On January 10, the FDA’s Center for Devices and Radiological Health (CDRH) said the warning letter was the latest in a series of compliance actions taken for Olympus endoscopes and endoscopic accessories. I was. The FDA also notes steps he has taken since 2015 to address improper endoscope reprocessing.
“CDRH has been involved in extensive and ongoing work with Olympus to address compliance issues related to endoscope reprocessing,” said the CDRH Director. Jeff Shuren“However, as stated in a recent warning letter, Olympus [medical device reporting] MDR reporting and quality system requirements. ”
“During a recent inspection, CDRH determined that Olympus did not meet requirements to ensure the quality and performance of the device, including adequate testing and documentation of the device assembly process,” he added. “Furthermore, Olympus did not create an MDR procedure for him and he did not submit his MDR within the required timeframe.”
In November, FDA Warning statement It told Aizu Olympus, an Olympus subsidiary in Fukushima Prefecture, Japan, that it had failed to establish and maintain procedures for validating device designs for endoscopes. It was also pointed out that the design history record (DHR) of the endoscope was not properly maintained by ensuring that the manufacturing process was not validated.
About a month later, FDA sent another email. Warning statement Olympus in Tokyo, Japan, said it had failed to comply with the agency’s MDR requirements for its endoscopes. Specifically, he points out that the recall of the Uretero-Reno Fiberscope and Uretero-Reno Videoscope devices did not follow proper protocol.
“Your company failed to file an MDR for each of the complaints mentioned within the required 30-day timeframe,” the FDA said. “As a result of these complaints, your company has implemented a recall Z-2518-2018 for his Uretero-reno fiberscope URF-P6, in which such an event could lead to a possible perforation of a patient’s organ. It has been established that it can lead to
In 2015, government agencies issued updated guidance requiring premarket review of reprocessing validation data for certain critical devices. The following year, Congress twenty onest century cure act To determine that a reprocessed endoscope is not substantially equivalent to a predicate device if the manufacturer provides inappropriate information about the reprocessed product.
“CDRH issued warning letters to manufacturers, provided safety information to the public and health care providers, and held public advisory committees seeking information on how to effectively reprocess medical devices,” it said. Shulen said. “Furthermore, CDRH will facilitate the next generation of innovative design improvements for these devices, working with manufacturers to transition to devices with features that eliminate the need for reprocessing, and working with manufacturers to We have corrected and verified the procedure.”
The center said the risk from improper reprocessing of medical devices is relatively low and that providers should follow labeling and reprocessing instructions to properly clean and reprocess device and accessory components. says.
“CDRH does not recommend that a procedure be canceled or postponed without a discussion of benefits and risks between providers and patients,” Shuren said. We encourage prompt reporting of adverse events to help us identify and better understand the risks associated with our devices.”