天玑骨科手术机器人的临床使用风险分析与对策探讨  

Risk control and countermeasure discussion on application of TIANVI orthopedic robot

作　　者：杨倩倩 丁立祥 郭大为 胡竞竞 郭宇阳 YANG Qian-qian;DING Li-xiang;GUO Da-wei;HU Jing-jing;GUO Yu-yang(Operation Room,Beijing Shijitan Hospital Affiliated to Capital Medical University,Beijing 100038,China;Department of Spine Surgery,Beijing Shijitan Hospital Affiliated to Capital Medical University,Beijing 100038,China;Department of Clinical Medical Engineering,Beijing Shijitan Hospital Affiliated to Capital Medical University,Beijing 100038,China;Beijing Information Science and Information Technology University,Beijing 100192,China)

机构地区：[1]首都医科大学附属北京世纪坛医院手术室,北京100038 [2]首都医科大学附属北京世纪坛医院脊柱外科,北京100038 [3]首都医科大学附属北京世纪坛医院医学工程处,北京100038 [4]北京信息科技大学,北京100192

出　　处：《生物医学工程与临床》2022年第4期497-501,共5页Biomedical Engineering and Clinical Medicine

摘　　要：探讨天玑骨科手术机器人在临床使用中的潜在风险及管理措施,以保证它在临床使用中的安全性和有效性。基于天玑骨科手术机器人的工作原理和技术特点,应用失效模式和效果分析法评估其使用风险和危害性,再应用鱼骨图法分析导致其故障的各种潜在风险要素。通过骨外科、手术室、医工处及供应室等多部门协作,制定并实施护理配合、消毒灭菌、质量控制及应急处理环节的风险控制措施,为2020年81台天玑骨科手术机器人提供了安全保障。基于风险评估和分析结果,制定并实施天玑骨科手术机器人在各临床使用环节中相应的风险管理措施,具有重要的临床意义和参考价值。To explore the potential risks and management measures of TIANVI orthopedic surgical robot for ensuring its safety and effectiveness in clinical practice. Based on working principle and technical characteristics of TIANVI orthopedic surgical robot, the application of failure mode and effect analysis method were used to evaluate its operational risks and hazards, and then the fishbone diagram was used to analyze various potential risk factors of failure. The risk control measures of nursing cooperation, disinfection and sterilization, quality control and emergency treatment were formulated and implemented by cooperation of multiple departments such as orthopedic surgery department, operating room, medical department and supply room,which provided security for 81 cases of orthopedic robotic surgery in 2020. It is demonstrated that based on results of risk assessment and analysis, it is of great clinical application value and reference significance to develop and implement risk management measures for each clinical link of surgical robot.

关 键 词：骨科 手术机器人 临床使用 失效模式和效果分析法 风险分析 质量控制 鱼骨图 

分 类 号：R197.39[医药卫生—卫生事业管理]