By Chris Newmarker, December 16, 2016
FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry and FDA staff released this week.
The plan for the agency to publicly disclose emerging safety signals drew fire from industry groups earlier this year. AdvaMed, for example, said in its public comment to FDA that releasing emerging signals information could cause “unnecessary confusion” and cause health providers and their patients to avoid medical devices that were safe and useful.
At the same time, patient safety advocates have criticized FDA for failing to promptly report potentially deadly problems with medical devices. In one of the more egregious examples, FDA and device maker Olympus may have dragged their feet warning the U.S. public that a widely used Olympus endoscope was linked to deadly superbug outbreaks between 2012 and 2015, according to an early 2016 report from the office of Sen. Patty Murray, D-WA.
The final guidance from FDA seeks to strike a balance between the needs of industry and the needs of patients, says Scott Mitreuter, product manager at quality management services provider Sparta Systems (Hamilton, NJ).
“I’d say the industry, in particular the manufacturers, would be worried that the FDA could be portraying their products in a negative light, prior to full and lengthy investigations being completed. … The FDA addressed this in the guidance by being specific in what it will include in public notification, and their process for validating the information, and only using the information if the data is sound and verifiable,” Mitreuter said.
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