FDA Issues Updated Guidance for Reusable Devices Linked to ‘Superbugs’

ChrisPole/iStock/Thinkstock(NEW YORK) — The U.S. Food and Drug Administration issued final guidance on Thursday on the reuse of medical devices and the possibly resultant spread of infectious agents, partially in response to the reusable endoscopes that are believed to have caused the spread of a “superbug” at a California medical center.

“Medical devices intended for repeated use are commonplace in health care settings,” the FDA statement read. “They are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. While the majority of reusable devices are successfully reprocessed in health care settings, the complex design of some devices makes it harder to remove contaminants,” the agency noted.

In the updated guidance, the FDA calls on device manufacturers to not only consider reprocessing early in the design phase of these devices, but also to conduct testing that proves their cleaning, disinfection and sterilization instructions “consistently reduce microbial contamination.”

Further, the FDA will request that manufacturers submit scientific data from that testing to the agency. Previous guidelines, implemented in 1996, made no such request.

“Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes,” the FDA’s Center for Devices and Radiological Health Chief Scientist and Deputy Director for Science William Maisel said, “patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low.”

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