介入瓣膜类医疗器械临床试验质量控制要点探讨

Discussion on quality control in clinical trials of interventional valvular medical devices

随着心脏瓣膜介入治疗领域的快速发展,介入瓣膜治疗产品创新研发已成为全球研究的热点。目前国内介入瓣膜类医疗器械上市产品严重缺乏,大规模的介入瓣膜类产品正在进行早期人体试验或确证性临床试验。实施有效的临床试验质量控制,对于确保临床试验数据用于支持器械产品上市意义重大。笔者通过分析本院介入瓣膜类医疗器械临床试验质量控制存在的问题,结合器械产品和疾病的特点,探讨此类临床试验质量控制要点,对此类临床试验规范实施和高质量的完成提供参考和借鉴。

With the rapid development of the field of interventional therapy of cardiac valve,the innovative researches of interventional therapy of cardiac valve products have become the focus of global research.At present,there is a serious shortage of interventional valvular medical devices on the market in China,and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials.The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products.By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital,and combining the characteristics of device products and diseases,we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.