体外诊断试剂医疗器械项目风险管理研究

Research on Project Risk Management of Medical Device Industry in Vitro Diagnostic Reagents

目的：探讨体外诊断试剂医疗器械项目风险管理。方法：本次研究结合我院实际管理的状况，在采用医疗设备质量管理体系方法的基础上，分析体外诊断试剂医疗器械的管理重点，并根据实际管理过程中存在的问题和缺陷提出相应的解决办法。结果：需要建立体外诊断试剂临床试验风险管理体系，在风险识别阶段、定性分析阶段以及风险应对阶段对其中存在的问题进行有针对性的处理，从而形成一个具有可操作性的监督管理方法，防范于未然，尽可能地避免风险的发生。结论：体外诊断试剂医疗器械项目风险管理方法能够在一定程度上控制体外诊断试剂在医院的合理使用，确保试验过程及试验结果的安全性和有效性，为我院医疗器械管理部门的有效监督打下基础。

Objective： The risk management of medical equipment in the in vitro diagnostic reagent is discussed Methods： Based on the medical equipment quality management system and combined with management of the actual situation, this study analyzed the medical equipment management of the in vitro diagnostic reagents, put forward corresponding solutions according to the problems and defects existing in the actual management of the process. Results It is needed to establish the risk management system of in vitro diagnostic reagents for clinical trials. In stages of risk identification, qualitative analysis and risk response, the existent problems are processed, thus operation supervision and management methods are formed to avoid risk. Conclusion： In vitro diagnostic reagents, medical equipment project risk management methods can control the rational use of in vitro diagnostic reagents in hospital in a certain extent, it can ensure the safety and effectiveness of the test process and test results, thus lay a foundation for the effective supervision of medical apparatus and instruments in hospital management.