and sterilizing tape.
50 Downward Displacement Validator Plus Steriliser .bench top class N downward displacement autoclave capable of processing both wrapped and unwrapped loads50
54 3.2 LOADING AND RECORDING OF ITEMS FOR STEAM STERILISATION Sterilant needs to have contact and/or penetrate all surfaces of the all itemsDo not:crush items togetherallow items to touch the floor, top, door or walls of the chamberAllow enough space between each item for:air removal,steam penetration,draining of condensatedrying to occur
55 Loading the steriliser All loads/cycles must have a chemical indicator to distinguish between processed and unprocessed loadsA “control” pouch containing a class 5 or 6 chemical indicator and batch label attached is included in all loads as per direction from the Chief Dental Officer, Jan 2010
59 Examples of sterilisation cycles Recognised InternationalTemperature, Pressure, TimeRelationshipInternational Units of PressureTemp CkPapsimbbarHolding time (minutes)1211031510301.031261382013801.38101321862718601.8641342033020302.033
60 Physical checks Cycle completed check print out for: Temperature has reached 134°CTime at 134°C > 3 mins + penetration timePressure 203kpa or 2030mb or 30psi
61 stand alone printerOther types?In built printer
65 3.3 Releasing & Unloading a Sterilised Load To ensure that the staff unloading the steriliser check that sterilisation has occurred in accordance with the validated process and authorises the release of the load
66 3.3 Releasing & Unloading a Sterilised Load Ensures that the sterilant has contact with, and/or penetrates all surfaces of all items being reprocessedImmediately cycle has completed - Visually checkChemical indicators have changed colour correctlyNo visible wet packs & packs intactPrintout confirms sterilisation parameters are met – signIf no printer, check the class 4,5 or 6 chemical indicator
67 3.3 Releasing & Unloading a Sterilised Load Only in exceptional circumstances (such as involved in providing direct patient care) would a delay to removing a completed sterilization load, be considered acceptable and no more than 30 minutes from when the cycle has finished.
68 3.3 Releasing & Unloading a Sterilised Load When releasing and authorising the load for use :Check items unloaded correspond with load documentationCheck and record results of process challenge devices (if used) on sterilizing log chartCheck and record results of biological indicator (if used) on sterilizing log chartTo ensure that the sterilant has contact with, and/or penetrates all surfaces of all items being reprocessed.
69 3.3 Releasing & Unloading a Sterilised Load Document in steriliser record/logSign the sterilizer cycle printout and attachDocument time of releaseSignature or identification of person releasing the loadEnsure the items unloaded correspond with load documentationAttach the “control” pouch batch labelAttach the control class 5 chemical indicatorImmediately notify the supervisor if not met.69
70 Cooling items Away from high activity areas Do not use forced cooling by fans or air con.Do not place on solid surfaces, as condensation from vapour (still within the pack) can result.Items dropped on the floor, placed on a dirty surface, compressed, torn, have broken seals, or are wet, are considered non-sterile and shall be reprocessed.70
71 The key pieces of legislation relating to recordkeeping are Public Records Act 2002Public Services Act 1996Electronic Transactions (Qld) Act 2001Evidence Act 1977See also QH clinical records retention and disposal schedule
72 Each Sterilizer’s information is written once on the front page The front coverRead the front cover of the log and enter the following information with a black biro/pen.The numbers shown in the step by step instructions, correspond to the following image.Enter your district name. e.g Cairns. Enter the name of the facility. This is the actual site where the sterilizer is installed.District/ Facility sterilizer no. This is a number that has been allocated by the facility and/or district. Only one number is to be allocated and used for a sterilizer to avoid confusion.If this sterilizer cycle record book is to be used for a loan sterilizer, place a tick in the box. Enter from where the loan sterilizer came from.Enter the sterilizer make. Fill in the sterilizer model number. As sterilizer manufacturer’s improve their sterilizers, the model number changes for their reference, parts may be quite different from one model to another. Fill in the sterilizer serial number. This number is a unique number only for that particular machine.Enter the QH Asset number allocated to this sterilizer.Fill in the first cycle number that is to be entered in the sterilizer cycle record book. (Remember, if you take this number from the sterilizer cycle counter, this should be a sequential number following on from the previous cycle).Enter the date the sterilizer cycle record (log) book commenced.Print your name. Sign that you have opened this book and completed the information required for successful use of the sterilizer cycle record book. (OPTIONAL to include the performance qualification information - see next step).
