基于真实世界数据的输液泵临床使用不良事件风险分析

Risk analysis of adverse events in clinical use of infusion pumps based on real-world data

以美国食品药品监督管理局(Food and Drug Administration,FDA)制造商和用户器械使用体验(Manufacturer and User Facility Device Experience,MAUDE)数据库中上报的输液泵不良事件为数据来源,分析了不良事件的表现形式、形成原因、引发后果及风险程度,从不良事件形成原因出发对输液泵临床使用人员、医疗机构设备管理者及设备生产厂商提出了相关建议,可为输液泵临床安全使用提供参考。

The adverse events of infusion pumps reported in the Manufacturer and User Facility Device Experience(MAUDE)database of the U.S.Food and Drug Administration(FDA)were used as the data source to analyze the manifestations,causes,consequences and risks of adverse events.Some suggestions were put forward based on the causes of adverse events to infusion pump users,medical institution equipment managers and equipment manufacturers,and references were provided for ensuring infusion pumps'safety in clinical use.