气管插管不良事件分析

Analysis of Adverse Events of Endotracheal Intubation

目的:分析气管插管在临床使用中发生不良事件的特点和规律,为产品的安全使用提出意见建议。方法:对2019-2021年福建省上报的99份气管插管不良事件报告进行回顾性统计分析。结果:99份不良事件报告中严重伤害报告占45.45%;65岁以上患者占39.4%;不良事件发生时间集中在插管时及术后管理过程中;伤害表现主要为多次重复插管、咽喉部黏膜损伤等;器械故障部位主要为套囊、充气管、指示气囊;故障表现主要为漏气、破裂等压力不足故障。结论:注册人应改进产品设计、完善说明书风险提示信息;医疗机构应加强气管插管术后气道管理的宣传培训;监管机构应及时修订强制性标准,保障公众用械安全。

Objective: To analyze the traits and frequency of the adverse events of endotracheal intubation in order to put forward suggestions for its safety. Methods: Retrospective analysis was performed on 99 cases of endotracheal intubation adverse events that were reported in Fujian province between 2019 and 2021. Results: Serious injury reports made up 45.45% of the 99 adverse event reports. 39.4% of patients were 65 years of age or above. In most cases, adverse events occurred during and after endotracheal intubation. The frequent intubations and throat mucosal damage were the main injuries. The cuff, inflating tube, and balloon are the device’s primary failure sites, and leakage, rupture, and other pressure deficiency failures are its primary failure modes. Conclusion: The manufacturers should improve product design and risk information in the product instructions. Medical institutions should strengthen the publicity and training of airway management. Regulatory authorities should timely develop and revise mandatory standards to ensure the safe use of medical devices.