FDA Warning Letter Cites Olympus for Three-Year Delay in Reporting Superbug Infections

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FDA Warns Olympus for 3yr. Delay in Reporting Superbug
FDA Warns Olympus for 3yr. Delay in Reporting Superbug

FDA Warns Olympus for 3yr. Delay in Reporting Superbug
FDA Warns Olympus for 3yr. Delay in Reporting Superbug

Gastrointestinal scope maker Olympus Corp. failed to alert federal regulators for more than three year about 16 patient superbug infections the company learned about in 2012, though it was required to do so within 30 days.

The Food and Drug Administration (FDA) cited that lapse and other safety violations in the warning letter to Olympus. Pentax Medical and Fujifilm also received warning letters as a result of FDA inspections at the three companies’ facilities in March and April, the Los Angeles Times reports.

The gastrointestinal scopes—duodenoscopes—are used in a procedure known as ERCP, endoscopic retrograde cholangiopancreatography. A flexible scope with a tiny camera is put down a patient’s throat to diagnose and treat problems in the digestive tract including cancers and blockages in the bile duct. About 700,000 ERCP procedures are performed each year in the U.S. The infection risk arises because the tip of the instrument is difficult to clean. Even when the manufacturer’s cleaning instructions are scrupulously followed, dangerous bacteria can remain trapped in a channel in the tip, the Times explains.

Deadly infections linked to the scopes became a major issue this year and it appears the manufacturers knew about the problems well before the story broke. Under federal regulations, manufacturers are required to report injuries and deaths related to their devices to the FDA within 30 days. Medical experts and federal lawmakers welcomed the FDA’s warning letters, but they continue to question why the FDA took so long to act despite earlier warnings about the infection risk. California Rep. Ted Lieu called the reporting delay “flat out unacceptable,” and urged congressional hearings. Lieu said lives might have been saved if manufacturers had reported infections in a timely manner, according to the Times.

The FDA warning letters cited a range of violations found during the spring inspections of Olympus, Pentax Medical and Fujifilm facilities. The companies have 15 business days from receipt of the August 12 letters to respond to the violations. Olympus controls about 85 percent of the specialty endoscope market in the U.S. and its scopes have been linked to six of nine recent superbug outbreaks, including the outbreak at UCLA where three patients died, the Times reports. Patient deaths and infections linked to the scopes have also occurred in Washington and Illinois.

According to the FDA, Olympus became aware of one incident in November 2013 and another in June 2014. The company submitted data on both events to the FDA in March of this year, a month after the Times reported the UCLA outbreak. The 2012 incident appears to be an outbreak that occurred at a Netherlands hospital. As a result of the Dutch outbreak, Olympus sent an urgent warning to European hospitals in January 2013, telling them to use a special brush in cleaning the duodenoscopes. Olympus, however, did not notify U.S. hospitals or the FDA. The FDA said it did not learn of the European alert until last year. The Justice Department has sent subpoenas to the three scope makers in connection with the recent outbreaks.

Despite the infection risks, on Monday the FDA reiterated its opinion that that the scopes should remain in use because there is no better alternative for many patients.