Several hospitals have reported difficulty maintaining their existing Olympus OER-Pro reprocessors due to the lack of available PM kit. PM kits are reportedly no longer being manufactured due to the OER-Pro approaching end-of-life. This alert is to share this information that could affect all users of OER-Pro reprocessers.
The FDA issued an alert in June of 2025 on certain Olympus products that includes the Olympus OER line of automated endoscope reprocessors (AERs), citing ongoing quality system violations at the Olympus Aizu plant. These devices are blocked from U.S. import until compliance issues are resolved – with no known completion date. For hospitals with planned replacement purchases of these systems, these purchases can’t be completed and hospitals are having to extend to the life of old reprocessors.
The key points from the FDA alert included the information below.
Key implications:
- Limited ability to purchase or replace Olympus AER units
- Growing maintenance and downtime risk for aging OER-Pro units
- Potential reprocessing bottlenecks in various departments
Recommended actions:
- Plan contingencies for reprocessing and potentially longer disinfecting cycle times
- Evaluate short term alternatives to OER units requiring PM or maintenance
- Monitor the FDA and Olympus websites for updates and resolution timelines
Miga Solutions will continue to monitor this situation and send additional relevant information as it becomes available.
– The Miga Team
