Easi-Sterilise Information session for Clinicians

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Easi-Sterilise Information session for
Clinicians

• Getting it right, every step of the way

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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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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

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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 wont 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 manufacturers 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
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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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Special adaptors may be needed
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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/instrument
  s

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Washer disinfector printout
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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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Colour interpretation chart
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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/unprocesse
  d 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. 134C _at_ 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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Packaging Instruments Class 1 Chemical
Indicators
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Packaging Instruments
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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 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.

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Downward Displacement Validator Plus Steriliser

• .

bench top class N downward displacement autoclave
capable of processing both wrapped and unwrapped
loads
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Small Pre vacuum
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Lisa 500 series
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Large Pre-vacuum Sterilisers
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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 of Laminated Packaged Instruments
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Loading hollow ware pouches
Place hollow ware on a 45 degree angle
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Lisa 500 series
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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 134C
• Time at 134C gt 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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Top of the printout
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New Lisa 500 series manual
WH 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 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

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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/recor
  ds/documents/disposal_retention_sched.pdf

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Each Sterilizers information is written once on
the front page
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Found on CHRISP Oral Healthwebsite
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In the case where one or more items (but not all)
have failed, in a successful cycle
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Section 4

• Stock management

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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

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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 -
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• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Quality

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5.1 Water Quality

• 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

• 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

• 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

• 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

• Washer/disinfectors usually operate within the
  following temperature ranges
• Rinsing 40C - 50C
• Washing 50C - 60C
• Disinfecting 70º for 100mins
• 75º for 30 mins
• 80º for 10 mins
• 90º for 1 min
• Final rinsing 80C - 90C
• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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
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
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Validation Documentation

• 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 validationperformance 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

• Installation Qualification (IQ)
• Proves that the steriliser and the where
  installed comply with the manufacturers
  specifications
• Operational Qualifications (OQ)
• Determines that the installed steriliser and
  equipment is working within the defined limits
  when used as per manufacturers 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)

• Heat distribution study
• Temperature profile Cold Spot
• Service technician performs (empty chamber)
  whilst calibrating the temperature gauge.
• Or may be provided by the manufacturer.
• Doesnt need to be routinely checked every time.

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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 BIs
• 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

• 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

• Contact
• Email CHRISP_at_health.qld.gov.au
• Intranet for SOP WSA http//www.health.qld.gov.
  au/chrisp/sterilising/oral_health_SOP.asp