Sterilization, disinfection and reprocessing

Transcription

1 Sterilization, disinfection and reprocessing David R. Woodard, MSc, CIC, FSHEA Definitions 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. Tools and techniques Brushes (clean) pressurized air, scrubbing, Picks (clean) 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 1

2 Point of use Immediate removal of materials Enzymatic cleaner Locations ED Clinics Out patient setting Physician offices Cleaning Cleaning 2

3 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 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. Other agents involved in cleaning Enzymes dissolve protein (organic matter) Lipase (fat) Protease (protein) Amylase (starch) 3

4 TYPES OF MATERIALS CLEANED Aluminum low alkaline detergent. manually cleaning use a motion in the direction of the grain, rather than a circular motion against the grain. Glassware washed with low alkaline detergent. Rinse with large amounts of water. final rinse, use distilled water, or demineralized water. Rubber goods scrubbed thoroughly with soft fiber brush detergent low alkaline. Thorough rinsing, and followed by air-drying. Stainless steel washed, rinsed, and dried as soon as possible low alkaline detergent 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) Time Temperature 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) 4

5 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] 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 Halogens Iodine (Iodophore) Effective agent usable in food preparation Inactivated by organic materials (blood) Stains Chlorine Effective agent usable in food preparation Inactivated by organic materials (blood) Corrosive 5

6 Other agents Chloramine-T Retains more chlorine More bactericidal Alcohol Not sporicidal Flammable Incompatible with many items Contact time issues! Other products Aldehydes Glutaraldehyde - CIDEX Good product, sporicidal; tuberculocidal; viricidal Characteristic unpleasant odor Environmental issues Toxicity Exposure levels Clean-up requirements Cidex OPA Not gluteraldehyde! Different rules and constraints Watch dating Watch compatability data (IFU) 6

7 Non-steam 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 Sterilization Steam Dry Heat Ethylene Oxide Glutaraldehyde Peracetic Acid Plasma Gas (vaporized hydrogen peroxide) 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 (IFU) Cannot sterilize wood, medications, talc, rubber bands. 7

8 Steam sterilization orapid heating and penetration oshort exposure times (<20 minutes) ono toxicity to workers osafety of workers ocheap ocooks on protein if product is not clean odamages delicate instruments The process o Product must be clean and free of protein (blood) or other dirt o Product must be packaged so that the steam can penetrate o The autoclave must be loaded correctly o The autoclave must be operated correctly o The steam must be adequate (clean and of proper water concentration) 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 8

9 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 Steam issues osteam can be too wet (>4% humidity) oaltitude of hospital (sea level vs.?) osteam can be too hot (superheated) [no moisture] osteam can contain other chemical (chloramines used to clean steam generators) that can stain or damage instruments. oquality of water Specific Steam issues *** Condensation on large instruments Calcification Chemicals Rust Staining Inadequate drying Inadequate wrapping Wet packs 9

10 Flashing passe unwrapped sterilization flash pans flash trays Do not do whole trays Do not do weird things Have an up supply of frequently dropped items Track to evaluate use Report use to ICC/OR committee Flashing or just in time othe same guidelines used for routine steam sterilization in central must apply. oit still takes time odo not abort the cycle ocleaning of device before processing orecord keeping for implants oreview of record by competent individual Record of IUSS The same tracking process as for items put up in sterile processing. Review daily for compliance Report to ICC at its regular meeting Use evidene to support additional sets We need to flash the hyster tray because we only have one 10

11 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 Steam Indictors 11

12 Packaging Ethylene Oxide 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 Major Environmental Concerns 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 12

13 Advantages Effective in the presence of organic materials. Water soluble Non-toxic Liquid or vapor formulation effective Limits and drawbacks o Process one scope at a time (slow) o Cannot wrap items (storage issues) o Items must be clean and thoroughly rinsed. Plasma sterilization o Vaporized hydrogen peroxide o Good for delicate instruments o Generally safe for heat sensitive instruments. o Time (75 minutes per cycle) 13

14 Advantages o Instruments can be wrapped (storage) o Cannot use on long or thin lumen o Small units available (table top devices) o No special ventilation requirements. Ideal properties for a sterilant 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. Post process issues o Protect sterility until ready to use. o Protect device from damage o Shelf life o Storage o Transportation o Handling 14

15 Post procedures Steam HOT!!!!!!!!!!!!!!!!! Condensate dampness (wet packs) Quality of product! ETO Aeration Hot Failure o Indicators do not turn (color tests) o Time, temperature or pressure parameters not met o Aborted cycle o Recall policy o All items since the last good test cycle! o EDUCATION! 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 CLEANING!!!!!! 15

16 Storage Dating Expiration dates - o Event related outdates o Dated for function and need o Economic rationale (Dr. Jones has been dead for years) o Space 16

17 Potential errors Disinfecting Issues 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!!!!! 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. 17

18 Things to be done Make a cleaning matrix showing: Who cleans post discharge e.g. EVS Who cleans when in use. How often general use equipment is cleaned Who cleans general use equipment Identification of cleaned items Rags, tags and bags. Things Cleaning and disinfecting of patient care equipment Who cleans the: Ventilator IV pole Rolling Stock (wheel chairs, suction machines) How do you know it clean? Things you must know 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. 18

19 Important reference material AAMI guidelines The how to for everything from loading to processing. Manufacturer s Instructions for Use (IFU) The issues and instructions provided by the manufacturer to keep your product in warranty. Questions? 19