The fine art of bug killing – sterilization, disinfection and reprocessing

1. The fine art of bug killing – sterilization, disinfection and reprocessing David R. Woodard, MSc, CIC

2. Disclosures • I am not an employee of any company that makes disinfectants or sterilizing devices. I have received no financial incentive from any company that makes disinfectants or sterilizing devices. The use of a “trade” name or picture does not imply endorsement of the device by CASA, APIC or me.

3. Disclosures • I am not an employee of any company that makes disinfectants or sterilizing devices. I have received no financial incentive from any company that makes disinfectants or sterilizing devices. The use of a “trade” name or picture does not imply endorsement of the device by CASA or me.

4. Dr. Earle Spaulding • “You can clean without disinfecting, but you cannot disinfect without cleaning”

5. Basicelements • Cleaning • Disinfecting • Packaging • Sterilizing • Storage

6. Cleaning – the removal of visible soil from the surfaces, joints and lumen of instruments or devices. This is done using a mechanical process to prepare the instrument (product) for further processing. Brushes, pressurized air, scrubbing, picks Definitions

7. Cleaning • Remove all visible soil • Decrease the bioburden • Increase workers safety • Do early in process to avoid dried on materials. • Safe compounds • NOT intended to disinfect or sterilize

8. How to • Mechanical process • Friction • Detergent • Make fats soluble or “isolate” • Carrier (water) • Detailed • Use standard process • Monitor activity • Use only the very best products

9. Essential components • Surfactant – decreases surface tension permitting water and detergent to disperse throughout area. • Precipitants – condense metallic ions to prevent them from effecting process. • Chemical buffers – maintain the pH of the cleaning solution to maximize the effect of the detergent.

10. Other cleaning agents • Enzymes – dissolve protein (organic matter) • Lipase (fat) • Protease (protein) • Amylase (starch)

11. TYPES OF MATERIALS CLEANED • A. Aluminum • low alkaline detergent. • manually cleaning use a motion in the direction of the grain, rather than a circular motion against the grain. • B. Glassware • washed with low alkaline detergent. • Rinse with large amounts of water. • final rinse, use distilled water, or demineralized water. • C. Rubber goods • should be scrubbed thoroughly with soft fiber brush • detergent should be low alkaline. • Thorough rinsing is essential, and followed by air-drying. • D. Stainless steel is to be washed, rinsed, and dried as soon as possible, using a low alkaline detergent

12. Disinfecting • A process that eliminates living pathogenic microorganisms on inanimate objects – • Does not work on most virus • Does not work on most spores • Does not work on “prion”? • May have other limits (high level vs. low level)

13. Characteristics of a disinfectant • Broad kill spectrum • Not affected by environment (pH) • Not toxic • Mix with available water (hardness) • Stable (evaporation) • Won’t harm target surfaces (metal, fabric)

14. Important disinfecting thoughts • Proper dilution – more is not better! • Employee safety • Environmental safety • Exposure limits (Permissible exposure level) • Compatibility (gloves, basins, other products) [chlorine and ammonia]

15. Different types (US) • Phenolic – “gold standard” • Smells “like a hospital” • Toxicity • Won’t kill spores • Quaternary ammonium • Specific pathogen approvals (read the label!) • Affected by water hardness • Affected by bioburden

16. Halogens • Iodine (Iodophore) • Good killer – usable in food preparation • Inactivated by organic materials (blood) • Stains • Chlorine • Good killer – usable in food preparation • Inactivated by organic materials (blood) • Corrosive • Bleach!

17. Other products • Chloramine-T • Retains more chlorine • More bactericidal • Alcohol • Not sporicidal • Flammable • Incompatible with many items

18. Other products • Aldehydes • Gluteraldehyde • Good product, sporicidal; tuberculocidal; viricidal • Characteristic unpleasant odor • Environmental issues • Toxicity • Exposure levels • Clean-up requirements

19. Newer products • Hydrogen peroxide • Oxidizer (may harm some instruments) • Reverts to hydrogen and oxygen (safe?) • Peracetic acid • Rapid action but smells bad (vinegar) • Works in presence of organic materials

20. Sterilization • Steam • Dry Heat • Ethylene Oxide • Gluteraldehyde • Peracetic Acid • Plasma Gas (vapourized hydrogen peroxide)

21. Sterilization • Any thing can be autoclaved one time! • To sterilize any item adequately, you must first obtain guidelines from the manufacturer as to what the limitations and parameters have to be. • Cannot sterilize wood, medications, talc, rubber bands.

22. Steam sterilization • Rapid heating and penetration • Short exposure times (<20 minutes) • No toxicity to workers • Cheap • Cooks on protein if product is not clean • Damages delicate instruments

23. The process • Product must be clean and free of protein (blood) or other dirt • Product must be packaged so that the steam can penetrate • The autoclave must be loaded correctly • The autoclave must be operated correctly • The steam must be adequate (clean and of proper water concentration)

24. It takes longer than you think! • Steam will “cook” the microorganism in a very short period of time but • Autoclave must be brought to temperature • Temperature must be maintained throughout the process • Safety Factor {just in case} (1/2 of the “scientific kill time at temperature) • Generally 20 minutes

25. Examples • Prevacuum – (132C x 4 minutes) • 1 minute to heat up • 2 minutes to kill • 1 minute Safety factor • Gravity (121C x 12 minutes) • 12 minutes to heat up • 12 minutes to kill • 6 minutes Safety factor

26. Steam issues • Steam can be too wet (>4% humidity) • Altitude of hospital (sea level vs. ?) • Steam can be too hot (superheated) [no moisture] • Steam can contain other chemical (chloramines used to clean steam generators) that can stain or damage instruments.

