Our recent blog post, Medical Device “Emerging Signals”, updated about FDA’s intent to notify the public about “new information about a medical device used in clinical practice”. FDA’s intent to alert the public to the most current information known about a medical device to prevent potential risk to patients is a good concept — implementation requires cooperation from hospitals and medical device manufacturers.
In a blog entry posted January 13, 2016, Michael Mezher, RAPS, addressed a Senate report released on duodenoscopes that were found to be the source of infection in patients. In Mezher’s article, the report found hospitals did not report safety issues in a timely fashion to the medical device manufacturers who were then to report to FDA. Also, it was found that there were no reports in design changes that were made to the scope from the device manufacturers. The delays in reporting safety issues and design changes without review meant patients were at risk because the scopes were still in use.
Lessons learned – more oversight, guidance and improvements in reporting can be made for better outcomes. The report makes recommendations for the FDA to determine if a design change is necessary on the scopes, require unique device identifiers (UDIs) to improve device monitoring, and update guidance on when device manufacturers need to submit a new 510(k) for device modifications. These recommendations were made in efforts to improve safety on medical devices.
FDA’s emerging signals draft guidance is a step to transparency and may result in less risk to patient health. The patient is counting on hospitals, device manufacturers and FDA working together responsibly.
To read Mezher’s complete article on RAPS.org, please click here. Contact us if you need regulatory filing assistance or quality system support to ensure your Medical Device Reporting (MDR) processes are compliant.