Devices & Diagnostics

FDA tasks 3 duodenoscope makers to conduct safety studies

In the wake of the UCLA superbug scare associated with contaminated duodenoscope use, the FDA has tasked three medtech companies to analyze how health workers clean these devices.

Three companies that make duodenoscopes have been tasked by the Food and Drug Administration to conduct post-market surveillance studies. The idea is to zero in on what sterilization techniques are at fault, allowing serious infections to be transmitted among patients.

After all, the duodenoscope was the main culprit in the recent UCLA superbug scare – in which a reusable duodenoscope that was difficult to clean wound up being the root cause of a CRE outbreak. The FDA has since issued guidance that calls for makers of reusable medical devices to thoroughly test and label their devices, and outline appropriate methods to clean them. This is the next step.

“This is a significant step in the effort to combat infections spread through duodenoscopes,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a statement. “The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used.”

The companies tasked with careful postmarket duodenoscope scrutiny are Olympus America, Fujifilm Medical Systems and Hoya Corp. They will have 30 days to submit their surveillance plans to the FDA – detailing how they’ll evaluate how well health care workers clean and disinfect these devices.

[Image courtesy of Flickr user Carreiro Manuel]

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