Report of Adverse Effect Involving Medical Device. Hospitals and device manufacturers are required by law to report adverse events involving a medical device, but the same rules do not apply to doctors or their offices.
Congressman Mike Fitzpatrick (R-PA) and Congresswoman Louise Slaughter (D-NY) recently proposed new legislation that would require doctors and doctors’ offices to report adverse outcomes due to medical devices.
The proposed legislation was prompted as a result of issues concerning power morcellators used in gynecological procedures to remove uterine fibroids. The laparoscopic procedure became popular due to a smaller incision allowing for a faster recovery as well as less scarring.
Manufacturers, however, failed to warn that these devices, when used to cut up and remove fibroids, may spread previously undiagnosed cancerous tissue.
Lawsuit for The Manufacturers of The Devices
Numerous lawsuits have since been filed against the manufacturers of these devices for failure to provide sufficient warnings about the risks. Lawmakers believe this new legislation may help improve the process of reporting device issues to help protect patients in a timely manner.
The bill, known as the “Medical Device Guardian’s Act” proposes an amendment to the Federal Food, Drug, and Cosmetic Act to “require physicians and physician’s office to be treated as covered device users required to report on certain adverse events involving medical devices, and for other purposes.” This wording “protected” doctors, meaning the FDA reports could not be used against them in a civil case.
If passed, the bill would make all medical centers and providers equal under the eyes of the law, concerning the requirements to report adverse events involving medical devices.