2Presented by SPSmedical Largest sterilizer testing Lab in North America with over 50 sterilizersDevelop and market sterility assurance products that offer advanced technologiesProvide full day sterilization Seminars and on-site Facility audits for compliance with best practicesCorporate member: CSA and AAMI, serving on numerous sterilization working groups
3ANSI/AAMI ST79 consolidates five (5) other standards into Association for the Advancement of Medical InstrumentationANSI/AAMI ST79 consolidates five (5) other standards intoone comprehensive guide, which was published in October,These other standards are:ST46 Steam sterilization and sterility assuranceST42 Steam sterilization using table-top sterilizersST37 Flash sterilizationST35 Decontamination of medical devicesST33 Selection and use of packaging systems
4Standards, Recommended Practices, and Guidelines are also developed by Association of periOperative Registered NursesStandards, Recommended Practices,and Guidelines are also developed bythe AORN Recommended PracticesCommittee and approved by theAORN Board of Directors.The 2008 edition is now availableand comes in text and CD-ROM.JCAHO inspects facilities for compliance with best practices.
5Objectives At the end of this program, participants will be able to… discuss the different types of steam sterilizers,list issues related to processing heavy trays and/or instruments that require extended cycles,identify examples of extended cycles required by leading orthopedic instrument manufacturers,review the recommended parameters for when Flash sterilization is considered acceptable, andexplain minimum cycle times for flashing loads with porous versus nonporous items.
6How important is it to comply with best practices? According to CDC statistics, more than 5,000patients each day come down with a nosocomial(hospital acquired) infection and over 360 per day* die.These statistics are expected to get worse, as many of thesepreventable infections can no longer be treated with traditionalantibiotics.While the delivery of non-sterile instruments certainly is not aleading cause of surgical site infections, this has beendocumented by the CDC as one of the problems.* Statistics based on 250 business days per year
7How important is your work? “A major responsibility of the perioperative registerednurse is to minimize patient risk for surgical woundinfection…One of the measures for preventing surgicalwound infections is to provide surgical items that are freeof contamination at the time of use. This can beaccomplished by subjecting them to a sterilizationprocess”.-2008 AORN Recommended Practices and Guidelines
8Sterilization is a patient safety issue and requires a “systems approach” SurgeryPrepares soiled items for decontaminationSterile Processing & Distribution (SPD)Clean & disinfect soiled items in decontamination areaInspect and assemble items in prep & pack areaProcess items in sterilization areaMaintain sterility of items in sterile storage areaDistribute items sterile, complete and on time.Infection ControlAudit Surgery/SPD for compliance with best practices
9Chamberland autoclave built in 1880 Steam SterilizationSaturated steam under pressureis one of the oldest methodsused to sterilize items.AAMI, AORN and the CDCrecommend steam sterilizationas the PROCESS of CHOICE,because it’s fast, efficient andrelatively inexpensive.Chamberland autoclave built in 1880
10Steam Sterilizers All Class II medical devices are subject to FDA clearance per a 510(k)approval.Sterilization Parameters:TimeTemperatureSaturated Steam
11Steam Sterilization There are two (2) different types of steam sterilizers:Gravity displacementDynamic air removalPre-vacuumSteam-flush-pressure-pulseNote: Flash sterilization is typically a “shortened cycle” that can usually be run on any type of steam sterilizer.
12Steam SterilizationSteam sterilizers usually have the following standardcycle parameters:gravity displacement (250°F/121°C for 30 min. exposure, or 270°F/132°C for 15 min. exposure, plus drying)dynamic air removal (270°F/132°C for 4 min. exposure, or 275°F/135°C for 3 min. exposure, plus drying)
13Tray Weight AAMI standards (for users) recommend… The weight of an instrument set should be based on:proper body mechanicsthe design and density of the individual instruments comprising the set,the recommendations of the medical device and sterilizer manufacturersthe distribution of mass (the density) in the set and sterilizer load.
14AAMI ST 77 passed November, 2005 (for Mfg’s) Covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument cases, cassettes, and organizing trays.Among other things, ST77 limits total tray weight to 25 pounds. This will assist users in two important ways:Ergonomics = safer to lift and transport,Sterilization = use standard exposure & dry times.
15Sterilization Parameters The FDA requires manufacturer’s to validatesterilization parameters for all Containment devices(rigid containers, instrument cases, organizing traysand cassettes).AAMI standards state that medical devices purchasedby healthcare facilities should include written,validated processing instructions from the manufacturer.
16Extended Cycles?Did you know some heavy and/or complex instrument sets (i.e. orthopedic trays) have been validated with extended cycles in their instructions for use?
