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FDA finds duodenoscope contamination risk still too high

by Thomas Dworetzky, Contributing Reporter | April 23, 2019

“While the firms have made some progress toward completing these studies, they are still not in compliance with the timetable they agreed upon to complete these studies,” noted the agency, adding that should companies “fail to adequately respond to our concerns,” more action will be taken. The FDA is also working with the makers to come up with new designs to lessen the risk of scope contamination.

Despite the concerns, the agency stressed that the infection risk for an individual patient “remains relatively low given the large number of such devices in use,” and that infection rates have come down after improved reprocessing techniques were employed — the number of reports associated with patient infections peaked in 2015 at 250 reports and has fallen 62 percent to under 100 reports a year in 2017 and 2018.

In March, 2018, the FDA issued warning letters to the three duodenoscope manufacturers over their failure to comply with postmarket reprocessing surveillance studies — required of them after inadequate reprocessing of the devices led to bacterial contamination causing illness and patient deaths.

In 2013, the agency discovered a link between multi-drug-resistant bacteria and duodenoscopes, despite the fact that users were following the manufacturer-recommended cleaning procedures.

According to the FDA, the endoscopic retrograde cholangiopancreatography (ERCP) procedure using the scope — about which the agency posted an updated alert Feb. 23, 2015 — exposed 179 patients at UCLA to deadly bacteria, with two deaths confirmed and seven other patients infected. In the UCLA case, the scopes were cleaned according to the company’s guidelines, but the process did not kill the aggressive bacteria, according to reports at the time.

Since then, the FDA has worked with all three duodenoscope makers selling scopes in the U.S. to improve processing instructions and ensure they are validated properly, according to the agency.

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