March 4, 2015 — The duodenoscope responsible for a deadly outbreak of antibiotic-resistant “superbug” bacteria at UCLA was sold for years without FDA-approval and still does not have clearance, according to CNN.
Olympus Medical Systems, a Japanese medical-device and camera-maker, started selling the TJF-Q180V scope in 2010. The scope had a modification to the “elevator” mechanism, which is a complex component that helps the scope bend into tight spaces.
A spokeswoman for the FDA said the agency did not realize the scope was not approved until 2013 or early 2014. At the FDA’s request, Olympus submitted an application late last year. The application is still pending, meaning that the scopes were being used without clearance.
Similar scopes sold by Pentax and Fujifilm applied for and received clearance.
According to a lawyer representing an 18 year-old victim of the CRE infection outbreak, Olympus removed a cleaning channel but failed to update the cleaning protocol.
The FDA requires that 99.9999% of bacteria can be removed from the scope with standard sterilization procedures. However, scope-makers are struggling to prove their scopes can be adequately sterilized, with data submitted on two occasions failing to meet rigorous standards.
In February 2015, the FDA issued a Safety Communication to warn:
“Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”
The FDA is reluctant to pull any of the devices off the market because they are used in “life-saving” procedures, such as cancer biopsies. Furthermore, duodenoscopes are used in over 500,000 procedures per year, but only a few people have developed infections.
Earlier this year, hospitals in Los Angeles and Seattle each reported deadly outbreaks of antibiotic-resistant bacteria on the scope. UCLA reported that 179 people were exposed to CRE, including seven who were infected and two who died. At Virginia Mason Medical Center in Seattle, over 30 people were infected and 11 died since 2012.
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