Reprocessing of instruments Reprocessing of instruments for office based practices for office based practices including Day surgeries, including Day surgeries,

dental practices and aged dental practices and aged care facilitiescare facilities

Lynne Noring

National standards National standards and State Policy and State Policy

• Australia/ New Zealand 4815 2006 Australia/ New Zealand 4815 2006 Office based health care facilities –Office based health care facilities –Reprocessing of reusable medical Reprocessing of reusable medical and surgical instruments and and surgical instruments and equipment, and maintenance of equipment, and maintenance of associated environment.associated environment.

• NSW infection Control policy NSW infection Control policy

Cleaning and handling of Cleaning and handling of used equipmentused equipment

Standard precautionsStandard precautions

• Treating all used items as a Treating all used items as a potential source of infection potential source of infection

• Wash hands and cover any Wash hands and cover any skin lesions with occlusive skin lesions with occlusive dressingsdressings

• Wear appropriate personal Wear appropriate personal protection such as utility protection such as utility gloves specially designed gloves specially designed repellent masks/eye repellent masks/eye protection/face shields and protection/face shields and fluid resistant aprons or fluid resistant aprons or gowns.gowns.

• Thermal disinfect the Thermal disinfect the cleaning brushes either at cleaning brushes either at the beginning or end of the beginning or end of each day.each day.

why is the pre-requisite to why is the pre-requisite to sterilisation the cleaning sterilisation the cleaning process.process.• Reduce the microbial Reduce the microbial

contaminates.contaminates.• Remove tissue debris, blood Remove tissue debris, blood

and other organic material so and other organic material so the sterilant can make the sterilant can make contact with every part of contact with every part of the item being sterilised.the item being sterilised.

• To prevent the deterioration To prevent the deterioration of instruments and of instruments and equipment.equipment.

• If an item is not clean prior to If an item is not clean prior to being placed into the being placed into the steriliser it will not be sterile.steriliser it will not be sterile.

There are 2 types of soil you There are 2 types of soil you will come in contact with when will come in contact with when cleaning reusable equipment.cleaning reusable equipment.• VisibleVisible contaminates contaminates

including including blood,bone.tissue and blood,bone.tissue and inorganic soils such as inorganic soils such as dirt or dust.dirt or dust.

• Non-visibleNon-visible contaminates Micro – contaminates Micro – organisms, bacteria, organisms, bacteria, and virus.and virus.

Water quality for cleaning Water quality for cleaning

• Water supply should Water supply should be of good quality.be of good quality.

• Water suitable for Water suitable for drinking is suitable for drinking is suitable for cleaning.cleaning.

• Water with high Water with high mineral content is mineral content is unsuitable due to unsuitable due to mineral deposits mineral deposits shortening the shortening the equipment life and equipment life and interfering with the interfering with the effect of the cleaning effect of the cleaning agents.agents.

Collection proceduresCollection procedures

• Procedures for the Procedures for the collection of used collection of used reusable items from reusable items from treatment areas shall treatment areas shall be formulated by each be formulated by each office – based health office – based health care facility.care facility.

• Collection equipment Collection equipment shall be puncture and shall be puncture and leak resistant, and leak resistant, and made of a material that made of a material that is able to be cleaned.is able to be cleaned.

Reprocessing Area Reprocessing Area

• All used items are to be All used items are to be cleaned in a designated cleaned in a designated area to prevent the area to prevent the possible contamination possible contamination of items processed.of items processed.

• On receipt in the On receipt in the reprocessing area, reprocessing area, items should be sorted items should be sorted to type and to type and corresponding cleaning corresponding cleaning method. Example method. Example manual, mechanical manual, mechanical and cannualted.and cannualted.

Sorting for reprocessingSorting for reprocessing

• All equipment that is All equipment that is unwrapped is unwrapped is considered to be considered to be contaminated whether contaminated whether used or not.used or not.

• A check for A check for completeness and completeness and defects shall be made defects shall be made during the sorting during the sorting process.process.

• All facilities should have All facilities should have written procedures for written procedures for handling specialized handling specialized equipment.equipment.

The equipment the facility The equipment the facility should ideally include.should ideally include.• Separate hand washing Separate hand washing

facilitiesfacilities• Adequate bench space Adequate bench space

with smooth surfaces with smooth surfaces without crevices.without crevices.

• Good lightingGood lighting• Efficient ventilationEfficient ventilation• Adequate storage spaceAdequate storage space• Bins for disposal of wasteBins for disposal of waste• Non-slip flooringNon-slip flooring• Cleaning sinks and Cleaning sinks and

washer /disinfectorwasher /disinfector• Ultrasonic cleanerUltrasonic cleaner• Drying facilities.Drying facilities.

