FDA Issues Supplemental Duodenoscope Reprocessing Measures

August 12, 2015 | Strategic Insights for Health System


The U.S. Food and Drug Administration (FDA) has issued supplemental measures to enhance duodenoscope reprocessing in an August 4, 2015, safety communication. Following FDA's safety communication on duodenoscope reprocessing earlier this year (see the February 25, 2015, HRC Alerts), the agency convened a panel of experts who developed several additional steps that healthcare facilities can take to further reduce the risk of infection and increase the safety of these medical devices, including microbiological culturing, ethylene oxide sterilization, use of a liquid chemical sterilant processing system, and repeat high-level disinfection.

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