U.S. Reps. Mike Fitzpatrick (R.-Pa.) and Louise Slaughter (D.-N.Y.) proposed the Medical Device Guardian’s Act to raise awareness over the possible risks of medical devices. The bill responds to the long delay in public awareness of the risks associated the laparoscopic power morcellator, a women’s surgical tool linked to spreading uterine cancer.
Currently, the FDA requires hospitals and device manufacturers to report deaths and serious injuries linked to medical devices through the agency’s database of adverse events. While physicians are not required to report, they are encouraged to and can even do so by smart phone.
The bill proposes to include physicians on the list of mandated reporters and protects them from having their reports used against them in a civil case.
The FDA plans to create a national evaluation system that would use data generated during patient care to identify safety issues faster. The FDA said it “needs support from Congress and the industry to build this system,” according to The Wall Street Journal.
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