Infection Control Today

FEB 2019

ICT delivers to infection preventionists & their colleagues in the operating room, sterile processing/central sterile, environmental services & materials management, timely & relevant news, trends & information impacting the profession & the industry

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10 ICT January/February 2019 By Nancy Chobin SPD dialogue RN, AAS, ACSP, CSPM, CFER Q Q: We have been trying to fi gure out if AAMI, AORN or the CDC offers guidance regarding the requirement of an internal chemical indicator (CI) on each layer of a set of instruments if multiple layers are present. We cannot fi nd any documentation on this. Our container system dictates the placement of two CIs inside the container. Can you help us with this? A: CIs are an important part of your overall sterilization quality assurance process. It is important that you select a quality CI that has been validated for the specifi c sterilization method and cycle you are using. They are designed to detect problems associated with incorrect packaging, incorrect loading or malfunction. To be clear, CIs are not a sterility test. For the purpose of this discussion, I will only refer to CIs for the steam sterilization process. First, let's talk about selection of CIs. Your CI should be cleared by the Food and Drug Administration (FDA) for use in the United States. Second, read the manufacturer's written instructions for use (IFU) to determine what cycle types (gravity and/or dynamic air removal) and in what temperatures the CI can be used. Not all CIs are validated for use in all cycles and all temperatures. This is especially true of table-top sterilizers. It is important to read the IFUs before purchase of any chemical indicators to ensure you can use it as specifi ed. According to AAMI (ST-79 [2017], "…use CIs that are labeled for use in the selected sterilization cycle (see the written IFU of the CI manufacturer and the sterilizer manufacturer);" and "obtain data from the manufacturer on the reliability, safety, performance characteristics, and use of their products (e.g., how to interpret indicator results, the reliability of the indicator in maintaining endpoint response during storage of sterilized items, the sterilization conditions that the indicator will detect, the shelf life of the indicator, and the storage requirements for the indicator itself before and after sterilization)." For some time now, AAMI ST-79 (2017) has categorized chemical indicators into "types" (previously they were referred to as "classes"). CIs should be used externally (e.g. sterilization tape) and internally in all packs/sets. While chemical indicators do not specifi cally indicate an item is "sterile" they do provide important information about each individual pack. The minimum type of CI used should be a Type 4. These indicators are called "multi-critical process variable indicators" (AAMI ST-79 [2017] and are designed to react to two or more of the critical variables and intended to indicate exposure to a sterilization process at stated values of the chosen variables. However, you can also use a Type 5 chemical integrator or Type 6 emulating indicator as well. The Type 5 chemical integrator's results closely parallel the results of a biological test (BI) however they do not contain spores so cannot be substituted for a BI. The Type 6 CIs are cycle-specifi c, so they can only be used on the cycles specifi ed in the manufacturer's IFUs. AAMI recommends that an internal CI be used inside each package, tray or rigid container that will be sterilized. The decision as to which CI is used should be based solely on cost, but the expected outcome. Obviously, the challenge to get air removed and the sterilant penetrate into a paper-plastic pouch is less challenging than in a wrapped multi-level set or rigid container. Some facilities use different Types of CI based on the packaging or the complexity of the set; for example, a Type 4 CI inside paper-plastic pouches but a Type 5 or Type 6 CI inside a wrapped set or rigid container. Also, consider the following: • Placement of the CI is just as important as the selection of the CI. • In paper-plastic pouches, the CI should be placed in the center of the pouch, facing up so the end user can read the CI result through the clear side of the pouch. A CI that is upside down is of no use to the end user. • In wrapped sets, the CI should be placed in the most challenging location for air removal and steam penetration. Usually, that is the middle (center) of the set. If the wrapped set has more than one level, the CI should be placed in the center of EACH level. • When it comes to rigid containers, the location of the CI is dependent upon the container manufacturer's IFUs. In some cases, the IFU may indicate the CI should be placed in the center of the set in the inside basket. In others, it may specify in two opposite corners of the inside basket. If the rigid container has more than one level, you should place the CI in the same location(s) on each level. If you are using more than one manufacturer's rigid container systems, understand they may differ in the location of the CI and you must follow the specifi c container manufacturer's IFUs for placement of the CI. • For reusable basin sets, place a CI in the bottom basin (for single basin) and in each basin (bottom) for a double basin set. Some manufacturers offer a CI with a long "tail" to help locate the CI in larger items such as basin sets. • The importance of CIs cannot be over-emphasized. They monitor every package in the load, as opposed to a biological test pack which is located in one specifi c location inside the sterilizer. It is possible to have only some packages or one package with a CI result that is inconclusive or failed to meet the manufacturer's specifi ed color change or result, the end user should not use the package/set. The sterile processing department (SPD) should be contacted by the end use regarding the problem and return the unused package along with load identifi cation information. It is the responsibility of SPD to perform an investigation of the cause of the inconclusive/failed CI. Consideration should be given to recalling the entire load, but this decision should be made only after the physical monitoring (print-out) and CI results located elsewhere in the load (i.e., inside a test pack). In summary, CIs are an important part of sterilization quality monitoring. It is important to start with a quality chemical indicator that has been validated for the cycles and temperatures in use in your area/department. Sterile processing staff should be in-serviced in use of the specifi c CI being utilized including the recommended placement inside sets. SPD staff as well as end users should be provided information about the interpretation of the CI. Reference charts, if provided by the CI manufacturer, should be provided to end users. Every available method to monitor the sterilization should be utilized, including chemical indicators. Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, is a sterile processing consultant and educator. References: ANSI/AAMI: ST79:2017. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Basics of Sterile Processing 6th Edition. Sterile Processing University, LLC. Lebanon, N.J. Quantity and Location of Chemical Indicators

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