The U.S. Food and Drug Administration (FDA) recently issued warning letters
to three manufacturers of duodenoscopes. The letters highlight a range
of violations committed by the medical device makers, including the failure
to report infections tied to the scopes.
As we have previously discussed on this
San Diego Injury Blog, the inability to thoroughly sterilize the specialty endoscopes was linked
to a drug-resistant “superbug” that claimed the lives of three
California patients earlier this year. All of the infected patients underwent
endoscopy procedures at UCLA’s Ronald Reagan Medical Center. An
internal investigation linked the outbreak of Carbapenem-resistant Enterobacteriaceae
(CRE) to a contaminated duodenoscope. In total, nearly 180 patients were
FDA’s warning letter to Olympus Corp. confirms that the medical device maker was aware of the
risk of infection prior to the deadly outbreak. The agency alleges that
the company failed to timely notify the FDA about 16 patients who contracted
a Pseudomonas aeruginosa infection, of which some resulted in abscesses,
after undergoing an endoscopic procedure with the manufacturer’s
devices. According to the FDA, Olympus became aware of the infections
on May 16, 2012, but did not notify the agency until 2015.
Under the Federal Food, Drug, and Cosmetic Act, medical device makers must
notify the FDA no later than 30 calendar days after receiving or otherwise
becoming aware of information, from any source, that reasonably suggests
that a device may have caused or contributed to a death or serious injury.
Los Angeles Times reports, federal lawmakers and patient safety experts applauded the FDA’s
actions, while also expressing concern regarding how long the issues went
unreported. “The fact that it took the leading scope manufacturer
three years to report patient infections is flat out unacceptable,”
Rep. Ted Lieu (D-Los Angeles) stated. “If scope manufacturers had
reported infections earlier, then lives might have been saved.”
If you or someone you love has been seriously injured by a dangerous or
defective medical device, don’t hesitate to contact
a San Diego product liability attorney at the Law Offices of Robert Vaage
for a free consultation.