Objectives. The Perioperative Nurse s Role 6/24/2016. Instrument Processing & Sterilization Chesapeake Perioperative Consortium 2016

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1 Instrument Processing & Sterilization Chesapeake Perioperative Consortium 2016 Ensuring our patients get clean, sterile instruments every time. Objectives Define the perioperative nurse and surgical tech s role in instrument care and sterilization Describe the point of use care of instruments State the various types of sterilization methods and their indications for use. Discuss the quality assurance measures taken to ensure proper sterilization. The Perioperative Nurse s Role Partner in the process of preparing of preparing instruments and assumes different levels of ownership for cleaning, inspection, packaging, sterilization, and storage of sterile supplies 1

2 Nurses & Tech Responsibilities Patient advocate Ensure that instruments are in good working order Ensure that instruments have been packaged and sterilized properly Keep our patients safe! Point of Use All instruments opened for a case are considered contaminated whether used or not Keep instruments clean during the procedure Wipe with sterile water, NOT saline Flush lumens with a syringe filled with sterile water Point of Use Continued Return to original containers Ensure sets are complete before returning to Sterile Processing Remove blades and sharps from instruments Remove drill bits/saw blades and discard Segregate sharp instruments from other instruments Open all instruments 2

3 Point of Use Spray instruments with enzymatic cleaner prior to returning to Sterile Processing to prevent formation of bioburden Return instruments promptly to Sterile Processing Returning items to Decontamination Remove all trash from set, paper, linen, etc. Restring instruments on stringer Spray with enzymatic cleaner Close tray with lid and transport dirty trays separately from clean, unused trays Decontamination Area Area designed to contain contamination Negative air pressure environment Personnel wear PPE for protection from exposure to contamination All instruments are cleaned whether used or not 3

4 Cleaning Mechanical Cleaning Washer/disinfector/deconta -minator Built into a wall between the decontam area and the clean area Instruments are processed according to IFU s (Instructions for use) Special Needs Equipment Cleaning Eye instruments Flexible endoscopes Robotic Instruments Ultrasonic Cleaning can be used to dislodge and remove debris from instruments with nooks and crannies Preparation and Packaging Inspection: instruments are dried, and checked for cleanliness, integrity, alignment, sharpness of edges, and proper function Items that do not function should be sent out for repair An instrument that fails during surgery can harm a patient 4

5 Assembly and Packaging Packaging materials are intended to maintain sterility of the items until intended use Packaging materials must be appropriate for the item and sterilization process Fluid resistant Blue Wrap: disposable Fabric: reuseable Pouches made from plastic and paper, or Tyvek Steam sterilized Used for single item Peel Packs Aluminum, stainless steel Gaskets to promote a secure seal and a valve or filter system to permit penetration and evacuation of sterilant Containers are cleaned and checked for integrity New filter every time Container is locked with a tamper evident seal Durable Rigid Containers 5

6 Rigid Container Locks Before Sterilization After Sterilization After Sterilization Check for holes/tears Filters in Trays Wrapped Items Circulator should check for moisture in bottom of pan 6

7 Monitoring: Chemical Indicators/Integrators Parameters are met Indicators demonstrate a visible change when exposed to the parameters Heat sensitive tape, labels, strips that are placed inside the package If no visible indicator, the package is considered contaminated Items packaged for sterilization must be clearly labeled with contents and initials of the assembler Indelible, nonbleeding, nontoxic marker should be used to make packages Lot control sticker placed on outside of package indicates sterilization date, sterilizer used, and cycle or load number. Labeling Sterilization Definition Sterile - the substance is completely free of all living microorganisms, and is incapable of producing any form of life. 7

8 (SAL) Sterility Assurance Level Sterilization provides the greatest assurance that items are sterile. Critical items are sterilized with a SAL of 10 (minus 6). Equal to, or less than, one chance in a 1 million that any viable microorganism will be present on an item after sterilization. Sterilizer must be capable of killing 1 million spores in half the time for which it is programmed. (For example: If the exposure phase is 4 minutes, the manufacturer must demonstrate that 1 million spores are killed in 2 minutes). Spaulding Classification Levels (Levels of Disinfection) Category Critical Items introduced into the body. Implants, Interments Disinfection Level Sterilization Autoclave, Steris Sterilization Kills all vegetative forms of Bacteria, all viruses, all fungi. Highly resistant bacterial spores may survive. Spaulding Classification Levels (Levels of Disinfection) Category Semicritical Items come in contact with mucus membranes. Endoscopes, Anes. Equipment Disinfection Level High level disinfection Glutaraldehyde solution Ortho-Phthalaldehyde solution High level disinfection Kills TB, vegetative bacteria, most viruses and most fungi. Does not kill bacterial spores. 8

