医疗器械中人的可靠性分析

医疗器械产品是一类直接关系到人生命健康的特殊产品.长期以来,医疗器械产品的使用安全性一直是亟待解决的重大问题.在医疗器械产品设计中进行人的可靠性分析能够进一步提高医疗质量,防止医疗事故.但是,这方面的工作目前还处于起步阶段.本文主要从医疗器械人的可靠性方面人手,定性及定量的分析人在使用器械时的可靠性问题.用SHEL模型来定性的分析医疗器械中人的可靠性的影响因素;用故障树方法及概率树对具体的多功能医用手术床进行定量分析;用第二代可靠性分析方法-CREAM解决定量分析的主观性问题;最后提出建立医疗器械人的可靠性数据库.以此为医疗器械产品设计提供了人的可靠性分析的方法.

Human reliability analysis in medical device application

Medical devices are special products that have a direct relationship to people＇s health and life.Over the years,the safe use of medical devices has been the major issues to be solved.There are many researches in human reliability in nuke industry but few in medical industry.The research of human reliability for medical devices is still in the beginning stage.Analyzing the reliability of the medical devices will improve the quality of medical treatment and prevent the iatric accident.The qualitative and quantitative methods were proposed to analyze the human reliability for medical devices.First,SHEL（named after the initial letters of its components＇names,Software,Hardware,Environment,and Liveware） model was applied to make a qualitative analysis for the human reliability of the medical devices,and the affected factors were found out.Second,the fault tree and the probability theory were used to make a quantitative analysis for an application example.The CREAM was taken as the risk evaluation methods to quantify the probability of occurrence of harm externally.At the end,it was suggested to build the database of the medical devices.According to the discussion of the paper,we hope to explore a scientific and rational method to analyze the human reliability of medical appliance.