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November 13, 2019

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IDSA Comments on Duodenoscope Sterilization at FDA Panel Meeting

The U.S. Food and Drug Administration recently convened a meeting of the Medical Devices Advisory Committee that included a discussion of the risks of infection with reprocessed duodenoscopes. The agency is revisiting the conclusions of a 2015 panel that did not reach consensus on potential sterilization requirements for duodenoscopes due to perceived manufacturer burden. In postmarket microbiological studies of reprocessed duodenoscopes based on the most up-to-date guidance, FDA found that contamination has remained consistent at around 5% of all duodenoscopes.

In order to gauge stakeholder input on the severity of existing concerns regarding the device, FDA invited IDSA, the Society for Healthcare Epidemiology of America, and the Association for Professionals in Infection Control and Epidemiology to give a 10-minute joint presentation outlining shared concerns and recommendations for duodenoscope sterilization.

The presentation was developed by IDSA staff and the SHEA Sterilization and High-Level Disinfection Group, which includes several IDSA members. Group member Michael Anne Preas, MS, RN, CIC, who works in infection prevention at the University of Maryland Medical Center, presented on behalf of our societies. Additional perspectives represented in the discussion included endoscope reprocessors, adult and pediatric physicians, gastroenterologists, human factors experts, and public health professionals. Recommendations from the meeting will inform future FDA requirements for duodenoscope manufacturers.

 

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