On the recordJuly 12, 2016
Mr. Speaker, I rise in support of the Medical Device Guardians Act. The Guardians Act updates current laws regarding the reporting of unsafe medical devices by requiring that physicians and their offices be added to the list of entities that must report unsafe medical devices to the device manufacturer and to the FDA. The tragic stories of women harmed by one particular device known as a laparoscopic power morcellator highlight the need for the Guardians Act. Despite cancer being spread for years by the blades of this device, no one ever reported this deadly safety defect to the FDA. That is until Amy Reed, a mother of six and a doctor underwent morcellation and had cancer spread throughout her body. It should not have fallen on patients to get the FDA's attention. This bill simply codifies an existing mandate of the American Medical Association's Code of Medical Ethics, which recognizes that physicians are in the best position to identify and report unsafe devices. Today, reporting unsafe devices to the FDA is as easy as downloading an app on a smartphone. This is a reasonable fix that will save lives. I urge my colleagues to support it. ____________________





