New bill may require docs report medical device adverse events to FDA

regulatory

A bill introduced in Congress Wednesday would require doctors to report adverse events from medical devices to the U.S. Food and Drug Administration.

The legislation, known as the "Medical Device Guardian's Act," is intended to alert the FDA to potential problems with medical devices that could harm patients, according to a report in The Wall Street Journal.  

Currently, the FDA requires hospitals and device manufacturers to report deaths and serious injuries linked to medical devices, and while it encourages physicians to report adverse events, it is not required by law. The legislation would add physicians and practices to the list of mandated reporters. It would also protect doctors from having any reports to the FDA used against them in a civil case, according to bill's sponsors, U.S. Reps. Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY).

The impetus for the bill was the long delay in reporting dangers from laparoscopic power morcellators, a device used in hysterectomies and to treat uterine fibroids.The FDA in 2014 placed a "black box warning" on power morcellators after it became aware the device can harm patients. The FDA became aware of the problem in late 2013 when a patient, who also happened to be a doctor, underwent surgery and the morcellation device caused her cancer to spread. Hers was the first adverse event report received by the FDA, but hundreds of other safety reports followed.

One of the manufacturers of power morcellator devices, Johnson & Johnson, is settling a number of lawsuits claiming that its product, which has since been pulled from the market, harmed women by spreading cancer, FierceMedicalDevices previously reported.

To learn more:
- read the article

Suggested Articles

Payers have made strides digitizing and automating many core processes, yet prior authorization remains a largely manual, cumbersome process.

The Department of Health and Human Services announced proposed changes to privacy restrictions on patients' substance use treatment records.

Virtual care, remote monitoring, telehealth and other technologies have long been on the “nice to have” list for healthcare. But that's changing.