The unapproved scope, TJF-Q180V, is made by Olympus Medical Systems. It was introduced in 2010 with a modification to the exact component that has been blamed on harboring antibiotic-resistant bacteria.
According to the FDA, the agency did not notice that Olympus never actually sought clearance for the duodenoscope until late 2013 or early 2014. Last year, Olympus finally asked for permission to sell the scope. The application is still pending.
The FDA is not keen on recalling the device because it is used in life-saving procedures, like cancer biopsies and gallstone treatment. However, two other companies who manufacture very similar scopes — Pentax and Fujifilm — applied for and received clearance for their products.
The FDA is asking all three scope-makers to prove that the scopes can get rid of 99.9999% of all microbes. So far, the companies have twice submitted data that failed to meet this standard, according to the agency.
Last month, the FDA issued a Safety Communication to warn that “Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.”
The warning was issued after several “superbug” outbreaks at hospitals. Last month, two patients died, seven were infected, and about 180 were exposed to potentially deadly bacteria on scopes used at UCLA’s Ronald Reagan Medical Center in Los Angeles. Just one month before that outbreak, officials at a hospital in Seattle reported that 11 patients died and dozens more were infected by dirty scopes over the last two years.