The Medical Device Guardians Act would require physicians and physicians’ offices to report “adverse events” that occur when a medical device is in use and would also consider those individuals and institutions “protected.” Bill sponsors want to change the law after a “long delay in public awareness of the risks of a women’s surgical tool called the laparoscopic power morcellator,” the Wall Street Journal reported.
Starting in 2014, concerns arose about the likelihood for power morcellator devices to spread undetected sarcoma during certain gynecological procedures, and in November 2014 the FDA recommended against the use of the devices. However, medical studies and literature calling the devices’ safety into question had been floating around since the 1990s, the WSJ reported, though the FDA never received a report until 2013 when Dr. Amy Reed spoke up after a hysterectomy.
While current regulation requires manufacturers, importers and hospitals to report adverse events and product issues to the FDA, individual doctors don’t share the same burden. They are encouraged to and have been provided with multiple ways of doing so, including via smartphone.
Should this bill be adopted, doctors and doctors’ offices would be required all the same to report adverse events, and in doing so would be protected from those FDA reports being used against them in a civil case.
While many are praising this requirement–such as Rita Redberg, a cardiologist at the University of California San Francisco Medical Center, who told the WSJ it would be a “huge step forward”–the FDA noted that the current reporting system has “important limitations.”
The outlet also noted that the FDA is working on plans for a system that would use data collected during patient care to better understand safety issues and address them more quickly. The FDA also told the WSJ that the agency needs Congress and industry support to build such a system.
REFERENCE: Fierce Medical Devices; 09 JUN 2016; Alyssa Huntley