Federal regulators have learned that Olympus Corp. received reports of patients developing life-threatening CRE superbug infections but waited nearly 3 years to disclose the events, according to a new letter published by the U.S. Food & Drug Administration (FDA).
FDA Sends Warning Letter to Scope Makers
August 18, 2015 – According to the letter, Olympus Corp. failed to alert the FDA about a cluster of 16 bacterial infections in patients who underwent treatment with the company’s duodenoscopes. Olympus didn’t report the incidents until this year, when it came under scrutiny for a series of more recent outbreaks.
The agency’s letter adds fuel to a controversy ignited earlier this year over superbug infections linked to duodenoscopes, which are used in more than 500,000 routine medical procedures annually.
According to the FDA, Olympus in May 2012 received a report involving 16 patients who developed bacterial infections “of which some resulted in abscesses, after undergoing an endoscopic procedure with your firm’s devices.”
But the company didn’t inform health authorities until this year, violating requirements to report adverse events linked to medical devices within 30 days, FDA said, adding that Olympus apparently lacks the proper protocol for reporting such problems.
The alleged violations were uncovered during inspections in March and April at 4 Olympus facilities, 2 in the U.S. and 2 in Japan. According to the FDA, Olympus subsequently responded to the agency’s findings; however, the company’s response “did not include documentation or evidence of the corrective actions and did not provide evidence of implementation.”
Olympus, which is currently facing numerous lawsuits over infections allegedly caused by its duodenoscopes, issued a brief statement pledging to cooperate with the FDA.
“We are reviewing the FDA’s warning letter so that we can provide the required response in a timely manner,” the company said.
Two other duodenoscope manufacturers – Pentax Medical and Fujifilm Holdings Corp. – received warning letters from the FDA after inspections at the companies’ plants earlier this year. The timing of the inspections and subsequent letters suggest a potential crackdown by the FDA, which has been accused of acting too slowly in response to the superbug outbreaks.