Olympus gets two FDA warning letters over safety of reprocessed endoscopes

In the ongoing multiyear tussle between the FDA and Olympus, the agency faulted processes and communication.

Olympus Medical has received two warning letters from the Food and Drug Administration over safety issues related to reprocessing endoscopes, which involves cleaning and disinfecting the devices so that they can be reused.

During inspections in July and September 2022, the FDA determined that Olympus didn’t provide adequate testing and documentation of the device assembly process. In addition, the company didn’t meet medical device reporting (MDR) requirements, according to a Jan. 10 statement from Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH).

“CDRH has been involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes,” Shuren wrote. “However, as described in the recent warning letters, Olympus is not in compliance with MDR reporting and quality system requirements.”

The warning letters are addressed to Tokyo-based Olympus Medical Systems and subsidiary Aizu Olympus. Among the devices made by Olympus Medical are urological endoscopes, duodenoscopes and bronchoscopes.

“During recent inspections, [the FDA] determined that Olympus did not meet requirements to assure the quality and performance of the devices such as adequate testing and documentation of the device assembly process,” Shuren said. He also faulted Olympus for not developing reporting procedures to ensure the agency is told of “any infections or reprocessing failures connected to the devices.”

In a background statement about endoscope sterilization published this week, the FDA wrote that “inadequate cleaning between patient uses can result in the retention of blood, tissue and other biological debris (soil) in certain types of reusable medical devices.”

Olympus said in an emailed statement that it is working with the FDA.

"Comprehensive responses to each Warning Letter have been submitted to FDA on time, and the implementation of appropriate actions to address the FDA’s concerns is progressing on time,” Olympus said. “The company is committed to implementing sustained improvements to its Quality System to ensure that we consistently meet requirements and are in full compliance with regulations."

Concerns about the safety of reprocessed endoscopes date back to 2013, when the Centers for Disease Control and Prevention (CDC) alerted the FDA about a potential association between multidrug resistant bacteria and duodenoscopes.

“Upon further investigation, it became clear that these cases of infection were occurring despite confirmation that the users were following proper manufacturer cleaning and disinfection or sterilization instructions,” the FDA stated in a report detailing the problem and its response.

Olympus and Pentax have been withdrawing their duodenoscopes with a fixed endcap from the market.