U.S. lawmakers are wondering why European hospitals were warned about contaminated duodenoscopes two years before the deadly Superbug outbreak in Los Angeles and U.S. health care providers weren’t warned until earlier this year.
Two warning letters Olympus Corp sent to European hospitals in 2013 and 2014 about contamination of the TJF-Q180V duodenoscope recently surfaced, adding more fuel to the controversy surrounding the medical devices used to diagnose and treat a number of diseases.
Olympus Corp., the manufacturer of the scrutinized endoscope, did not take action in the U.S. until after the February 2015 outbreak at UCLA and Cedars-Sinai medical centers. After seven patients were sickened and two died, the manufacturer issued alerts. By then, about 200 more patients may have also been infected at UCLA, and many more could have been infected in hospitals across the country.
A number of these patients and surviving family members have since filed lawsuits against Olympus.
Both Olympus and the U.S. Food and Drug Administration (FDA) are taking criticism for their prior inaction in the wake of an outbreak. It raises questions about how much the device maker knew about possible contamination from difficult-to-clean scopes and why U.S. hospitals and and surgeons were not warned.
“That is not how device makers should run their business. It’s clear Olympus knew something was not correct about its existing cleaning instructions,” Rep. Ted Lieu (D-Los Angeles) told the Los Angeles Times.
Under pressure from patients and officials to take action, the FDA will convene a panel meeting on May 14-15 to evaluate the scopes.
“FDA is convening this committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information,” the agency said in its meeting notice.
FDA officials knew Olympus was never able to prove the scopes could be properly cleaned and knew of the risk of infection but did not notify any outside agencies. The FDA learned last summer about two previous warning letters Olympus sent to European hospitals. Again, the FDA did not warn American health care providers.
Europe Warned in 2013, 2014
As far back as January 2013, Olympus knew the TJF-Q180V duodenoscope – the same model involved in the California superbug controversy – was difficult to clean. That month it sent out an “Important Safety Advice” notice to hospitals in response to a “reported case of a contaminated Olympus Video-Duodenoscope TJFQ180V.”
The notice warns that the scopes have to “undergo detailed preparation and inspection before patient use.” Attached to the letter is a detailed quick reference for proper pre-cleaning and reprocessing of the scope.
In August 2014, Olympus sent another communication, and urgent “field safety corrective action.” This letter addressed “a few complaints of residual debris in the distal end of the TJF Q180V duodenoscope” and “prevention of cross infection among patients.”
The company recommended an additional cleaning brush and cleaning around specific parts at the tip of the device, “around the forceps elevator.” It also updated the cleaning manual.
Olympus sent a warning notice to hospitals and the FDA following the February outbreak in California. Later, it learned an outbreak in October 2014 in Seattle was linked to the same model scope. This outbreak also occurred after Olympus’s European warnings.
Reports of Superbug Reached FDA Late or Not at All
Device makers are required to report incidents to the FDA within 30 days of learning about an incident. But reports of the superbug infections and duodenoscopes arrived late to federal officials and sometimes, reports were simply not made, USA Today reported.
In fact, from 2012-14, patients in at least eight hospitals were infected by bacteria linked to duodenoscopes. Device makers waited for several months before filing reports or did not file anything. These reports, called Medical Device Reports (MDRs) help the FDA act quickly to deal with issues like the superbug outbreak.
Even so, the MDR system relies heavily on manufacturers to self-report.
“This system of filing these (MDR) reports is the only thing in place that can tell us that devices are having problems, (and) . . . it often puts the interests of (device) manufacturers and the hospitals ahead of the public,” Lisa McGiffert told USA Today. McGiffert heads up the Safe Patient Project at Consumers Union, the publisher of Consumer Reports. “It’s a pretty weak system.”
Last month, new FDA-approved guidelines for cleaning the devices made their way to several hospitals across the country. Despite growing concern, neither Olympus nor the FDA has mentioned a recall of the devices.