Aim. Learning outcomes. 13 May Megan Reilly RN BN Cert IV Assessment & Workplace Training MHlthSc (Inf Control) Immunise Cert MACN CICP 1

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1 Aim Apply the principles and practices of reprocessing reusable podiatry instruments and equipment to the officebased practice setting Learning outcomes Describe the chain of infection related to the office-based practice setting List required infection prevention and reprocessing reference documents Explain the key processes in collecting, sorting, manually and mechanically cleaning RMDs Describe assembling, packaging, sterilization and storage requirements of items State the procedures for maintaining the reprocessing environment Identify reprocessing validation processes Control) Immunise Cert MACN CICP 1

2 Purpose Reduce the number of disease-causing agents in the podiatry service environment To prevent or minimise the transmission these microorganisms from patient to patient, podiatry health professional to patient, and from patient to podiatry health professional Render items and areas as free as possible from infectious agents Risk management approach Podiatry patient Podiatry clinic PDCP Instruments & equipment Patient centred approach Spread of infection A pathogenic organism of sufficient virulence and in adequate numbers to cause disease A reservoir or source that allows the pathogen to survive and multiply A mode of transmission from the source to the host A portal of entry through which the pathogen can enter the host; and A susceptible host Chain of Infection Control) Immunise Cert MACN CICP 2

3 Minimum infection prevention and control standards for the maintenance of a safe and healthy environment for podiatry healthcare professionals and patients Standard precautions Regular hand hygiene Use of personal protective equipment (PPE) Respiratory hygiene/cough etiquette Use of appropriate environmental barriers Aseptic technique Appropriate handling and disposal of sharps and other clinical and related waste Appropriate reprocessing of reusable instruments and equipment Effective environmental cleaning Spills management Design and maintenance of premises Control) Immunise Cert MACN CICP 3

4 Guidelines and standards PBA Guidelines for Infection Control, 2010 Australian Guidelines for the Prevention and Control of Infection in Healthcare, 2010 Australasian Podiatry Council Infection Prevention & Control Guidelines for Podiatrists, 2012 AS/NZS 4187, AS/NZS 4815, AS , AS 2945, AS 2182 PBA Guidelines for Podiatrists with Blood-Borne Infections, 2010 RACGP Infection Prevention and Control Standards, 2014 AS/NZS 4815:2006 scope Sets out procedures and process development which can be validated for the cleaning, disinfection and sterilisation of reusable medical and surgical instruments and equipment, and maintenance of associated environments in office-based health care facilities not involved in complex patient procedures and processes Medical, dental and allied health facilities, skin penetration establishments and veterinary practice Reprocessing environment Separate designated area Well lit, well ventilated Uncluttered and easily cleaned bench space Clearly defined clean and dirty zones Unidirectional work flows from dirty to clean to sterile Control) Immunise Cert MACN CICP 4

5 Level of reprocessing Items must be reprocessed to a level appropriate for their intended use The appropriate level depends on: the body sites where the item will be used the risk associated with the particular procedure Spaulding classification system Risk classified according to the site where the items are to be used Contact sites classified as: Critical Semicritical Noncritical Instruments and equipment processed accordingly Control) Immunise Cert MACN CICP 5

6 Minimum levels of reprocessing Critical site instruments should be sterile at the time of use. Single use, steam sterilised or low temperature chemical sterilisation (heat sensitive) Semicritical site single use, sterilised after each use. If not possible high level disinfection is the minimum level of reprocessing that is acceptable Noncritical site cleaning after every individual use, intermediate or low level disinfection may be appropriate in specific circumstances Level of risk Process Examples Storage Critical Entry or penetration into sterile tissue, cavity or bloodstream Clean as soon as possible after using Steam sterilisation Dry heat sterilisation* Low chemical sterilant Single use? Sterility must be maintained Semi-critical Contact with intact non-sterile mucous membrane or nonintact skin Non-critical Contact with intact skin Clean as soon as possible after using Steam sterilisation High level disinfection (thermal or chemical for heat intolerant items) Clean as necessary with detergent If disinfection is necessary, disinfect with low or intermediate level TGA listed/registered disinfectant after cleaning? Store to prevent environmental contamination? Store in a clean dry place to prevent environmental contamination Cleaning Removal of soil and reduction in the number of microorganisms from a surface Washing with water and detergent Ultrasonic, manual or automated Control) Immunise Cert MACN CICP 6

