美国FDA MAUDE数据库呼吸机不良事件监测分析

Monitoring and Analysis of Ventilator Adverse Events in FDA MAUDE Database

目的:分析呼吸机不良事件相关数据,探讨影响呼吸机安全性的相关因素,为临床合理及安全使用呼吸机提供建议。方法:通过对美国MAUDE数据库中1287份呼吸机不良事件情况进行统计分析,初步探讨呼吸机的风险因素。结果:呼吸机不良事件器械故障主要为触摸屏故障、报警系统故障、设备部件故障和通电故障等;患者伤害主要为血氧饱和度下降和损伤。结论:呼吸机生产企业应当加强呼吸机易损零部件质量控制,主动对自身产品进行可疑不良事件的监测;使用单位应加强对呼吸机使用人员的培训和护理改善,并加强对呼吸机的维护;监管部门应强化监测工作力度,加强风险管控。

Objective:To analyze the data of ventilator adverse events,explore the related factors affecting the safety of ventilator,and provide suggestions for clinical rational and safe use of ventilator.Methods:Through the statistical analysis of 1287 ventilator adverse events in MAUDE database,the risk factors of ventilator were discussed.Results:The main failure of ventilator adverse events were touch screen failure,alarm system failure,equipment component failure and power failure;the main injury of patients were decrease of blood oxygen saturation and injury.Conclusion:Ventilator manufacturers should strengthen the quality control of vulnerable parts of ventilator,and take the initiative to monitor the suspicious adverse events of their products;users should strengthen the training and nursing improvement of ventilator users,and strengthen the maintenance of ventilator;regulatory departments should strengthen the monitoring work and strengthen risk control.