医院医疗设备不良事件的管理策略探讨

Strategies of adverse events monitoring for medical device in hospital

介绍了国内医疗设备不良事件监督管理的发展历程,提出现阶段医疗设备不良事件监管工作中仍存在的问题并对原因进行了分析。结合国内外发展现状,提出完善相关规章制度、拓宽器械监管渠道、强化重点医疗器械的监管、规范不良事件的报告程序等对策,以保证医疗设备的合理使用及患者的生命安全。

The history of medical device adverse events supervision in China was introduced, and the problems and causes were analyzed. Some measures were put forward to ensure medical device rational utilization and patient safety, including complete rules and regulations, extending medical device supervision channels, strengthening monitoring of key medical devices and standardizing adverse events report procedure.