When medical devices cause harm, manufacturers and hospitals are legally bound to report problems to the FDA. But shockingly, physicians aren’t. Right now, there’s no legal requirement for doctors, who don’t have to report medical device problems, even when the most dangerous implants or tools are involved.

The Medical Device Guardians Act

While many doctors, along with some patients, will report adverse events voluntarily, it’s absolutely certain that hundreds, if not thousands, of major problems fall through the cracks. Patients are hopeful that this gap in “post-marketing surveillance” will be closed soon, with the introduction on Wednesday, June 16, 2016 of a bill hoping to change the legal requirements for reporting adverse events.

If passed, the “Medical Device Guardians Act” would change a mere phrase in the Federal Food, Drug and Cosmetic Act, but that minor change will have major implications for public safety.

It’s purpose, according to sponsor Mike Fitzpatrick, a Republican State Rep. from Pennsylvania, is “to amend the Federal Food, Drug, and Cosmetic Act to require physicians and physician’s offices to be treated as covered device users required to report on certain adverse events involving medical devices, and for other purposes.”

A Small Change With Big Consequences

As currently written, the Food, Drug, and Cosmetic Act uses the phrase “device user facility” to describe those entities required to report medical device adverse events. Elsewhere, the word “facility” is used on its own, but you can already see the problem. Doctors aren’t “facilities”; hospitals are. That definition is far too narrow, in Fitzpatrick’s view, and it should be changed. The Medical Device Guardians Act would remove the word “facility,” and replace it with “user.” In the new act, “user” (or “covered device user”) would take on a broad range of meanings, including:

  • hospitals
  • ambulatory surgical facilities
  • nursing homes
  • outpatient treatment facilities
  • physicians
  • physician’s offices

Device user facility,” on the other hand, is currently defined to include:

  • hospitals
  • ambulatory surgical facilities
  • nursing homes
  • outpatient diagnostic facilities
  • outpatient treatment facilities

The difference is immediately clear. The new Food, Drug and Cosmetic Act would go beyond these “facilities” to include the people in those facilities who actually use medical devices. Fitzpatrick says physicians, who are closest to the real-world use of these devices, are most likely to notice disturbing safety trends before they become public health crises.

Medical Device Reporting Is Broken

We already have good evidence that making this minor change in the law’s language will have a huge impact on public health.

In recent months, major breakdowns in the way medical device problems are reported have been linked to thousands of deaths and severe injuries. The Medical Device Guardians Act itself was inspired by the deaths of three women, Barbara Leary, Brenda Leuzzi and Linda Interlichia, who all had undiagnosed cases of uterine cancer artificially exacerbated by a medical device called the power morcellator. Despite medical reports of the device’s dangers as early as the 1990s, the first adverse event reported to the FDA only came in 2013.

Reporting Can Save Lives Infographic

Essure, a permanent birth control implant, is another telling example. In its public statements, the FDA made clear that Essure had only been linked to five instances of fetal death. But an independent investigation identified more than 300 reports of fetal death, a terrifying number that had never been passed on to the public.

In light of these apparent failures, it’s clear that our medical device requirements need a complete overhaul. Mike Fitzpatrick, along with the bill’s co-sponsor Connecticut Rep. Louise Slaughter and hundreds of thousands of patients, are hoping the Medical Device Guardians Act is a first step in the right direction. Of course, change is never quick in the world of legislation. Even after its passage, the bill’s new requirement would only go into effect after 3 years.