News
safety is our priority

Manufacturers, Hospitals, and FDA at Fault for Failing to Alert Public of Medical Device’s Risks

Duodenoscopes are medical devices used to diagnose and treat problems in the bile and pancreatic ducts. By late 2013, two hospitals, one in Washington and one in Illinois, had linked outbreaks of antibiotic-resistant infections to closed-channel duodenoscopes. Both hospitals concluded that even after proper cleaning, these duodenoscopes could remain contaminated. Shockingly, it took more than 17 months for duodenoscope manufacturers and the FDA to alert hospitals, doctors, and the public to the risk posed by these devices.

According to a recent Senate report entitled, “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients,” the outbreaks identified in Washington and Illinois were not isolated incidents. The Senate investigation revealed that between 2012 and 2015, closed-channel duodenoscopes were linked to at least 25 separate incidents of antibiotic-resistant infections that sickened hundreds of patients. The report also states that “it is likely that there are more incidents of infections linked to these devices that have never been identified.”

The Senate investigation also revealed that by the fall of 2012, Olympus, the manufacturer of 85 percent of duodenoscopes used in the U.S., knew that its devices had been linked to antibiotic-resistant infections at hospitals in the U.S. and Europe. By early 2013, Olympus knew of two independent reports finding that the closed-channel model duodenoscope could harbor and spread bacteria even after cleaning it in compliance with the manufacturer’s instructions. Despite this knowledge, Olympus never alerted the FDA, hospitals, or physicians in the U.S. of the problem until February 2015. It did, however, send some European hospitals alerts in 2013 and 2014 advising them to use extra caution when cleaning these devices.

The Senate investigation also revealed that 16 separate hospitals in the U.S. had traced antibiotic-resistant infections to these duodenoscopes, yet not one sent the required adverse event form to the device manufacturers. According to the report, these hospitals failed to promptly alert the FDA and CDC. The investigation found that in part because of the manufacturers’ and hospitals’ failures to disclose important information to the FDA, “it took the agency overly long to accept that duodenoscope-linked infections were not the result of hospital cleaning errors.” The Senate report states, “[a]s a result, contaminated duodenoscopes spread serious infections for at least three years before manufacturers and FDA alerted hospitals in the United States.” In the meantime, at least 68 patients in the U.S. contracted antibiotic-resistant infections from these devices.

Clearly, this situation involved numerous errors, missteps, and oversight on the part of the manufacturers, hospitals, and the FDA. Click here to read the full Senate report.