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Easi-Sterilise Information session for Clinicians “Getting it right, every step of the way”

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Presentation on theme: "Easi-Sterilise Information session for Clinicians “Getting it right, every step of the way”"— 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 incidents  Implementing a continuous quality improvement program  Acknowledge an absence in effective communication when changes are made  To build on current level of knowledge in light of ever changing technology, standards, guidelines, advisories and legislation

3 Aim of this workshop Provide 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 followed  Assist in identifying gaps in knowledge and provide opportunities for improvement

5 SOPs & WSAs  To assist Oral Health facilities operationalise QH policy and guidelines  A resource for staff  Update and supersede the OH Critical Instrument Tracking (2003)  A framework to assist staff identify competence and areas where education and improvement may be needed  A resource to identify opportunities for improvement within the department that will require further education and training


7 1.1 Standard Precautions Standard 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 In the context of sterilising practice and ALL the Standard Operating Procedures, standard precautions include:  Hand Hygiene  Hand cream – approved by infection control – not in packing area or handling of sterile stock  Personal Protective Equipment Gloves Face shields, hair protection, safety glasses and masks Fluid resistant gowns/aprons  OHS Requirements

9 1.2 Soiled Pickup Collection  Standard Precautions - PPE  Contaminated items - dedicated collection trolley/container  Keep instrument sets together  Secure sharps Collection containers are:  puncture-resistant  leak-proof and made of either plastic or metal  with a lid or liner that can be closed

10 1.3 Sorting Prior To Cleaning Instruments and items sorted by; Type Method of cleaning e.g. Manual, ultrasonic, Instruments and items are checked for; Completeness Defects Sharps or blades that have not been removed Heavily soiled items Single use only items must not be returned for reprocessing Report concerns to supervisor

11 Cleaning  Cleaning removes organic and inorganic soil, blood, fats etc which contain pathogenic micro-organisms  Gross Debris should be removed chairside  Cleaning minimises contamination levels of bioburden (number of micro-organisms) prior to sterilisation  For 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 Cleaning  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.

14 1.5 Pre Cleaning  Pre cleaning can be performed by methods such as dry wiping, damp wiping or use of a commercially available single use only instrument sponge  Place 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 instructions  Drying cabinet  Disposable low-lint cloth for hose, battery and external parts  Air pressure gun (for removal of excess moisture)  Disposable syringe

16 1.6 Hand Cleaning For Immersible Items Problems associated with incorrect drying  Items should NOT be air dried/ dripped dry Good conditions micro-organisms multiply in 20-30 minutes  Wet packaging result in unsterile item  Can cause rusting, corrosion, pitting to the item

17 Handpieces  handpieces  outside surfaces cleaned using detergent wipe,  rinsed by wiping  dried  slow speed motors  outside surfaces cleaned using detergent wipe,  rinsed by wiping,  dried  lubricated (manually or automatic) may need special adaptors  Dried, wrapped & processed in a wrapped cycle

18 Special adaptors may be needed

19 Ideally, handpieces and slow speed motors are cleaned and lubricated using mechanised cleaning equipment

20 Special adaptors may be needed

21 1.8 Ultrasonic Cleaner Purpose Ultrasonic cleaning is a form of mechanical cleaning that uses high frequency ultrasonic waves (cavitation) that dislodges fine particles from the surfaces of instruments.

22 Ultrasonic cleaning is an effective cleaning method for instruments prior to the reprocessing 1.8 Ultrasonic cleaner

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 rinse  Means the cleaning process is verifiable  Lumened items still require Flush brush Flush  Unlock and open items  Use appropriate washer baskets/inserts  Keep sets together

24 1.9 Washer Disinfector Machines REPORT IMMEDIATELY:  Cycle parameters not meeting set requirements or variations to cycle parameters – failed cycles  Items that appear dirty or stained are returned to the cleaning area for recleaning/destaining  Excess water – check the following: the machine temperature, amount of rinse aid going into the machine or the way in which the machine was loaded  Damaged instruments

25 1.9 Washer Disinfector Machines Releasing the load and unloading the washer disinfector  Authorising 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 signed  Care opening the doors due to heat and moisture  Inspect load not become dislodged or displaced  Avoid injury and damaging the equipment/instruments

26 Washer disinfector printout

27 Section 2 Packaging and Wrapping Procedures

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 / instruments  can be assembled and functioning  then disassembled or loosely assembled for sterilisation as per manufacturers instructions  Hinged or ratchet instruments are opened and unlocked  Sharp items protected with a tip protector or enclosed in a cassette

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, and  If hollowware is nestled - insert separators  Individual packs do not include combinations of hollowware, instruments, gauze dressings, drapes or tubing

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 items  The method shall be envelope fold or square fold technique  The type and method of wrapping and packaging is facility specific  Check prior to use the wrapping material is not damaged or expired  The 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

33 2.3 Wrapping, Packaging & Labelling  Flexible packaging materials  Check for damage and expiry date  Correct size pouch for contents  Hollowware openings are against non-laminate surface  Any 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 area

34 2.3 Wrapping, Packaging & Labelling  Labelling of packs:  All packs, bags, pouches and wrapped items must be labelled if contents are not visible  Use a non-toxic, water resistant, felt tipped marking pens and rubber stamps using similar ink or pre-printed tape  Writing on wrapping could damage the integrity of the material

35 2.3 Labelling To occur prior to the sterilizing process utilising: 1.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 sterilization Sterilizer number Sterilizer cycle number

36 Blue = Unprocessed Sterilizer number

37 Colour interpretation chart

38 2.4 Using and Reloading Batch Label Gun  Upper adjustable print display - Setting the date and the steriliser number  Date must appear as DD(space)MM(space)YY starting from the far left  The sterilizer number must be positioned to the far right

39 White mark (L) Side Date - dd mm yy (R) Side - Steriliser number Steriliser cycle number White mark

40 Chemical Indicators  Class 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 test  Class 3 – Single parameter – critical parameter e.g. dry heat  Class 4 – Multi parameter eg. Time at Temp.  Class 5 – Integrating indicator – time temp and moisture  Class 6 – Emulating indicator (cycle verification) – eg. 134°C @ 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

44 Packaging Instruments

45 Dental Instruments  Sterile at point-of-use  must be stored to maintain sterile conditions  must be tracked when used Extraction instruments

46 The way we were……

47 Section 3 Sterilising

48 3.1 Batching & Recording of a load prior to sterilisation  MUST HAVE DOCUMENTED EVIDENCE OF ALL ITEMS of a sterilising process = tracking/tracing proof  Assists in the recall of an item/load  Recording 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 . bench top class N downward displacement autoclave capable of processing both wrapped and unwrapped loads Downward Displacement Validator Plus Steriliser

51 Small Pre vacuum

52 Lisa 500 series

53 Large Pre-vacuum Sterilisers

54 3.2 LOADING AND RECORDING OF ITEMS FOR STEAM STERILISATION  Sterilant needs to have contact and/or penetrate all surfaces of the all items Do not:  crush items together  allow items to touch the floor, top, door or walls of the chamber  Allow enough space between each item for:  air removal,  steam penetration,  draining of condensate  drying to occur

55 Loading the steriliser  All loads/cycles must have a chemical indicator to distinguish between processed and unprocessed loads  A “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

56 Loading of Laminated Packaged Instruments

57 Loading hollow ware & pouches Place hollow ware on a 45 degree angle

58 Lisa 500 series

59 Examples of sterilisation cycles Recognised International Temperature, Pressure, Time Relationship International Units of Pressure Temp CkPapsimbbarHolding time (minutes) 1211031510301.0315 1261382013801.3810 1321862718601.864 1342033020302.033

60 Physical checks Cycle completed check print out for:  Temperature has reached 134°C  Time at 134°C > 3 mins + penetration time  Pressure 203kpa or 2030mb or 30psi

61 stand alone printer In built printer Other types?

62 Top of the printout


64 W&H Lisa™ Manual New Lisa 500 series manual

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 reprocessed Immediately cycle has completed - Visually check  Chemical indicators have changed colour correctly  No visible wet packs & packs intact  Printout confirms sterilisation parameters are met – sign  If 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 documentation  Check and record results of process challenge devices (if used) on sterilizing log chart  Check and record results of biological indicator (if used) on sterilizing log chart

69 3.3 Releasing & Unloading a Sterilised Load Document in steriliser record/log  Sign the sterilizer cycle printout and attach  Document time of release  Signature or identification of person releasing the load  Ensure the items unloaded correspond with load documentation  Attach the “control” pouch batch label  Attach the control class 5 chemical indicator  Immediately notify the supervisor if not met.

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. 

71 The key pieces of legislation relating to recordkeeping are  Public Records Act 2002  Public Services Act 1996  Electronic Transactions (Qld) Act 2001  Evidence Act 1977  See also QH clinical records retention and disposal schedule  ds/documents/disposal_retention_sched.pdf

72 Each Sterilizer’s information is written once on the front page

73 Found on CHRISP Oral Health website


75 In the case where one or more items (but not all) have failed, in a successful cycle

76 Section 4 Stock management

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 Sterility  Temperatures in this area are in the range 18◦C - 22◦C with a relative humidity ranging from 35% - 68%  Secure from public access  Limited staff thoroughfare/working in this area  Sterile goods shall always be segregated from non- sterile goods  Protected from direct sunlight

79 4.1 Dedicated Area For Sterile Goods Environmental considerations for Event Related Sterility  For open shelving store items 250mm above floor level & at least 400mm from ceiling fixtures  Surfaces such as walls, floors, ceilings and shelving shall be non-porous, smooth and easily cleaned  Air-conditioning & ventilation conditions should be in accordance with AS1668.2  New overhead lighting is fitted flush to the ceiling to minimise dust entrapment

80 4.1 Dedicated Area For Sterile Goods  The environment shall be  Dedicated storage areas  Store in a clean, dry, dust free environment  Insects and vermin free  Protected from direct sunlight  250mm above floor level & at least 400mm from ceiling fixtures

81 4.2 Stock Rotation  The purpose of stock rotation is to use sterile stock according to the date of manufacture. /sterilisation  Rotate stock so previously sterilised and stored items will be used first  Take from left & replace to the right  Handle only when necessary  Do 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 used  if 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 as  Incorrect cleaning in storage areas  Moisture and condensation  Exposure to harsh as well as external climatic conditions  Dust, Vermin and insects  torn/soiled wrapping or poor storage

84 Maintain sterile stock Do Not  Handle without washing and drying hands  Pack in a manner that could damage the wrapping  Bundle using rubber bands or similar  Stack on top of each other - they should be stored vertically  Place on or near potentially wet surfaces  Exposed to aerosolising procedures – only take to chairside what is needed.

85 Section 5 Quality

86 5.1 Water Quality  To ensure water used in cleaning of re-usable medical devices is of optimum quality for effective and efficient processing

87 Water quality for cleaning  Water quality affects cleaning procedures  Water must be potable (drinking quality)  Hard water = calcium and magnesium  Damages instruments  Damages equipment  May prevent chemicals working as intended  Unfiltered tap water may contain excessive amounts of microorganisms depending on source

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 development  Daily test or each day of use  Document results  Report 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 acid

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 Internal  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 pouch  Where 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 indicator Examples include;  sterilizer indicator tape  chemical 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.


98 5.7 Leak Rate (vacuum) Test Class B and Class S sterilisers with air detector – weekly Class B and Class S sterilisers without air detector – daily Record the results.

99 5.8 Bowie Dick Type Test To 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 5.8 BOWIE DICK TYPE TEST

100 5.9 Routine Cleaning of Reprocessing Equipment Equipment Maintenance example DailyWeekly3 Monthly6 monthly UltrasonicAll internal and external surfaces Washer disinfector Filters, spray arms, drains, door seals, gaskets, Drying cabinetAll surfaces Filters, door seals, vents, door gaskets. Steam sterilisers Drain, floor of steriliser, door seal, Clean chamber Replace air filter clean water chambers

101 Validation Documentation Important to document all the procedures! 1.pre-cleaning 3.drying of instruments 4.packaging 5.loading steriliser 6.unloading steriliser 7.physical checks 8.sterilisation log book of sterile items 10.validation 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 specifications Operational 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)

104 Validation IQ+OQ+PQ Commissioning (IQ) + (OQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance qualification (PQ) Physical qualification & testing Microbiological qualification & testing

105 Installation qualification (IQ) Heat distribution study Temperature 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 testing  Thermocouple testing to ensure the inside of the packs of your challenge load has reached the selected temperature x 3 times with BI’s  Hold at or slightly above this temperature and at the correct pressure  Must be done at every validation  Whole load that will be considered your “validated, challenged load” needs to be available.

107 When Validation 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:  Email:  Intranet for SOP & WSA: _SOP.asp _SOP.asp

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