FDA Says Olympus Failed to Report Scope Infections for 3 YearsAug 19, 2015
The U.S. Food and Drug Administration (FDA) says that Olympus Corp. failed to report patient infections linked to specialty endoscopes for three years. LA Times reports that the company is already under investigation for several superbug outbreaks linked to their duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP).
The FDA sent warning a letter to Olympus citing a failure to report 16 patient infections the company became aware of in 2012. The agency also sent letters to two other scope makers, Pentax Medical and Fujifilm. The letters, posted online Monday, further indicate the manufacturers knew about the risk of spreading infections well before the superbug outbreaks came to light earlier this year. Federal regulations require companies to report adverse events to the FDA within 30 days. LA Times reports that the warning letters are the most serious action the FDA has taken towards the scope makers since the outbreak.
Cases of infection with antibiotic-resistant bacteria were linked to duodenoscopes at UCLA's Ronald Reagan Medical Center in February. The FDA action was welcomed by some medical experts and lawmakers, but questions were still raised about why action was so delayed. "The fact that it took the leading scope manufacturer three years to report patient infections is flat out unacceptable," said Rep. Ted Lieu (D-Los Angeles), according to LA Times. "If scope manufacturers had reported infections earlier, then lives might have been saved."
Officials inspected Olympus, Pentax and Fujifilm in March and April. The Aug. 12 letters cited a wide range of violations, and gave the companies 15 business days to respond. Agency spokeswoman Jennifer Dooren said "The FDA takes these violations very seriously and will continue to monitor these firms to ensure they take appropriate corrective action," according to LA Times.
According to the FDA, Olympus knew of 16 patient infections in May 2012 but did not report them until March 2015. The FDA also cited two other instances where Olympus failed to report adverse events in a timely manner. In November 2013 and again in June 2014, the company learned of incidents. The company did not submit data on these events until March, one month after widespread media coverage of the superbug outbreaks at UCLA. "Failing to file a report on time places patients at serious risk unnecessarily," said Lawrence Muscarella, a hospital safety consultant in Montgomeryville, Pa., according to LA Times. "A three-year delay in filing a report is unreasonable, compromises safety and should have been flagged months ago."