FDA advises continued use of medical device linked to superbug outbreak
By Yael Levin
March 4, 2015 5:57 p.m.
The U.S. Food and Drug Administration advised hospitals Wednesday to continue using Olympus Corp. of Americas duodenoscopes, even though they were linked to the recent superbug outbreak at UCLA and are not currently FDA-approved for sale.
Without the device, hospitals would not be able to meet the clinical demand for 500,000 annual U.S. endoscopic retrograde cholangiopancreatography procedures – commonly known as ERCP – which save hundreds of thousands of lives, the FDA said in a statement. The recommendations come after several health care providers asked the FDA whether they should stop performing ERCPs on patients following the UCLA outbreak.
Olympus Corp. duodenoscopes do not currently have 510(k) clearance, a code that mandates that medical device manufacturers inform the FDA of their intent to market the devices at least 90 days in advance of the product’s release.
The agency said it is waiting to approve the device until after Olympus provides it with more data, but it does not think the company’s lack of 510(k) clearance is linked to the superbug spread.
The FDA also said Monday that it knew since 2013 about problems with cleaning medical scopes linked to the outbreak and had given manufacturers three chances to change their policies, the Los Angeles Times reported.
The UCLA Health System found the scopes were linked to a superbug outbreak last month that exposed at least 179 people to an antibiotic-resistant strain of bacteria, infected seven people and killed two. The superbug is called carbapenem-resistant Enterobacteriaceae, commonly known as CRE, and kills up to half of the individuals that it infects.
The Centers for Disease Control and Prevention first informed the FDA in 2013 that the scopes could transmit antibiotic-resistant bacteria even when medical professionals were following the cleaning instructions mandated by the manufacturer, said Leslie Wooldridge, spokeswoman for the FDA, in an email statement.
Two individuals have sued Olympus, the manufacturer of the duodenoscopes that UCLA uses, in the past week.
Wooldridge said the agency has received complaints about scopes involving three different manufacturers: Fujifilm, Olympus and Pentax.
She said Olympus modified its scopes after being notified by the FDA in 2013, but did not apply for 510(k) clearance from the FDA at that time.
“In March 2014, the FDA informed Olympus that a 510(k) must be submitted, which the company did in October. That submission is pending because the FDA requested more data from the company,” Wooldridge said in the statement.
Most recently, the Los Angeles Times reported Wednesday that a second superbug outbreak at Cedars-Sinai Medical Center occurred during procedures linked to one Olympus Corp. duodenoscope used from August 2014 to February. Four patients have been infected and 64 others may have been exposed, the Los Angeles Times reported. The hospital is about 5 miles from UCLA.
Mark Miller, executive director of marketing services at Olympus Corp., said the company could not comment on active legal matters or speculation.
“Olympus continues to monitor and investigate this issue. We are working with the FDA, relevant medical societies and our customers regarding these concerns including the consideration of alternative cleaning and reprocessing methods,” Miller said in an email statement.
Compiled by Yael Levin, Bruin senior staff.