The four steps to the cleaning The four steps to the cleaning processprocess• Pre-rinse –cold waterPre-rinse –cold water• Wash- hot water and a Wash- hot water and a

cleaning agentcleaning agent• Rinse – 1 or more rinses Rinse – 1 or more rinses

with hot water with hot water 80 to 90 ˚c with a drying 80 to 90 ˚c with a drying

agent added, in agent added, in accordance with accordance with manufacturers manufacturers recommendations.recommendations.

• Drying – shall be by means Drying – shall be by means of a drying cabinet or lint of a drying cabinet or lint free cloths or disposable free cloths or disposable lint free cloths.lint free cloths.

Cleaning agentsCleaning agents

• Shall be used to remove residual soil Shall be used to remove residual soil and organic matter from instruments and organic matter from instruments and equipment. Only those intended and equipment. Only those intended by the manufacturer for use in by the manufacturer for use in cleaning medical devices shall be cleaning medical devices shall be used.used.

Safe use of cleaning agentsSafe use of cleaning agents

• Staff should be trained Staff should be trained in application, in application, handling and safe use handling and safe use of cleaning agents for of cleaning agents for instrument cleaning.instrument cleaning.

• Product data bulletins Product data bulletins and material safety and material safety data sheets for all data sheets for all cleaning agents shall cleaning agents shall be obtained, read and be obtained, read and implemented.implemented.

Cleaning agents should be,Cleaning agents should be,

• BiodegradableBiodegradable• Non-corrosiveNon-corrosive• Non-toxicNon-toxic• Non-abrasiveNon-abrasive• Low foamingLow foaming• Free rinsingFree rinsing• Preferably liquidPreferably liquid• mild alkali formation with a ph range 8.0 to 10.8mild alkali formation with a ph range 8.0 to 10.8However some instruments and equipment maybe However some instruments and equipment maybe

made of materials where the use of neutral made of materials where the use of neutral detergents are more appropriate.detergents are more appropriate.

Labelling of cleaning agents Labelling of cleaning agents should include,should include,• The name of the productThe name of the product• The manufacturerThe manufacturer• The purpose of the product The purpose of the product • The directions for dilution and useThe directions for dilution and use• The batch numberThe batch number• The expiry date The expiry date • Advice not to be mixed with other chemicalsAdvice not to be mixed with other chemicals• Safety and first aidSafety and first aid• Specific storageSpecific storage• Hazards natureHazards nature

Abrasive cleanersAbrasive cleaners

• Steel wool Steel wool

• Stainless steel Stainless steel brushes brushes

• Powders and Powders and pastespastes

Manual cleaning equipment Manual cleaning equipment

• Sinks Sinks

• Assorted brushes Assorted brushes with soft and hard with soft and hard bristles. lumen bristles. lumen brushes with a brushes with a variety of variety of diameters and diameters and lengths.lengths.

• Soft lint free clothsSoft lint free cloths

Mechanical cleaning Mechanical cleaning methodsmethods• Ultrasonic washersUltrasonic washers

• Indexing/tunnel Indexing/tunnel washer disinfectorswasher disinfectors

• Stand alone Stand alone washer/disinfectorswasher/disinfectors

• Cannulised sonic Cannulised sonic washers washers

Thermal disinfection Thermal disinfection

• Thermal disinfection Thermal disinfection is is notnot a sterilisation a sterilisation process. Items used process. Items used for critical procedures for critical procedures must be sterilised.must be sterilised.

• Thermal disinfection Thermal disinfection uses heat and water uses heat and water at temperatures that at temperatures that destroy pathogenic destroy pathogenic vegetative vegetative organisms.organisms.

0

10

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30

40

50

60

70

80

90

100

100 30 10 3 1 0.32

Thermal disinfection 0-100 Thermal disinfection 0-100 temp/Celsiustemp/Celsius100-0.32 time/minutes100-0.32 time/minutes

Temperature

Time

Methods of mechanical Methods of mechanical cleaningcleaning• Washer cycles include, cold Washer cycles include, cold

pre-rinsepre-rinse• Hot wash with cleaning agentHot wash with cleaning agent• One or more rinses with hot One or more rinses with hot

water at a suitable water at a suitable temperature for thermal temperature for thermal disinfection to be achieved.disinfection to be achieved.

• Drain, leaving the contents at Drain, leaving the contents at a temperature for quick a temperature for quick drying.drying.

