FDA: Scope Linked to Superbug Deaths Not Approved
FDA: Scope linked to superbug deaths not approved – CNN is reporting that the manufacturer of the endoscope involved in two superbug deaths at UCLA never obtained permission to sell the device, according to an official at the Food and Drug Administration.
According to Karen Riley, deputy director of strategy for the FDA’s Office of External Affairs, Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn’t notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market.
According to FDA rules, a manufacturer must seek clearance for a new model if it includes changes that “could significantly affect the safety or effectiveness of the device.” The TJF-Q180V duodenoscope, used to check out ducts in the gastrointestinal system, includes a modification to the exact part of the device that’s been implicated in the superbug outbreaks.
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