我国在用医疗器械安全管理体系研究

Research on the safety management system of medical devices in China

文章侧重于评价医疗机构在用医疗器械的安全管理,主要研究在用医疗器械安全管理体系的建立,完善我国医疗器械的安全管理。通过对医疗机构进行问卷调查,分析在用医疗器械安全管理存在的问题,并针对问题提出对策和建议。经过调查,医疗机构在医疗器械安全管理方面存在人员组织、硬件设施以及软件等的问题,通过对这些方面改进,可以建立一个较为完善的安全管理体系,从而提高我国在用医疗器械安全管理质量。

The paper focuses on the evaluation of the safety management system of medial devices. The domestic safetymanagement will be established and improved by the questionnaire survey of the medical institutions, the analysis ofthe problems existing in the safety management of medical devices, and the countermeasures and suggestions for theseproblems. Through investigation, there are some problems in the safety management of medical devices like thepersonnel, the hardware facility and the software and so on. Through the improvement on these aspects, a relativelyperfect safety management system can be established, so that the quality of the safety management of the medicaldevicescan be improved in China.