73 Found on CHRISP Oral Health website A user guide is available at
75 In the case where one or more items (but not all) have failed, in a successful cycle Documenting failed itemsIn the case where one or more items (but not all) have failed, in a successful cycle, an additional action is required in the sterilizer cycle record book. Remembering any pack which fails in a cycle should not be left to cool with items that have not failed or be allowed to enter product circulation. The next step is to account for the batch labels on the failed packs.Step 1 Remove the batch label from each failed item, and adhere them on to the reverse side of the sterilizer cycle record sheet.When applying labels to the failed items record, start placing them from the top left. If labels from earlier failed cycles are already applied, use the next available space. To show that all failed packs are accounted for, sign (or initial) before the first batch label and after the last and count (tally).The purpose of the signature is twofold. Firstly it will be easier to pick out the range of failed items. Secondly it forms part of the accountability element in that by signing you are vouching for the correctness of your action.Step 2. Tick supervisor notified box as applicable. Enter the date of notification. Print the name of person notified. Print your name.Step 3. Document recommendations and/or actions as advised by the supervisor.
77 4.1 Dedicated Area For Sterile Goods Only those sites that can ensure environmental control (temperature and humidity) and meet sterile stock storage requirements of AS/NZS 4815 can move to event related sterility. If these storage requirements can not be met the unused items must be reprocessed after 3 months
78 4.1 Dedicated Area For Sterile Goods Environmental considerations for Event Related SterilityTemperatures in this area are in the range 18◦C - 22◦C with a relative humidity ranging from 35% - 68%Secure from public accessLimited staff thoroughfare/working in this areaSterile goods shall always be segregated from non-sterile goodsProtected from direct sunlightENVIRONMENT CONTROLSTemperatures in this area are in the range 18◦C - 22◦C with a relative humidity ranging from 35% - 68%The area is to be secure from public accessLimited staff thoroughfare/working in this area to minimise movement of airborne contaminationSterile goods shall always be segregated from non-sterile goodsThis area is required to be protected from direct sunlight
79 4.1 Dedicated Area For Sterile Goods Environmental considerations for Event Related SterilityFor open shelving store items 250mm above floor level & at least 400mm from ceiling fixturesSurfaces such as walls, floors, ceilings and shelving shall be non-porous, smooth and easily cleanedAir-conditioning & ventilation conditions should be in accordance with AS1668.2New overhead lighting is fitted flush to the ceiling to minimise dust entrapmentENVIRONMENT CONTROLSFor open shelving store items 250mm above floor level & at least 400mm from ceiling fixturesSurfaces such as walls, floors, ceilings and shelving shall be non-porous, smooth and easily cleanedAir-conditioning & ventilation conditions should be in accordance with AS1668.2New overhead lighting is fitted flush to the ceiling to minimise dust entrapment
80 4.1 Dedicated Area For Sterile Goods The environment shall beDedicated storage areasStore in a clean, dry, dust free environmentInsects and vermin freeProtected from direct sunlight250mm above floor level & at least 400mm from ceiling fixtures80
81 4.2 Stock RotationThe purpose of stock rotation is to use sterile stock according to the date of manufacture./sterilisationRotate stock so previously sterilised and stored items will be used firstTake from left & replace to the rightHandle only when necessaryDo not overstock – damage & compromise
82 Time-Related Sterility based upon an arbitrary date allocated to sterilised packs/pouches etc by which they should undergo re-processing and sterilisation if they have not been usedif storage & handling conditions are not ideal, or if the packages are frequently handled, items may need to be reprocessed more frequently
83 Event-Related Sterility This process is a method of determining if an item is still sterile by assessing whether it has undergone any events, which may have compromised its sterility, such asIncorrect cleaning in storage areasMoisture and condensationExposure to harsh as well as external climatic conditionsDust, Vermin and insectstorn/soiled wrapping or poor storage83
84 Maintain sterile stock Do NotHandle without washing and drying handsPack in a manner that could damage the wrappingBundle using rubber bands or similarStack on top of each other - they should be stored verticallyPlace on or near potentially wet surfacesExposed to aerosolising procedures – only take to chairside what is needed.
86 5.1 Water QualityTo ensure water used in cleaning of re-usable medical devices is of optimum quality for effective and efficient processingWATER HARDNESS:NB. Hard water is high in minerals and can leave a residue on instruments and cleaning equipment. This can cause permanent damage and shorten the life of the instrument or machine and may also interfere with the action of the cleaning agent.Water hardness is determined by the amount of calcium and magnesium ions present in the waterIf a grey / white residue appears on the medical and surgical equipment after cleaning this can have a detrimental effect on the item and transference of this residue to a patient could have serious consequencesHardness can affect the activity of the detergent used for cleaning and may require increased concentrations of detergentCertain chemical formulations are only designed for soft water use and will allow hard water salts to precipitate outReverse Osmosis water is to be used for final cleaning rinse and in the sterilizerTESTS & MAINTENANCEWater testing can either be conducted by maintenance departments, or by chemical distribution representativesDetergent precipitation is particularly difficult to remove. In all cases precipitation is accelerated as water temperature increases. E.g. Initial wash temperature too highReport any residue left on instruments to the supervisorTESTING FREQUENCY (OPTIONAL):Daily:Detergent residueWeekly:Water pH testWater hardnessAt least monthly, and more frequently depending on water hardness test results:Chlorine/chlorine residueIronRECORDING/DOCUMENTATION:Record all test resultsRetain test strips if applicable and affix to record/documentation86
87 Water quality for cleaning Water quality affects cleaning proceduresWater must be potable (drinking quality)Hard water = calcium and magnesiumDamages instrumentsDamages equipmentMay prevent chemicals working as intendedUnfiltered tap water may contain excessive amounts of microorganisms depending on sourceSource AS 4187: pg 17Water hardness is determined by the amount of calcium and magnesium ions present in the water and can be easily tested with test kits available from most chemical manufacturers.High water hardness will leave a white-grey coloured residue on all types of surfaces, which in the case of instruments will shorten their life span. Water hardness also affects the activity of the detergent, requiring increased concentrations. Water hardness can be determined on the following scale:Water hardness Range, μg/gSoft to medium 0 to 75Medium to hard 76 to 140Hard to very hard 141 to 240Very hard to extreme >240The effect of water hardness on both instruments and cleaning/disinfection equipment should be recorded. Consideration should be given to the use of softened, filtered, demineralized, or even distilled water in at least the final rinse stage of the washing process and preferably all washing stages. Water treatment, reverse osmosis or softening units should be selected having regard to the total demand, volume and rate of treated/softened water required in the instrument washing area. Water with high mineral content is unsuitable for the rinsing of instruments due to mineral deposits permanently damaging and seriously shortening the life of the instruments. High mineral content may also interfere with the efficacy of cleaning agents.Care shall be taken in the selection of detergents and drying agents used in instrument cleaning, particularly if the water supply is not treated or softened.NOTE: Certain detergent formulations are only designed for soft water use and will allow hard water salts to precipitate out onto equipment. In some cases, parts of the detergent will also precipitate out. Detergent precipitation is particularly difficult to remove. In all cases, precipitation is accelerated as water temperature increases.
88 5.3 Ultrasonic Machine Testing Ensures that the machine is functioning effectively.Testing can be accomplished using validated test methods to prove that the transducers are working effectively soil is able to be removed – new test methods in developmentDaily test or each day of useDocument resultsReport test failures
89 5.4 Mechanical Washer Cycle Monitoring Proof that the mechanical washer disinfector attains the correct parameters for the set cycle and thus enables the conditions for effective cleaning and/or thermal disinfection
90 5.4 Mechanical Washer Cycle Monitoring Washer/disinfectors usually operate within the following temperature ranges Rinsing: 40°C - 50°C Washing: 50°C - 60°C Disinfecting: 70º for 100mins 75º for 30 mins 80º for 10 mins 90º for 1 min Final rinsing: 80°C - 90°C All results shall be checked prior to the release of each load and the printout signed
91 5.5 Internal & External Chemical Control External and or internal chemical control (indicators) shall be used to identify that an item has been through a sterilising process. The indicators are specific to the sterilising process being used eg. Steam, hydrogen peroxide, ethylene oxide, peracetic acidExternal (Mandatory)Visually denotes that a package has been exposed to the physical conditions present inside the steriliser chamber and not within the pack itself:Sterilising tape on the outside of all wrapped items (Class 1 indicator)Single items in flexible packaging to be packaged in a pouch specific to the sterilising process being used, with a visible chemical impregnated indicator, usually located in the edge seal, or on the opening end of pre-formed pouchesClosure security tags for rigid containers may also contain an impregnated indicatorAfter sterilisation and prior to use the external indicator is checked to ensure it indicates the item has been exposed to a sterilisation processInternalInternal indicators and their use depends on the oral health facilities protocols. If wrapped items are two consecutive wraps, it is usual practice for the pack to be opened by the assistant and the operator is to visually check the external indicators and the internal chemical indicator to ensure the item is sterile.Internal chemical indicators classes are as followsClass 3: single parameter indicators (Optional) - commonly used in dry heat sterilisers.A single parameter indicator that responds to only one critical parameter required for specific sterilisation process eg temperature or steamClass 4: multi-parameter indicator for two or more critical parameters (Optional)- commonly used in steam sterilizersIs a multi parameter indicator and is designed to react to two or more critical parameters, it indicates exposure to a sterilisation cycle at stated valuesClass 5: integrating indicators designed to react to all critical parameters (Optional) commonly used in steam sterilizersIs an integrating indicator which is designed to react to all required parameters of a particular sterilisation process and at a greater than specific range? The performance and confidence level of an integrator is compared to the inactivation of a test organismClass 6: emulating indicators designed to react to all critical parameters for cycle verification (Optional) commonly used in steam sterilizersUsed in steam sterilisers providing an integrated response to the various combinations of temperature, time and pressure and the presence of steam. Confirm the correct sterilising conditions within the sterilising chamber and aids in the detection of sterilising malfunctions and human error91
92 5.5 Internal & External Chemical Control Control Pouch (Mandatory)A separate sterilising pouch with a 'control' Class 1 chemical indicator and batch label attached and a Class 5 or 6 Chemical Indicator inside, must be placed onto a sterilizer tray and used in every sterilization cycle.
