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?