FDA Hopes to Calm Superbug Fears with New Guidance
Friday, March 13, 2015
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.