The U.S. FDA’s Center for Devices and Radiological Health (CDRH) has issued two warning letters to Olympus Medical Systems Corp., a manufacturer of endoscopes, and one of its subsidiaries following facility inspections.

The warning letters concern violations related to medical device reporting (MDR) requirements and quality system regulations for endoscopes and endoscope accessories, including surgical and gastrointestinal endoscopes and automated endoscope reprocessors, according to the FDA. These endoscopes are subject to reprocessing, which involves both cleaning and high-level disinfection or sterilization so the devices can be reused.

Endoscopes manufactured by Olympus include urological endoscopes, duodenoscopes, and bronchoscopes, which are devices that allow healthcare providers to see and access the urinary tract, gastrointestinal tract, and respiratory tract, respectively, during diagnostic and therapeutic procedures. These warning letters are the most recent in the history of CDRH’s compliance actions against Olympus related to MDR and quality system requirements. 

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

FDA Inspections

During recent inspections, CDRH 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. In addition, Olympus did not develop MDR procedures, and did not submit MDRs within the required timeframes.

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. 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 will continue to ensure that Olympus fully addresses the violations described in the warning letters.

Endoscope Reprocessing

CDRH remains committed to ensuring the safety of reprocessed medical devices for U.S. patients and has continued to work with multiple medical device manufacturers on this effort. This is a shared responsibility among the FDA and other federal agencies, public health systems, state and local health departments, medical device manufacturers, healthcare facilities, professional societies, and others.

Since 2015, CDRH has communicated about and taken action on infections related to reprocessing of endoscopes. In light of concerns about the adequacy of reprocessing endoscopes, Congress gave the FDA new authorities in 2016 through the 21st Century Cures Act to determine that a reusable device is not substantially equivalent to a predicate device if the data submitted to support reprocessing claims are inadequate.

Accordingly, CDRH updated its 2015 guidance to include FDA premarket review of reprocessing validation data for certain critical device types. CDRH has issued warning letters to manufacturers and safety communications to the public and healthcare providers and held a public Advisory Committee meeting seeking information on how to effectively reprocess medical devices. In addition, CDRH has facilitated improvements in innovative design of the next generation of these devices, has worked with manufacturers to transition to devices with features that eliminate the need for reprocessing, and has worked with manufacturers to modify and validate their reprocessing instructions. 

CDRH says it will continue to keep healthcare providers and the public informed if new or additional information becomes available on issues related to these devices.