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CESO Education DayCESO Education DayNovember 30, 2004November 30, 2004
Shawn Kenny Manager, Central Processing DepartmentShawn Kenny Manager, Central Processing DepartmentUniversity Health Network – Toronto General HospitalUniversity Health Network – Toronto General Hospital
GoalsGoals
• Sterilization Technologies
• Sterility Assurance
• HLD Technologies
• Current Challenges
Sterilization TechnologiesSterilization Technologies
• Steam1. PreVacuum
2. Gravity Displacement
3. Flash
• Ethylene Oxide (EO)
• Hydrogen Peroxide Plasma (Sterrad)
• Ozone (TSO3)
• Gamma Irradiation
Sterilization TechnologiesSterilization TechnologiesSteamSteam
• Most commonly used sterilization method in health care facilities
• Cost effective• High or low volume• Environmentally
safe
Sterilization TechnologiesSterilization TechnologiesSteamSteam
PreVacuum• Sterilization conditions
created by creating chamber vacuum to displace air within chamber and instrumentation
• Short exposure time• High temperature• Drying phase
Sterilization TechnologiesSterilization TechnologiesSteamSteam
Gravity Displacement• Steam is injected directly into the chamber
sleeve and air is displaced passively through a drain
• More ‘gentle’ method, often utilizing lower temperatures with longer exposure times
• Drying phase
Sterilization TechnologiesSterilization TechnologiesSteamSteam
Flash• Point of care sterilization• Utilizes gravity displacement or prevacuum• Wrapped or unwrapped• Porous and Non-Porous cycles• Normally no drying phase• Urgent requirements, not recommended for
normal practice
Sterilization TechnologiesSterilization TechnologiesEthylene OxideEthylene Oxide
• Low temperature sterilization for delicate devices
• Long cycle time (aeration)
• Low volume• Controlled
substance
Sterilization TechnologiesSterilization TechnologiesEthylene OxideEthylene Oxide
Sterilization TechnologiesSterilization TechnologiesHydrogen Peroxide PlasmaHydrogen Peroxide Plasma
• Low temperature• Short cycle time• Expensive• High load failure rate• Environmentally safe• Destructive process for
many materials• Ineffective for long
narrow lumens• Proprietary technology
Sterilization TechnologiesSterilization TechnologiesOzoneOzone
• Low temperature• Inexpensive• Low volume• Short cycle time• Environmentally safe• Destructive process for
many materials• Ineffective for long
narrow lumens• Proprietary technology
Sterilization TechnologiesSterilization TechnologiesGamma IrradiationGamma Irradiation
• Used in manufacture of single use medical devices
• High throughput for packaged materials
• No current standards for use as sterilization method outside the manufacturing process
Sterility AssuranceSterility AssuranceMechanical IndicatorsMechanical Indicators
• Time, temperature and pressure
• Every load• Part of Sterilization
Record
Sterility AssuranceSterility AssuranceChemical IndicatorsChemical Indicators
• Indicates sterilant exposure only
• Every item or package
• Internal and external• Must be verified at
point of use• Class 1 Indicator
(AAMI)
Sterility AssuranceSterility AssuranceBowie-Dick TestingBowie-Dick Testing
• Daily Air Removal Test (DART)
• Performed daily prior to first active load (or after significant maintenance)
• Prevacuum autoclaves only
Sterility AssuranceSterility AssuranceBiological IndicatorsBiological Indicators
• Log reduction in viable spores
• Daily / Parameter change / Sterilizer maintenance/repair
• Incubation required• Part of Sterilization
Record• Steam, Hydrogen
Peroxide Plasma, Ozone (geobacillus stearothermophilus)
• Ethylene Oxide (bacillus subtilis)
Sterility AssuranceSterility AssuranceIntegratorsIntegrators
• Currently, most commonly used for Flash sterilizers
• Quantifiable measurement of steam exposure (time / temperature / quality)
• Class 5 Indicator (AAMI)
High Level DisinfectionHigh Level DisinfectionPasteurizationPasteurization
• High temperature (170 F x 20 min)
• High volume• Requires “sterile”
driers• Mechanical
indicators only
High Level DisinfectionHigh Level Disinfection“Soaking”“Soaking”
Gluteraldehyde• Occupational health hazard• Being eliminated where possibleCIDEX OPA• Safe• Contraindicated for urological proceduresAccelerated Hydrogen Peroxide• Safe• Expensive• Destructive to many materials
High Level DisinfectionHigh Level DisinfectionParacetic AcidParacetic Acid
• “Point of care” sterility?
• Expensive
• Low volume
• Destructive to materials over time
• Mechanical, chemical and biological indicators (available)
High Level DisinfectionHigh Level DisinfectionAutomated Scope ProcessorsAutomated Scope Processors
• Emerging technologies
• Gluteraldehyde, CIDEX OPA, Paracetic Acid
• Some technologies conflicting with current standards
Current ChallengesCurrent Challenges
• “Oddball” parameters for sterilization• Loaner instrumentation• Manufacturers keeping up with
technology• Technology keeping up with
manufacturers• Standards organizations keeping up
with technology• SUMeds
In SummaryIn Summary
• 2004 was a tough year to be a sterile processing manager in Ontario…
• 2004 has been a GREAT year to be a sterile processing manager in Ontario!– Increased public awareness– Increased institutional awareness– Increased government awareness
Questions?Questions?