|Olympus' TJF-Q180V duodenoscope, as shown on the company's website|
The safety communication to health providers comes amid mounting lawsuits after a deadly superbug outbreak at UCLA's Ronald Reagan Medical Center.
FDA on Thursday relayed an Urgent Safety Notification from Olympus in which it updates reprocessing instructions for TJF-Q180V duodenoscope, which health authorities have implicated in the spread of the drug-resistant bacterial strain carbapenem-resistant Enterobacteriaceae (CRE).
Among other things, the new instructions call for a smaller cleaning brush and additional recess flushing and forceps elevator raising and lowering steps are among the changes to reprocessing procedures.
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 Olympus duodenoscope--a type of endoscope threaded down through the digestive tract and into the small intestine. Duodenoscopes are also sold in the United States by manufacturers including Fujifilm and Pentax, and are used in half a million U.S. procedures a year.
Olympus had been selling the TJF-Q180V, one of its latest models, without FDA 510(k) clearance related to modifications. (FDA, though, says it will allow sales to continue while Olympus seeks clearance.)
FDA actually reviewed the new reprocessing instructions as part of its ongoing 510(k) review, and is recommending that health providers using Olympus' TJF-Q180V duodenoscope train themselves on the new instructions and implement them as soon as possible.
The LA Times reported last week that lawsuits have been filed in Los Angeles County Superior Court on behalf of at least five people killed or injured in the outbreak. More lawsuits seem likely.
The safety communication is "in response to current events, concerns raised by healthcare professionals and medical societies, and in consultation with the U.S. Food and Drug Administration (FDA)," according to a statement from Olympus relayed by a company spokesman.
"In addition to the current reprocessing procedures, customers are receiving instruction for immediate action regarding additional high level disinfection steps," the statement said. "Customers are also being notified now that in May, an additional cleaning brush will be made available to further facilitate new recommended manual cleaning procedures."
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