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FDA Presses Hospitals to Report Medical Device Problems
The FDA wants hospitals to do a better job reporting medical device problems after finding many lapses, including the failure to flag a hysterectomy device’s potentially deadly risk, according to a report in the Wall Street Journal.
The FDA plans to hold a meeting on December 5 to identify ways to improve the reporting system. The agency wants to know when medical devices cause serious injuries or deaths, but it says hospitals often don’t file the required reports.
The FDA’s current focus includes laparoscopic morcellators. One agency investigation found that Brigham and Women’s Hospital in Boston should have reported a 2012 case in which power morcellation spread uterine cancer in a 51-year-old woman, who died a year later. The hospital has acknowledged this also happened to another patient the following year.
Starting in late 2013, the Journal highlighted dangers with the bladed power tools, which gynecologists use to perform hysterectomies through small incisions. The devices can also spread undetected cancers.
But the FDA has found that no one, including hospitals, filed reports to an agency safety database until after the morcellator problems became publicized. The U.S. Government Accountability Office has been investigating the morcellator risks and is expected to issue a report in January 2017.
The FDA published warnings about morcellators in 2014, and Johnson & Johnson, once the largest morcellator maker, pulled them from the market the same year. Some gynecologists are still using the devices, however.
Source: Wall Street Journal; December 2, 2016.