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Chemical Indicators: Class 5 Integrating Indicators Slide 2 Presented by SPSmedical Largest sterilizer testing Lab in North America with over 50 sterilizers Develop and market sterility assurance products that offer advanced technologies Provide full day sterilization Seminars and on-site Facility audits for compliance with best practices Corporate member: CSA and AAMI, serving on numerous sterilization working groups Slide 3 Association for the Advancement of Medical Instrumentation Meets in Washington, DC throughout each year and establishes guidelines for sterility assurance which become our American National standards. Membership includes: Healthcare facilities Healthcare organizations Government agencies Medical device manufacturers Testing Labs and Consultants Slide 4 Objectives At the end of this program, participants will be able to Identify the different classes of chemical indicators, Discuss the appropriate application for each chemical indicator, Review proper placement of internal chemical indicators based on packaging and contents of each item, Discuss new ISO requirements for Class 5 indicators. Slide 5 Chemical Indicators AAMI ST79:2006 recognizes five classes: Class 1 Process Indicators Class 2 Specific Test Indicators Class 3 Single parameter Indicators Class 4 Multi-parameter Indicators Class 5 Integrating Indicators Class 6 Emulating Indicators Slide 6 Quality Control Class 1 Process Indicators are intended for use as an external indicator to distinguish between processed and unprocessed items. Slide 7 Quality Control Class 2 Specific Test Indicators are Bowie-Dick type indicators for use with air removal testing. Two Options: 1)Buy a commercial test pack (single use or reusable), 2)Make your own test pack using freshly laundered towels (10x10x11-12) with an indicator sheet placed in the center and single wrapped. Slide 8 Quality Control Pre-vacuum type Steam sterilizers should be tested daily with a Bowie-Dick type test. This is usually done in the morning, before the first processed load. Slide 9 Quality Control The Bowie-Dick test is placed over the drain in empty chamber and run at 273F for 3.5 - 4 mins. The indicator inside the test pack should show a uniform color change to pass. *For test packs other than the Lantor Cube, a cart should be used. Processed - PASS Slide 10 Chemical Indicators Chemical indicators should be used externally and internally for each item processed. AAMI Says Internal CIs should be Class 3, 4 or 5 and chosen based upon how many critical process variables are to be monitored and how much information is desired about the sterilization process. Slide 11 Chemical Indicators The chemical indicator should be placed in that area of the package, tray, or container considered least accessible to sterilizing agent penetration. This area may or may not be at the center of the package, tray, or container and may or may not be at the center of the sterilizer chamber. Slide 12 Chemical Indicators Where would you place your CI in this tray? What classification CI would you choose? Slide 13 Chemical Indicators Chemical indicators are intended to provide information about local conditions within the sterilizing chamber and thus to alert the user to potential sterilization process failures. The basic performance descriptor of any chemical indicator is its endpoint response, which is the observable change as specified by the manufacturer that occurs after the indicator has been exposed to certain predefined process conditions. Slide 14 Chemical Indicators This observable change generally involves either the melting of a chemical substance or a chemical reaction resulting in a color change. Slide 15 Quality Control Class 3 Single Parameter Chemical Indicators These are designed to react to one parameter of the sterilization process, to indicate exposure at a stated value. Indicator melts when reaching a specific temperature, e.g. 270F Slide 16 Quality Control Class 4 Multi-Parameter indicators are designed to react to two (2) or more critical parameters, to indicate exposure at stated values. Slide 17 Chemical Indicators The majority of internal chemical indicators in use today for Steam and/or EO gas are multi-parameter color change indicators designed to react to two or more of the critical parameters of sterilization. Other low temperature processes are monitored with single parameter chemical indicators. Slide 18 Chemical Indicators As discussed, different classes of CIs have been developed to suit different monitoring needs. Some types are sensitive to certain specific problems, such as a temperature deficiency, while others can be less sensitive to an individual parameter but can simultaneously test the overall process. Even chemical indicators of the same basic type can differ in response characteristics, means of detecting exposure conditions, and reliability. Slide 19 Class 5 Indicators (commonly referred to as Integrators) Class 5 Integrating indicators react to all critical