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    Physicians lead charge for defective medical device reporting measures

    A Pennsylvania physician is lobbying Congress to act on a new proposal that would require doctors to report defective medical equipment to the Food and Drug Administration (FDA).

    The Medical Device Guardians Act, cosponsored by Reps. Mike Fitzpatrick (R-Pennsylvania) and Louise Slaughter (D-New York.), was introduced in the House of Representatives earlier this summer. The bill comes after years of concerns that the current FDA review process is not catching medical device defects. The most prominent example concerns problems that showed up with power morcellator use in women. The devices are used to break up fibroids, but their use has been linked to the spread of uterine cancer cells in patients. 

    The measure calls for amending the wording of the Federal Food, Drug, and Cosmetic Act to include physicians and physician offices in the term “covered device user.” That would have the effect of requiring doctors to report known defects in medical devices. As currently worded, the law requires only reporting from hospitals, ambulatory surgical facilities, nursing homes and outpatient treatment facilities.

    Anti-morcellator activist and thoracic surgeon Hooman Noorchashm, MD, PhD, says the bill would be the quickest way to start doctor reporting because it uses the FDA’s current reporting structure rather than creating a new process for doctors to use.

    Noorchashm’s wife, Amy Reed, MD, says she had cancerous tissues spread throughout her abdominal cavity during a hysterectomy in which a morcellator was used to remove fibroids. 


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