U.S. Rep. Brian Fitzpatrick (R-PA) on May 22 proposed a bipartisan bill that would require physicians to be treated as covered medical device users who then could issue reports to the federal government on any flawed devices.
“Underreporting of faulty medical devices has contributed to the harm or death of Americans across the country and we must ensure those on the front lines take the steps necessary to save lives,” Rep. Fitzpatrick said on Tuesday.
Rep. Fitzpatrick sponsored the Medical Device Guardians Act, H.R. 2915, with lead cosponsor U.S. Rep. Lloyd Doggett (D-TX) to amend the Federal Food, Drug, and Cosmetic Act to classify physicians as they are under an existing mandate of the American Medical Association’s Code of Medical Ethics as being in the best position to identify and report defective devices, according to a summary of the bill provided by the congressman’s office.
Additionally, H.R. 2915 would add physicians’ reports to the list of groups that are protected under current law from having their reporting to the U.S. Food and Drug Administration (FDA) used against them in a civil lawsuit case, the summary says.
“I will continue to raise awareness of faulty or harmful medical devices and advance legislation that protects patients and puts their interests first,” Rep. Fitzpatrick said.
H.R. 2915 was inspired by Dr. Amy Reed, 44, a mother of six, who died in 2017 after having her uterine fibroids treated via a laparoscopic power morcellator. The device’s blades hit an undetectable fibroid cancer, spread it throughout the doctor’s body, and advanced her Stage 1 cancer to Stage 4, which she fought for almost four years, according to Rep. Fitzpatrick’s office.
Dr. Reed’s report on the device became the first “adverse event report” received by the FDA, according to the lawmaker’s office, which noted that a subsequent 2017 report from the Government Accountability Office also confirmed gaps in the FDA’s approval process for power morcellators, as well as the agency’s failure to identify the unsafe device.