Fitzpatrick Requests Hearing On Medical Device Safety

Press Release

Congressman Mike Fitzpatrick (PA-08), joined by several colleagues from across the country, requested the Committee on Energy and Commerce conduct hearings on the impact of unsafe medical devices on patients and the failings of the U.S. Food and Drug Administration.

"Many medical devices prove lifesaving, however some devices are having devastating effects on patients, and there must be an effective process in place to track these failures and to quickly remove these devices from the market" said Fitzpatrick. "Most of our device safety laws were written in the 1970's. Experts have continued to question the ability of regulators and the outdated laws to identify unsafe devices -- and it is putting Americans' health at risk. It's time we bring our medical device safety laws into the 21st Century. We must, and we can, maximize innovation and maximize safety."

Fitzpatrick was joined by his colleagues, Congresswomen Louise Slaughter (New York), Stephen Lynch (Massachusetts) Gwen Moore (Wisconsin), and Brenda Lawrence (Michigan), as well as Congressmen Chris Smith (New Jersey) and Ryan Zinke (Montana) on a letter to Energy and Commerce Chairman Fred Upton and Ranking Member Frank Pallone, requesting a hearing.

The letter highlights the cases of the laparoscopic power morcellator and the permanent contraceptive device Essure -- both FDA approved devices that have caused serious harm and even death. Regulators have yet to remove either device from the market.

According to a study by Johns Hopkins Medicine, medical errors are the third leading cause of death in the United States, equating to 10 percent of all annual deaths.. The congressional letter asserts that an improved ability by regulators and the medical community to identity and remove unsafe medical devices from the market could save thousands of lives each year.

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