基于伤害流行病学模型的医疗器械不良事件分类研究

The Study on Classification of Medical Device Adverse Events Based on Epidemiological Model of Injure

当前医疗器械不良事件监测已成为上市后医疗器械风险管理的重要研究方向。本文基于伤害流行病学模型,重点研究了与医疗器械不良事件发生机制相关的四类因素及其相互的关系,从而提出了医疗器械不良事件分类类型。

Nowadays, medical device adverse events（MDAE） monitoring has become the more important research direction of the post-marketing medical device risk management. The study, based on the epidemiological model of injure, analysed 4 sorts of the mechanism-related factors of MDAE and then raised the viewpoint on the classification of MDAE.