Devices & Diagnostics

Senate steps in to take action against medical device company that failed to report infections

Scope devices that are difficult to clean have been called out in certain cases for causing antibiotic-resistant infections in the past. Olympus, a Japan-based device maker, failed to report infection investigations to the FDA or American hospitals, and they are now being called out.

Staphylococcus aureauMagnification 20,000

A yearlong investigation into closed-channel duodenoscopes developed by Olympus, the Japanese maker of 85 percent of the device used in the U.S., was led by Senator Patty Murray, Democrat of Washington. A Senate report was released Wednesday in response to a number of infections that were discovered in the Seattle area.

Apparently the device, a long, flexible tube with a camera at the tip used to look at small ducts in the small intestine that drain the liver or gallbladder, is difficult to keep clean and sanitary. These in particular were linked to at least 250 cases of antibiotic-resistant infections worldwide from 2012 to early 2015. The issue, though, is that the FDA received only 75 reports relating to possible infection from duodenoscopes from January 2013 through December 2014, as The New York Times reported.

When a death or injury from a device is reported (anywhere in the world), manufacturers have 30 days to report it to the FDA.

The Senate report points out that Olympus reportedly knew about two particular investigations in the Netherlands back in 2013, but the company failed to inform the FDA or American hospitals until 2015.

“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’s ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes,” Mark A. Miller, a spokesman for Olympus, said in a statement, The Times reported.

Murray, however, was not satisfied with Olympus’ reaction to the issue, as well as the delayed response by the FDA and hospitals.

“It is their responsibility when the device that they have manufactured has safety defects to notify the patients, the doctors, the hospitals,” she said. “People should know this. We should not allow manufacturers to knowingly allow the use of any device or medication that’s not safe. Some of the hospitals were late in notifying patients, and the FDA did not take action immediately when they began to get reports.”

The Senate report asks that the FDA evaluate whether or not the duodenoscopes should be recalled, it asks Congress to require that “unique device identifiers” be added to insurance claims to help link potential negative patient outcomes to devices and it requests that Congress develop a medical device evaluation system.

Photo: Flickr user NIAID