1. CESO Education Day November 30, 2004 Shawn Kenny Manager, Central Processing Department University Health Network – Toronto General Hospital

2. Goals Sterilization Technologies Sterility Assurance HLD Technologies Current Challenges

3. Sterilization Technologies Steam 1.PreVacuum 2.Gravity Displacement 3.Flash Ethylene Oxide (EO) Hydrogen Peroxide Plasma (Sterrad) Ozone (TSO3) Gamma Irradiation

4. Sterilization Technologies Steam Most commonly used sterilization method in health care facilities Cost effective High or low volume Environmentally safe

5. 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

6. 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

7. Sterilization Technologies Steam 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

8. Sterilization Technologies Ethylene Oxide Low temperature sterilization for delicate devices Long cycle time (aeration) Low volume Controlled substance

9. Sterilization Technologies Ethylene Oxide

10. Sterilization Technologies Hydrogen 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

11. Sterilization Technologies Ozone Low temperature Inexpensive Low volume Short cycle time Environmentally safe Destructive process for many materials Ineffective for long narrow lumens Proprietary technology

12. 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

13. Sterility Assurance Mechanical Indicators Time, temperature and pressure Every load Part of Sterilization Record

14. 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)

15. Sterility Assurance Bowie-Dick Testing Daily Air Removal Test (DART) Performed daily prior to first active load (or after significant maintenance) Prevacuum autoclaves only

16. 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)

17. Sterility Assurance Integrators Currently, most commonly used for Flash sterilizers Quantifiable measurement of steam exposure (time / temperature / quality) Class 5 Indicator (AAMI)

18. High Level Disinfection Pasteurization High temperature (170 F x 20 min) High volume Requires “sterile” driers Mechanical indicators only

19. 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

20. High Level Disinfection Paracetic Acid “Point of care” sterility? Expensive Low volume Destructive to materials over time Mechanical, chemical and biological indicators (available)

21. High Level Disinfection Automated Scope Processors Emerging technologies Gluteraldehyde, CIDEX OPA, Paracetic Acid Some technologies conflicting with current standards

22. 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

23. 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

24. Questions?