• Drying.Drying.• Washer disinfectors need to Washer disinfectors need to

cleaned and maintained cleaned and maintained regularly to prevent colonizing regularly to prevent colonizing and formation of biofilms and formation of biofilms which could contaminate the which could contaminate the instruments processed within.instruments processed within.

Ultrasonic cleaners Ultrasonic cleaners

• The tank must be filled with cold The tank must be filled with cold or tepid water add a measured or tepid water add a measured amount of recommended amount of recommended detergent. Operate the machine detergent. Operate the machine to degas the solution.to degas the solution.

• Tested to see if the transducers Tested to see if the transducers are functioning correctly and the are functioning correctly and the results recorded. results recorded.

• Rinse the instrument of visible Rinse the instrument of visible contaminates before immersing contaminates before immersing the instruments.the instruments.

• The instruments should be placed The instruments should be placed in a suitable basket in an open in a suitable basket in an open position before being submerged position before being submerged into the water tank close the lid into the water tank close the lid and commence the cycle.and commence the cycle.

• After the specific time, remove After the specific time, remove the instruments and rinse in clean the instruments and rinse in clean running hot water.running hot water.

Method of manual cleaningMethod of manual cleaning

• Flush the item with running Flush the item with running water.water.

• Fill the container or bowl with Fill the container or bowl with warm water and neutral or in warm water and neutral or in some cases enzymatic some cases enzymatic cleaning solution.cleaning solution.

• Dismantle all removable parts Dismantle all removable parts or open items before placing or open items before placing into the cleaning solution.into the cleaning solution.

• Hold the items low in the Hold the items low in the container and wash all container and wash all surfaces, brush lumens and surfaces, brush lumens and valves.valves.

• Remove stubborn stains by Remove stubborn stains by soaking in an approved stain soaking in an approved stain removing solution if the removing solution if the instrument manufacturers instrument manufacturers recommendation permits.recommendation permits.

Method of rinsing and drying Method of rinsing and drying for manual cleaning.for manual cleaning.

• Rinse the item Rinse the item thoroughly in hot thoroughly in hot running water.running water.

• Dry in a drying cabinet Dry in a drying cabinet or with lint free cloths or or with lint free cloths or disposable lint free disposable lint free cloths. – items should cloths. – items should never be dried in never be dried in ambient air.ambient air.

• Then visually inspect the Then visually inspect the cleanliness of all items.cleanliness of all items.

Manually cleaning of Manually cleaning of respiratory equipment.respiratory equipment.• All items shall be All items shall be

dismantled and thoroughly dismantled and thoroughly cleaned in detergent and cleaned in detergent and water. Manufactures water. Manufactures recommendations should recommendations should be considered, followed by be considered, followed by thorough rinsing in clean thorough rinsing in clean running water to remove running water to remove any residue.any residue.

• Where thermal disinfection Where thermal disinfection or sterilisation processes or sterilisation processes are not available for semi-are not available for semi-critical items, single use critical items, single use devices shall be used.devices shall be used.

Chemical disinfectionChemical disinfection

• Chemical disinfection can Chemical disinfection can only be used when thermal only be used when thermal disinfection is unsuitable.disinfection is unsuitable.

• Any chemical disinfectants Any chemical disinfectants that are used must be that are used must be registered with the registered with the Therapeutic Goods Therapeutic Goods Administration in AustraliaAdministration in Australia

• Instruments should Instruments should notnot be be stored in chemical stored in chemical disinfectants before or disinfectants before or after any form of after any form of processing.processing.

Materials that may inhibit or Materials that may inhibit or restrict chemical disinfection.restrict chemical disinfection.

• Hard waterHard water

• Fibres or lint from Fibres or lint from cleaning materialscleaning materials

• Food, fluid and fatsFood, fluid and fats

• Body fluids and Body fluids and excrementsexcrements

• Organic materialsOrganic materials

• Physical soilsPhysical soils

Instrument Grade Instrument Grade DisinfectantsDisinfectants• High level High level

instrument grade instrument grade disinfectant is the disinfectant is the minimum level to be minimum level to be used on semi-critical used on semi-critical instruments which instruments which contact unbroken contact unbroken mucous membranes mucous membranes that are normally that are normally not sterile.not sterile.

Instrument grade Instrument grade disinfectantsdisinfectants• Intermediate or low level Intermediate or low level

disinfectants may be used disinfectants may be used for non-critical instruments for non-critical instruments which are normally which are normally restricted to contact with restricted to contact with unbroken skin.unbroken skin.

