利用射频识别技术 保障体外诊断试剂质量安全  

Investigation on the Security Risk Prevention and Standardized Management in the Process of Transportation and Storage for in Vitro Diagnostic Reagents

作　　者：王敏[1] 王永庆 张小林 王忠民 张建伟 金建 赵旺胜 姜宁玲 衣鲁江 沈怡雯 孟玲 顾民 

机构地区：[1]南京医科大学第一附属医院药学部,南京210029 [2]南京医科大学第一附属医院信息中心,南京210029 [3]江苏中健之康信息技术股份有限公司,南京210019 [4]南京医科大学第一附属医院检验学部,南京210029 [5]南京医科大学第一附属医院院长办公室,南京210029

出　　处：《药学与临床研究》2016年第2期182-184,共3页Pharmaceutical and Clinical Research

基　　金：江苏省"六大高峰人才"项目资助(2014-YY-001);江苏省卫生厅医学重点人才项目(RC201170;H201108);奥赛康临床药学基金(201412-1);江苏高校优势学科建设工程资助项目(JX10231801)

摘　　要：目的:探讨体外诊断试剂规范化管理体系。方法:对体外诊断试剂在供应和使用过程中存在的安全和质量风险因素进行分析,并介绍运用"一体化冷链运输射频识别周转箱"对体外诊断试剂进行整个流程规范化可溯源管理。结果:建立了体外诊断试剂从采购、冷链物流运输、入库验收到使用一整套规范的动态跟踪管理体系。结论:射频识别技术对体外诊断试剂各环节可进行实时监控与记录,确保试剂的质量安全与可溯源。Objective: To explore the standardized management system of in vitro diagnostic reagents.Methods: The safety and quality risks were investigated in the process of provision and application of in vitro diagnostic reagents, and it was introduced how our hospital applied multi-function RFID circulating boxes to the standardized traceable management of in vitro diagnostic reagents. Results: Our hospital established the dynamic tracking management system in purchase, cold-chain transportation, warehouse entry inspection and use of in vitro diagnostic reagents. Conclusions: The RFID technology can simultaneously monitor and record all steps to ensure the quality, safety and traceablity of the reagents.

关 键 词：体外诊断试剂 一体化冷链运输RFID周转箱 冷链运输 溯源 

分 类 号：R954[医药卫生—药学]