Research on the Current Situation of Clinical Use and Management of Surgical Robots in China

Ma Liping; Guo Yunjian; Zhou Chenyu

Abstract：Objective To analyse the current status of the clinical use and management of surgical robots in China and to provide scientific evidence for the standardization of clinical use.Methods It conducted policy research on domestic surgical robot regulations,registration,and approval processes,along with a nationwide survey and on-site investigation into the current management and use of surgical robots in hospitals.Results (1) Surgical robots are not classified as AI medical devices.(2) Multiple departments are working together to promote the development of surgical robots,but supporting management systems need to be strengthened.(3) The use of surgical robots is concentrated in specific specialties:Urology (46.81％),Gastrointestinal Surgery (14.51％),Thoracic Surgery (14.20％),Gynecology (11.03％),Hepatobiliary Surgery (7.64％).(4) The mechanisms for selecting and training surgical robot operators are not well-established.Conclusion Strengthen national-level regulatory frameworks and improve management standards for surgical robots.Enhance the management capabilities of healthcare institutions and ensure supporting measures are in place.Standardize clinical training for the use of surgical robots and gradually achieve systematic and standardized training.Encourage the reporting and continuous improvement of adverse events related to robotic surgeries.