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The Food and Drug Administration sent warning letters last week to three medical device manufacturers whose endoscopes have been blamed for spreading deadly bacteria. This is the agency’s strongest regulatory action yet since outbreaks in Los Angeles, Seattle, and elsewhere made headlines earlier this year.
The devices, made by Olympus, Pentax, and Fujifilm, are used in hundreds of thousands of procedures each year. The FDA says the companies failed to report problems with the scopes as required by law and in some cases failed to ensure that the devices could be adequately cleaned. Olympus and Pentax were specifically cited for failing to relay to FDA reports that their devices “may have caused or contributed to a death or serious injury” within 30 days of learning about the event. Pentax and Fujifilm were cited for failing to make sure their instructions for cleaning the scopes were valid.
Olympus spokesman Mark Miller said in an -email that the company is reviewing the warning letter “so that we can provide the required response in a timely manner.” Representatives for Pentax and Fujifilm did not immediately respond to requests for comment on Monday.
The FDA has already offered hospitals advice on ways to improve cleaning the scopes, which have been linked to at least 13 deaths and dozens of infections at U.S. hospitals. An expert panel convened by the agency in May determined that duodenoscopes, the devices linked to outbreaks at UCLA Medical Center and Virginia Masson Medical Center, aren’t reliably safe. But the agency has declined to take them off the market, citing the needs of patients for sometimes lifesaving procedures.
The warning letters, dated Aug. 12 and made public Monday, followed inspections in March and April of the manufacturers’ facilities in Japan and the U.S. They suggest companies knew about the problems years before they became public this year. For example, Olympus learned that 16 patients contracted the bacterial infection
Pseudomonas aeruginosa after endoscopies in May 2012. Companies are supposed to report such events to the FDA within 30 days. Olympus didn’t file a report until 2015, the agency says. Pentax didn’t report cases of the deadly superbug known as carbapenem resistant-enterobacteriaceae, or CRE—the FDA learned of the infections from a company that imports Pentax devices instead, according to the warning letter.
The FDA asked the companies to respond with plans to correct the violations within 15 business days.