What is the recommended procedure when a sterilizer fails the biological test?
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Education: Failed Test Help Why do tests fail? Have you failed a spore test? Don't panic. Review your sterilization procedures, check for common human errors and review infection control protocol. These simple steps will help identify the cause of most common failed biological monitoring test.
Reviewing sterilizer loading Overloading sterilizers is the #1 most common cause of failures. Understanding proper loading is key to ensuring properly sterilizer instruments and cassettes.
WHAT CAUSES MAIL-IN INVALID TESTS? Understand all the requirements when filling out your Mail-In Spore Test Envelopes. Confusing the spore test strip with the control strip could cause an invalid result as well as mailing in a spore test 30 or more days AFTER the initial spore test date… Tests must be received within a 30 day timeframe from initial test date. Watch and learn more.
YOU’RE NOT ALONE If you’re spore test failure was not due to human error (improper packaging, overloading the sterilizer, running and incorrect cycle, failure to run a warm up cycle) and you are concerned / unclear if you can confidently release a load please know that you are not alone. And clinical consultants are available at 8558-STERILE, M-F, 8am-5pm MST to answer your questions.
May 17, 2019 By: Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS Tags: Infection Prevention, Patient Safety, Surgical Instruments Share A sterilization failure is a significant event. Receiving a positive biological indicator (BI) result from a sterilizer can be devastating and presents a patient safety concern because it could result in infection. This article addresses the proper action to take in the event of a positive BI result and biological recall. Welcome to OR Manager, your source of information and insight into the clinical and business management of the surgical suite. This article is only available to OR Manager subscribers. To read this article, and gain access to all OR Manager resources, please log in below: LOGIN Not a subscriber? That’s OK, subscribe today! OR Manager offers all-access subscriptions at an affordable rate. With your subscription – or your team’s group subscription – you’ll receive access to all that OR Manager has to offer, including our monthly issues, CE credit opportunities, job postings, and discounts to our industry-leading conferences. Explore Subscription Options Please contact our Customer Service Team if you are unable to log in at or 1-888-707-5814. Sterilization
monitoring is necessary for each autoclave load, including mechanical and chemical indicators as required and recommended, plus, depending on your location, spore testing (biological indicators aka BI). Let’s face it, it is to say the least disappointing to discover that an error has been made or that equipment isn’t working. Worse than that, though, is not realizing that a critical process is not working. Depending on your location, a spore test may be required or recommended and the indicated
use and frequency also varies. In some locations, spore tests may not be explicitly recommended, however the autoclave manufacturer's instructions for use (IFU) need to be followed, which would include indicated spore testing. Spore testing provides a reliable method for sterility assurance. In autoclaves, the Geobacillus stearothermophilus spore is used. Unlike mechanical or chemical indicators, spore testing determines that spores – the most resistant microorganisms –
have been killed during sterilization. In the case of an unpackaged load, it indicates that instruments were sterilized prior to exiting the autoclave. In-office and laboratory spore tests are available. In-office spore testing requires use of an incubator and is quicker, while laboratory testing provides independent
third-party results. With the availability of digital records for in-office spore testing, verification and results can be logged using digital records/print-outs. Regardless of which type of test is used, spore test and control strips/ampoules must be handled properly as that in itself can cause a spore test to fail. For example, in the case of laboratory testing, failure to make sure the test and control strips are received by the laboratory within the required time of the initial test, or
improper handling in the laboratory, causes failure. Spore tests also have a shelf life and in the case of Tuttnauer’s in-office spore tests the shelf life is 2 years. Using spore tests beyond the shelf life is another cause of failed tests. Here we describe the steps required for in-office spore testing using the quickest as our example: Spore test vials The test is negative, i.e., it was a ‘pass’ result, if the spores from the test vial are killed and the spores from the control vial are alive. The test is positive if the spores in the test vial were not killed (a ‘fail’ result) and categorized as inconclusive if the spores from both vials were killed (also regarded as a ‘fail’). Spore test incubator Why do ‘positive results’ occur for spore tests?The most common reason for a positive result is air being trapped in the autoclave chamber. Trapped air can be caused by overloading the autoclave, or incorrect loading such as the plastic sides of paper-plastic pouches not all facing in the same direction. These are operator errors. A third reason for a positive result is failure of the autoclave to reach the correct pressure, which can be due to operator error, or autoclave malfunction e.g., failure of vacuum pulses to properly remove air. Other reasons for a failed spore test associated with operator error include manipulating or interrupting cycles, using the wrong cycle parameters or incorrect packaging – e.g., packaging that is too thick or folded, failure to perform maintenance and failure to preheat the autoclave (if indicated). Alternatively, while less common, a positive result may be due to mechanical failure of the autoclave.
What to do following a positive spore test resultA single positive spore test does not necessarily indicate failure. Further investigation and further spore testing is required. Steps to take include the following:
Note that the requirement for the most conservative approach with respect to loads always applies with implantable devices. For other loads, this requirement varies – be sure to follow the regulations and recommendations for your location. ConclusionsSpore testing is performed for sterility assurance. Failed spore tests require immediate attention. Based on findings, operator errors indicate a need for training or the autoclave may need to be taken out of service for repairs/replacement. Complete sterilization logs must be maintained, including all sterilization monitoring – both for legal reasons and to enable tracking and reprocessing of affected loads. Resources
About Tuttnauer - We're a one-stop shop for sterile dental processing Tuttnauer provides end to end sterile processing solutions for dental and medical clinics, including; advanced autoclave sterilizers, thermal washer-disinfectors, indicators and sterile processing products. Our comprehensive line of chemical and biological indicators ensure safe, reliable and timesaving processing and sterilization. Based on decades of infection control knowledge and experience, Tuttnauer delivers a comprehensive range of indicators for the precise monitoring and control of cleaning, decontamination, and sterilization. For further information and to inquire about purchasing Tuttnauer consumables for your practice, visit the Consumables Section on our website. Dr. Collins graduated as a general dentist from the University of Glasgow and holds an MBA and an MA from Boston University. During her career, she has lived and worked in 5 countries and has given presentations internationally. Fiona is currently the ADA’s representative to the Association for the Advancement of Medical Instrumentation (AAMI), a member of the ADA, OSAP, a participant in infection control-related Standards working groups in AAMI, and a Fellow of the Pierre Fauchard Academy. What steps would you take if a biological test failed?What do I do if I get a failed (positive) Biological Indicator?. Step 1 – Inform supervisors and technicians of the BI failure.. Step 2 – Quarantine instruments processed in the failed load. ... . Step 3 – Remove the sterilizer from service and inform your service/biomed group.. What steps should be taken if a sterilizer fails a test?Following is a list of four steps that are recommended after a spore test failure.. Step One — Take the unit out of service. ... . Step Two — Review sterilization procedures. ... . Step Three — Retest and observe operational parameters. ... . Step Four — Determine the fate of the sterilizer.. What should you do if a spore test comes back as failed?Have you failed a spore test? Don't panic. Review your sterilization procedures, check for common human errors and review infection control protocol. These simple steps will help identify the cause of most common failed biological monitoring test.
What is the first step to be taken after a sterilization failure is detected through spore testing?The sterilizer should be removed from service, and all records of mechanical and chemical monitoring should be reviewed since the last negative BI test. Then, repeat the test immediately after loading the sterilizer using the same cycle that produced the failure.
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