7 Disinfection The inactivation of non-sporing organisms Using heat and water (thermal) or by chemical means Automated Sterilisation Validated process used to render a product free of all forms of viable microorganisms Steam under pressure Dry heat sterilisation* Control) Immunise Cert MACN CICP 7

8 Initial treatment Gross residual soil is removed as soon as possible Dry wiping Damp wiping Remove burs from handpieces Discard waste and single use sharps Follow Standard Precautions Collection Collect and transport used items in a dedicated labelled rigid walled container with lid Able to be cleaned and maintained in a dry condition Rinse in cool running water if cleaning delayed Do not soak for prolonged periods Sorting Sort according to type of instruments Check for completeness and defects Instruments are cleaned and sterilised prior to being sent for repairs All unwrapped instruments are considered contaminated whether used or not and must be subjected to full cleaning process Control) Immunise Cert MACN CICP 8

9 Cleaning Essential first step in an effective disinfection or sterilisation process Automated method preferred Washer-disinfector Minimises sharps injury Keeps instruments in good condition Validated process Ultrasonics may be used Manual cleaning Water quality Clean water supply of good quality Potable water Local water authority can provide information on quality Distilled water Good quality Cleaning agents Remove residual soil and organic matter Trained in application, handling and safe use Product data bulletins and SDS available, read and requirements implemented Packaged and dispensed safely Does not promote contamination Not leave any residue after rinsing Control) Immunise Cert MACN CICP 9

10 Cleaning agents Manual Wash Mild alkaline instrument detergent ph range: Low foaming properties Non-corrosive Non-toxic Non-abrasive Free rinsing Bio-degradable Preferably liquid Use and rate of concentration as per manufacturer s instructions Automated Wash Alkaline instrument detergent or as per mechanical washer manufacturer s instructions ph range: Biodegradable Nonabrasive Low foaming Free rinsing Preferably liquid Use and rate of concentration as per manufacturer s instructions, automatic dispensing system is preferred Ultrasonic cleaning Use sound waves to create vacuum bubbles within the cleaning agent and water solution that subsequently implode, dislodging soils from the surfaces of the instruments No plastics, glass syringes, mirrors and lenses Ultrasonic cleaning - Method Filling the machine Follow manufacturer s instructions! Fill the tank with cold water to fill line indicator Add the specified amount of instrument detergent Plug lead from the machine into a power point and turn on the power Degas the machine by closing the lid and turning the switch on for the timeframe specified by the manufacturer Degassing must occur each time the solution is changed Performance test daily and record Control) Immunise Cert MACN CICP 10

11 Aluminium foil test Vertically suspend 3 pieces of aluminium foil in the tank; evenly spaced between the ends of the tank Each piece ~0.025mm thick and extend to ~ 6mm clear from the sides and bottoms of the tank Wire frame may be required to support foil pieces Operate ultrasonic cleaner for 10 seconds Remove the sheets and observe the number and distribution of perforations and wrinkles Similarly perforated and wrinkles passed If holes primarily in middle sheet of foil, or if 3 pieces are only wrinkled without holes failed Drain tank and clean thoroughly to remove residue Pencil load test Rub surface of unglazed ceramic disc or plate have a mat finish and diameter of ~ 50mm with a standard HB pencil lead Immerse the disc in the ultrasonic cleaner Completely removes the pencil lead within 3 minutes passed Chemical test Available chemical testing system Pre-prepared test which indicates that sufficient energy for cavitation is taking place, by a colour change from green to yellow Foil tests can indicate cavitation but contaminate the bath and cannot be used in between instrument loads Simulated soil tests for ultrasonics detection of protein residues Control) Immunise Cert MACN CICP 11

