Proposed Legislation Could Mandate Physician Reporting of Adverse Events With Medical Devices


New legislation introduced last week by Reps. Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) may have substantial implications for the daily routines of cardiologists who treat patients with devices.

Implications. Proposed Legislation Could Mandate Physician Reporting of Adverse Events With Medical Devices

The Medical Device Guardians Act would require physicians and physicians’ offices to report any adverse events that arise after the use or implantation of a medical device. The bill stems from controversy over a uterine morcellator that led to the spread of undiagnosed cancer after being used in a patient in 2013—a complication that was never reported to the US Food and Drug Administration (FDA) until the patient spoke out. If the bill becomes law, physicians would also be given additional protection against lawsuits related to medical devices.

“While many medical devices prove lifesaving, we know that some can cause harm and have devastating consequences on patient[s],” said Fitzpatrick in a press statement. “It’s time we reform the FDA, its processes and procedures to allow for maximum innovation and maximum safety. Agencies, physicians and lawmakers should all be committed to this common cause, and open to these bipartisan solutions.”

The second bill, called Ariel Grace’s Law, would remove the legal protection given to manufacturers of devices that underwent the FDA’s premarket approval process. The bill is named after a stillborn baby whose cause of death was related to Essure (Bayer), the fallopian tube sterilization coils approved in 2002 as a minimally invasive alternative to tubal ligation.

Commenting on the proposed legislation for TCTMD, Mitchell Krucoff, MD (Duke Clinical Research Institute, Durham, NC), said that patients, physicians, and regulators alike all “want safe medical devices,” but he raised concerns that this legislation is a “blunt instrument [intended] to do some delicate work” rather than providing a more nuanced solution.

Cardiac devices have had their fair share of complications, Krucoff said, listing stent thrombosis, paravalvular leak, and “misbehaving” defibrillator leads as a few examples. However, “the reality . . . is that all medical devices taken together are very heterogeneous in their characteristics,” he observed.

Device-related complications are indeed under-reported, Krucoff continued, “but turning on a spigot and making it mandatory to report every patient who has any kind of complication . . . could also create a nightmarish watershed of aimless reports.”

‘Dual-Purposing’ Existing Information Could Save Time

Rita Redberg, MD (University of California, San Francisco), a long-time advocate for better oversight of medical devices, told TCTMD in an email that these bills would likely affect cardiologists and orthopedic surgeons “more than most doctors, as we use and implant the most devices.” LAA closure devices, PFO occluders, stents—“especially the newer ones”—defibrillators, and cardiac resynchronization therapy (CRT) devices are most likely to be impacted, she predicted.

Generally positive about the legislation, Redberg said the fact that physicians have never been required to report device complications is a “major gap . . . as we are first line.”

The biggest limitation to adverse event reporting will be time, she noted, “so making the process as user-friendly . . . as possible is key. It is also important to improve the search capabilities of the adverse event reporting database.”

Krucoff strongly agreed. He has previously advocated for greater linkage between electronic health records (EHRs) and outcomes, and has worked with the FDA to strengthen existing medical device registries. Already-existing data “could be tracked or mapped for safety surveillance purposes without anybody having to do extra work,” he said. This “dual-purposing” of information would be more likely than legislation to preserve innovation without compromising safety, Krucoff added.

Redberg, for her part, doesn’t believe that more reporting of adverse events will stifle advances in device development. Rather, “for all devices, including innovative ones, we are balancing the risks and benefits, and to do so we must have accurate information on both,” she said.

But Krucoff pointed out that the progress, by nature, relies to some degree on failure. “Early-generation devices . . . are inevitably less safe and effective than subsequent generations,” he said. “But the very first of these breakthrough technologies still offer therapeutic options to patients that previously were unavailable. So the context is very important to preserve and whether legislation will [accomplish] that is less clear.”

As for the future of the bills, whether they will become law is uncertain. Fitzpatrick is in his last term in the House and the summer congressional break begins in a few weeks. Also, making it to the President’s desk will require bipartisan Senate support.

 


 

 

 

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Sources
  • Fitzpatrick, Slaughter announce package of medical device, FDA reform bills. https://louise.house.gov/media-center/press-releases/fitzpatrick-slaughter-announce-package-medical-device-fda-reform-bills. Published June 8, 2016. Accessed June 14, 2016.

Disclosures
  • Krucoff reports serving as a special government employee of the US FDA and working widely with the device industry.
  • Redberg reports no relevant conflicts of interest.

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