9 Disinfection Kills all living microorganisms with the exception of high numbers of bacterial spores Does not provide the margin of safety associated with sterilization Sterilization Methods Steam Gas Ethylene Oxide (ETO) Chemical Hydrogen Peroxide (Sterrad) Dry Heat and radiation are not used in the U.S. Criteria for Sterilization Contact Temperature Time Moisture Concentration of Sterilant 9

10 Advantages of Steam Sterilization Readily available Economical Enables fast sterilization: destruction of resistant spores occurs quickly Compatible with most in house packaging materials Leaves no toxic residue and is environmentally safe Steam Sterilization Parameters Time Temperature Pressure Varies depending on machine 270 deg F. 27 psi, resulting in saturated steam Preparing Load for Sterilization 10

11 CSP Sterilizers Loads Cooling Pre-Vac VS Gravity Displacement Pre-Vac Vacuum pump displaces the air in the chamber and creates a vacuum Offers a greater margin of safety with regard to air removal Exposure time is shorter Gravity Displacement Steam replaces the air in the chamber by gravity Takes longer for sterilization and depends on gravity to remove air Should not be used when pre-vac is available More common in dental offices and clinics 11

12 IUSS (Immediate Use Steam Sterilization) Replaced the term flash sterilization Appropriate only for processing an item needed urgently and no sterile replacement is immediately available. Should NOT be used for routine sterilization and not for whole trays of instruments Should not use for implantable devices Item must be cleaned in same manner that it would be cleaned in Central Sterile Processing Item should be sterilized in containers specifically for IUSS (flash pack) Items may be wet at end of process because there is no dry time IUSS Items sterilized by IUSS are vulnerable to contamination during the transporting process Sterilizers are located away from the OR which increases risk of contamination during transport Documentation of IUSS Time Temperature Pressure Your name Room # that instruments are going to 12

13 Example of Documentation Low Temperature Sterilization H2O2 Sterrad Uses Hydrogen Peroxide and radiowaves to create plasma gas Eventually will replace Ethylene Oxide gas Sterrad Advantages Low temperature Takes 90 minutes -Environmentally safe -Can sterilize sensitive items such as ultrasound probes and lighted retractors Disadvantages Cannot sterilize instruments in metal trays Cannot use cotton and/or cellulosic material (no paper 13

14 Sterrad Tape Parameters Before Sterilization After Sterilization Beige Tape: Red Words turn to Yellow Words Gas Sterilization ETO (Ethylene Oxide) A chemical technique of destroying viruses, bacteria and other microorganisms Used for Intricate and delicate instruments Plastic and porous materials Electric instruments Advantages/Disadvantages for ETO Advantages Easily available Effective against all types of microorganisms Easily penetrates through masses of dry materials Doesn t require high temperature, humidity or pressure Non-corrosive and nondamaging Disadvantages Long exposure time needed (total cycle with aeration 7 ½ hours Expensive compared to steam Explosive Irritating to tissues 14

15 ETO (Gas) Tape Parameters Before Sterilization After Sterilization Green Tape: Yellow Stripe Turns to Red Stripe ETO (Gas) Integrator Parameters Before Sterilization After Sterilization Beige turns to blue inside Accept window Wrapped Gassed Item 15

16 Steris Sterilization Uses Peracetic Acid Low Temperature Chemical Sterilization Chemical sterilization using automated unit Prepackaged single dose sterilant Unit automatically dilutes the peracetic acid and runs sterilization and rinse cycles. Used to process endoscopes Steris Biological Monitoring (BI) Biologic Monitoring determines whether or not microorganisms have been destroyed Most accurate method of ensuring that conditions necessary for sterilization have been met ETO sterilizers should be tested with every load H2O2 tested every day and preferably every load BI is run in each steam sterilized every day that the sterilizer is in use BI is run in every load containing an implant Implants should not be released until results of biological monitoring are known to be negative for growth 16

17 BI Ampules containing spores Steam sterilizers: Geobacillus stearothermophilus ETO: Bacillus atrophaeus Both are highly resistant non pathogenic microorganisms BI Incubator After the BI is run thru the autoclave/sterilizer it is then incubated Growth is visible in 3 hrs, 1 hr, or 30 minutes Must be incubated before results are read and a control BI is incubated at the same time References Spry & Goodman, Essentials of Perioperative Nursing (2016) AORN 2016 Guidelines for Perioperative Practice 17

18 The END! Questions? 18