• There may be instances There may be instances where a hospital grade where a hospital grade disinfection maybe used in a disinfection maybe used in a office based health care office based health care facility.facility.

• Formal policies and Formal policies and procedures need to be procedures need to be developed for the use of developed for the use of hospital grade disinfectants.hospital grade disinfectants.

General housekeeping General housekeeping

• There needs to be written There needs to be written policies and procedures for policies and procedures for the routine cleaning of all the routine cleaning of all the sterilising and ancillary the sterilising and ancillary equipment including;equipment including;

MethodMethod FrequencyFrequency Manufacturers instructionsManufacturers instructions Cleaning agents and Cleaning agents and

materials.materials. All waste should be All waste should be

removed from the removed from the reprocessing area via reprocessing area via designated disposals exits. designated disposals exits. AS4031,AS/NZS4261,NZS43AS4031,AS/NZS4261,NZS4304 should also be consulted.04 should also be consulted.

Education and trainingEducation and training

• Office - based health Office - based health care facilities care facilities responsible for responsible for instrument instrument reprocessing are also reprocessing are also responsible for responsible for ensuring the ensuring the appropriate education appropriate education and training of staff is and training of staff is kept up to date on a kept up to date on a regular basis .regular basis .

Interchange of instruments and Interchange of instruments and equipment.equipment.• Instruments should not be Instruments should not be

interchanged between interchanged between necropsy, human and necropsy, human and animal use.animal use.

• Instruments used on Instruments used on animals should not be animals should not be reprocessed in sterilisers reprocessed in sterilisers and associated equipment and associated equipment and environments used for and environments used for reprocessing instruments reprocessing instruments used for humans.used for humans.

• Infection transmission Infection transmission hazards exist where these hazards exist where these requirements are not met.requirements are not met.

Instruments on loan Instruments on loan

• On receipt into the health On receipt into the health care facility, instruments on care facility, instruments on loan from loan companies or loan from loan companies or other health care facilities or other health care facilities or individual clinicians , shall individual clinicians , shall undergo a complete routine undergo a complete routine cleaning and processing prior cleaning and processing prior to sterilisation.to sterilisation.

• Perceived lack of time shall Perceived lack of time shall not be permit the cleaning not be permit the cleaning process to be bypassed.process to be bypassed.

• There should be a contracted There should be a contracted arrangement between the arrangement between the health care facility and the health care facility and the loan supplier to define the loan supplier to define the responsibilities of the parties.responsibilities of the parties.

Sterilisation of unwrapped Sterilisation of unwrapped instruments.instruments.• To avoid danger of contamination, To avoid danger of contamination,

use unwrapped instruments for use unwrapped instruments for critical procedures immediately critical procedures immediately after sterilisation. after sterilisation.

• However this is an unacceptable However this is an unacceptable practice and should only take practice and should only take place when an item is dropped place when an item is dropped and another one is not available and another one is not available and the item must have and the item must have undergone a full cleaning process undergone a full cleaning process prior to being placed in the flash prior to being placed in the flash sterilising unit. sterilising unit.

• Lack of time or equipment is not Lack of time or equipment is not an acceptable excuse for this an acceptable excuse for this process to take place.process to take place.

• The lack of a drying process The lack of a drying process causes instruments to corrode, causes instruments to corrode, and jointed instruments to and jointed instruments to become stiff.become stiff.

LubricationLubrication

• If lubricants are required If lubricants are required for basic instruments they for basic instruments they need to be,need to be,

Water miscibleWater miscible Compatible to the Compatible to the

sterilising agent.sterilising agent. Lubrication is not a way of Lubrication is not a way of

overcoming inadequate overcoming inadequate cleaning practices.cleaning practices.

Routine lubrication of Routine lubrication of instruments following the instruments following the cleaning process often cleaning process often results in extremely heavy results in extremely heavy contamination.contamination.

Insulated instruments Insulated instruments

• Need to be tested to Need to be tested to ensure the integrity ensure the integrity of the insulation of the insulation materialmaterial

• This can be done by This can be done by trained SSD staff trained SSD staff member or a bio-member or a bio-medical engineer medical engineer depending on the depending on the frequency of the frequency of the equipment use.equipment use.

HandpiecesHandpieces

• Such as those used for Such as those used for ear,nose,oral maxillo-ear,nose,oral maxillo-facial surgery, dental facial surgery, dental and oral surgery and and oral surgery and invasive podiatry shall to invasive podiatry shall to be cleaned and sterilised be cleaned and sterilised after each use.after each use.

• The internal surfaces of The internal surfaces of handpieces may become handpieces may become soiled with patient soiled with patient debris during use which debris during use which can be expelled into or can be expelled into or onto subsequent onto subsequent patients.patients.

