Infection Control Today

OCT 2018

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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8 www.infectioncontroltoday.com ICT October 2018 By Nancy Chobin SPD dialogue RN, AAS, ACSP, CSPM, CFER Q Rigid containers of varying dimensions Q: We were recently cited for not performing rigid container testing. We have not heard of this test. Can you advise what this is and why this is needed? A: The Association for the Advancement o f M e d i c a l I n s t r u m e nt a t i o n ( A A M I ) recommends that rigid containers (including those used for immediate-use steam steril- ization) be biologically tested before purchase and periodically to verify that the sterilizer is able to sterilize inside the containers (ANSI/ AAMI ST79). Conventional process challenge devices or test packs (PCDs) are based on textile test packs, not rigid containers, hence the recommendation to test rigid containers periodically. According to ANSI/AAMI ST79, "the sterilant enters through discrete portals in a container system. The sterilant must then work its way throughout the inside of the container system and then to the items being sterilized. Two barriers need to be overcome before the inside of the container system reaches equilibrium with the sterilizer chamber." Therefore, rigid containers are very different from regular wrapping material, where the entire surface is permeable to the sterilant. "Rigid sterilization container systems vary widely in design, mechanics and materials of construction. Work practices, sterilizer performance characteristics, and the function of the healthcare facility utilities supplying the sterilizer can also affect the dynamics of the sterilization process. These factors can markedly affect the specifi c performance characteristics of rigid sterilization container systems and their suitability for particular sterilization methods and cycles." Healthcare personnel bear the ultimate responsibility for ensuring that any packaging method or material, including a rigid sterilization container system, is suitable for use in steril- ization processing and sterility maintenance." (ANSI/AAMI ST79) Another reason why AAMI recommends rigid container testing in healthcare facilities is that the manufacturers of container systems can only test their products in specific sterilization equipment. Sterilizers having the same sterilization cycle parameters could vary in size and in air removal effi ciency. Manufacturers cannot possibly test all combinations of sterilizer sizes, cycles and process ef ficiencies. Therefore, users need to perform testing to identify any technical problems that must be resolved in consultation with the container system manufacturer, the sterilizer manufacturer and consultants. (ANSI/AAMI ST79) Pre-purchase testing (testing before the containers are purchased) is recommended to ensure that the conditions essential to sterilization can be achieved and that the specific configuration of the container contents is compatible with the sterilization process and the requirements at the point of use. (ANSI/AAMI ST79) In each rigid sterilization container system to be tested, BIs and CIs should be placed strategically alongside each other at locations that present the greatest challenge to air evacuation and sterilant penetration. Consult with the rigid container manufacturer regarding their recommended procedure for testing. Containers of each size to be used or being used should be tested, as well as a representative sample of each type of sterilizer. Testing consists of maximum-load testing and small-load testing. For example, if there are three 48-inch steam sterilizers in the department, the maximum-load tests can be performed in any one of the three sterilizers. However, if the department has three different types, brands, or sizes of sterilizers, they should all be tested with containers. Furthermore, if the facility is using containers from more than one vendor, each vendor's containers should be tested as described. Container testing does not replace routine biological monitoring with a BI PCD. Test Container: Biological indicators and Type 4, Type 5, or Type 6 CIs should be placed in the areas that create the greatest challenge to steam penetration and air removal. Because these locations vary from one manufacturer to another, the manufacturer of the rigid sterilization container should be consulted regarding the placement of BIs and CIs. If the container manufacturer recommends that the BI be suspended from the underside of the container lid, the BI manufacturer should be consulted for guidance on how to perform this testing and on where to place the BI (e.g., adjacent to the fi lter). In gravity-displacement steam sterilizers, the corners of the container system and the underside of the lid, away from the fi lters, are the likeliest locations for air pockets. Rigid containers have three dimensions: height, length, and width. If any one of these dimensions is different, it is considered a different size of container. The test container systems should represent the sizes that are being considered for purchase or are already being used for routine processing. Performing Rigid Container Testing

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