12 Ultrasonic cleaning - Method Operating the machine Follow manufacturer instructions! All items free of visible contamination and rinsed before placing into designated basket Disassemble and open items to be processed Place instruments in ultrasonic basket (no more than 1 layer) and not on the floor of the ultrasonic Place delicate or small pieces of items into lock down baskets Ultrasonic cleaning - Method Lower basket into the ultrasonic tank Fully close lid and operate for recommended time Remove items by lifting the instrument basket or clean gloved hands Thoroughly rinse instruments in hot running water, manually clean or place in washerdisinfector Dry in drying cabinet or with lint-free cloths or disposable low lint cloths Do not dry in ambient air Manual cleaning - Equipment Water 2 dedicated sinks Bowl if 2 nd sink not available Small brush with firm plastic bristles Light grade nylon or similar nonabrasive scouring pad Cleaning agent Wire dental burr brush Lint-free cloths or disposable low-lint cloths Control) Immunise Cert MACN CICP 12

13 Manual cleaning - Method Perform hand hygiene Don appropriate PPE Fill sink or bowl to recommended level with correct amount of warm water and detergent Dismantle or open all items prior to placement in detergent solution Hold items low in sink and wash all surfaces Remove stubborn stains by using scouring pad or approved stain removing agent Manual cleaning - Method Rinse item in warm-to-hot water Place on clean side of the sink Remove PPE and perform hand hygiene Dry in a drying cabinet or with lint-free cloths or disposable low lint cloths Do not dry in ambient air Place on clean side of reprocessing area for inspection and packaging Automated cleaning Utilises water and cleaning agent solution sprayed at high pressure through rotating spray arms to dislodge and remove the soil from the surfaces of instruments Tepid pre-rinse; warm to hot wash stage and one or more hot rinses, at least one of which achieves thermal disinfection, drying stage Printout or process recorder Control) Immunise Cert MACN CICP 13

14 Washer-disinfector - Method Follow manufacturer instructions! Manually rinse if no pre-rinse cycle Open and/or dismantle instruments Place a single layer of instruments in the baskets Place a single layer of baskets on each shelf of the washer disinfector rack When a load is ready, push rack into the washer disinfector and make sure the rack aligns properly with the water manifolds (if applicable) Washer-disinfector - Method Remove PPE and practise hand hygiene Close the door and initiate the cycle After completion, check process parameters have been achieved Unload cleaned instruments and place on clean side of instrument reprocessing area to be dried (if the washer disinfector has no drying stage) prior to inspection and packaging Control) Immunise Cert MACN CICP 14

15 Inspection Inspect instruments with the naked eye in strong light to ensure they are: clean dry free of residues and stains complete free from damage and in good working order Return unclean items to cleaning section of the instrument reprocessing area and repeat complete cleaning process Separate instruments requiring repair Lubrication Solid and hinged instruments do not need to be routinely lubricated or milked following the cleaning process Periodic lubrication maybe advised Water miscible and compatible with the sterilisation process Mixed or diluted as per manufacturer s instructions Discarded after each use Assembling Configuration of packs, trays or sets must not compromise sterilisation Hollowware (bowls) Openings against non-laminate surface (e.g. paper) Separated by non-porous spacers All openings face the same direction Contents cannot be dislodged Control) Immunise Cert MACN CICP 15

16 Assembling Instruments Weight of contents does not exceed maximum allowable weight Placed in a single layer, mass evenly distributed Sharps tips protected from damage Hinged or ratcheted items open and unlocked Multi-part instruments dissembled or loosened Trays must be perforated Assembling Consumables Consumable items such as gauze and cotton balls should be obtained sterile Gauze, cotton balls, dressings, drapes or hollow-ware must not be in the same package as standard instruments Opened but unused consumables must be discarded Assembling Linen Sterile single-use drapes and gowns are preferred Reusable linen drapes and gowns that may be used for surgical procedures must be laundered in accordance with AS/ NZS 4146:2000 Steriliser manufacturer s instructions for use must be consulted to ensure the steriliser is capable of sterilising dense packs of linen and drapes Control) Immunise Cert MACN CICP 16

17 Packaging Packaging materials should comply with the applicable part of the AS/NZS 1079 flat wrappers (non-woven and paper)* laminated pouches or reels (flexible packaging)* paper bags rigid reusable sterilisation containers Check for damage and expiry date prior to use Choose correct size for contents Allow an empty space of ~2cm around each edge of the item Handles of instruments must be inserted towards the end of the pouch/reel that will be opened Sealing Heat sealers, self-sealing pouches, sterilising indicator tape String, non-adhesive tape, staples & elastic bands must not be used Sterilising indicator tape should not be used to seal flexible packaging material Sterilising indicator tape Open end of the bag/pouch sequentially folded over 2-3 times prior to taping across the folded edge with one continuous piece of tape extending across 25mm around the back of the pouch on both sides Labelling Label all packs, bags and pouches Use a prepared labelling system, felt-tip, water resistant non-toxic marking pen or rubber stamp using solvent-based ink Write on the outer parameter of the laminate side of pouches or reels (outside of sterile window area) Consider easy visual identification for stock rotation, ease of access, minimise handling and compromising sterility of items Control) Immunise Cert MACN CICP 17

18 Labelling Clear and precise for easy identification and recall if required All packs have a batch label. Details on the batch label gun is checked and updated for each sterilizer cycle Minimum information required Date of sterilization Sterilizer number Steriliser cycle or load number Allow tracking of items to the client and ensures traceability back to the sterilisation cycle number Types of sterilisers Type Intended Use N B S Unwrapped, solid items All wrapped (single or double) or unwrapped items, including porous and cannulated items that do not exceed the specifications of Hollow load Type A Items as specified by the steriliser manufacturer. Capable of sterilising unwrapped solid items and at least one of the following: porous items small porous items Hollow load Type A Hollow load Type B single layer wrapped items double wrapped items Control) Immunise Cert MACN CICP 18

19 Sterilising equipment Temperature pressure-time relationship 0 C kpa Mb Psi Holding time An operator s manual is available on-site at all times Performance testing Conducted on a daily basis to determine steriliser is functioning correctly and is safe to be used for sterilising instruments for patient care Type N cycles cannot be effectively performance tested Type S cycles must be performance tested according to manufacturer s instructions Type B cycles must be performance tested Leak rate (vacuum) test Undertaken on an empty chamber prior to undertaking a Bowie Dick type test Check the sterilizer manufacturer s instructions to determine whether the chamber should be warm or cold Daily (no air detector) prior to air removal/steam penetration testing Weekly (if air detector fitted) prior to air removal/steam penetration testing Installation qualification Operational qualification Performance qualification Control) Immunise Cert MACN CICP 19

20 Bowie Dick type test Class 2 chemical indicator Mandatory daily test for pre-vacuum sterilisers For use when processing porous loads Performed before loads are processed each day and after the vacuum/leak rate test Process challenge device (PCD) Class 2 indicator Helix type Mandatory daily test for hollow A loads/devices (e.g. dental handpieces) Processed in B class sterilisers Loading Items not placed into the steriliser until a complete load is available avoid errors, contamination of packaging by moisture, increase in micro-organisms, deterioration of chemical indicators, packaging and adhesives Load types are to be the same as those validated during yearly performance re-qualification Light items on top shelves and heavy items on lower shelves Packs/pouches/items loaded in the boundaries of the steriliser trays or racks Control) Immunise Cert MACN CICP 20

21 Loading Hollowware placed on a 45 0 angle allow air removal, steam penetration and drainage of condensate Bagged instruments can be placed on a 45 angle using a toast rack Single laminated pouches placed vertically in a spacer with laminate to paper Laminated pouches, if placed horizontally, placed with paper facing downward and not over lapping Physical monitors At the completion of every cycle, the process record must be checked to ensure that process parameters were met Time, temperature, pressure Trained to read and interpret the data contained on the process record in order to ensure that the correct process parameters have been met and that process failures, should they occur, will be detected Control) Immunise Cert MACN CICP 21