17SYNTHES: Sterilization Parameters Power Drive PNWrapped Temperature Minimum Exposure TimePre-vacuum °C/ °F minutesGravity Displacement – Not recommendedUnwrapped (Flash) is same as wrapped parameters.17
18DePuy a Johnson & Johnson Company Instruments – Rev. D, Page 2.Large Bone (Total Hips, Knees, Shoulders, Ankles, Elbows, Wrist)Sterilization InstructionsCycle Type Minimum Temperature Minimum Exposure Time / Dry TimePre-vacuum º C min. / 20 min. dry time for metalwith 4 pulses or metal/poly trays and 45 minutesfor all poly trays.º C min./ 20 min. dry time for metal or metal/poly trays and 45 minutes for all poly trays.Note: DePuy Moreland Revision Instruments are recommended at 132°C for 18 mins pre-vacuum.
19ZimmerRecommendations for Care, Cleaning, Maintenance and Sterilization for Zimmer Manual Orthopaedic Surgical InstrumentsCycle Type Temperature Sterilization TimePre-vacuum 270°F/132°C min.8 min. for wrapped Universal Instrument Cases without defined load configurations. 18 min. for Acetabular reamer system.Gravity displacement sterilization cycles are not recommendedbecause cycle times are too long to be practical.
20Issues with Extended Cycles Extended cycles can have a detrimental effect onefficiency and sterility assurance for healthcare facilities.For example…1) Extended cycles tie up the sterilizer and can backlog sterilizer loads needing to be processed. Does your facility have enough resources for these delays?
21Issues with Extended Cycles 2) Devices validated for standard cycles may be damaged in extended cycles. Have you contacted each device mfg. if extended cycles are used?3) Barrier characteristics of sterile packaging (disposable wrap and rigid container filters) may be adversely affected. What testing has been done by mfg’s to validate their packaging’s barrier effectiveness in extended cycles?
22Issues with Extended Cycles 4) ANSI/AAMI/ISO states:“Users should not over process the culture medium, as extended sterilization may induce changes that can affect its growth-promoting properties. The ability of the culturing medium to promote the growth of low numbers of microorganisms should be demonstrated.”What testing has your BI mfg done to validate their media’s growth promotion ability in extended cycles?
23AAMI Recommendations“Because of the increased complexity of instrumentation,consideration may be given to the installation of a separatesteam sterilizer designated for use on medical devicesrequiring nonroutine cycles”How many of you are aware that your facility is running extended cycles?
24FLASH Sterilization Surgery may need to decontaminate and flash sterilize an instrument or instrument set for quickturnaround.AORN recommended practices cautions facilities thatflashing should only be used when there isinsufficient time to process by the preferred wrap orcontainer method.
25FLASH Sterilization Flash sterilization should not be used as a substitutefor sufficient instrumentinventory.
26FLASH Sterilization (Examples of typical cycle parameters) Gravity-displacement sterilizer270°F/132°C, 3-4 min. exposure for nonporous items270°F/132°C, 10 min. exposure for porous itemsPre-vacuum sterilizer270°F/132°C, min. exposure for porous or nonporous items
27FLASH Sterilization Flash sterilization should be used only in selected clinicalsituations and in a controlledmanner.Flash sterilization should only beconsidered if all of the followingconditions are met:
28Sterilization & Infection Control Flash Sterilization Conditions1) The device manufacturer’s written instructions are available and followed.Many device manufacturers only provide terminalsterilization parameters and not flash. It is importantthat users verify the items can be flashed and how.
29Sterilization & Infection Control Flash Sterilization Conditions2) Items are disassembled and thoroughly cleaned with detergent and water to remove soil, body fats and other substances.This requires an appropriate cleaning area with anapproved detergent, cleaning brushes and personalprotective equipment (PPE) worn properly by staff.
30Sterilization & Infection Control Flash Sterilization Conditions3. Lumens are flushed with the cleaning solution and rinsed thoroughly.Lumens are particularly difficult to clean andsterilize. It is important to consult with the devicemanufacturer for cleaning information.
31Sterilization & Infection Control Flash Sterilization Conditions4. Items are placed in an instrument tray or container in a manner that allows proper steam contact.Specialized flash containers are available and can beused according to their label claim. Flash containersshould be cleaned between uses.
32Sterilization & Infection Control Flash Sterilization Conditions5. Measures are taken to prevent contamination during transfer to the sterile field.Personnel may use sterile towels as “potholders” orsterile gloves when removing trays from the sterilizer.The flashed items may then be removed from the trayby the scrub person and taken to the sterile field.
33Sterilization & Infection Control Flash Sterilization Conditions6. Documentation of cycle information and monitoring results is maintained to provide for tracking to the individual patient.Physical parameters, chemical indicators andbiological indicators should be monitored/used to testthe efficacy of the sterilizer. Records should be keptfor each sterilization cycle.