Processing handpieces.Processing handpieces.

• Documented cleaning procedure must be followed.Documented cleaning procedure must be followed.• At the end of the procedure, handpieces need to be operated At the end of the procedure, handpieces need to be operated

and run to discharge water and air for a minimum of 30 and run to discharge water and air for a minimum of 30 seconds. This is to flush out any gross debris that may have seconds. This is to flush out any gross debris that may have entered the turbine and air or water lines.entered the turbine and air or water lines.

• Handpieces maybe hand clean and lubricated following Handpieces maybe hand clean and lubricated following manufacturers recommendations or hand cleaned and then manufacturers recommendations or hand cleaned and then processed using an automatic flush-through and lubricated processed using an automatic flush-through and lubricated system.system.

• Handpieces need to be also packaged and steam sterilised Handpieces need to be also packaged and steam sterilised and remain in a sterile package before each use.and remain in a sterile package before each use.

• It is not an acceptable practice wiping or soaking handpieces It is not an acceptable practice wiping or soaking handpieces in a chemical disinfectant.in a chemical disinfectant.

• Handpieces pose a challenge to the downward displacement Handpieces pose a challenge to the downward displacement sterilisation process, due to limitations to the air removal sterilisation process, due to limitations to the air removal process and steam penetration.process and steam penetration.

Air water syringes for dentalAir water syringes for dental

• The tip needs to be The tip needs to be removed after each use for removed after each use for cleaning and sterilisation. cleaning and sterilisation.

• The air water line needs to The air water line needs to be cleared by flushing be cleared by flushing thoroughly with water for 30 thoroughly with water for 30 seconds.seconds.

• If sterilising is not possible, If sterilising is not possible, single use tips shall be single use tips shall be used.used.

• Ultrasonic scalers for dental Ultrasonic scalers for dental procedures the tip needs to procedures the tip needs to be cleaned and sterilised be cleaned and sterilised and the scaler flushed with and the scaler flushed with running water for 30 running water for 30 seconds. And the handle seconds. And the handle hand cleaned.hand cleaned.

Diagnostic ultrasound Diagnostic ultrasound transducers. transducers. • Intracavity probes such as Intracavity probes such as

(transvaginal transrectal or (transvaginal transrectal or transoesophageal ) require transoesophageal ) require cleaning in accordance to cleaning in accordance to the manufacturers the manufacturers recommendations and recommendations and either sterilisation if either sterilisation if possible or high level possible or high level disinfectant using only disinfectant using only instrument grade instrument grade disinfectant should be used.disinfectant should be used.

• Sheaths/ sleeves or Sheaths/ sleeves or protective barriers must not protective barriers must not be used as a substitute for be used as a substitute for cleaning, disinfection or cleaning, disinfection or sterilisation procedures.sterilisation procedures.

Use of textilesUse of textiles

• Where an office- based Where an office- based health care facility has a health care facility has a laundry which is dedicated laundry which is dedicated to processing drapes, to processing drapes, gowns and other textiles gowns and other textiles that need to be sterile and that need to be sterile and area needs to be set a side area needs to be set a side for inspection, folding and for inspection, folding and assembly of these textiles. assembly of these textiles. If this is not possible If this is not possible consideration should be consideration should be given to outsourcing given to outsourcing textiles or the use of single textiles or the use of single use.use.

• Inappropriate textiles and Inappropriate textiles and laundering practice pose laundering practice pose an infection risk.an infection risk.

Packaging and wrapping prior Packaging and wrapping prior to sterilisationto sterilisation• The purpose of packaging is The purpose of packaging is

to provide an effective to provide an effective bacteria barrier against bacteria barrier against potential contamination and potential contamination and to maintain sterility.to maintain sterility.

• Materials should permit the Materials should permit the removal of air from the pack removal of air from the pack and allow penetration of the and allow penetration of the sterilising agent and removal sterilising agent and removal of the sterilising agent and of the sterilising agent and water vapour.water vapour.

• Materials need to be Materials need to be compatible to the sterilising compatible to the sterilising method selected.method selected.

• Sharp instruments should be Sharp instruments should be packaged in such a way the packaged in such a way the tips cannot pierce the tips cannot pierce the packaging material.packaging material.

Pack sizePack size

• The principle determining The principle determining the size, mass and the size, mass and contents of packs is that contents of packs is that the contents are dry and the contents are dry and sterile immediately on sterile immediately on completion of the completion of the sterilisation cycle. sterilisation cycle.

