Lax FDA oversight allowed dirty medical scopes scandal to spread, says Senate report

January 14, 2016

Contaminated medical scopes have sickened many more patients than initially estimated by federal regulators, according to a U.S. Senate health committee report published Wednesday. More robust regulatory oversight could have prevented that, adds the report.

Between 2012 and 2015, duodenoscopes have been linked to more than two dozen outbreaks of antibiotic-resistant infections, often called superbugs, that sickened at least 250 patients in the United States and Europe. More than a dozen people have died under circumstances linked to outbreaks in various hospitals.

CREThe result of a year-long investigation by Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA), the report documents what Murray calls a "systemic and unacceptably slow response to growing evidence that duodenoscopes could not be reliably decontaminated between patient use, and makes clear that FDA's current system to monitor medical device safety is unable to effectively identify device problems when they occur." This poses an unacceptable risk to patients, adds the news release issued by HELP.

A type of medical endoscope, the duodenoscope is used to treat cancers, gallstones and other digestive conditions. The device has a movable "elevator" mechanism at the tip, which improves its functionality, but makes it more difficult to clean, allowing bacteria to become trapped within the scope.

An outbreak caused by contaminated scopes at the UCLA Ronald Reagan Medical Center in Los Angeles in February 2015 first brought this issue to the fore. Last month, the Los Angeles Times published a follow-up investigative piece, which revealed that several outbreaks had occurred over the past three years but that Olympus, a company that manufactures duodenoscopes and has the largest market share, by far, treated each incident as an isolated event and blamed improper cleaning protocols at the hospitals for the infections.

FDA and other regulatory bodies were slow to react, although FDA did eventually send warning letters to Olympus and two other manufacturers of duodenoscopes, Pentax and Fujifilm, noting inadequate reporting of problems with the products and a failure, in some cases, to ensure that they could be properly cleaned between use.

"Patients should be able to trust that the devices they need for treatment are safe and effective," said Murray in the news release. "This investigation makes clear that current policies for monitoring medical device safety put patients at risk and . . . allowed tragedies to occur that could have, and should have, been prevented," she adds. The report includes a number of recommended legislative and regulatory changes that, Murray hopes, will prevent such incidents from occurring in the future. Her recommendations include calling on FDA to determine if "closed channel" duodenoscopes are needed to prevent infections and, if so, to begin a recall and repair program and to require that unique device identifiers be included in medical data to allow FDA to more quickly identify risks linked to a specific device.

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