Editor's Note The Food and Drug Administration (FDA) on January 21 issued final guidance for “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The document updates and clarifies information regarding sterilization processes and details about pyrogenicity the FDA recommends that sponsors include…

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Using best practices to sterilize surgical instruments can help lower infection rates and, in some cases, prevent death. Over the past few years, staff at Banner Boswell Medical Center in Sun City, Arizona, have worked to reduce immediate use steam sterilization (IUSS) rates. Thanks to improved communication and workflow between…

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Editor's Note Sterilized wrapped instrument trays demonstrated significantly greater protection than sterilized rigid containers against the ingress of airborne bacteria in this study. Of 111 rigid containers tested, 97 failed to maintain barrier performance, allowing bacterial ingress, while 0 of 161 wrapped trays had detectable contamination. Contamination rates of rigid…

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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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