The FDA has warned 3 duodenoscope manufacturers that they’ve failed to comply with a federal requirement to assess whether current cleaning and disinfecting methods effectively reduce infection risk.
In 2015, the FDA ordered the manufacturers—Olympus Corporation of the Americas, Pentax of America Inc, and Fujifilm Medical Systems USA Inc—to conduct postmarket surveillance studies to determine whether health care facilities were able to properly clean and disinfect the devices. Two years earlier, the US Centers for Disease Control and Prevention alerted the FDA to a possible link between multidrug-resistant infections and duodenoscope use.
Voelker R. Duodenoscope Warning. JAMA. 2018;319(15):1540. doi:10.1001/jama.2018.3986
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