Currently, when physicians perform procedures using a medical device and discover issues associated with that device, the physician has the option to report the problem to the U.S. Food and Drug Administration (FDA) through its MedWatch system. While physicians are not mandated to report such incidences, hospitals and device makers must, under current law, make these reports.
House Representatives Mike Fitzpatrick (Republican-Pennsylvania) and Louise Slaughter (Democrat-New York) proposed the “Medical Device Guardian’s Act” on June 8, 2016, requiring doctors and doctors’ offices to report poor and adverse outcomes associated with medical devices. The Medical Device Guardian’s Act (H.R. 5404) is an amendment to the Federal Food, Drug, and Cosmetic Act that would “require physicians and physician’s offices to be treated as covered device users required to report on certain adverse events involving medical devices, and for other purposes.”
Under the proposed legislation, physicians would be required to report adverse events and would be protected when doing so. This means that the FDA reports would not be used against the reporting physicians in a civil case. If passed, the bill would require all medical centers and providers to be equal under the eyes of the law concerning requirements to report adverse events involving medical devices.
The proposed legislation followed alleged issues reported with the use of laparoscopic power morcellators during gynecologic procedures; however, power morcellators were not the only medical devices to be associated with issues.
Power morcellators are used, for example, to remove uterine fibroids and enable surgeons to cut up and remove fibroids, through a smaller incision made through the patient’s abdomen. Power morcellators have been touted as providing a faster recovery time and less scarring. Because it is not easily possible to determine if a fibroid contains cancerous cells, when these devices cut up an unknown cancer, the surgery may spread cancerous cells through a patient’s body, affecting patients’ health and life spans. The manufacturers of power morcellators have not warned of this serious, sometimes deadly, side effect.
According to Fortune magazine, after power morcellators were released to the market in the 1990s, there was some evidence that the device may spread a rare, but dangerous, type of uterine cancer. Despite this, the FDA did not receive direct reports of this serious side effect until late 2013; it was not until 2014 that the federal regulators added a “black box warning,” its most serious, to power morcellators to help increase awareness of the devices’ potential dangers. Lawsuits brought over power morcellators have been mounting over allegations that the device makers failed to provide sufficient warnings about the risks associated with the devices.
Lawmakers believe the new legislation would help improve the process of reporting device issues, which may enable defects, such as those alleged to occur with use of power morcellators, to be caught earlier and better ensure patient safety and health is not at risk.