22 External chemical indicators External (Mandatory) Class 1 chemical indicator A Class 1 external chemical or process indicator must be present on the outside of every packaged/wrapped/ pouched item in the load A class 1 chemical indicator must be used in each sterilizer load of unwrapped items After sterilisation the external class 1 chemical indicator is checked to ensure it indicates the item has been exposed to a sterilisation process Prior to use the external class 1 chemical indicator is checked to ensure it indicates the item has been exposed to a sterilisation process Internal chemical indicators Internal (Optional) Class 4, 5 or 6 chemical indicator An appropriate internal multi parameter time and temperature chemical indicator may be used within each package to be sterilized Must be used when using on-loan steam steriliser, when awaiting a technician to carry out IQ and PQ on newly purchased or major repaired steriliser or when using a steriliser without a printer Place the indicator in an area within the package considered least accessible to penetration of steam Interpreted at the time of use of the pack Biological indicators Routine biological testing is not mandatory for validated sterilisation processes Biological testing is required to be performed during Installation qualification (IQ), Operational qualification (OQ) and Performance Qualification (PQ), referred to as Validation Place the biological indicator test pack in the areas as identified as cold spots during chamber mapping The sterilised vials should have no growth (negative). The control vial should have growth (positive) Recording of results shall be clear and precise (batch information & placement in the sterilizer) If a sterilised vial has growth positive, it is recorded as a FAIL, report the result to the Practice Manager, isolate load contents, and steriliser to be Out of Order until proved safe for use Control) Immunise Cert MACN CICP 22

23 Unloading Before opening the sterilizer remove and check the steriliser printout/electronic display to confirm the sterilisation parameters have been met Check and sign the printout or verify electronic record to confirm that the sterilisation process has achieve the correct sterilisation parameters Perform hand hygiene Open door and pull out the tray containing the control pouch, check pouch, check to see if chemical indicator has changed colour Carefully remove load using tray lifter Unloading Check class 1 external chemical indicator/s for a clear even colour change Check item/s are not wet Check wrapping is intact Check flexible packaging materials are intact and seal is secure Check batch/item information corresponds with the load documents and that the batch label and/or ID label has/have not dislodged during sterilisation Check and record results of process challenge devices (if used) on sterilizer cycle record Check and record results of biological indicator (if used) on sterilizer cycle record Items that do not meet these parameters are not considered sterile and shall be quarantined (recall policy) Steriliser cycle records A record is maintained for each sterilising cycle Dedicate a steriliser log sheet to every steriliser For each sterilising cycle the following records must be maintained: date of cycle steriliser number or code (if there is more than one steriliser) cycle or load number (if more than one load per day) exposure time, temperature and pressure name or identification of the loading operator name or identification of the person authorising release of load contents specific contents of the load readout result of physical, chemical or biological/enzymatic indicators that are used Control) Immunise Cert MACN CICP 23

24 Steriliser cycle records Use a black pen Cross out errors with a single line (with writing still visible) and initial Do not use white-out or an eraser Identify failed cycles in the log sheet and reprocess load In the event of a steriliser being moved/ replaced, the log sheet remains at the site where the sterilising of those instruments took place Steriliser cycle records A daily review of the log sheet/s is undertaken by another staff member May include 2 people releasing a load and/or an end of day check A current log of staff signatures, initials, names and positions updated and retained with records Store completed sheets in a dedicated area in a manner that enables identification of the practice where the sterilising was undertaken Keep and attach steriliser printouts to the back of the log sheet Thermal printouts fade over a period of time. Process in place for photocopying and retaining as proof of evidence of sterilising parameters Recall procedure Documented procedure in the event of sterilisation failure what constitutes a sterilisation failure the person with the responsibility to initiate the recall procedure a manner of recording the action taken this should include reason for recall batch identification type nature of items recalled including type and number other persons or agencies contacted Control) Immunise Cert MACN CICP 24

25 Cooling prior to storage Dedicated cooling areas shall be away from high activity areas Place the tray in a dedicated cooling area until completely cool (minimum 30 mins - 2 hours) and even longer for large sets, prior to transferring load to storage area Items shall not be placed on solid surfaces as sweating may occur compromising sterility Do not force cool items by fans or boosted air conditioning compromising sterility of items Sterile stock storage Temperatures range 18 C - 22 C with a relative humidity ranging from 35% - 68% Secure from public access Limited staff thoroughfare/working in this area to minimise movement of airborne contamination Sterile goods segregated from non-sterile goods Protected from direct sunlight For open shelving store items 250mm above floor level & at least 400mm from ceiling fixtures Non-porous, smooth and easily cleaned surfaces such as walls, floors, ceilings and shelving Air-conditioning & ventilation conditions should be in accordance with AS New overhead lighting fitted flush to the ceiling to minimise dust entrapment Sterile stock storage The sterile storage area is cleaned in accordance with the facilities cleaning guidelines Keep storage containers clean, dry and in good condition Cardboard boxes are not used as storage containers as they are porous and cannot be adequately cleaned When storing sterile stock ensure the oldest manufactured date is at the front/top so that it is used first Do not overstock, cram, or squash sterilised stock into containers/drawers/shelves as this may compromise the integrity of the items If possible, use the principle of taking from the left & replacing to the right. If stored in containers take from the front & replace at the back Control) Immunise Cert MACN CICP 25

26 Ultrasonic cleaner At the end of each day of use: Emptied External surfaces, lid, chamber and drain wiped with a solution of ultrasonic detergent and water rinsed Dried with a disposable low-lint cloth Where flushing type ultrasonic cleaner is used, run a complete empty cycle with fresh water and detergent, empty and leave dry after the final use for the day Leave lid off following end of day cleaning and drying procedure Annual electrical safety check Washer-disinfector Daily surface cleaning Checking and cleaning filters Checking and cleaning door seals Checking and cleaning jets and spray arms Checking and cleaning door gaskets Checking that detergent and rinse dispensers are clear and functioning 6 12 monthly maintenance Control) Immunise Cert MACN CICP 26

27 Drying cabinet Daily surface cleaning Checking and cleaning filters Checking and cleaning door seals Checking and cleaning vents Checking and cleaning door gaskets Quarterly preventative maintenance Benchtop steriliser Floor of the steriliser is free of debris Recording devices are functioning Clean door gasket and check for damage Air filter is clean Chamber drain is clean and free of debris Loading tray/trolley and external surfaces are cleaned daily Steriliser chamber is cleaned weekly Maintenance 12 monthly or more frequently Calibration & validation Validation IQ+OQ+PQ Commissioning (IQ) + (OQ) Performance qualification (PQ) Installation Qualification (IQ) Operational Qualification (OQ) Physical qualification & testing Microbiological qualification & testing Control) Immunise Cert MACN CICP 27

28 Validation Documentation Important to document all the procedures! 1. pre-cleaning 2. cleaning 3. drying of instruments 4. packaging 5. loading steriliser 6. unloading steriliser 7. physical checks 8. sterilisation log book 9. storage of sterile items 10.validation of YOUR sterilisation process Competency Podiatry staff who reprocess instruments must be given formal training in the relevant procedures health.asp Should undergo competency testing and documentation on a regular basis Effective infection prevention Maintaining a safe environment for people, patients and DHP in the office based health care setting Identify risks Assess, classify and manage risks Develop risk management protocols and communication strategies to effectively minimise the risks Control) Immunise Cert MACN CICP 28

29 References Podiatry Board of Australia. (2010). Guidelines for infection control. Available from Podiatry Board of Australia - Policies, Codes and Guidelines Podiatry Board of Australia. (2010). Guidelines for podiatrists with blood-borne infections. Available from Podiatry Board of Australia - Policies, Codes and Guidelines NHMRC and ACSQH. (2010). Australian guidelines for the prevention and control of infection in healthcare. Available from ents/cd33_infection_control_healthcare_ pdf RACGP. (2014). Infection prevention and control standards. For general practices and other office-based and community-based practices. Available from RACGP - RACGP Infection prevention and control standards References Standards Australia/Standards New Zealand. AZ/NZS 4187:2014. Reprocessing of reusable medical devices in health service organizations. Available from AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organizations Standards Australia/Standards New Zealand. AS/NZS 4815:2006. Office-based health care facilities. Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment. Available from AS/NZS 4815:2006 Officebased health care facilities - Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment Standards Australia. AS Ultrasonic cleaners for health care facilities. Part 2: Benchtop. Sydney: Australia. Standards Australia. AS 2945 (Int) Batch-type washer/disinfectors for health care facilities. Available from Standards Australia. AS Sterilizers-steambenchtop. Homebush: Standards Australia. Control) Immunise Cert MACN CICP 29