During the first half of 2015, the Joint Commission’s top “not compliant” survey citations stemmed from Infection Control IC.02.02.01, which relates to reducing the risk of infections associated with medical equipment, devices, and supplies. Surveyors cited critical access hospitals in 60% of the surveys, hospitals in 54%, and office-based surgery…

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Editor's Note The Food and Drug Administration (FDA) on November 13 ordered Custom Ultrasonics (Ivyland, Pennsylvania) to recall all of its automated endoscope reprocessors from healthcare facilities because of federal law violations and a consent decree entered with the company in 2007. The violations could result in an increased risk…

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Editor's Note The Food and Drug Administration (FDA) has identified bronchoscopes as a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if not adequately reprocessed. The FDA is proactively investigating these devices to determine if additional reprocessing steps should be taken.…

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Editor's Note On September 11, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) issued a health advisory recommending that healthcare facilities arrange for a professional to assess their reprocessing procedures for maintaining, cleaning, disinfecting, and sterilizing reusable medical devices. The agencies recommend that facilities…

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Editor's Note Huntington Memorial Hospital, Pasadena, California, alerted health authorities on August 19 to a suspected outbreak of bacterial infections associated with contaminated duodenoscopes, the Los Angeles Times reports. Three patients with Pseudomonas bacterial infections had procedures with Olympus duodenoscopes. The bacteria are similar to the carbapenem-resistant Enterobacteriaceae superbug at…

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Editor's Note The Food and Drug Administration (FDA) sent warning letters August 12 to three manufacturers of duodenoscopes involved in transmitting deadly bacteria earlier this year, the Boston Globe reports. The FDA says the companies (Olympus, Pentax, and Fujifilm) failed to: report problems with the scopes as required by law…

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The Association for the Advancement of Medical Instrumentation (AAMI) has published its first standard on flexible endoscope reprocessing. ANSI/AAMI ST91: 2015 Flexible and Semi-rigid Endoscope Processing in Health Care Facilities was developed from research and input from manufacturers of flexible endoscopes, users, consultants, and regulatory bodies. The new standard, which…

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Editor's Note Despite reprocessing in accordance with US guidelines, viable microbes and residual contamination persisted on gastrointestinal endoscopes after each reprocessing step, in this study, suggesting current guidelines are not sufficient to ensure successful decontamination. Investigators observed all reprocessing activities, using a checklist to ensure that protocols were performed in…

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Editor's Note The Food and Drug Administration on August 4 released a Safety Communication that contains supplemental measures to enhance duodenoscope reprocessing. The measures emerged from an expert panel meeting earlier this year. In addition to following manufacturer reprocessing instructions, the FDA says facilities can use one or more of…

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At least half the battle in making and sustaining process improvements is getting the entire team on board with a new workflow. One key to getting buy-in from staff is to clarify why changes are needed and what the consequences may be if the new processes aren’t followed. In a…

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