Presentation on theme: "Chemical Indicators: Class 5 Integrating Indicators"— Presentation transcript:
1Chemical Indicators: Class 5 Integrating Indicators
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
3Meets in Washington, DC throughout Association for the Advancement of Medical InstrumentationMeets in Washington, DC throughouteach year and establishes guidelinesfor sterility assurance which becomeour American National standards.Membership includes:Healthcare facilitiesHealthcare organizationsGovernment agenciesMedical device manufacturersTesting Labs and Consultants
4Objectives 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.
5Chemical IndicatorsAAMI 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
6Quality Control Class 1 Process Indicators are intended for use as an external indicator todistinguish betweenprocessed andunprocessed items.
7Quality Control Class 2 Specific Test Indicators are Bowie-Dick type indicators for use withair removal testing.Two Options:Buy a commercial test pack (single use or reusable),Make your own test pack using freshly laundered towels (10x10x11-12”) with an indicator sheet placed in the center and single wrapped.
8Quality ControlPre-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.
9Quality ControlThe Bowie-Dick test is placed over the drain in empty chamber and run at 273°F for 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
10Chemical IndicatorsChemical 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.
11Chemical IndicatorsThe 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.
12Chemical IndicatorsWhere would you place your CI in this tray? What classification CI would you choose?
13Chemical IndicatorsChemical 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.
14Chemical IndicatorsThis observable change generally involves either the melting of a chemical substance or a chemical reaction resulting in a color change.
15Indicator melts when reaching a specific temperature, e.g. 270°F Quality ControlClass 3Single ParameterChemical IndicatorsThese are designed to react to one parameter of the sterilization process, to indicate exposureat a stated value.Indicator melts when reaching a specific temperature, e.g. 270°F
16Quality Control Class 4 Multi-Parameter indicators are designed to react totwo (2) or more critical parameters, to indicate exposure at stated values.
17Chemical IndicatorsThe majority of internal chemical indicators in use todayfor Steam and/or EO gas are multi-parameter “colorchange” indicators designed to react to two or more of thecritical parameters of sterilization. Other low temperatureprocesses are monitored with single parameter chemicalindicators.
18Chemical IndicatorsAs discussed, different classes of CI’s 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.
19Class 5 Indicators (commonly referred to as Integrators) Integrating indicators react to all critical parametersof the sterilization process over a specified range ofsterilization cycles and their performance correlatesto BI performance as stated on their labeling.
20Class 5 Indicators AAMI says… “the results of Class 5 integrating indicators may serve asthe basis for the release of processeditems, including implants if you cannot wait for BI results.For monitoring wrapped loads,these integrating indicators mustbe used within an appropriatechallenge test pack.”
21Class 5 IndicatorsAAMI 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.
22Class 5 Chemical Indicator ANSI/AAMI/ISO :2005 outlines more rigidcriteria for a device to be labeled as a Class 5Integrating Indicator.▬ Class 5 integrating indicators are the only class of CI’s that must have a response correlated to a BI▬ Stated values must correlate to the results of the BI at 250ºF, 275ºF and a minimum of one point between▬ Must now have a stated value at 250ºF that is greater than 16.5 minutes▬ Pass dry heat test showing the CI does not reach it’s endpoint in 30 minutes at 280ºF
23Benefits of ANSI/AAMI ISO Class 5 Integrating Indicator:▬ Stated values are equivalent to or exceed the performance requirements of BI’s▬ 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 killedSPSmedical C5 meets these new more stringent requirements.Check with your supplier for documentation.
24Class 5 IndicatorsChemical 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.
25Class 5 IndicatorsBecause standard sterilizers do not have enough accuracy of exposure conditions as found in resistometers, it is nearly impossible for a user to replicate mfg’s label claims.
26Class 5 IndicatorsOften, the stated goal of the integrator manufacturer is to design a product that will provide as much information as a biological indicator.
27Class 5 IndicatorsThe 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.
28Class 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 cyclesNeither AAMI nor AORN provide end users with recommendations on their appropriate useCorrelates to the BI at (1) time/temperature whereas ISO compliant C5s correlate at 3 time/temps.
29SUMMARYDue 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.
30SUMMARYHowever, 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!
32Purchasing 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
33References & 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: