FDA Calls for Better Reporting of Medical Device Incidents
December 7, 2016 | Risk Management News
Driven largely by failures to report potentially deadly hazards related to laparoscopic power morcellators, the U.S. Food and Drug Administration (FDA) is calling on hospitals to do a better job reporting medical device problems, according to a December 2, 2016, article in theWall Street Journal. (For more information see the November 2, 2016, HRC Alerts. ) The FDA planned to hold a meeting on December 5, 2016, to work on ways to modernize and streamline its reporting system, the article said. The agency wants to know when medical devices cause death or serious injuries, which it says hospitals often don't report.