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体外诊断试剂有效管理与质量安全控制的探讨
引用本文:戴捷,苏磊. 体外诊断试剂有效管理与质量安全控制的探讨[J]. 中国医学装备, 2011, 8(11): 80-82
作者姓名:戴捷  苏磊
作者单位:懈放军第三医院医学工程科,陕西宝鸡,721004
摘    要:体外诊断试剂作为一种特殊的医疗诊断药品已广泛的应用于医学的科学研究和临床检验,由于目前相关法规执行力度不够和监管措施不到位而造成医院在体外诊断试剂的使用管理上存在某些问题,因此只有对体外诊断试剂进行有效管理与质量安全控制,才能够对试剂的规范、安全使用起到监控作用,有效提高体外诊断试剂的质量安全,为临床检测结果的准确性、稳定性提供保障。落实对体外诊断试剂的有效管理和质量安全控制。

关 键 词:体外诊断试剂  质量控制  有效管理

Discussion on effective management of implementing external diagnostic reagent and quality control
DAI Jie,SU Lei. Discussion on effective management of implementing external diagnostic reagent and quality control[J]. China Medical Equipment, 2011, 8(11): 80-82
Authors:DAI Jie  SU Lei
Affiliation:DAI Jie,SU Lei Department of Medical Engineering,the Third Hospital of PLA,Baoji 721004,China.
Abstract:External diagnostic reagents, a kind of special medical apparatus, have been widely applied in medical scientific research and clinical examination. Due to incomplete relevant regulation and beyond-reach supervisory measures, many problems are caused and existed on using management of external diagnostic reagent in hospital. Therefore, effective management of external diagnostic reagent and quality control play an effective role in supervising on reagent normalization and safe usage.
Keywords:External diagnostic reagent  Quality control  Effective management
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