FDA on Thursday released final guidance that will require reusable medical device makers to provide proof that their devices can reliably be cleaned before being approved by the agency, the Los Angeles Times reports.
Background
The final guidance comes after a superbug outbreak linked to a reusable medical device (Terhune/Petersen, Los Angeles Times, 3/12).
As many as 179 patients could have been exposed to Carbapenem-Resistant Enterobacteriaceaeafter having an endoscopic retrograde cholangiopancreatography at the UC-Los Angeles' Ronald Reagan Medical Center between October 2014 and January 2015. So far, seven patients have been confirmed to have CRE infections, and two of those patients died.
Meanwhile, Cedars-Sinai Medical Center in Los Angeles this month reported that four patients had been infected with CRE and up to 67 more might have been exposed after being treated with the same type of scope. FDA has received at least 75 reports, involving at least 135 patients, about ERCP endoscopes -- also called duodenoscopes -- over the last two years (California Healthline, 3/6).
FDA released draft guidelines for reusable medical device makers in 2011. FDA Chief Scientist Stephen Ostroff said that the agency had "accelerated" its work on finalizing the rules in response to the recent outbreaks.
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