Dive Brief:
- Olympus on Friday said it intends to promptly address concerns that led the Food and Drug Administration to issue import alerts blocking some of the company’s endoscopy devices from entering the U.S.
- The FDA, in its letter to healthcare providers last week, said it was preventing future shipments of the products, manufactured at Olympus’ Aizu facility in Fukushima, Japan, until further notice, due to ongoing quality system violations. Providers currently using the devices without problems can continue to do so, the agency said.
- The Tokyo-based company said the bronchoscopes, laparoscopes, ureterorenoscopes and automated endoscope reprocessors subject to the import alert generated about 1% of its consolidated revenue in the fiscal year ended in March.
Dive Insight:
While Olympus reiterated its commitment to addressing the issues raised by the FDA and said it aims to meet the highest quality standards for its products, the agency has continued to raise concerns with the device maker.
Import alerts allow the FDA to detain shipments without having to examine the devices and are used to protect consumers from products with a history of regulatory violations.
Olympus has been working to improve quality assurance in Japan in response to FDA notifications over the past three years. The agency’s latest action follows three warning letters sent to the company from November 2022 to March 2023 as part of its work to reduce infection risk associated with reprocessed endoscopes. Inspectors found Olympus was noncompliant with current best practices in manufacturing requirements.
Former Olympus CEO Yasuo Takeuchi said in May that the company expected to complete its commitments to the FDA by the end of its fiscal year, which ends on March 31, 2026.
Takeuchi, Olympus’ board chairperson, assumed CEO duties after Stefan Kaufmann resigned in October following allegations of illegal drug purchases. The company has since hired former Medtronic executive Bob White as CEO. White, a former president of Medtronic’s medical surgical portfolio, took up the CEO post at Olympus on June 1.
With some Olympus products restricted, endoscopy rival Boston Scientific could benefit, at least in the near term, J.P. Morgan analyst Robbie Marcus wrote in a research note Wednesday.
KeyBanc Capital Markets analyst Brett Fishbin told clients that Olympus’ problems with the FDA could boost competitor Steris’ market share positioning.
For Olympus’ devices currently in use, the FDA advised providers to follow instructions for proper cleaning and reprocessing, not to use devices that are damaged or have failed a leak test, and to discuss with patients the benefits and risks of procedures involving the devices.
Olympus said that based on its initial evaluation, the FDA’s action does not impact the import of its devices into any other countries globally.
