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

Easi-Sterilise Easi-Sterilise Information session Information session

for Cliniciansfor Clinicians

““Getting it right, every step of the way”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 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

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.

QH Commitment 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

SOPs & WSAsSOPs & 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

1.1 Standard Precautions1.1 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.

1.1 Standard Precautions1.1 Standard PrecautionsIn the context of sterilising practice and ALL the Standard Operating Procedures, standard precautions include:

Hand HygieneHand cream – approved by infection control – not in packing area or handling of sterile stockPersonal Protective Equipment

• Gloves • Face shields, hair protection, safety glasses and masks• Fluid resistant gowns/aprons

OHS Requirements

1.2 Soiled Pickup Collection1.2 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

1.3 Sorting Prior To Cleaning1.3 Sorting Prior To CleaningInstruments 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

reprocessingReport concerns to supervisor

CleaningCleaning 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

CleaningCleaning

Steam will not penetrate contamination left on instruments

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

1.5 Pre Cleaning1.5 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.

1.5 Pre Cleaning1.5 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

1.6 Hand Cleaning For Immersible Items1.6 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

1.6 Hand Cleaning For Immersible Items1.6 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

HandpiecesHandpieces 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

Special adaptors may be neededSpecial adaptors may be needed


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

1.8 Ultrasonic Cleaner1.8 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.

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

1.8 Ultrasonic cleaner1.8 Ultrasonic cleaner

1.9 Washer Disinfector Machines1.9 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


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


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

Washer disinfector printout

Section 2Section 2

Packaging and Wrapping Procedures

2.1 Organisation Of Packing Area2.1 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.

2.2 Assembly Of Instrument Trays And 2.2 Assembly Of Instrument Trays And HollowwareHollowware

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

2.2 Assembly Of Instrument Trays And 2.2 Assembly Of Instrument Trays And HollowwareHollowware

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

2.3 Wrapping and Packaging2.3 Wrapping and Packaging

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

2.3 Wrapping, Packaging & 2.3 Wrapping, Packaging & LabellingLabelling

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


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


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

2.3 Labelling2.3 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

Blue = UnprocessedSterilizer number

Colour interpretation chart

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

White mark

(L) Side Date - dd mm yy

(R) Side - Steriliser number

Steriliser cycle number

White mark

Chemical IndicatorsChemical 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

Chemical Indicators Chemical Indicators do not indicate sterilizationdo 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.

Packaging Instruments & Class 1 Chemical Indicators

Packaging Instruments

Dental InstrumentsDental Instruments

Sterile at point-of-use must be stored to maintain sterile

conditions

must be tracked when used

Extraction instruments

The

way

we

were……

Section 3Section 3

Sterilising

3.1 Batching & Recording of a load prior 3.1 Batching & Recording of a load prior to sterilisationto 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

Warning: Warning: Do Not Store Unprocessed Do Not Store Unprocessed Items In The SterilizerItems 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.

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

Downward Displacement Validator Plus Steriliser

Small Pre vacuum

Lisa 500 series

Large Pre-vacuum SterilisersLarge Pre-vacuum Sterilisers

3.2 LOADING AND RECORDING OF ITEMS 3.2 LOADING AND RECORDING OF ITEMS FOR STEAM STERILISATIONFOR 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

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

Loading of Laminated Packaged Instruments

Loading hollow ware & pouches

Place hollow ware on a 45 degree angle

Lisa 500 series

Examples of sterilisation cyclesRecognised International

Temperature, Pressure, Time Relationship

International Units of Pressure

Temp C kPa psi mb bar Holding time (minutes)

121 103 15 1030 1.03 15

126 138 20 1380 1.38 10

132 186 27 1860 1.86 4

134 203 30 2030 2.03 3

Physical checksCycle completed check print out for:

Temperature has reached 134°C

Time at 134°C > 3 mins + penetration time

Pressure 203kpa or 2030mb or 30psi

stand alone printer

In built printer

Other types?

Top of the printout

W&H Lisa™ Manual

New Lisa 500 series manual

3.3 Releasing & Unloading a Sterilised Load3.3 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


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


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.


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


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.

Cooling itemsCooling 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.

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

Each Sterilizer’s information is written

once on the front page

Found on

CHRISP Oral

Healthwebsite

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

Section 4Section 4

Stock management

4.1 Dedicated Area For Sterile Goods4.1 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


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


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


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

4.2 Stock Rotation4.2 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

Time-Related SterilityTime-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

Event-Related Sterility 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

Maintain sterile stockMaintain sterile stockDo 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.

Section 5Section 5

Quality

5.1 Water Quality5.1 Water Quality

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

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

5.3 Ultrasonic Machine Testing5.3 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

5.4 Mechanical Washer Cycle Monitoring5.4 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

5.4 Mechanical Washer Cycle Monitoring5.4 Mechanical Washer Cycle Monitoring

Washer/disinfectors usually operate within the following temperature ranges

Rinsing: 40°C - 50°C Washing: 50°C - 60°CDisinfecting: 70º for 100mins

75º for 30 mins80º for 10 mins90º for 1 min

Final rinsing: 80°C - 90°CAll results shall be checked prior to the release of each load and the printout signed

5.5 Internal & External Chemical Control5.5 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


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.


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.


External (Mandatory) – Class 1 chemical indicator

Examples include; sterilizer indicator tape chemical indicators found on commercially

manufactured packs/pouches

5.6 Biological Indicators5.6 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

5.7 Leak Rate (Vacuum) Test5.7 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.

5.7 Leak Rate (vacuum) Test5.7 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.

5.8 Bowie Dick Type Test5.8 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

5.9 Routine Cleaning of Reprocessing 5.9 Routine Cleaning of Reprocessing EquipmentEquipment

EquipmentMaintenance example

Daily Weekly 3 Monthly 6 monthly

Ultrasonic All internal and external surfaces

Washer disinfector

Filters, spray arms, drains, door seals, gaskets,

Drying cabinet All surfacesFilters, door seals, vents, door gaskets.

Steam sterilisers

Drain, floor of steriliser, door seal,

Clean chamber

Replace air filter

clean water chambers

Validation DocumentationValidation DocumentationImportant to document all the procedures!1. pre-cleaning2. cleaning3. drying of instruments4. packaging5. loading steriliser6. unloading steriliser7. physical checks8. sterilisation log book9. storage of sterile items10.validation of YOUR sterilisation process

Annual validationAnnual validationperformance qualification (PQ)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.

Commissioning of sterilisersCommissioning of sterilisersInstallation 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)

ValidationIQ+OQ+PQ

Commissioning(IQ) + (OQ)

InstallationQualification (IQ)

OperationalQualification (OQ)

Performance qualification (PQ)

Physical qualification & testing

Microbiological qualification & testing

Installation qualification (IQ)Installation qualification (IQ)

Heat distribution studyTemperature profile “Cold Spot” Service technician performs (empty chamber)

whilst calibrating the temperature gauge. Or may be provided by the manufacturer. Doesn’t need to be routinely checked every time.

Performance qualification (PQ) Performance qualification (PQ) physical qualificationphysical 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.

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.

More Information

Contact:

Email: [email protected] Intranet for SOP & WSA:

http://www.health.qld.gov.au/chrisp/sterilising/oral_health_SOP.asp

mailto:[email protected]



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

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