34Caution: Increased Risk Pressure on personnel could eliminate one ormore steps in the cleaning and sterilizationprocess. ALL Steps in the sterilization processmust be performed properly!
35FLASH Sterilization Decontamination process is essential for removing bioborden.Cleaning- remove debris from all parts of instrument, disassemble (if possible).Instruments should be dry before sterilization
36FLASH SterilizationPackaging & wrapping should not be used in flash cycles (unless specifically approved)Special handling of items during transportSterile glovesAvoidance of contact with unsterile surfacesNote: Specialized flash sterilization containers are commercially available and may reduce the risk of contamination during transport.
37FLASH SterilizationEach sterilization cycle should be monitored to verify thatparameters required for sterilization have been met.1) Physical indicators:TimeTemperaturePressure
38Quality Control Is the sterilizer chart or printout reviewed and initialed after eachcycle, before openingthe door?Physical indicators shouldbe recorded and maintainedfor each sterilizer cycle.
39FLASH Sterilization 2) Chemical Indicators: It is recommended that one or more CI’s be used becauseCI’s give immediate information regarding sterilizationprocess efficacy.
40Chemical Indicators Pre-vacuum type Steam sterilizers should be tested daily with a Bowie-Dicktype test.This is usually done in themorning, before the firstprocessed load.
41Chemical Indicators The Bowie-Dick test is placed over the drain in empty chamberand run at 273°F for 3.5 minutes.The indicator inside the test packshould show a uniform colorchange to pass.9/05/ CAHPass Test Sheet
42FLASH Sterilization 3) Biological Indicators: Should be used daily and with every load that containsan implant.Each sterilization MODE needs to be tested with abiological indicator (gravity and pre-vac). A controlshould be run each day from the same lot as the test BI.
43FLASH Sterilization Both the BI and CI are placed loose in an empty tray or rigidcontainer (in the area mostdifficult to sterilize) This if oftenthe area nearest the drain.
44Why an Empty Chamber? This configuration is a more rigorous biological challenge to sterilizer performance than is afilled chamber.Minimizes heat-up time (because there is little metal to absorb the heat) which minimizes the lethality of the process making it harder to kill the BI
45FLASH Sterilization An unprocessed control BI (from the same lot) shouldbe incubated each day thesterilizer is tested to confirmspore viability and properfunction of the incubator.
46FLASH SterilizationA lot number should be assigned to each flash sterilizationload and a load record should be generated for eachsterilization cycle:assigned lot number, including sterilizer identification and cycle numbergeneral contents of the loadduration and temperature of the exposure phase of cyclesignature or other identification of the operatordate and time of the cycle
47Implantable DevicesFlash sterilization should NOT be used for implantabledevices. Implants are foreign bodies, and they increasethe risk of surgical site infection.Careful planning, appropriate packaging, and inventorymanagement in cooperation with suppliers can minimizethe need to flash implantable medical devices.
48Smith & Nephew Important Sterilization Note: Smith & Nephew, the Association of Operating RoomNurses (AORN), and the Center for Disease Control(CDC) in Atlanta (USA), do not recommend the use offlash steam sterilization on implants. Due to the increasedrisk of contamination, Smith & Nephew encourages thereturn of all opened porous coated implants for recleaningand sterilization.
49Implantable DevicesIf flash sterilization is unavoidable, full traceability of the item to the patient should be maintained. Both a BI and Class 5 integrator are recommended with implants.
50Wrap up QuestionsAre sterilizers being monitored by physical, chemical and biological indicators?Are you requesting written sterilization parameters from your medical device manufacturers?Are you running extended cycles?If flash sterilization is being used, is it being done only in selected clinical situations and in a controlled manner?If implants are being flashed, are you using a BI and a Class 5 integrator every time?Are the items traceable to the patient?
51Conclusion Infection Control, Surgery and Sterile Processing should work together to comply with sterilization best practices.Flash only in selected clinical situations,Avoid flashing implantable devices, andFollow medical device mfg’s validated instructions for sterilization parameters (time & temperature).Remember to follow validated instructions for use asprovided by the medical device manufacturer.
53Purchasing AAMI Standards If your organization is not a member of AAMI, you may purchase the Standards directly from SPSmedical at our member discount. The member discount saves you 40-50% depending on the document.For example:ORDER CODE: AAMI ST:79List Price: $220Member Price: $110
54References & Resources Association for the Advancement of Medical Instrumentation1110 North Glebe Road, Suite 220, Arlington, VAFax:Association of periOperative Registered Nurses2170 South Parker Road, Suite 300 Denver, COCanadian Standards Association5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADAFax: (416)Certification Board for Sterile Processing & Distribution2 Industrial Park, Suite 3 Alpha, NJ 08865International Assoc. of Healthcare Central Service Materiel Management213 W. Institute Place, Suite Chicago, IL 60610Fax: