By Richie Crider
It's been 15 years since FDA approved the first robotically assisted surgical device (RASD) and, since then, the use and complicity of the technology has increased significantly, making it more difficult for the agency to match up its regulatory approach with the pace of innovation.
When FDA and industry met during a recent public meeting to discuss just how far RASDs have progressed since 2000, the year FDA approved the da Vinci robotic surgery system, it was clear the agency has a lot of work left to do.
"Generally speaking, what we are actually dealing with is a partnership between people, surgeons mostly, technology, robotic devices, and information to change interventional procedures," said Russell Taylor, director of the laboratory for computational sensing and robotics at Johns Hopkins University (Baltimore). "I think the current RASD definition that we were presented is too narrow and will become increasingly less useful as we go ahead."
According to Taylor, RASD development is progressing toward more of a hybrid system in which information is combined with interactive surgeon control to help carry out some desired procedure. However, he said, eventually surgical robots may become only one element in an increasingly information-intensive environment. Taylor said he believes FDA needs to have safety and engineering standards in place to make sure the RASD functions in a way that is precise, repeatable and accurate.
"Interoperability of interfaces and systems will become more and more important," Taylor said. "There will be increasing need for standards describing both functional interfaces and information records. Also, there will be a need for certified implementations of open standards in software and system."
Overall, Taylor said, trying to regulate RASDs is fraught with challenges, such as determining the sorts of evidence that should be provided with iterative changes to marketed RASD platforms, and identifying additional data needed to support indications for specific procedures when the RASD is cleared for general use. Because of that, he believes RASDs should undergo rigorous testing over a full range of motions and speeds in realistic use setting to ensure the robot can perform desired tasks without risk to the patient.
"More and more the robot in only going to be one element in a really information-intense environment," he said. "In many respects, the robot may more appropriately be thought of as the room. That means we really do have to consider the architecture of interventional procedures overall."
Daniel Herron, professor of surgery and a chief surgeon at Mount Sinai Medical Center (New York), however, said he believes that despite the complexity of tasks the robots can perform, the level of evidence required to support approval or clearance should be parallel to that required for existing devices of similar function.
"The level of evidence required should reflect the device's functions, and evidence should include bench, animal and cadaver testing," he said. "Outcome testing is unnecessary, as it would be for a grasper, scalpel, stapler, energy device, etc."
Herron also believes current RASD regulations need to be revised to address anticipated future RASD development.
"It is hard to imagine that the mainframe and terminal paradigm for RASD will persist," he said.
"Future robots will become increasingly integrated within familiar interfaces and ultimately become truly intuitive if not invisible"
Registries may help to better evaluate RASDs
In discussing the agency vision for RASD, William Maisel, deputy director for science and chief scientist at the Center for Devices and Radiological Health (CDRH), touted the use of registries in keeping pace with RASD innovation.
"Historically, we've always thought of registries as being for postmarket surveillance, and certainly that's a great place to rely upon them," he said. "Registries for devices are particularly important because they can help capture not only the device performance but the performance of the ecosystem, the surgeons, and the hospitals, and how they are performing in real life."
Joshua Nipper, acting director of the division of surgical devices in CDRH's Office of Device Evaluation, discussed the Center's current approach to reviewing RASDs.
"We look at the performance specification, such as reliability, stability, kinematics and collision avoidance, and human factors such as ease of use," he said. "Interoperability is an issue for devices manufactured by RASD developers and then there are third-party devices manufactured by others. We review them differently. We have asked third-party companies to show interoperability with current versions of the RASD and also to have plans for future technologies."