药品和医疗器械缺陷认定标准探析  

The Discussion on Judging Standard of Medicine and Medical Device Defect

作　　者：马辉[1] 

机构地区：[1]首都医科大学,北京100069

出　　处：《医学与社会》2014年第10期71-74,共4页Medicine and Society

基　　金：北京市教育委员会社科计划面上项目"医疗产品损害赔偿责任特殊性研究";编号为SM201110025006;北京市哲学社会科学规划项目"与基本医疗相适应的损害赔偿规则研究";编号为13FXB020

摘　　要：药品、医疗器械致人损害时,缺陷的认定应采用不合格标准,理由如下:一是如采用不合理危险标准,该标准与药品不良反应、医疗器械不良事件、发展风险免责制度及医疗服务的行为债务性质相矛盾;二是合理性判断本身困难重重;三是鉴定机构只能提供合格与否的鉴定意见;四是司法实务界倾向采用不合格标准;五是采用不合格标准并不明显降低患者保护水平,其他制度可以弥补。The standard of drug or medical device defect should adopt eligibility criteria, and the reasons are as follows. First, if the unrea- sonable risk criteria is adopted, it is in contradiction with drug side effect, medical device adverse events, exculpatory clause for risk occurrence and the nature of medical service practicing behaviors and debts. Second, it is hard to make reasonable judge. Besides, accrediting agency can only provide accreditation proposals of the product quality. Last, if adopting eligibility criteria does not significantly reduce patient protection lev- el, the other systems can make up.

关 键 词：药品缺陷 医疗器械缺陷 认定标准 

分 类 号：R195.1[医药卫生—卫生统计学]