基于真实世界数据的达芬奇机器人手术系统安全性研究-《中国医学物理学杂志》

文章信息/Info

作者:: 饶兰1; 张培茗2; 柴岗3; 高中4; 1.上海理工大学医疗器械与食品学院，上海 200093； 2.上海健康医学院医疗器械学院，上海 201318； 3.上海交通大学医学院附属第九人民医院整复外科，上海 200011； 4.上海市医疗器械检测所，上海 201318

Author(s):: RAO Lan1; ZHANG Peiming2; CHAI Gang3; GAO Zhong4; 1. School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology, Shanghai 200093, China; 2. School of Medical Instrument, Shanghai University of Medicine & Health Sciences, Shanghai 201318, China; 3. Department of Plastic and Reconstruction Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; 4. Shanghai Testing and Inspection Institute for Medical Devices, Shanghai 201318, China

Keywords:: Keywords: real-world data; Da Vinci surgical robot; adverse event; safety

摘要:: 目的：分析达芬奇机器人手术系统在临床的使用情况，减少安全事故，提高系统的安全性。方法：以FDA的MAUDE数据库作为真实世界数据来源，依据FDA MAUDE数据库中对不良事件提供的分类方式进行分析，将达芬奇机器人手术系统不良事件报告分为"故障"、"伤害"、"死亡"、"其他"、"未明确给出回答"5类进行分类统计，分析设备故障类型及导致伤害或死亡的原因。结果：近10年总体不良事件数量由快速上升而后变为逐渐下降趋势，设备故障类不良事件数量至2014年后逐渐增多，到2018年有所下降，受达芬奇机器人手术系统复合增长率及使用频率增加等因素影响，2013年达芬奇机器人手术系统造成患者死亡及受伤的不良事件数量达到峰值。结论：随着达芬奇机器人手术系统应用的增加，安全事故时有发生，通过增加医生使用该系统的培训、降低设备的故障率和配备专业的仪器维护人员能有效提高该系统的安全性。

Abstract:: Abstract: Objective To investigate the use of Da Vinci robotic surgery system in clinic for reducing safety accidents and enhancing the safety of the system. Methods The MAUDE database of FDA was used as the source of real-world data. According to the classification of adverse events in the FDA MAUDE database, the adverse event reports of Da Vinci robotic surgery system were classified into "Malfunction", "Injury", "Death", "Others" and "No Answers Provided" for statistical analysis, and the types of system malfunctions and the reasons causing injuries or deaths were analyzed. Results The number of total adverse events in the past decade changed from a rapid rise to a gradual decline. The number of adverse events in equipment malfunctions had gradually increased since 2014, and was declined in 2018. Due to the compound growth rate of Da Vinci robotic surgery system and the increased frequency of use, the number of adverse events in the Da Vinci robotic surgery system that caused deaths and injuries reached the peak in 2013. Conclusion With the increasing application of Da Vinci robotic surgery system, safety accidents frequently occur. By providing doctors with the enhanced training of system operations, reducing the rate of equipment malfunctions and being?staffed?with professional instrument maintenance personnel, the safety of the system can be effectively improved.