医疗器械不良事件半定量风险估计的分析方法研究

Semi-quantitative risk estimation analysis for medical device adverse events

介绍了伤害严重度和伤害发生概率的定义和分析方法,以无源一次性使用植入医疗器械、无源一次性使用非植入医疗器械和有源可重复使用医疗器械为例,阐述了医疗器械不良事件半定量风险估计应根据产品用途和不良事件表现分析伤害严重度并分级、根据产品使用特点定义并计算伤害发生概率,可为质量专业人士更好地理解半定量风险估计的分析方法提供参考。

The definitions and analysis methods of severity of harm and probability of occurrence of harm were introduced.It's pointed out during the semi-quantitative risk estimation of medical device adverse events severity of harm had to be analyzed and graded based on product use and adverse event performance,and probability of occurrence of harm had to be defined and calculated based on product use characteristics,with passive disposable implantable and non-implantable medical devices and active reusable medical devices taken as examples.References were provided for medical device the quality profession to understand the analysis methods of semi-quantitative risk estimation.[Chinese Medical Equipment Journal,2022,43(8):73-76,80]