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

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Easi-Sterilise Information session for Clinicians

“Getting it right, every step of the way”


Why are we here l.jpg
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


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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.


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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

QH Commitment


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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


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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.


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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


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    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


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    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


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    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


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    Cleaning

    Steam will not penetrate contamination left on instruments

    If the item is not clean it won’t be sterilised


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    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.


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    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


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    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


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    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


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    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



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    Special adaptors may be needed

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



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    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.


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    1.8 Ultrasonic cleaner

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


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    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


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    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


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    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



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    Section 2

    Packaging and Wrapping Procedures


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    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.


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    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


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    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


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    2.3 Wrapping and Packaging

    Provides a protective barrier against sources of potential contamination. Wrapping/packaging methods must facilitate aseptic removal of contents


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    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 


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    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


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    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


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    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 sterilization

    • Sterilizer number

    • Sterilizer cycle number


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    Blue = Unprocessed

    Sterilizer number



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    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


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    White mark

    (R) Side - Steriliser number

    (L) Side

    Date - dd mm yy

    Steriliser cycle number

    White mark


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    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


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    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.




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    Dental Instruments

    • Sterile at point-of-use

      • must be stored to maintain sterile conditions

      • must be tracked when used

    Extraction instruments


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    The

    way

    we

    were……


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    Section 3

    Sterilising


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    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


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    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 bioburdenon unprocessed items; and

    • (d) the deterioration of:

      • (i) chemical indicators, packaging and labelling; and

      • (ii) adhesive of self seal pouches, labelling and sterilizing tape.


    Downward displacement validator plus steriliser l.jpg

    .

    Downward Displacement Validator Plus Steriliser

    bench top class N downward displacement autoclave capable of processing both wrapped and unwrapped loads





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    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


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    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



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    Loading hollow ware & pouches

    Place hollow ware on a 45 degree angle



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    Examples of sterilisation cycles

    Recognised International

    Temperature, Pressure, Time

    Relationship


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    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


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    stand alone printer

    Other types?

    In built printer



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    New Lisa 500 series manual

    W&H Lisa™ Manual


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    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


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    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 colourcorrectly

    • 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


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    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.


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    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


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    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.


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    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.


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    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

    • http://paweb.sth.health.qld.gov.au/sqrm/hims/records/documents/disposal_retention_sched.pdf





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    Section 4 failed, in a successful cycle

    Stock management


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    4.1 Dedicated Area For Sterile Goods failed, in a successful cycle

    • 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


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    4.1 Dedicated Area For Sterile Goods failed, in a successful cycle

    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


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    4.1 Dedicated Area For Sterile Goods failed, in a successful cycle

    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


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    4.1 Dedicated Area For Sterile Goods failed, in a successful cycle

    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


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    4.2 Stock Rotation failed, in a successful cycle

    • 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


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    Time-Related Sterility failed, in a successful cycle

    • 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


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    Event-Related Sterility failed, in a successful cycle

    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


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    Maintain sterile stock failed, in a successful cycle

    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.


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    Section 5 failed, in a successful cycle

    Quality


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    5.1 Water Quality failed, in a successful cycle

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


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    Water quality for cleaning failed, in a successful cycle

    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


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    5.3 Ultrasonic Machine Testing failed, in a successful cycle

    • 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


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    5.4 Mechanical Washer Cycle Monitoring failed, in a successful cycle

    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


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    5.4 Mechanical Washer Cycle Monitoring failed, in a successful cycle

    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


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    5.5 Internal & External Chemical Control failed, in a successful cycle

    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


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    5.5 Internal & External Chemical Control failed, in a successful cycle

    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.


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    5.5 Internal & External Chemical Control failed, in a successful cycle

    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.


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    5.5 Internal & External Chemical Control failed, in a successful cycle

    External (Mandatory) – Class 1 chemical indicator

    Examples include;

    • sterilizer indicator tape

    • chemical indicators found on commercially manufactured packs/pouches


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    5.6 Biological Indicators failed, in a successful cycle

    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


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    5.7 Leak Rate (Vacuum) Test failed, in a successful cycle

    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.


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    5.7 Leak Rate (vacuum) Test failed, in a successful cycle

    Class B and Class S sterilisers with air detector – weekly

    Class B and Class S sterilisers without air detector – daily

    Record the results.


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    5.8 BOWIE DICK TYPE TEST failed, in a successful cycle

    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


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    5.9 Routine Cleaning of Reprocessing Equipment failed, in a successful cycle


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    Validation Documentation failed, in a successful cycle

    Important to document all the procedures!

    • pre-cleaning

    • cleaning

    • drying of instruments

    • packaging

    • loading steriliser

    • unloading steriliser

    • physical checks

    • sterilisation log book

    • storage of sterile items

    • validation of YOUR sterilisation process


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    Annual failed, in a successful cyclevalidationperformance 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.


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    Commissioning of sterilisers failed, in a successful cycle

    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)


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    Installation qualification (IQ) failed, in a successful cycle

    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.


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    Performance qualification (PQ) physical qualification failed, in a successful cycle

    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.


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    When failed, in a successful cycle

    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.


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    More Information failed, in a successful cycle

    • Contact:

      • Email: [email protected]gov.au

      • Intranet for SOP & WSA: http://www.health.qld.gov.au/chrisp/sterilising/oral_health_SOP.asp


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