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The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) has published guidance for medical device manufacturers that is intended to mitigate the risk of cross-contamination from valves and accessories used with flexible gastrointestinal endoscopes. This is the latest in a series of recommendations the agency has released following an outbreak of infections linked to flexible endoscopes.
Between 2012 and the spring of 2015, endoscopes caused at least 250 life-threatening infections worldwide, including infections with the superbug carbapenem-resistant enterobacteriaceae, according to the results of an investigation conducted by a U.S. Senate committee. In its most recent guidance, which was first proposed in January 2015, the FDA aims to highlight the cross-contamination risk associated with specific irrigation valves and accessories used with flexible gastrointestinal endoscopes, clarify terminology related to these devices, and outline risk mitigation strategies.
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