Water Enzymatic

1. Water Enzymatic Example of reducing surface tension with water. First picture is a drop on water beading on fabric. Second picture had enzymatic detergent added to drop, thus reducing surface tension.Example of reducing surface tension with water. First picture is a drop on water beading on fabric. Second picture had enzymatic detergent added to drop, thus reducing surface tension.

2. Nonionic Enzymatic #1 (Proper Dilution: 1oz/gallon) Proper pre-cleaning Proper dilution Processed in AER No air cycle No alcohol flush Endoscope hung vertically to dry White fabric placed in bottom of cabinet to catch residue from distal tip

3. Nonionic Enzymatic #2 (Under Diluted: 4oz/gallon) Proper pre-cleaning 4X concentration Processed in AER No air cycle No alcohol flush Endoscope hung vertically to dry White fabric placed in bottom of cabinet to catch residue from distal tip

4. Nonionic Enzymatic #1 (No Rinse) Proper pre-cleaning Proper dilution 1oz/gallon No rinse cycle prior to HLD Rinse cycle after HLD No air cycle No alcohol flush Endoscope hung vertically to dry White fabric placed in bottom of cabinet to catch residue from distal tip

5. 5 Cleaning

6. 6 Cleaning Mix medical grade detergent strictly in accordance with detergent manufacturer’s instructions Mark the sink Measuring device for detergent tethered to sink Water temperature and exposure time according to IFU

7. Highlights Double pouch only if pouch validated for this purpose* Write only on plastic side** Marker - indelible, nonbleeding, non toxic Do not include pouches within set** Manufacturers’ instructions readily available Containers biologically tested Packaging

8. Critical devices enter normally sterile areas of the body or vascular system Examples – mosquito, scalpel, IV catheter most surgical instruments Semi-critical devices contact, but do not penetrate mucous membranes Examples – thermometer, bronchoscope, colonoscope Non-critical devices contact intact skin Examples – blood pressure cuff, crutches 8 Spaulding Classification

9. Critical items MUST be sterile All microorganisms including spores - Killed Semi-critical items must be at least high-level disinfected All microorganisms except high numbers of spores - Killed Non-critical devices – low level disinfection (detergent and water) 9 Spaulding Classification

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11. SSI – current model no longer cleared by FDA Significant changes since original clearance Those in existence will be serviced No new ones to be sold in USA FDA has given users until 8/2011 to transition to other technology 11 Liquid Peracetic Acid Sterilization

12. SSI Device manufacturer has 12 months to remove system from its processing instructions Alternative technologies listed on FDA web site FDA web site SSI alternatives 12 Liquid Peracetic Acid

13. SS1 – off the market Aug 2011 No replacement sterilizer system Facilities must transition for sterilization Assess situation Use existing technology Purchase autoclavable devices Purchase new sterilization technology Liquid Peracetic Acid

14. Sterilization 1990s to present Hydrogen Peroxide

15. Hydrogen Peroxide Strong oxidizing agent Nonmutagenic Noncarcinogenic Plasma generated by electromagnetic energy Electrons freed, negative and positive particles Creates 4th state of matter 15 Hydrogen Peroxide Gas Plasma Sterilization

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17. Issues – Hot Topics

18. What are they? 5 min to 20 min dynamic air removal 2700F Longer than sterilizer manufacturer validation WHY Complexity of design Lumens Density Material – plastic Layers Testing indicates it take longer to reach 10-6 Prion cycle in Europe Extended Cycles

19. Should not mix devices with standard cycle time requirements with devices requiring extended cycles unless: Packaging validated for extended cycle Need to review IFU, talk with packaging company Other devices permit extended cycle BI media validated for extended cycles Need to obtain information from BI vendor/company Hospitals need to know their sterilization methods are valid for extended cycles – do results verify manufacturer validation? Extended cycles impact turnaround 19 Extended Cycles

20. Communication between OR and SPD critical to move OR schedule Formalized process for OR schedule review IFU periodic review Staff must refer to IFUs – ongoing Some device manufacturers have removed flash instructions from IFU Some device manufacturers have removed peracetic acid from IFU Increasingly accountable to be current Impact – Extended Cycles

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