Transcript Sterilization Technologies

CESO Education Day
November 30, 2004
Shawn Kenny Manager, Central Processing Department
University Health Network – Toronto General Hospital
Goals
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Sterilization Technologies
Sterility Assurance
HLD Technologies
Current Challenges
Sterilization Technologies
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Steam
1. PreVacuum
2. Gravity Displacement
3. Flash
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Ethylene Oxide (EO)
Hydrogen Peroxide Plasma (Sterrad)
Ozone (TSO3)
Gamma Irradiation
Sterilization Technologies
Steam
• Most commonly
used sterilization
method in health
care facilities
• Cost effective
• High or low volume
• Environmentally
safe
Sterilization Technologies
Steam
PreVacuum
• Sterilization conditions
created by creating
chamber vacuum to
displace air within
chamber and
instrumentation
• Short exposure time
• High temperature
• Drying phase
Sterilization Technologies
Steam
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 Technologies
Steam
Flash
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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 Technologies
Ethylene Oxide
• Low temperature
sterilization for
delicate devices
• Long cycle time
(aeration)
• Low volume
• Controlled
substance
Sterilization Technologies
Ethylene Oxide
Sterilization Technologies
Hydrogen Peroxide Plasma
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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 Technologies
Ozone
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Low temperature
Inexpensive
Low volume
Short cycle time
Environmentally safe
Destructive process for
many materials
• Ineffective for long
narrow lumens
• Proprietary technology
Sterilization Technologies
Gamma 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 Assurance
Mechanical Indicators
• Time, temperature
and pressure
• Every load
• Part of Sterilization
Record
Sterility Assurance
Chemical Indicators
• Indicates sterilant
exposure only
• Every item or
package
• Internal and external
• Must be verified at
point of use
• Class 1 Indicator
(AAMI)
Sterility Assurance
Bowie-Dick Testing
• Daily Air Removal
Test (DART)
• Performed daily
prior to first active
load (or after
significant
maintenance)
• Prevacuum
autoclaves only
Sterility Assurance
Biological 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 Assurance
Integrators
• Currently, most
commonly used for
Flash sterilizers
• Quantifiable
measurement of
steam exposure
(time / temperature /
quality)
• Class 5 Indicator
(AAMI)
High Level Disinfection
Pasteurization
• High temperature
(170 F x 20 min)
• High volume
• Requires “sterile”
driers
• Mechanical
indicators only
High Level Disinfection
“Soaking”
Gluteraldehyde
• Occupational health hazard
• Being eliminated where possible
CIDEX OPA
• Safe
• Contraindicated for urological procedures
Accelerated Hydrogen Peroxide
• Safe
• Expensive
• Destructive to many materials
High Level Disinfection
Paracetic Acid
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“Point of care” sterility?
Expensive
Low volume
Destructive to materials over time
Mechanical, chemical and biological
indicators (available)
High Level Disinfection
Automated Scope Processors
• Emerging
technologies
• Gluteraldehyde,
CIDEX OPA,
Paracetic Acid
• Some technologies
conflicting with
current standards
Current 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 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?