• This is usually established This is usually established when the performance when the performance qualifications are qualifications are conducted on your conducted on your sterilisers, using sterilisers, using thermocouples and thermocouples and biological indicators. biological indicators.

Labelling packsLabelling packs

• Labelling should always be done Labelling should always be done prior to sterilisation so the prior to sterilisation so the packaging material integrity is not packaging material integrity is not compromised.compromised.

• All Packaged items for sterilisation All Packaged items for sterilisation needs labels for identification of needs labels for identification of the contents the contents

• The following is the only methods The following is the only methods that should be used for labelling that should be used for labelling packages for sterilisation,packages for sterilisation,

Soft tipped alcohol-based felt Soft tipped alcohol-based felt marking pens.marking pens.

Pre-printed tapesPre-printed tapes Pre-printed bagsPre-printed bags Stamping systemsStamping systems Pre-printed labelsPre-printed labels Computerized generated labels.Computerized generated labels.

Sealing of packs and bagsSealing of packs and bags

• The purpose of sealing The purpose of sealing is to maintain pack is to maintain pack integrity ,to ensure the integrity ,to ensure the package will remain package will remain sealed during the sealed during the sterilisation process.sterilisation process.

• Sealing is usually Sealing is usually achieved by the use of achieved by the use of heat seals, self sealing heat seals, self sealing pouches or sterilising pouches or sterilising indicator tape.indicator tape.

Methods which compromise Methods which compromise pack integrity.pack integrity.

• StringString

• Non-adhesive tapeNon-adhesive tape

• StaplesStaples

• Elastic bandsElastic bands

• PaperclipsPaperclips

• Ball point pens or Ball point pens or pencils pencils

Sterilisation equipmentSterilisation equipment

• Methods of sterilisation in Methods of sterilisation in office -based health care office -based health care facilities are steam under facilities are steam under pressure and dry heat.pressure and dry heat.

• Steam kills micro-Steam kills micro-organisms by coagulation organisms by coagulation of the cell protein. of the cell protein.

• Dry heat kills micro –Dry heat kills micro –organisms by oxidation organisms by oxidation this causes the this causes the continuous loss of moisture continuous loss of moisture by the micro-organism in by the micro-organism in the heated environment.the heated environment.

Steam sterilisationSteam sterilisation

• Steam possess Steam possess three important three important qualities that qualities that make it an make it an effective sterilant.effective sterilant.

1.1. Latent heat Latent heat

2.2. MoistureMoisture

3.3. PenetrationPenetration

Types of Steam Types of Steam

1.1. Saturated steam Saturated steam 2.2. Wet saturated steamWet saturated steam3.3. Superheated steamSuperheated steamSaturated steam is theSaturated steam is theonly steam suitable for only steam suitable for

steam sterilisation.steam sterilisation.TheThe maximum allowable maximum allowable

steam wetness is 3% steam wetness is 3% which is equivalent which is equivalent to 97% dry saturated to 97% dry saturated steam.steam.

Small steam sterilisers.Small steam sterilisers.

• In Australia and New In Australia and New Zealand small Zealand small steam sterilisers are steam sterilisers are known as bench top known as bench top or portable. or portable.

• AS2182 specifies AS2182 specifies the manufacturers the manufacturers requirements for requirements for this type of this type of steriliser.steriliser.

Types of sterilising cycles and Types of sterilising cycles and their intended use.their intended use.• Type N = the sterilisation of unwrapped, solid items.Type N = the sterilisation of unwrapped, solid items.• Type B = The sterilisation of all wrapped (single or double) or Type B = The sterilisation of all wrapped (single or double) or

unwrapped items, including porous and cannulated items that do unwrapped items, including porous and cannulated items that do not exceed the specifications of hollow load type A from the not exceed the specifications of hollow load type A from the AS4815 2006AS4815 2006

• Type S = the sterilisation of items as specified by the Type S = the sterilisation of items as specified by the manufacturer of the steriliser. The available cycles needs to be manufacturer of the steriliser. The available cycles needs to be capable of sterilising unwrapped solid items and at least one other capable of sterilising unwrapped solid items and at least one other of the following types;of the following types;

Porous itemsPorous items Small porous itemsSmall porous items Hollow load type AHollow load type A Hollow load type BHollow load type B Single layer wrapped items Single layer wrapped items Double wrapped items.Double wrapped items.

TubingTubing

• Tubing poses a Tubing poses a challenge to the challenge to the sterilisation process sterilisation process due to the inability of due to the inability of effective cleaning. effective cleaning. There is also a risk of There is also a risk of air entrapment during air entrapment during sterilisation. Therefore sterilisation. Therefore it is wise to use sterile it is wise to use sterile single use tubing. single use tubing.

