Surgeons have unveiled a novel framework that provides a ‘critical safety net’ for the advancement, evaluation and supervision of surgical robots.
The roadmap marks a significant milestone in the evolution of surgical robotics, offering guidance in harnessing the potential of transformative technologies while prioritising patient safety, clinical efficacy and ethical considerations.
The framework is detailed in a consensus statement published in Nature Medicine and represents a collaborative effort involving 81 researchers from 12 countries.
The initiative comes at a pivotal moment in the evolution of robotic-assisted surgery.
Patents related to foundational features of the da Vinci system are about to expire.
The robotic surgical system has been a cornerstone in the field since its introduction by Intuitive Surgical in 1999.
The milestone spurred a surge in innovation, leading to other systems boasting advanced functionalities beyond those of predecessors.
The carefully crafted and comprehensive framework is designed to navigate the integration of robots into surgical practice, ensuring readiness for widespread adoption.
Hani Marcus of UCL Queen Square Institute of Neurology is the lead author of the consensus statement.
He emphasised the framework’s inclusive nature, including input from clinicians, patients, hospitals and developers.
‘This framework transcends mere clinical considerations, placing patients at its core. It encompasses recommendations ranging from evaluating ergonomics to assessing economic viability, underscoring the diverse perspectives essential for successfully integrating these technologies into the operating theatre.’
The framework maps out key stages for evaluating robotic systems throughout their lifecycle, encompassing pre-clinical and early clinical assessment, comparative evaluation and long-term monitoring.
Early clinical evaluation emphasises the importance of documenting modifications to robots and their software, fostering collaborative relationships between robots and surgeons, and implementing transparent patient consent procedures.
The subsequent comparative evaluation stage advocates for refining techniques, establishing governance policies, and conducting comparative studies against established standards to bolster the evidence base.
Finally, long-term monitoring emphasises the need for standardised clinician training and ongoing patient outcome assessment to ensure robotic-assisted surgery's continued efficacy and safety.
Professor Danail Stoyanov of UCL Computer Science and Director of the Wellcome/PSRC Centre for Interventional and Surgical Sciences (WEISS) highlighted the significance of this framework in navigating the proliferation of robotic technologies, particularly amid the advent of artificial intelligence and autonomous robots.
‘With the emergence of a multitude of robotic systems, this framework serves as a critical safety net. It addresses current challenges and positions us to adapt to future advancements, safeguarding the integrity and efficacy of robotic-assisted surgery.’
The collaborative effort underscores the interdisciplinary nature of robotic surgery research, with WEISS serving as a nexus for collaboration among researchers from diverse disciplines, including medical physics, biomedical engineering, computer science, and mechanical engineering, alongside clinical researchers from institutions such as the UCL Division of Surgery & Interventional Sciences and leading hospitals.
