Reliability, biocompatibility and other standard medical device safety concerns still apply. But a few areas stand out in robotic-assisted surgery, said Mark Toland, CEO at surgical robotics developer Medical Microinstruments (MMI).
“Most of the safety elements that have been incorporated into robotics have really been driven off of the robot connecting to something in the hospital. … The FDA’s more focused in on cybersecurity and then, secondarily, user error,” he said
Before joining Italy-based MMI, Toland was president and CEO of Corindus Vascular Robotics, which he helped sell to Siemens for $1.1 billion in 2019. He recently explained how some robotic surgery safety systems help surgeons do their best work while keeping patients safe from errors or malfunctions.
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Surgical robotics cybersecurity
Secure connectivity is a challenge for developers of surgical robotics and many other medical devices.
“You insert technology into the hospital and that data needs to transfer over and through something in a setting that’s not your building. It’s a building owned and operated by a different entity,” Toland said. “You need to have a certain level of security to ensure [the FDA is] comfortable with that.”
In 2015, University of Washington researchers successfully hacked the Raven II teleoperated robotic system, but said surgical robotics systems in hospitals with private networks would likely not have the same vulnerabilities. Raven II was controlled over the internet, including an unmanned aerial vehicle (UAV) wireless network.
However, as medical devices of all types are increasingly connected to wireless and hardwired networks, cybersecurity remains a key concern — especially for devices that could cause serious harm or death if they fail or malfunction.
Citing the growing threat, the FDA has cybersecurity guidance and other resources at its website.
User errorPutting a robotic system between a surgeon’s hand and their instrument offers the potential to improve performance, but also introduces complexity and new risks. User error will be a safety risk as long as people are operating surgical robotics.
“Almost all the robots are operated by a human,” Toland said. “There are actually very few robots that are autonomous.”
The MMI Symani system uses handheld controls that track a surgeon’s hand movements with an electromagnetic reference field. The system’s software can smooth a surgeon’s hand tremors to keep the robot’s micro instruments from shaking, and safety features detect if the controls are dropped or moved in a dangerous way.
Intuitive’s DaVinci system features infrared head sensors to prevent the patient cart’s robotic arms from moving if the surgeon’s head is not in the viewer. The DaVinci system also requires surgeons to “match grips” before taking control of the instruments to prevent inadvertent activation, and to prevent inactive instruments from accidentally dropping items when activated.
Stryker’s Mako robotic-arm assisted Total Knee Arthroplasty has safety planes built into its software.
“These safety planes serve as virtual walls which protect the saw blade from contacting the anatomy prior to entering the stereotactic boundary,” Stryker explains in the system’s user manual. “The orientation of these safety planes changes with each cut to protect the anatomy accordingly; however, all safety planes are offset approximately 20 mm from the bone.”
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This is a basic safety feature found on most automated machinery to stop system operation at any time. They’re brightly colored and within easy reach in case of a malfunction or another emergency.
Intuitive Surgical’s DaVinci system has a red emergency stop button on the side of the surgeon console armrest. MMI’s Symani Surgical System has yellow emergency stop buttons on the surgeon’s chair and the patient console.
Cutting-edge software safety
Medical device developers are increasingly tapping artificial intelligence (AI), algorithms and sensors to collect, analyze and use data to improve device performance. For developers of surgical robotics systems, that offers improved safety, speed and patient outcomes.“More and more robot companies are starting to build algorithms of work meaning if you’ve got the best doctor in the world that does a particular algorithm in motion, how does that then translate — can you replicate that in the robot? That’s a whole different world of software safety elements,” Toland said.
Interoperative AI is the application of data during procedures that can allow a surgeon to put the surgical robot on autopilot to perform some or all of a procedure.
“That’s a journey that we are just now starting, which is kind of the exciting part of this high-tech world around robotics,” Toland said. “There are some companies out there that have gotten there relatively quickly. Procept is one of them. Procept has a robotic system, and the physician doesn’t do anything. There’s no robotic-assisted approach other than mapping it and turning it on it. That is on the forefront of where we’re going with algorithmic work in the interoperative AI world.”
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