With surgeons using robotically assisted surgical devices in new ways, the FDA wants more information on how to best assess these tools to ensure the safety of patients while enhancing innovation.
To that end, academics, clinicians and members of industry gathered last week at the FDA’s White Oak campus in Silver Spring, Md., to discuss questions related to interoperability, training and differentiating between general use and specific indications of RASDs.
William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, noted that healthcare providers are using devices in ways that the agency hasn’t thought of or off-label, adding that it would be a shame to not learn from these real-world examples. One way to capture lessons is through a national or international registry.
Currently, Intuitive Surgical’s da Vinci system is the only RASD marketed in the U.S. Its latest model, the SP999, was introduced last year. With more devicemakers looking to enter the RASD market in the coming years, the complex technology will pose regulatory challenges for the FDA, according to an agency white paper released ahead of the meeting.
This complexity only will increase with time, and the current definition of the technology is too narrow and will become “less useful,” as developers forge ahead with innovative products, according to Russell Taylor, PhD, the John C. Malone professor of computer science at The Johns Hopkins University.
While some might view this growing complexity as potentially leading to more adverse patient events, workshop presenter Daniel Herron, MD, professor of surgery at the Mount Sinai Hospital, didn’t agree. “All you need is a clamp, scalpel or a needle driver to cause great harm,” he said.
Indeed, the white paper pointed to many benefits of using the technology versus other surgical methods, including increased precision and accuracy of motion.
The general consensus was that the bar should not be set too high in terms of getting new RASDs to market. “It’s going to be interesting to see how new robotics will be judged,” said urologist Vipul Patel, MD, professor of Urology at the University of Central Florida College of Medicine.
Da Vinci was cleared by demonstrating substantial equivalence to laparoscopic devices. Patel wondered if getting new RASDs to market would be difficult if they had to prove substantial equivalence to da Vinci due to intellectual property and patent concerns. He expressed reservations about too many regulatory burdens impeding innovation: “That’s not good for us in the long term,” he said.
As part of the workshop, the FDA was interested in gathering input for approving indications for specific procedures and general use. The FDA generally considers new, specific indications to fall within the scope of the cleared general use, though they should be supported by additional preclinical, animal, literature or clinical data.
Myriam Curet, MD, a surgeon and chief medical officer at Intuitive, said that general indications don’t necessarily mean anything to healthcare professionals. She suggested a proposed paradigm through which a general indication could be supported by data on specific procedures most representative of the indication as a whole.
Steven Schwaitzberg, MD, professor and chair, department of surgery at University at Buffalo School of Medicine and Biomedical Science, said data collection may be necessary to support specific procedures, such as adding a pediatric indication.