Dry heat sterilisersDry heat sterilisers

• The portable dry heat type The portable dry heat type steriliser is different from the steriliser is different from the steam because air removal is not steam because air removal is not part of the process.part of the process.

• Items need to be sealed within Items need to be sealed within impermeable containers. And can impermeable containers. And can withstand a temperature of 160˚c withstand a temperature of 160˚c for a minimum holding time of for a minimum holding time of 120 mins plus penetration time.120 mins plus penetration time.

• Dry heat steriliser (hot air Type) Dry heat steriliser (hot air Type) are specified in AS2487 are specified in AS2487 appliances that do not meet the appliances that do not meet the requirements of this standard requirements of this standard should not be used under any should not be used under any circumstances.circumstances.

• This type of steriliser is not This type of steriliser is not designed to sterilised liquids designed to sterilised liquids therefore this should not be therefore this should not be attempted.attempted.

Peracetic acid liquid chemical Peracetic acid liquid chemical sterilisation sterilisation

• Peracetic acid (PAA) is generally used in Peracetic acid (PAA) is generally used in operating theatres or endoscopy units.operating theatres or endoscopy units.

• When used correctly it provides them with When used correctly it provides them with a sterile product rather than a chemically a sterile product rather than a chemically disinfected product.disinfected product.

• PAA is an effective biocide and for PAA is an effective biocide and for sterilisation 35% peracetic acid is mixed sterilisation 35% peracetic acid is mixed with 10 litres of warm water rendering a with 10 litres of warm water rendering a final concentration of 0.2%.final concentration of 0.2%.

PAA as a SterilantPAA as a Sterilant

• Concentration 0.2%Concentration 0.2%• Temperature range 50 – 56 Jc Temperature range 50 – 56 Jc • Holding Time 12 minutesHolding Time 12 minutes• The cycle time is between 20-35 minutes and is dependant The cycle time is between 20-35 minutes and is dependant

on the initial water temperature and water pressure.on the initial water temperature and water pressure.• Items need to be thoroughly cleaned before being loaded Items need to be thoroughly cleaned before being loaded

into purpose built trays that sit into the chamber. As it is a into purpose built trays that sit into the chamber. As it is a wet process the items are immersed for 12minutes followed wet process the items are immersed for 12minutes followed four rinses with filtered portable water. At the end of the four rinses with filtered portable water. At the end of the cycle filtered air is purged into the chamber to remove cycle filtered air is purged into the chamber to remove excess water. The unit remains sealed until released by the excess water. The unit remains sealed until released by the operator.operator.

• The PAA system is designed for ‘’just in time’’ processing as The PAA system is designed for ‘’just in time’’ processing as items cannot be stored following the process.items cannot be stored following the process.

(LTP) Low Temperature (LTP) Low Temperature Hydrogen peroxide plasma Hydrogen peroxide plasma sterilisation.sterilisation.• LTP is a relatively new LTP is a relatively new

process when compared to process when compared to other sterilisation methods.other sterilisation methods.

• The plasma is created in The plasma is created in ambient temperature. The ambient temperature. The substance used for the substance used for the sterilisation process is sterilisation process is hydrogen peroxide (58%). hydrogen peroxide (58%). This is in liquid form This is in liquid form originally and is vaporised in originally and is vaporised in the chamber then converted the chamber then converted to plasma by the addition of to plasma by the addition of an energy field which in this an energy field which in this case is created by the case is created by the turning on of a radio turning on of a radio frequency within the frequency within the chamber during deep chamber during deep vacuum.vacuum.

LTP how it kills micro-LTP how it kills micro-organisms.organisms.

• LTP destroys micro-organisms by LTP destroys micro-organisms by creating a plasma cloud. This cloud creating a plasma cloud. This cloud contains free radicals known to have contains free radicals known to have a biochemical interaction with cell a biochemical interaction with cell membranes, enzymes or nucleic membranes, enzymes or nucleic acids to disrupt the life functions of acids to disrupt the life functions of micro-organisms.micro-organisms.

Loading the sterilisers Loading the sterilisers

• Correct loading is essential Correct loading is essential for successful sterilisation.for successful sterilisation.

• Because the sterilant must Because the sterilant must contact the surface for contact the surface for sterilisation to be achieved sterilisation to be achieved loading trays shall be loading trays shall be loosely loaded to capacity. loosely loaded to capacity. only a single layer of packs only a single layer of packs shall be loaded on each shall be loaded on each tray.tray.

