4 Reps Introduce Faulty Device Reporting Bill

Four Democratic representatives have introduced the Medical Device Guardians Act to put into law an existing mandate of the American Medical Association’s Code of Medical Ethics recognizing that doctors are in the best position to identify and report unsafe medical devices. The bill also would add doctors’ reports to the groups, such as hospitals, protected from having their reporting to FDA used against them in a civil suit.

The representatives say the bill was inspired by Amy Reed, a mother of six who underwent a procedure using a laparoscopic power morcellator that hit an undetectable fibroid cancer and spread it throughout her body. She died at age 44 after fighting her cancer for 42 months.

Her report was said to be the first adverse event report received by FDA for the device, despite the same hospital having had a patient harmed by a morcellator one year earlier.