医疗器械安全质量管理问题探讨

Discussion on Safety Quality Management of Medical Devices

目的分析医疗器械上市前临床试用或验证中的缺陷,探讨医疗器械上市后的安全质量管理评价。方法采取定性分析与定量分析相结合的方法,分析医疗器械上市前临床试用中的缺陷以及医疗器械安全质量管理的途径。结果医疗器械安全质量通过医疗器械不良事件报告、医疗器械召回和医疗器械追踪得以实现。结论医疗器械进入市场后的不良事件报告、召回制度和追踪制度,是医疗器械进入市场后对其安全性、有效性和质量管理的重要环节。

Objective To analyze the defects of medical devices of clinical trial or verification in pre-markets and to explore the evaluation of safety quality management of medical devices in markets.Methods Combination of qualitative analysis and quantitative analysis is used to discuss the defects of medical devices of clinical trial in pre-markets and the manners of safety quality management of medical devices.Results Management of medical devices for safety and quality is to be achieved by means of reports of adverse events,recall and follow-up of medical devices.Conclusion Reports of adverse events,recall and follow-up after medical devices entering markets,are the important aspects in evaluation of safety,efficacy and quality management of medical devices.