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Infected medical scopes, insufficient FDA oversight led to grave risk for U.S. patients, probe finds

According to the report, 141 patients were infected between the time the risk was first noted in 2012 and the time the FDA issued its first warning in 2015.
By Doug G. Ware   |   Updated Jan. 13, 2016 at 8:07 PM

WASHINGTON, Jan. 13 (UPI) -- A Senate investigation has found that numerous patients in the United States were needlessly subjected to potentially deadly infections through the use of a device that allows doctors to view the inside of the small intestine -- a risk investigators say was largely created by insufficient federal oversight and failures attributed to the device's manufacturers and medical facilities.

The results of the Senate Health, Education, Labor and Pensions Committee investigation, released Wednesday, said nearly 150 U.S. patients contracted a serious bacterial infection from the use of the device, called a duodenoscope, during procedures between 2012 and 2015. Some of the cases had fatal consequences, the Los Angeles Times reported.

Duodenoscopes are used in endoscopic retrograde cholangiopancreatography (ERCT) procedures, in which physicians thread the scope down a patient's throat and into their intestine to search for things like tumors and gallstones.

According to the investigation, the main manufacturer of the device, Olympus Corp., became aware of the risk in early 2012, and two other U.S. manufacturers and a company that makes equipment to clean the device failed to follow federal regulations -- as did some hospitals, which the committee said didn't report the infections to device manufacturers.

The committee said some hospitals that did report the infections often didn't do so until long after they were discovered.

"Although at least 16 separate U.S. hospitals traced antibiotic-resistant infections directly to duodenoscopes, the hospitals generally did not raise alarms about these infections with federal regulators," the report said.

"Not a single hospital that experienced infection outbreaks tied to the duodenoscopes sent the required adverse event form to the device manufacturers," it continued.

The Senate committee initiated the investigation, led by Sen. Patty Murray, D-Wash., after dozens of people became infected in a Seattle hospital in 2012.

"Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented," Murray said.

Further, the report places some of the blame on the U.S. Food and Drug Administration, which it said used an "outmoded" and insufficient system to report potential device safety risks. In fact, the FDA didn't investigate until September 2013 and didn't issue its first warning until February 2015 -- after the Times ran a report about a related "superbug" outbreak at a Los Angeles hospital that killed three people.

Investigators said 141 people were infected through the use of a duodenoscope in the three years between first awareness of the problem and the FDA's initial warning.

The FDA requires device manufacturers to report adverse health conditions related to their products. Olympus, the report said, didn't do that in a timely manner, and when it did the reports were often submitted months later. Investigators said in the reports it did file, Olympus suggested the infection risk didn't originate with the devices themselves -- but rather from improper cleaning of the scopes.

Japan-based Olympus makes 85 percent of the scopes that are sold in the United States.

The FDA said it never recalled the scopes because no other device is available to perform ERCTs. In response Wednesday, however, the FDA said the safety of medical devices is "a top priority."

"The FDA has taken several actions to address the issue of duodenoscope-related infections and will continue to work to protect patients while ensuring access to these important devices for those who may benefit from minimally invasive procedures," spokeswoman Deborah Kotz said.

"Although we do not agree with all of the report's conclusions, we are closely reviewing the recommendations in the report as part of Olympus' ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes," company representative Mark Miller said, adding that Olympus has been cooperating with Senate investigators.

The Senate committee's report included a list of recommendations it believes would mitigate the risk of infection from duodenoscopes --such as an FDA investigation of the devices, a phased recall and a new protocol that doesn't leave the agency to solely rely on hospitals and device manufacturers to report potential problems.

Another recommendation submitted by the committee called for timely and routine reporting of incidents to be a requirement for hospitals to participate in Medicare.

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