Suits & Scrubs: Regulating Robotically Assisted Surgeries

By: Dejaih Johnson

Medicine is rapidly approaching a time where robots will perform surgeries autonomously. From minimally invasive surgery to emergency response and medical robotics, robotically assisted surgeries now represent one of the fastest growing sectors in the medical devices industry. The introduction of these robotic medical devices has made medical operations much more efficient and effective. Surgeons have reported quicker recovery times, less pain, and less blood loss when using a robotic medical device. Though these devices have the capacity to greatly improve the practice of medicine, their usage is not without issue. Over the past twenty years, robotic surgeries have resulted in more than 144 deaths, 1391 injuries, and 8061 device malfunctions. 

Lack of regulation in this area raises many regulatory, ethical, and legal issues. In the European Union (EU), for example, they have yet to establish a clear regulatory framework. Under the Medical Devices Directive, the EU classifies these devices as “Class IIb medical devices”. This means that surgical robots are regulated in the same category as scissors and scalpels. Additionally, the EU does not recognize separate qualifications for surgeons. This approach has proven problematic since surgeons using medical robots require special skills different from that of regular surgeons, such as the ability to control the robot’s manipulators. EU manufacturers are required to seek a certificate for each medical device they wish to sell, but the process is not specific to robotically assisted surgeries. 

On the other hand, the United States has taken a bit of a different approach. Currently, the Food and Drug Administration (FDA) regulates robots as medical devices. The issue, however, lies in the fact that the FDA can regulate them only as medical devices since the FDA lacks the authority to regulate the practice of medicine. Presently, robotic devices in the United States are only used under the supervision of surgeons. For example, surgeons enter calculations and program decisions into their robotically assisted surgical devices. But the United States has failed to fully develop an appropriate regulatory scheme to address this unique issue.

Scholars from varying disciplines have weighed in on the question of how to regulate this practice. One approach, developed by Guang-Zhong Yang, takes into account the uniqueness of medical robotics: the varying levels of autonomy at which the device may operate. As the level of autonomy increases, more stringent regulations and additional requirements would apply. Yang proposes six levels of autonomy for medical robotics, with accompanying levels of regulation and procedure for each. The six levels would break down as follows:

Level 0 – No autonomy: Includes tele-operated robots or prosthetic devices that respond to and follow the user’s command; may also include a surgical robot with motion scaling. 

Level 1 – Robot assistance: Robot provides some mechanical guidance or assistance during a task while the human has continuous control of the system (e.g., surgical robots with virtual fixtures and lower-limb devices with balance control). 

Level 2 – Task autonomy: Robot is autonomous for specific tasks initiated by a human. Operator has discrete, rather than continuous, control of the system (e.g., suturing where the surgeon indicates where a running suture should be placed, and the robot performs the task autonomously while the surgeon monitors and intervenes as needed). 

Level 3 – Conditional autonomy: System generates task strategies but relies on the human to select from among different strategies or to approve an autonomously selected strategy. Robot can perform a task without close oversight (e.g., where active lower-limb prosthetic device can sense the wearer’s desire to move and adjusts automatically without any direct attention from the wearer). 

Level 4 – High autonomy: Robot can make medical decisions but under the supervision of a qualified doctor (e.g., robotic resident who performs the surgery under the supervision of an attending surgeon). 

Level 5 – Full autonomy: No human needed; robot can perform an entire surgery. 

In addition to taking into account the varying levels of autonomy, manufacturers of the device would have to seek licensing and certification from the hospital. The upside of this would be that the framework allows regulators to establish a forward-thinking approach to the robotic medical devices. 

As technology advances faster than regulation, regulators must determine an appropriate framework to address the myriad of issues. Even in the uncertainty, however, it still remains there must be a response to the influx of regulatory, ethical, and legal questions raised. 

References:

Damini Kunwar, Robotic Surgeries Need Regulatory Attention(Jan. 8, 2020), The Regulatory Review, https://www.theregreview.org/2020/01/08/kunwar-robotic-surgeries-need-regulatory-attention/.

Guang-Zhong Yang, et al., Medical robotics – Regulatory, ethical, and legal considerations for increasing levels of autonomy(Mar. 15, 2017), Science Robotics, http://robotics.tch.harvard.edu/publications/pdfs/yang2017medical.pdf.