Certain import devices from Olympus’ Aizu facility in Japan will be refused entry due to outstanding quality system violations, the FDA says.
The US Food and Drug Administration (FDA) has issued import alerts for select Olympus Medical Systems devices manufactured in Japan due to due to unresolved concerns related to quality system regulation violations.
The affected devices include specific models of ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors. These products, produced by Olympus Medical Systems Corporation and its subsidiaries, will now be refused entry into the US under Import Alert 89-04, which cites noncompliance at Olympus’ Aizu manufacturing facility.
The FDA says in the alert that it has taken actions related to quality system requirements and compliance concerns with Olympus and that it is continuing to engage with the company to accelerate corrective actions related to the ongoing violations and minimize risk to patients.
“FDA takes seriously its role in assuring patients that medical devices are safe and effective,” reads the alert from the agency.
What Health Care Providers Should Know
According to the FDA, health care providers should:
- Be aware of the import alerts and consult the FDA’s table of affected models and Unique Device Identifiers.
- Note that the alerts do not apply to related products such as replacement parts, connectors, or single-use consumables.
- Continue using devices already in use, provided they are functioning properly and not showing signs of damage.
- Follow all labeling and reprocessing instructions for cleaning and sterilization.
- Remove from service any devices that are damaged or fail a leak test.
- Establish maintenance and inspection schedules per manufacturer guidance.
- Discuss risks and benefits with patients prior to procedures involving the affected devices.
- Promptly report any adverse events to the FDA to aid in ongoing safety monitoring.
The FDA emphasizes its ongoing engagement with the company to ensure corrective actions are implemented and patient safety risks are mitigated. The FDA says it will update providers and the public as more information becomes available.
ID 155728991 © Hyotographics | Dreamstime.com
