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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 risk factors existed in the process of supply and use of in vitro diagnostic reagents were analyzed, and the whole flow of the in vitro diagnostic reagents was formally and traceably managed by using the integrated cold chain transport RFID turnover box. Results: The establishment of a dynamic tracking management system using in vitro diagnostic reagents from the procurement, cold chain logistics transport, warehousing acceptance to use a set of norms. Conclusion: Radio frequency identification technology can monitor and record all aspects of in vitro diagnostic reagents in real time to ensure the quality, safety and traceability of reagents.