In letters dated March 26, Olympus sent updated, validated manual reprocessing instructions for the TJF-Q180V duodenoscopes, according to an EINNEWSDESK report.
The FDA reviewed the new reprocessing instructions and validation data as part of the ongoing review of the scopes 510(k) process, according to the report. The FDA recommends:
• Implementation of the new reprocessing instructions
• Staff training on the new instructions
• Contacting Olympus directly with any questions or concerns
Olympus will also soon release updated user manuals.