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Bill Would Require Doctors to Report Medical-Device Hazards
The Wall Street Journal

Doctors would be required to report potentially serious problems with medical devices they use to the U.S. Food and Drug Administration, under a new bill that a pair of lawmakers is expected to introduce in Congress Wednesday.

The proposed legislation, known as the “Medical Device Guardian’s Act,” is intended to help raise awareness of the possible risks of medical devices that could cause harm to patients. Sponsors of the bill said they were motivated to change the law after the long delay in public awareness of the risks of a women’s surgical tool called the laparoscopic power morcellator.

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