27. Flashing • “unwrapped sterilization” • “flash pans” • “flash trays” • Do not do whole trays • Do not do weird things (Bookwalter retractor) • Have an “up” supply of frequently dropped items

28. Flashing or “just in time” • The same guidelines used for routine steam sterilization in central must apply. • It still takes time • Do not abort the cycle • Cleaning of device before processing • Record keeping for implants • Review of record by competent individual

29. Flash log • The same tracking process as for items put up in sterile processing. • Review daily for compliance • Report to ICC at its regular meeting • Use to support additional sets • “We need to flash the hyster tray because we only have one”

30. Indicators • Devices that – • Change color upon exposure to heat (not indicator of sterility) • Change physical composition upon exposure to heat and pressure (and time) (sterility indicator) • Tape on wrapper • Safety and quality control

31. Ethylene Oxide & Peracetic Acid • EO (kills by chemical reaction – causes cellular destruction) • EO is carcinogenic • EO “carrier” is Freon-12 which has an effect on the ozone level. • Flammable • State of Los Angeles and AQMD want to eliminate!

32. Peracetic acid • Disrupts chemical bonds in the bacteria • Oxidizes enzymes denatures protein • Good for most delicate devices • Better indication for most devices with lumen • Requires special plumbing • A “contact” sterilant

33. The Good • Effective in the presence of organic materials. • Water soluble • Non-toxic • Liquid or vapour formulation effective

34. Limits and drawbacks • Process one scope at a time (slow) • Cannot wrap items (storage issues) • Items must be clean and thoroughly rinsed.

35. Plasma sterilization • Vapourized hydrogen peroxide • Good for delicate instruments • Generally safe for heat sensitive instruments. • Time (75 minutes per cycle)

36. The good the bad • Instruments can be wrapped (storage) • Cannot use on long or thin lumen • Small units available (table top devices) • No special ventilation requirements.

37. Ideal properties • Effective – good kill of target organisms • Toxicity – safe without major PPE • Speed – good “turn around time” • Costs – economic at level used • Implementation – works where needed • Safety – works on target devices without damage.

38. Post process issues • Protect sterility until ready to use. • Protect device from damage • Shelf life • Storage • Transportation • Handling

39. Post procedures • Steam • HOT !!!!!!!!!!!!!!!!! • Condensate – dampness (wet packs) • ETO • Aeration • Hot

40. Failure • Indicators do not turn (color tests) • Time, temperature or pressure parameters not met • Aborted cycle • Recall policy • All items since the last good test cycle! • EDUCATION!

41. Storage • Preserve the integrity of the product. • “Dust covers” are not necessary • Clean, dry and free of dust • Good illumination • Accessibility to the product • Product rotation (aging of the product) • Recall

42. California • Event related outdates and Title 22 • You must have program flexibility if you do not outdate your product. • Dated for function and need • Economic rationale (Dr. Jones has been dead for years) • Space

43. DisinfectingIssues • Product must be: • Tested each day of use/time used • Changed as manufacturer requires • Temperature sensitive • Test strips tested for accuracy (high/low) • Test strips expire! • Color acuity!!!!!

44. Reprocessing • Not a new concept • Not against the law • Not forbidden • Not bad medicine

45. Reprocessing • Considerations • Cost recovery • scalpel blades can be done but it’s cheaper to buy new ones • Turn-around time • Agency approvals • Support services • In house • Out of house

46. Not reasons to not reprocess • The FDA doesn’t approve • The hospital (physician) can be sued for malfunction • They won’t be as – • Sharp • Precise • Accurate • My kid is starting college!

47. Liability • Ensure that the reprocessing agency is assuming the liability for the product. The hospital will be no more liable for malfunction of a reprocessed item as if the item were new. • Notifying the patient – • Do you tell the patient now that the instruments used in the case have been reprocessed?

48. FDA • All valid reprocessing companies must meet the FDA 510 requirements. • Instruments or devices must meet the original manufacturer’s original approval. • Limited number of reprocessing events for each device • Must ensure sterility based on regulatory approved methods. (not washed with agar!)

49. Things you should not do • No hospital laboratory per se is qualified to perform sterility testing on manufactured goods. • No hospital laboratory per se is qualified to perform quantitative or qualitative testing of water (e.g. dialysis) for pathogens. • No hospital laboratory per se is qualified to do sterility testing when an autoclave fails.

50. Things you must do • Have a recall process that works for all items sterilized in your facility. • Ensure that all failures are reported to you and risk management (? And DHS) • Investigate and report on the investigation to the ICC. • Know your sterile processing director • Have lunch with your end-users.