FDA: Duodenoscope reprocessing is dirtier than we thought

The FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear. Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string of deadly “superbug” infections attributed to their duodenoscopes. The FDA ordered the companies to run post-market surveillance studies to assess the effectiveness of reprocessing the scopes; last year it sent the trio another set of warning letters over their failure to comply with that order. Today Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, warned of possible “additional action” if the companies don’t meet their deadlines. “While the firms have made some progress toward completing these studies, they are still not in compliance with the timetable they agreed upon to complete these studies. If the companies continue to fail to adequately respond to our concerns, the FDA will take additional action,” Shuren said in prepared remarks. Although the number of adverse event reports for the devices fell 62%, from 250 in 2015 to fewer than 100 in 2017, a spate of 205 reports from last October to the end of March included 45 patient infections, one patient exposure and ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Endoscopic / Arthroscopic Featured Food & Drug Administration (FDA) Regulatory/Compliance Fujifilm Hoya Corp. Olympus Pentax Source Type: news