Physicians would have to report medical device problems under new bill

A new bill in Congress aimed at changing the Food and Drug Administration’s medical device approval process would require physicians and their practices to report defects or issues with devices, while protecting doctors from being sued over those reports.

The legislation, sponsored by Reps. Mike Fitzpatrick, R-Pa., and Louise Slaughter, D-N.Y., was inspired by reporting problems with laparoscopic power morcellators, used to make tissue removal easier through small incisions and most often used during hysterectomies.

The Wall Street Journal reported that, while there had been discussion of the risks involved with morcellators for years, the FDA didn’t get a formal report about the tools spreading undetected uterine cancer until 2013, when Amy Reed, MD, went public about her own cancer diagnosis related to morcellation in a WSJ article.

Fitzpatrick and Slaughter wrote in a letter introducing the bill that “everyone in chain of care” should have a responsibility to report concerns about devices to the FDA.

“I think everyone would agree that when a medical device is found to be unsafe, there needs to be an effective process in place to track these failures, to remove devices from the market, and provide legal recourse for those impacted. Currently, that process is failing us, and our constituents are paying the price,” Fitzpatrick said in statement. “It’s time we reform the FDA, its processes and procedures to allow for maximum innovation and maximum safety.”

Doctors have been encouraged to report device issues to the FDA, but now physicians and their offices would be mandated to do so. The bill would prevent those reports from being used against physicians in civil litigation.

The FDA declined to comment on the legislation, but say in its statement it wants help from Congress in building a new system to quickly identify safety issues use data generated during patient care.