Physicians lead charge for defective medical device reporting measures

August 25, 2016

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).

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. 

 

The problem of defective devices not being reported quickly to the FDA goes beyond morcellators, contends another doctor who has examined the issue.

Rita Redberg, MD, MSc, a professor and director of women’s cardiovascular services at the University of California, San Francisco who has studied the device reporting issue says, “the disturbing thing is there’s probably lots of other [medical devices] we don’t know about,” that are also defective. 

Redberg points to past problems with the leads of implantable cardioverter defibrillators and pelvic mesh as examples of defective devices that are now known.

“In all of those, the problem was noted by doctors several years before it was acted on by the FDA,” she says. “Our tracking system is woefully inadequate for a number of reasons but certainly one of them is it takes a lot of time and effort to report adverse events and doctors and doctors’ offices are not required to do it.”

Noorchashm recently journeyed from Philadelphia to Washington, D.C. to meet with Sen. Bob Casey (D-Pennsylvania) to lobby on behalf of the measure. Casey is a powerful voice on the Senate Health, Education, Labor & Pensions Committee, where such a proposal would likely be considered, Noorchashm says.

Whether the measure gets through Congress in its current session could depend on how the Senate addresses it, Noorchashm explains. He’s lobbying for it to be considered as a separate piece of Senate legislation to ensure quicker passage. If the Senate decides instead to lump it into its 21st Century Cures Act, the complexity of that measure could slow debate and possible passage, he says.

“There’s very good bipartisan support in the House of Representatives, the question is whether the Senate is going to be able to push this forth and get it to the president,” during its current session, he says. 

 

John Frank has more than 39 years of experience as a professional journalist and is a contributing author for Medical Economics.