News Feature | June 9, 2016

"Medical Device Guardian's Act" To Expedite Self-Reporting Of Adverse Events

By Suzanne Hodsden

U.S. House Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-N.Y.) have sponsored the “Medical Device Guardian’s Act of 2016,” a bill that would require doctors and hospitals to report adverse events associated with medical devices while protecting them from potential liability exposed by their reports. Sponsors of the bill argue that medical practitioners are in the best position to observe concerning trends in device safety, and can report these events sooner than anyone else.

The bill was motivated by growing concerns over power morcellators, a surgical tool used in minimal incision surgical (MIS) procedures such as hysterectomy or myomectomy, where organs are cut into pieces that can be removed laparoscopically.  In 2014, the FDA issued guidance warning that these procedures excise tissue that is potentially cancerous and could risk the spread of cancer throughout the rest of the body.

Hooman Noorchashm and Amy Reed, two Philadelphia-based physicians, spearheaded efforts to raise awareness about morcellator safety after Reed was diagnosed with cancer not long after undergoing an MIS hysterectomy.  In an editorial published by the Philadelphia Inquirer, Reed and Noorchashm praised a letter signed by 12 congressmen and women last August, calling on the Government Accountability Office (GAO) to investigate potential negligence on the part of the FDA in clearing and surveilling morcellation technology.  

In a more recent editorial, Noorchashm and Reed proposed the Medical Device Guardians Act, which they claim is the most practical solution to medical device surveillance. Requiring the government to shoulder sole responsibility for “active surveillance” is likely to be costly and ineffective, argued Reed and Noorchashm, when doctors and hospitals are most likely to have the best access to relevant data.

“It is the fear of liability and the FDA’s lax enforcement of ‘self-reporting’ requirements that has created a ‘culture of complacency’ in the medical device space,” wrote Noorchashm and Reed. “Legislation that would protect individual practitioners from liability when reporting adverse outcomes associated with the use of medical devices, and prosecuting failures to ‘self-report’ would reveal problems very quickly.”

Current FDA policy requires manufacturers and hospitals to report all adverse events and additional labeling information to the agency, where it is available to the public through a centralized database. Though doctors are encouraged to report, they are not required to do so. The proposed bill would amend language in the current policy to add doctors’ offices to the list of reporters.

“In retrospect, it should not have fallen on patients to get the FDA’s attention,” wrote Reps. Fitzpatrick and Slaughter in a letter introducing the bill, reported the Wall Street Journal (WSJ).  “Everyone in the chain of care” should be responsible for reporting adverse events to FDA.

The FDA has not commented on the bill, but suggested in a statement that current agency surveillance efforts with medical devices have “important limitations.”  According to WSJ, the FDA has proposed a national evaluation system that would use data “generated during patient care to identify safety issues more promptly.”

In 2014, Johnson & Johnson halted international distribution of its portfolio of morcellation technology, but WSJ  reported that many gynecologists were still performing the procedure, arguing that the devices are an important tool that reduces risk to women undergoing surgery. The FDA recently approved a first-of-its kind container bag for certain power morcellator procedures.