93 5.5 Internal & External Chemical Control An appropriate internal multi parameter time and temperature chemical indicator (Class 5 or 6) is used in the following circumstances:In the mandatory OH Control pouchWhere delays to access to on-site technical support to undertake calibration, operational qualification and performance qualification for new sterilizers or temporarily loaned sterilizers occur.
94 5.5 Internal & External Chemical Control External (Mandatory) – Class 1 chemical indicatorExamples include;sterilizer indicator tapechemical indicators found on commercially manufactured packs/pouches
95 5.6 Biological Indicators Biological indicators are used to verify the microbial killing power of 10-6 of the sterilisation process by using a population of calibrated bacterial spores, on, or in, a carrier and packaged in a manner that the integrity of the inoculated carrier is maintained.Routine biological testing is not mandatory for steam sterilisers if process is validated
96 5.7 Leak Rate (Vacuum) Test To verify that air has not leaked into the sterilising chamber.The leak rate/vacuum test is not a sterilisation cycle.It is a special programmed cycle that draws a vacuum and holds the vacuum for a minimum of 10 minutes. If the rate of air that leaks into the chamber via a leaking chamber seal or hole in piping, a pressure rise will be measured that is greater than 1.3 kPa/min over 10 minutes, a fault indicator and printout.The level of vacuum will be different for each machine. The important thing is that it remains within 1.3kPa/min of the vacuum over the 10 minute period.96
98 5.7 Leak Rate (vacuum) Test Class B and Class S sterilisers with air detector – weeklyClass B and Class S sterilisers without air detector – dailyRecord the results.
99 5.8 BOWIE DICK TYPE TEST5.8 Bowie Dick Type TestTo detect air entrapment and evaluate the ability of a pre-vacuum steriliser to remove residual air that will then allow the steam penetration and attainment of the correct conditions for steam sterilisation. Needs a special cycle Daily on a warmed up steriliser before loads Different types on the market
100 5.9 Routine Cleaning of Reprocessing Equipment Maintenance exampleDailyWeekly3 Monthly6 monthlyUltrasonicAll internal and external surfacesWasher disinfectorFilters, spray arms, drains, door seals, gaskets,Drying cabinetAll surfacesFilters, door seals, vents, door gaskets.Steam sterilisersDrain, floor of steriliser, door seal,Clean chamberReplace air filterclean water chambers
101 Validation Documentation Important to document all the procedures!pre-cleaningcleaningdrying of instrumentspackagingloading steriliserunloading steriliserphysical checkssterilisation log bookstorage of sterile itemsvalidation of YOUR sterilisation process
102 Annual validation performance qualification (PQ) What is validation?A documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.What does this mean?The entire process is documented, challenged and repeatable, and establishes the efficacy (or not) of the sterilising process, that is monitored by the measurement of the critical requirements of time, temperature and pressure and parameters during each cycle.
103 Commissioning of sterilisers Installation Qualification (IQ)Proves that the steriliser and the where installed comply with the manufacturer’s specificationsOperational Qualifications (OQ)Determines that the installed steriliser and equipment is working within the defined limits when used as per manufacturer’s procedures.These shall documented and recorded and include calibration of all gauges, parameter monitoring, the recording device, specific performance tests (eg leak test) and process indicator tests (bowie dick tests)
105 Installation qualification (IQ) Heat distribution studyTemperature profile “Cold Spot”Service technician performs (empty chamber) whilst calibrating the temperature gauge.Or may be provided by the manufacturer.Doesn’t need to be routinely checked every time.
106 Performance qualification (PQ) physical qualification Time at temperature and pressure testingThermocouple testing to ensure the inside of the packs of your challenge load has reached the selected temperature x 3 times with BI’sHold at or slightly above this temperature and at the correct pressureMust be done at every validationWhole load that will be considered your “validated, challenged load” needs to be available.106
107 WhenValidation shall be repeated annually and every time significant changes are made.Examples of such changes include, but are not limited to, the following:(a) Any change to the sterilization parameters(b) Changes in packaging or loading specification which would provide a greater challenge to the sterilization process.(c) Changes in the items or types of instruments to be sterilized, such as the addition of a new complex medical item which would provide a greater challenge to the sterilization process.
108 More Information Contact: Intranet for SOP & WSA: