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我国手术机器人临床使用管理现状研究

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目的 分析我国手术机器人临床使用及管理现状,为规范手术机器人临床使用提供科学依据。方法 对国内手术机器人政策法规、注册审批等开展政策研究,同时对医院手术机器人使用管理现状开展问卷调查以及实地调研。结果(1)手术机器人不属于人工智能医疗器械;(2)国家多部门合力推进手术机器人发展,医疗机构相关配套管理建设急需加强;(3)手术机器人应用专科较为集中,泌尿外科占比46。81%、胃肠外科占比14。51%、胸外科占比14。20%、妇科占比11。03%、肝胆外科占比7。64%;(4)手术机器人操作人员遴选及培训考核机制不健全等。结论 加强国家层面的制度建设,完善手术机器人临床使用管理规范;提升医疗机构管理水平,做好配套保障措施;规范手术机器人临床使用培训,实现培训规范化、体系化;鼓励机器人手术相关不良事件上报及持续改进。
Research on the Current Situation of Clinical Use and Management of Surgical Robots in China
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.

surgical robotsclinical usemanagement status

马丽平、郭云剑、周辰雨、郭毅佳、刘心怡、王心舟

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国家卫生健康委医院管理研究所 北京 100044

北京大学第一医院 北京100034

首都医科大学 北京100069

浙江省台州医院循证医学中心 浙江 临海317000

内蒙古自治区人民医院 内蒙古 呼和浩特 010010

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手术机器人 临床使用 管理现状

2024

中国医院管理
中国医院管理杂志社

中国医院管理

CSTPCD北大核心
影响因子:2.15
ISSN:1001-5329
年,卷(期):2024.44(12)