The FDA’s Center for Devices and Radiological Health (CDRH) has issued two warning letters to Olympus Medical Systems Corporation and its subsidiary Aizu Olympus Co, Ltd. The Jan. 10 statement noted that after a series of facility inspections, the leading manufacturer of endoscopes was found to have violated medical device reporting requirements and quality system regulations.
Endoscopes are a series of medical devices designed to allow medical professionals to see lesions or other injuries inside of the body that would be undetectable through X-rays or MRIs. Olympus Medical Systems manufactures many subtypes of endoscopes including urological endoscopes to view the urinary tract, duodenoscopes to view the gastrointestinal tract, and bronchoscopes to view the respiratory system. These devices allow medical professionals to diagnose conditions and perform therapeutic treatments.
According to the FDA, one of the main topics of the warning letters addressed to Olympus Medical Systems concerned the facilities’ violation of medical device reporting requirements with regard to their endoscopes, endoscope accessories, and automated endoscope reprocessors. Medical device reporting requirements are a series of statutes that require manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
According to the letter, Olympus did not develop any medical device reporting procedures and did not submit medical device reports within the required timeframes. This was especially concerning to the FDA because Olympus uses reprocessed devices.
A reprocessed endoscope is subjected to cleaning and high-level disinfection or sterilization so that the devices can be reused. Adequate medical device reporting is especially important for reprocessed endoscopes to ensure that any infections or reprocessing failures associated with the endoscopes are communicated to and evaluated by CDRH in order to take action to prevent potential patient injury.
The other major violation concerned Olympus’ quality system requirements. According to the FDA, during facility 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.”
The FDA noted that compliance with quality system requirements is vital for endoscopes to be designed, validated, and manufactured for safe and effective use. Two notable deficiencies of the quality system requirements included a failure to ensure acceptable reprocessing validation and adequate instructions for use.
The CDRH stated in the announcement that it is “involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes.”