FDA Orders Postmarket Studies On Reprocessed Scopes Linked To Antibiotic-Resistant Infection

October 5, 2015 at 1:35 PM
FDA ordered three manufacturers of duodenoscopes, a device that was linked to outbreaks of antibiotic-resistant infections at a Washington hospital and in other health care facilities around the country, to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings. This comes after Senate health committee ranking Democrat Patty Murray (WA) pushed for a full review in March of FDA practices surrounding duodenoscopes, questioning why the agency waited so long to issue final guidance tightening...


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