New House Proposal Would Require Doctors To Report Medical-Device Dangers
It's not clear whether the measure, which was advanced by Rep. Mike Fitzpatrick, R-Pa., and Rep. Louise Slaughter, D-N.Y., will see action this session.
The Wall Street Journal:
Bill Would Require Doctors To Report Medical-Device Hazards
Doctors would be required to report potentially serious problems with medical devices they use to the U.S. Food and Drug Administration, under a new bill that a pair of lawmakers is expected to introduce in Congress Wednesday. The proposed legislation, known as the “Medical Device Guardian’s Act," is intended to help raise awareness of the possible risks of medical devices that could cause harm to patients. Sponsors of the bill said they were motivated to change the law after the long delay in public awareness of the risks of a women’s surgical tool called the laparoscopic power morcellator. (Levitz, 6/8)
Philadelphia Inquirer:
Bills Aim To Fix Medical-Device Dangers
The medical procedure was supposed to help Amy Reed. Instead, it spread cancer through the Bucks County woman's body, and helped spark a national fight that arrived at the Capitol on Wednesday. With Reed and her family looking on, two lawmakers rolled out bills to increase oversight of medical devices like the one that harmed her. (Tamari, 6/9)
Morning Consult:
Reps. Slaughter, Fitzpatrick Introduce Medical Device Safety Bills
Reps. Mike Fitzpatrick (R-Pa.) and Louise Slaughter (D-N.Y.) on Wednesday introduced a pair of bills designed to crack down on the medical device review and approval process. It is not clear whether they will see any action in committee this year. (Owens, 6/8)