中国食品药品监管Issue(12)：94-101,8.DOI:10.3969/j.issn.1673-5390.2025.12.010
电动吻合器真实世界临床使用风险调查研究
A Real-World Study on the Clinical Use Risks of Electric Surgical Staplers
摘要
Abstract
Objective:This study aims to investigate the real-world clinical use of electric surgical staplers and to provide references for risk prevention and control by relevant stakeholders.Methods:A questionnaire survey was conducted across 258 medical institutions in China.Combined with an analysis of product instructions for use(IFUs)and relevant domestic and international regulatory policies,a comprehensive evaluation of the clinical use risks of electric surgical staplers was performed.Results:The number of adverse event reports related to electric staplers has been increasing annually,with a notable surge in 2024.Several issues were identified during clinical use,including non-standardized operations and insufficient awareness of compliant medical device use.For instance,22.91%of users did not perform the required pre-compression procedure,and over 50%were unable to correctly distinguish the regulatory classification of electric surgical staplers.In addition,deficiencies in the standardization of product IFUs were observed.Conclusion:Electric surgical staplers present multiple risks,including inadequate guidance in IFUs and non-standardized clinical operations.Medical device registrants,user institutions,and regulatory authorities should strengthen coordinated,full life-cycle quality management to ensure the safety of medical device use.关键词
电动吻合器/上市后监测/安全性评价/真实世界研究/不良事件Key words
electric surgical staplers/post-market surveillance/safety evaluation/real-world study/adverse events分类
机械制造引用本文复制引用
LI Dong,YIN Jan-bing,ZHANG Lan,XU Hui-wei..电动吻合器真实世界临床使用风险调查研究[J].中国食品药品监管,2025,(12):94-101,8.基金项目
海南省科技专项资助项目(ZDYF2024LCLH007) （ZDYF2024LCLH007）
