临床试验用医疗器械管理模式的探讨

Discussion on Management Model of Medical Devices for Clinical Trials

摘要: 该研究通过分析目前临床试验用医疗器械管理存在的主要问题，结合医用耗材、医疗设备及诊断试剂的使用特点，建议可行性的管理模式，并对验收、发放、保管、回收等环节提出具体要求，为临床试验结果的真实可靠提供了有利的保障。

Abstract: By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.