Dive Brief:
- The Food and Drug Administration has blocked certain Olympus Medical devices from entering the U.S. because of quality system failings at a site in Japan.
- FDA officials issued the import alerts Tuesday to prevent 58 models of Olympus devices used in urinary, respiratory, abdominal and pelvic procedures from reaching customers in the U.S.
- The import alerts are the latest in a series of regulatory actions by the FDA, which accused Olympus in 2023 of having “a troubling disregard for patient safety.”
Dive Insight:
The FDA sent three warning letters to Olympus from November 2022 to March 2023 as part of its work to reduce the risk of infection associated with reprocessed endoscopes. Inspectors found the company was noncompliant with current best practices in manufacturing requirements. Olympus is yet to fix the problems.
“Despite extensive and ongoing efforts to address compliance issues, FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the FDA said in a statement.
The import alerts cover ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors. While imports will be refused entry to the U.S., healthcare providers can continue to use devices they already own that are working as intended. The FDA has asked users to follow the labeling and reprocessing instructions and advised against using damaged devices or those that fail a leak test.
Olympus has been working to resolve the quality issues identified by the FDA. In a May earnings call, Yasuo Takeuchi, who stepped down as CEO on June 1, said the company expected to complete its commitments to the FDA by the end of its 2026 fiscal year. Olympus’ fiscal year ends March 31. Olympus spent 11 billion yen on its regulatory transformation project in fiscal 2025.
The FDA said it is continuing to work with Olympus “to accelerate corrective actions related to ongoing violations and minimize risk to patients.”
