FDA Hopes to Calm Superbug Fears with New Guidance

FDA rolls out its guidance on reprocessing reusable medical devices, amid worries over superbugs.

Chris Newmarker

In the aftermath of the deadly superbug cases at UCLA's Ronald Reagan Medical Center, FDA has issued a new guidance document for reprocessing reusable medical devices.

The FDA's move comes amid revelations that Olympus, whose duodenoscopes have been implicated in the spread of the drug-resistant bacterial strain carbapenem-resistant Enterobacteriaceae (CRE), had been selling one of its latest models without FDA 501(k) clearance related to modifications. (The agency, though, says it will allow sales to continue while Olympus seeks clearance.)

At least seven patients were infected and two died from CRE at UCLA's Ronald Reagan Medical Center from October to January. The hospital believes that 179 patients may have been exposed to CRE from a contaminated, reprocessed duodenoscope--a type of endoscope threaded down through the digestive tract and into the small intestine. Duodenoscope are used in half a million U.S. procedures a year.

Olympus is now facing lawsuits related to CRE cases. Lawsuits claim the Japanese electronics giant redesigned its Olympus TJF-Q180V duodenoscope last year, but provided hospitals and doctors with cleaning instructions for an older model.

"At this time, FDA has no evidence that the lack of a 510(k) clearance was associated with the infections," Olympus previously told Qmed in a statement, and the FDA agreed. The agency will continue to allow sales of the duodenoscopes made by OIympus and competitors Fujifilm Holdings and Pentax, a subsidiary of Ricoh.

The Gastroenterology and Urology Devices Panel of FDA's Medical Devices Advisory Committee now plans a public meeting on May 14 and 15 to discuss infections associated with the use of duodenoscopes.

"Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low" William Maisel, MD, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in the latest news release announcing the new guidance.

"This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective," Maisel said.

The new guidance document, titled Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions:

FDA is also recommending medical device manufacturers consider reprocessing challenges early in device design.

FDA issued a draft guidance discussing the reprocessing of reusable medical devices in 2011. The agency considered almost 500 comments before issuing the final guidance.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

Like what you're reading? Subscribe to our daily e-newsletter.