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problems that prevent the sterilizer from getting good steam penetration during sterilization. Sterilizers that fail an air removal test typically need repairs.
Process challenge device/Biological indicator test pack The process challenge device (PCD) or biological indicator (BI) test pack checks the lethality of the sterilizer. The sterilizer must kill a high population of bacterial spores placed within a pack that steam has trouble penetrating. A process challenge device is run with the first load of the day. Process challenge devices must be placed in all loads that have implantable devices (medical devices placed in the body for more than 30 days). All loads with process challenge devices are placed in quarantine and shouldn’t be used until the results of the BI are known.
A control BI must be incubated every day that a BI test is per- formed. The control BI shows that spores within the BIs used in the test are alive and that the incubator is functioning. Only tests with positive (growing) control BIs can be used. A passing BI PCD test must have a negative BI from the PCD and a positive control BI. If the BI PCD test shows growth, then sterilization did not occur, so the items are considered not sterile and can’t be used.
Chemical indicators A chemical indicator (CI) strip is placed inside each pack, container, pouch, or wrapped item to be sterilized. A CI strip should also be placed on every level of multi-level trays. After sterilization, when the pack is opened, the CI is checked. A pass- ing indicator shows that steam made it into the pack. A failing indicator shows that it did not, so the items are considered not sterile and can’t be used.
Wet packs
Failing cycle parameters, BIs and/or CIs are all considered evi- dence of sterilization failures. Another indicator of sterilization failure is residual moisture on packaged instruments after the cycle, also known as wet packs. Wet packs indicate a problem with loading, steam quality or sterilizer performance. Wet packs can be seen on the outside as pooling or wetness on the external surface of the pack. It can also be internal, visible as pooling or water drops on the instruments or items inside a pack when it is opened. If wet items are stored, residual moisture may dry before the pack is opened. In this situation, evidence of residual moisture shows up as water stains or rings. Each wet pack or moisture event must be investigated, and the root cause identi- fied and corrected.
It’s important to note that wet packs are still wet packs even if used immediately. In fact, using an item that is wet immedi- ately after steriliation, whether wrapped or not, is defined as an IUSS event.
Short Cycles use abbreviated drying times and can produce
wet packs if packaging material weights change, set configura- tions change, containment devices change, or if the steam supply becomes wet. If Short Cycle wet packs occur, identify the root cause and correct it, and then perform cycle validation again to ensure that the solution worked.
Documentation All test results, sterility assurance failure investigations and wet pack reviews must be documented. The documentation
28 May 2021 • HEALTHCARE PURCHASING NEWS •
hpnonline.com References:
1. Association for the Advancement of Medical Instrumentation; ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA.
2. Association for the Advancement of Medical Instrumentation; ANSI/AAMI ST8:2013/(R)2018 Hospital Steam Sterilizers. Arlington, VA
3. Center for Clinical Standards and Quality/Survey & Certification Group; Change in Terminology and Update of Survey and Certification (S&C) Memorandum 09-55 Regarding Immediate Use Steam Sterilization (IUSS) in Surgical Settings. Centers for Medicare and Medicaid Services, 2014. Accessed 3/17/2021,
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/ SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf
should include the sterilizer used, results of the test, results of any investigation, the corrective actions taken, and the results of the corrective action.
These records are reviewed by surveyors, so it’s important to ensure that they are accurate and complete. It’s a good idea to routinely audit documentation practices to ensure that the documents are completed with all required signatures. It is equally important to ensure that all tests have been completed per facility policy and procedures. Surveyors need to confirm that policies and procedures reflect what is actually done in a department.
For example, some tests, such as leak tests, may provide data that should be evaluated for trends. It’s also important to audit and document trends when wet packs have been investigated and corrective action has been taken.
Assure Short Cycle best practices Short Cycles are terminal steam sterilization cycles with a vali- dated dry time that yields dry, terminally packaged items that can be placed in sterile storage. These cycles are typically used for metal ophthalmic instruments that can dry more quickly because of their size and weight.
Before any decision is made to implement Short Cycles, sterile processing managers need to diligently review all applicable device, packaging, and sterilizer IFU to assure that they docu- ment the use of similar Short Cycle parameters. If IFU disagree, they must be reconciled. If necessary, a cycle validation should be completed using the department’s most challenging Short Cycle loads to prove the effectiveness of shorter drying times. And since quality assurance is just as important for Short Cycles as for any other terminal sterilization process, a quality system should be put in place that includes cycle parameter checks, appropriate tests, trend audits and thorough documentation. A well-run Short Cycle program can help a department improve the efficiency and turnaround of its ophthalmic reprocessing practices. HPN
Arthur Henderson, RN, BA, CNOR, CRCST, CHL, GTS is a senior clinical education specialist for STERIS Corporation. Prior to STERIS, he served as the coordinator of education for the California Central Service Association, the assistant main OR manager at a large acute-care hospital, and the clini- cal educator for peri-operative services for another large acute-care facility. Henderson has developed and implemented an OR orientation program and an OR internship program for non- surgical nurses and has coordinated performance improvement and staff development programs for peri-operative services. He also has more than 25 years of experience as a registered nurse in a variety of specialties including GI, open-heart surgery, neurosurgery and cardiothoracic intensive care.
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