[Congressional Record Volume 162, Number 112 (Tuesday, July 12, 2016)]
[House]
[Page H4671]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                        MEDICAL DEVICE GUARDIANS

  (Mr. FITZPATRICK asked and was given permission to address the House 
for 1 minute and to revise and extend his remarks.)
  Mr. FITZPATRICK. 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.

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