parameters of the sterilization process over a specified range of sterilization cycles and their performance correlates to BI performance as stated on their labeling. Slide 20 Class 5 Indicators AAMI says the results of Class 5 integrating indicators may serve as the basis for the release of processed items, including implants if you can not wait for BI results. For monitoring wrapped loads, these integrating indicators must be used within an appropriate challenge test pack. Slide 21 Class 5 Indicators AAMI standards also state chemical indicators should clearly differentiate between adequately and inadequately processed items. For this reason, the endpoint response should be appropriate and unambiguous. Examples of adequate and inadequate exposures should be available from the manufacturer and clearly understood by the user. Slide 22 Class 5 Chemical Indicator ANSI/AAMI/ISO 11140-1:2005 outlines more rigid criteria for a device to be labeled as a Class 5 Integrating Indicator. Class 5 integrating indicators are the only class of CIs that must have a response correlated to a BI Stated values must correlate to the results of the BI at 250F, 275F and a minimum of one point between Must now have a stated value at 250F that is greater than 16.5 minutes Pass dry heat test showing the CI does not reach its endpoint in 30 minutes at 280F Slide 23 Benefits of ANSI/AAMI ISO Class 5 Benefits of ANSI/AAMI/ISO 11140-1:2005 Class 5 Integrating Indicator: Stated values are equivalent to or exceed the performance requirements of BIs Ensures the Class 5 CI does not change inappropriately or too quickly at significantly lower temperatures Class 5 Integrator can be used for ALL steam cycles Class 5 Integrator passes only if the BI is killed SPSmedical C5 meets these new more stringent requirements. Check with your supplier for documentation. Slide 24 Class 5 Indicators Chemical integrators are tested in resistometer vessels. A resistometer is a special sterilizer that is designed for very rapid attainment of the particular critical parameters of the sterilization process. These parameters are very closely controlled during the sterilization exposure. SPSmedical chemical indicator evaluator resistomer manufactured by Joslyn Valve Co. Slide 25 Class 5 Indicators Because standard sterilizers do not have enough accuracy of exposure conditions as found in resistometers, it is nearly impossible for a user to replicate mfgs label claims. Slide 26 Class 5 Indicators Often, the stated goal of the integrator manufacturer is to design a product that will provide as much information as a biological indicator. Slide 27 Class 5 Indicators The assumption is that if we know the process conditions that provide kill to the biological indicator, and the chemical integrator can be prevented from reaching its endpoint until those conditions have been met, reaching the endpoint gives a level of assurance similar or equal to that of a biological indicator. Slide 28 Class 6 Emulators Cycle specific indicators Multiple sterilization cycles require separate C6 indicators to monitor each time and temperature. Can NOT be used in all steam cycles Neither AAMI nor AORN provide end users with recommendations on their appropriate use Correlates to the BI at (1) time/temperature whereas ISO compliant C5s correlate at 3 time/temps. Slide 29 SUMMARY Due to the vast complexity of cleaning, packaging and sterilization of instruments today, no single element of a sterility assurance program, can be relied upon, by itself, to assure sterility. Slide 30 SUMMARY However, the careful selection and use of Class 5 indicators, along with attention to all aspects of sterilizer performance, processes, and compliance with industry standards certainly provides the highest level of sterility assurance possible! Slide 31 ! THANK YOU! SPS medical Supply Corp. Sterilization Products & Services 6789 W. Henrietta Road Rush, NY 14543 USA Fax: (585) 359-0167 Ph: (800) 722-1529 Website: www.spsmedical.com SPSmedical Supply Corp. Certificate is available after viewing by calling SPSmedical or e-mailing education@spsmedical.com education@spsmedical.com Chemical Indicators and Integrators Slide 32 Purchasing 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:79 List Price: $220 Member Price: $110 Slide 33 References & Resources Association for the Advancement of Medical Instrumentation 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795 703-525-4890 Fax: 703-276-0793 www.aami.org Association of periOperative Registered Nurses 2170 South Parker Road, Suite 300 Denver, CO 80231-5711 800-755-2676 www.aorn.org Canadian Standards Association 5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA 800-463-6727 Fax: (416) 747-2510 www.csa.ca Certification Board for Sterile Processing & Distribution 2 Industrial Park, Suite 3 Alpha, NJ 08865 908-454-9555 www.sterileprocessing.org International Assoc. of Healthcare Central Service Materiel Management 213 W. Institute Place, Suite 307 Chicago, IL 60610 312-440-0078 Fax: 312-440-9474 www.iahcsmm.org