FDA signs off on new version of Olympus' duodenoscope amid mounting scrutiny

Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia

The FDA has signed off on a new version of Olympus' controversial duodenoscope device, days after a cadre of lawmakers came down on the agency and the company for playing down early problems with the products that were linked to superbug outbreaks in the U.S.

Regulators cleared the Olympus TJF-Q180V "with modifications to the device's design and labeling intended to help reduce the risk of bacterial infections," the FDA said in a statement. Olympus' updated scope includes a tighter seal that will reduce the chance that patient fluids and tissue can leak into a closed elevator channel, which could potentially cause infections and spread bacteria.

Olympus will also voluntarily recall its original model of the device. The recall will affect about 4,400 scopes at U.S. healthcare centers and will be carried out by August 2016, the FDA said. In the meantime, Olympus will start implementing "corrective action" for the products starting in February, the company said in a statement.

In addition to recalling old versions of the device, Olympus plans to conduct annual inspections of the scopes "to identify any wear and tear" on the elevator channel sealing feature and screen for any debris on the scope's tip, which would flag contamination, the FDA said. "We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices," William Maisel, head of the FDA's Center for Devices and Radiological Health, said in a statement.

The FDA's latest move builds on its previous attempts to beef up oversight for Olympus' scopes. In March 2014, the agency told the company that it needed to submit a premarket notification for its "closed" elevator channel model, which was never cleared by the agency. A year later, the FDA issued updated cleaning and disinfection instructions for the device after superbug outbreaks cropped up at U.S. healthcare centers.

But some say that the agency has not gone far enough in its regulation of duodenoscope devices. Earlier this week, a group of senators pointed fingers at the FDA and Olympus for sweeping problems with the products under the rug, even as superbug outbreaks continued to proliferate.

Olympus knew about potential scope design flaws as early as spring 2012 after an outbreak in the Netherlands, but blamed the infections on hospitals' poor cleaning procedures, the senators said. And the FDA "wasted valuable time" in getting data from Olympus and two other manufacturers of the devices, Fujifilm and Pentax, on whether they had proper cleaning procedures in place, they added.

"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 Senate 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 FDA's statement
- get Olympus' release