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Bill would require doctors to report faulty medical devices

Emergency Room

A simple medical procedure can become a life-threatening tragedy if medical devices designed to heal instead cause harm. A new bipartisan bill in Congress aims to better regulate medical devices and protect patients, and for the first time require doctors to report issues that arise.

There's no current law in place requiring doctors to report problems or complications from medical devices, leaving the FDA sometimes unaware that problems exist.

Amy Reed, a mother of six, a doctor and now a cancer patient, went in for a routine surgery for fibroids. The medical device that was used spread a previously undiagnosed cancer throughout her body.

"These people had been shredding tumors inside people for 20 years," Reed said.

As a patient, Reed reported the problem with the device to the FDA. She was the first to do so, but hundreds of other complaints followed. An FDA warning was later sent out about the device, called a power morcellator.

The Medical Device Guardians Act would require that doctors report problems or possible complications from medical devices directly to the FDA. Reporting is currently not mandatory.

"Who knows how many devices have been hurting people and at what frequency because people haven't really been reporting it," said Reed.

Rep. Mike Fitzpatrick, R-Pennsylvania, and Rep. Louise Slaughter, D-New York, introduced the bill.

"Hundreds of Americans are being harmed by the very medical devices that they and their physicians have turned to for help," Fitzpatrick said.

Doctors already report problems with prescription drugs.

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