Northeastern Law professors David Simon and Hooman Noorchashm together with Dr. Michael Paasche-Orlow of Tufts Medical Center, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC), recently submitted two petitions for accountability in medical device safety. In a citizen petition to the FDA, they request that the agency scrutinizes off-label use of the Da Vinci Robotic System and VATS systems in hybrid convergent ablation — an increasingly widespread clinical treatment approach for isolated persistent atrial fibrillation in elderly Americans. The procedure is frequently reimbursed by Medicare; the petition’s goal is to ensure that these human subject investigational treatments are not being unknowingly reimbursed by the Centers for Medicare and Medicaid Services (CMS).

The AJRC, a joint venture of Northeastern Law and Tufts Medical Center, is a pioneering academic and activist initiative focused on advancing medical device safety through increasing awareness, fostering collaboration and facilitating resource sharing among patients and industry experts. Its mission is to drive positive change in the field by advocating for safer medical devices and promoting transparency and accountability.

“We need regulatory action to protect patients, providers and payors,” said Simon. “Unsafe devices not only hurt patients but also put physicians at risk of legal action. Payors play a particularly important role since physicians won’t use devices that payors refuse to reimburse.”

In regard to the Symvess lab-grown blood vessel developed by the biotech company Humacyte, the team states in a petition to the US Department of Health and Human Services that the product should be immediately recalled and the company’s license for the product should be suspended and revoked because Humacyte has not demonstrated that Symvess is safe and effective for its approved use, the product presents a health hazard and it is not safe and effective for its intended uses or is misbranded with respect to any such use. The New York Times reported that the FDA approved the vessel “even though its own scientists flagged questionable study results and potentially fatal ruptures of the product.”

“The vast majority of medical devices in the US go through the 510(k) clearance process,” said Noorchashm. “The trouble is that this regulatory process operates outside of any reasonable evidence-based safety adjudication. Even more concerning is that the 510(k) process is highly susceptible to fraud. So the role of safety watchdog groups, like the AJRC, in surveillance of FDA and corporate actions in the US medical device marketplace should not be understated.”