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.
More articles on gastroenterology:
Have Gilead Sciences & AbbVie shut Merck out of the HCV drug market?
6 reasons patients avoid undergoing screening colonoscopy
Dr. Atif Iqbal: Using the LINX device for GERD treatment
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.