Representative MarkFitzpatrick (R-PA) and Representative Louise Slaughter (D-NY) introduced the Medical Device Guardians Act during the summer of 2016. The bill would require doctors to report serious problems with medical devices to the Food and Drug Administration (FDA). Currently, doctors are asked to voluntarily report adverse events. If the bill passes, doctors would join hospitals and manufacturers in having a legal obligation to report problems that occur with devices. The law protects physicians (and encourages their reporting) by stating that such reports could not be held against a physician in a malpractice suit.
This bill was inspired by the stage 4 uterine cancer of Dr. Amy Reed, a constituent of Rep. Fitzpatrick, as well as the deaths of numerous women, including three in Rochester, NY. All underwent gynecologic procedures to remove what they thought were benign uterine fibroids using power morcellators. These devices have high-speed blades that pulverize tissue, and inadvertently spread undetected cancer in the patients, changing what was an early-stage cancer that could be easily removed to a potentially deadly stage 4 (metastatic) cancer. The dangerous use of power morcellators continued for years because doctors did not report that the devices were spreading cancer. The law would increase reporting by physicians, so that dangerous devices would be identified and removed from the market more quickly.
The National Center for Health Research President, Dr. Diana Zuckerman, asks, “even after doctors knew patients had been killed by power morcellators, why were those deaths not reported to the FDA and made available to all physicians? Were physicians concerned that they would be held responsible for not realizing that the fibroids contained cancer?” NCHR supports this bill because there is clear scientific evidence that the vast majority of adverse events from medical products are not reported by physicians, and the percentage may be especially low for devices. “Since most devices are allowed to be without any scientific evidence of safety,” Zuckerman points out, “requiring adverse events to be reported by physicians is especially important.”