Olympus, FDA implicated in Senate probe of duodenoscope devices

Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia

A group of senators is coming down on the FDA and manufacturers of duodenoscope devices linked to drug-resistant bacteria outbreaks at U.S. hospitals, revealing results of a probe which found that a leading maker of the products and regulators played down early problems with the devices.

The Democratic staff of the Senate Committee on Health, Education, Labor and Pensions released a report showing that 25 superbug outbreaks, including two in Los Angeles, were associated with duodenoscope devices, The Los Angeles Times reports, a higher number than previously announced. Senators point fingers at Olympus, saying that company knew of potential scope design flaws as early as spring 2012 after an outbreak in the Netherlands. The company played down those reports, though, blaming the issue on hospitals' poor cleaning procedures.

Olympus is standing by its products, saying that it has cooperated with the committee's calls for information regarding its duodenoscope devices. "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," Mark Miller, Olympus' VP of corporate and medical communications, said in a statement. The company has stepped up its efforts recently after the FDA required Olympus to submit postmarketing studies for the devices to the agency in October.

Sen. Patty Murray (D-WA)

The FDA, which has also come under fire for its role in the recent outbreaks, also took some of the heat in the Senate report. The FDA began investigating the scopes in September 2013 after reports of infections surfaced, but "wasted valuable time" in getting data from Olympus and two other manufacturers of the devices, Fujifilm and Pentax, on whether they could prove that the devices could be properly cleaned, the senators said. And regulators did not warn hospitals about the issue until February 2015 after a superbug outbreak at UCLA's Ronald Reagan Medical Center.

The findings point to flaws in the federal government's oversight of medical devices, as lax regulation leads to "life-threatening consequences" for patients, the senators said in their report. At least 141 patients across the U.S. were infected between the time the FDA first said that it would investigate the scopes and its warning last year.

"Patients should be able to trust that the devices they need for treatment are safe and effective," Sen. Patty Murray (D-WA), who kicked off the probe. "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."

- read the LA Times story
- here's Olympus' statement