美国FDA MAUDE数据库气管插管不良事件相关数据的分析

Analysis of Adverse Events Related to Tracheal Intubation of FDA MAUDE Database

目的:分析呼吸机用气管插管不良事件相关数据,探讨影响气管插管安全性相关因素,为临床合理及安全使用气管插管提出建议。方法:检索美国FDA MAUDE数据库,对2019-2021年间3777例气管插管不良事件报告进行统计分析。结果:气管插管不良事件器械故障方面主要表现为气囊问题、连接问题、导管问题和标签问题等;患者伤害方面主要表现为非计划性拔管、缺氧/低血氧饱和度和呼吸功能问题等。结论:通过分析美国FDA MAUDE数据库中2019-2021年气管插管不良事件发生原因,建议我国气管插管生产企业应积极主动开展不良事件监测工作,加强对气管插管的质量管控,落实企业主体责任;使用单位应严格执行气管插管术操作规范,熟练掌握插管技术,特别警惕呼吸机与气管插管配合使用进行机械通气所产生的风险;监管部门应加强监督检查和开展医疗器械不良事件培训工作。

Objective:To analyze the related data of adverse events of tracheal intubation for ventilator,explore the related factors affecting the safety of tracheal intubation,and put forward suggestions on the rational and safe clinical use of tracheal intubation.Methods:The US FDA MAUDE database was searched to conduct statistical analysis of 3777 cases of tracheal intubation adverse event reports from 2019 to 2021.Results:The instrument failures of adverse events of endotracheal intubation were mainly manifested as balloon problems,connection problems,catheter problems and label problems.Patients with injury mainly manifested as unplanned extubation,hypoxia/low oxygen saturation and respiratory function problems.Conclusion:By analyzing the causes of tracheal intubation adverse events in the US FDA MAUDE database from 2019 to 2021,it is suggested that tracheal intubation manufacturers in China should actively carry out adverse event monitoring,strengthen the quality control of tracheal intubation,and implement the main responsibility of enterprises.It is suggested that the use unit should strictly implement the operation specification of tracheal intubation,master the intubation technology,and be particularly alert to the risk of mechanical ventilation when the ventilator and tracheal intubation are used together.It is recommended that the regulatory authorities strengthen supervision and inspection and carry out medical device adverse event training to prevent and control product risks.