• Packs must remain in the Packs must remain in the confines of the chamber confines of the chamber and not touch the walls, and not touch the walls, floor or door.floor or door.

Unloading sterilisersUnloading sterilisers

• The load must be removed The load must be removed immediately on completion immediately on completion and visual inspection shall be and visual inspection shall be made to ascertain that the made to ascertain that the load is dry, packaging is load is dry, packaging is intact and that the sterilising intact and that the sterilising indicators colour change has indicators colour change has taken place.taken place.

• Directly after the sterilisation Directly after the sterilisation process items are very process items are very vulnerable to contamination vulnerable to contamination by moisture or improper by moisture or improper handling.handling.

• After sterilisation the loading After sterilisation the loading trays shall be kept away from trays shall be kept away from high activity areas.high activity areas.

Unloading procedures Unloading procedures

• Procedures for Procedures for unloading each type unloading each type of steriliser shall be of steriliser shall be developed and developed and documented and documented and ongoing compliance ongoing compliance with such with such procedures need to procedures need to be monitored.be monitored.

Performance qualification Performance qualification

• After commissioning After commissioning performance performance qualification is qualification is preformed annually or preformed annually or when significant when significant changes are made to changes are made to any aspect of any aspect of reprocessing activities reprocessing activities e.g. changes to e.g. changes to packaging material, packaging material, loading configurations loading configurations and sterilisation process and sterilisation process parameters.parameters.

• Also after major repairs Also after major repairs to the steriliser. to the steriliser.

Performance testing Performance testing

• Leak rate vacuum testLeak rate vacuum test• Air removal and steam Air removal and steam

penetration test.penetration test.• Air detector test Air detector test

(where applicable)(where applicable)• Note sterilisers that Note sterilisers that

use downward use downward displacement as a displacement as a method of air removal method of air removal cannot be effectively cannot be effectively performance tested performance tested prior to use.prior to use.

Monitoring Monitoring

• Chemical indicators Chemical indicators • biological indicators biological indicators • enzymatic enzymatic

indicatorsindicators• Process challenge Process challenge

devices.devices.• Data loggersData loggers• Thermocouples and Thermocouples and

digital readout digital readout thermometers.thermometers.

Monitoring of packaging Monitoring of packaging following sterilisation.following sterilisation.• Integrity of the outer wrapIntegrity of the outer wrap• Integrity of sealsIntegrity of seals• Correct labelling including;Correct labelling including; Date of manufactureDate of manufacture Batch numberBatch number Steriliser cycle or run Steriliser cycle or run

numbernumber Steriliser numberSteriliser number Contents of pack and Contents of pack and

operators identificationoperators identification• Correct colour change of Correct colour change of

chemical indicator.chemical indicator.

Criteria for release of Criteria for release of processed itemsprocessed items• To release the processed To release the processed

items, there should be items, there should be evidence that the process evidence that the process has compiled with all has compiled with all specific requirements, specific requirements, therefore achieving the therefore achieving the sterility assurance level or sterility assurance level or the level of disinfection the level of disinfection required.required.

• The person responsible for The person responsible for authorizing the release must authorizing the release must have full knowledge of all have full knowledge of all aspects of the validated aspects of the validated process and be satisfied that process and be satisfied that monitoring and control of monitoring and control of the entire process has met the entire process has met specifications.specifications.

Storage of sterile stock.Storage of sterile stock.

• Storage areas for sterile Storage areas for sterile stock should be controlled stock should be controlled to prevent contamination to prevent contamination and shall be dedicated for and shall be dedicated for that purpose only.that purpose only.

• The storage environment The storage environment should be free of dust, should be free of dust, insects and vermin.insects and vermin.

• Storage containers, trolleys Storage containers, trolleys and cupboards need to be and cupboards need to be kept clean and dry and in kept clean and dry and in good condition cardboard good condition cardboard boxes should not be used boxes should not be used as they are porous and as they are porous and cannot be cleaned and will cannot be cleaned and will harbour organisms.harbour organisms.

Summary Summary

• Staff health –infection controlStaff health –infection control• Cleaning , disinfection and chemical disinfection Cleaning , disinfection and chemical disinfection • Inspect, prepare and packagingInspect, prepare and packaging• Loading for sterilisation Loading for sterilisation • Steam Steam • SterilisationSterilisation• Unloading of sterile itemsUnloading of sterile items• Monitoring Monitoring • Release of sterile stockRelease of sterile stock• Storage of sterile stock.Storage of sterile stock.

Thank youThank you