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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10 www.infectioncontroltoday.com ICT October 2018 Ò Your department should have a policy and procedure for rigid container testing including the frequently of testing. AAMI recommends pre-purchase and periodic testing. Staf should be in-serviced in this process with competencies verifed. Unless otherwise directed by the container manufacturer, fve BI vials should be assembled for placement inside each test container. An additional BI vial will be needed to act as a control. The fve test BI vials and the control BI vial should be from the same lot. Unless otherwise directed by the container manufacturer: • Assemble the largest instrument set (including any optional absorbent material) recommended by the container system manufacturer. • Place four of the test BI vials in the test container. Place one BI vial in each corner of the inside basket. Keep the vials in place0, attaching the string to the corner of the basket with sterilization tape. • Attach the ffth BI vial under the lid. The BI should suspend into the container when the lid is closed. Check with the container manufacturer for where exactly to place the BI vial on the lid, according to whether the test is being conducted in a gravity-displacement or dynamic-air-removal cycle. The date, sterilizer number, cycle number and an identification location number should be written on the BI vials and, if possible, on the back of the CIs. The purpose of the identifcation location number is to identify the positions of any positive BIs or failed CIs. A photograph of the placement and location identifcation will assist with troubleshooting. The container is then closed and locked. Each test container should be labeled as such, so that it will not be inadvertently distributed. Recommended Testing: A maximum-load test and a small-load test should be run for representative sterilizers. For the remaining sterilizers, only the small-load test needs to be run. Note that rigid container testing is also performed for containers intended for use in EO sterilization. In this case, only the maximum-load test need be performed. Small-load testing is not required because the maximum-load test represents the greatest challenge to EO sterilization cycles. Maximum-Load Testing: The maximum-load test assesses the sterilizer's ability to sterilize under actual use conditions. For this test, the user places two test container systems on the bottom shelf over the drain and two test container systems on each of the other sterilizer shelves (if space permits). For example, if the sterilizer cart has three shelves, a total of six test containers will be needed. The chamber is otherwise fully loaded with conventionally packaged items. Small-Load Testing: The small-load test assesses a steam sterilizer's ability to sterilize under worst-case conditions. One test container (prepared as described above) should be placed on the sterilizer cart shelf over the drain line. No additional test containers or other items should be placed in the sterilizer chamber. A sterilization cycle is run with the exposure time recommended by the container system manufacturer. Test Results: When the sterilization cycle is completed, the test containers are removed from the sterilizer and the BI vials from the test containers. The container should be inspected for any signs of moisture on the instruments, on the optional absorbent material, or inside the container itself; any signs of moisture should be documented. After the BI vials are cooled they are incubated. All BI results must be negative, and all CIs must show a pass result. The results should be recorded as "container test pack testing" and identifed as either maximum-load or small-load. In the maximum-load test, positive BIs or failed or inconclusive CIs suggest that the sterilization process was not adequate. If the small-load test fails, failures indicate insuffcient steam penetration and/or insuffcient air removal, which could be caused by the sterilizer, the container system, or the sterilizer– container combination. In the event of any positive BI results, failed/ inconclusive CI results or moisture, a complete investigation into the cause is required. Your department should have a policy and procedure for rigid container testing including the frequently of testing. AAMI recommends pre-purchase and periodic testing. Staff should be in-serviced in this process with competencies verifed. In summary, rigid container testing is an important part of your overall quality assurance testing. Since this testing is recom- mended by AAMI, it should be performed and documented. Staff should be familiar with this process and know how to perform and document the testing. 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. Rigid container with BIs and CIs in each corner; full set of instruments inside container BI vial taped to corner of the inside basket of instruments BI vial suspended from lid of container Sterilizer cart loaded with rigid containers prepared for testing (maximum-load test). Test containers are placed on the cart frst in the specifed locations, then other items are loaded on the cart.) ➘ ➘ ➘ ➘ ➘ ➘

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