Olympus Gets FDA Warning Letter Over Failing to Meet Endoscope, Duodenoscope Medical Device Reporting Requirements

Federal regulators have issued a warning to Olympus Medical Systems, for failing to meet quality control standards and medical device reporting requirements involving endoscopes and duodenoscopes, which have previously been linked to deadly infection outbreaks when design defects caused the devices not to be properly cleaned between uses.

Duodenoscopes are a type of endoscope used during endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, difficulties cleaning device manufactured by several different companies have resulted in a number of problems in recent years, typically involving aggressive, antibiotic-resistant “superbugs”.

Concerns about the risk of duodenoscope infections emerged about seven years ago, following a number of outbreaks at different hospitals. Investigations by health officials identified problems with the cleaning procedures provided by Olympus and other manufacturers, which may allow the devices to transfer tissue or bacteria between patients.

In response to a continuing risk of problems, the FDA issued a safety communication in April 2022, urging hospitals nationwide to change over to using disposable duodenoscopes and disposable duodenoscope parts.

On January 10, the U.S. Food and Drug Administration issued warning letters to Olympus and its Aizu Olympus Co. Ltd. subsidiary, after facility inspections found violations of medical device reporting and quality system regulations involving endoscope and endoscope accessories, including duodenoscopes.

According to the Olympus warning letter, the company failed to report several complaints of malfunctions with a number of endoscope-type devices. These complaints were discovered during an inspection of the company’s Hachioji-shi, Tokyo, Japan facility in September.

“Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of the information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2),” the warning letter states.

In a press release, the FDA indicated it has been involved in “extensive and ongoing efforts” with Olympus over compliance issues related to reprocessing endoscopes. The FDA’s Center for Devices and Radiological Health (CDRH) has determined the company failed to meet its requirements to ensure the devices were adequately tested for quality and performance.

“For reprocessed devices, like those subject to the warning letters, adequate MDR reporting is necessary to ensure that any infections or reprocessing failures associated with these devices are appropriately communicated to and evaluated by CDRH to assure appropriate actions are taken to prevent potential patient injury,” the FDA press release states. “Compliance with quality system requirements for endoscopes is necessary to ensure these devices are designed, validated, and manufactured in a manner that allows for their safe and effective use, including completion of acceptable reprocessing validation and adequate instructions for use.”

CDRH indicates it is continuing to work with Olympus to address the violations.

FDA Promotes Use of Disposable Endoscope Components Due to Infection Risks

Questions about the safety of the devices first emerged after a duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections, which resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections were linked to problems with the “reprocessing” instructions provided by the manufacturer, which are used to clean the devices for use by another patient. FDA reviewers determined at that time that the instructions sent out at the time were inadequate, and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

In response to the problem, the FDA approved the first design with a disposable elevator tip, the most problematic and hard to clean part of the duodenoscope, in November 2019. Now, the agency says there are enough various disposable parts and entirely disposable duodenoscopes on the market that hospitals in the United States can, and should, transition to these devices and end use of reusable duodenoscopes with fixed endcaps.