New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

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Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed at strengthening the FDA medical device review process and increasing accountability for dangerous products.”

If passed, the Act will require doctors to report medical device-related deaths and serious injuries to the FDA. Under current rules, only medical device manufacturers, importers, and certain user facilities are required to report medical device-related deaths and serious injuries to the FDA.  User facilities are currently defined as “a hospital, an ambulatory surgical facility, a nursing home, and outpatient treatment facility, or an outpatient diagnostic facility which is not a physician’s office.” The proposed Act will extend the existing reporting requirements to include “a physician or physician’s office.”

The Act is the most recent effort by Rep. Fitzpatrick to reform the FDA medical device review and approval process. Reps. Fitzpatrick and Slaughter have pointed to recent controversies related to implantable sterilization devices and power morcellators used in laparoscopic surgery as motivation for introducing the Act. Last year, Reps. Fitzpatrick and Slaughter were part of a group of twelve members of Congress who requested the U.S. Government Accountability Office to investigate the events leading to the FDA’s black box warning against the use of power morcellators in November 2014. Black box warnings are the strongest warnings by the FDA and call attention to serious or life threatening risks.


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