血管内冲击波导管风险分析及全生命周期关键控制点探讨

Risk Analysis of Intravascular Shockwave Catheter and Discussion of Critical Control Points throughout Life Cycle

该研究概述血管内冲击波导管的临床应用、技术特点和生产工艺,结合MAUDE数据库相关产品的不良事件统计数据,对血管内冲击波导管的不良事件发生原因和产品失效模式进行分析,梳理产品存在的风险点。基于医疗器械全生命周期管理的方法,结合产品风险和医疗器械生产质量管理规范及附录要求,探讨性地提出此类产品在设计与开发、制造、使用阶段的关键控制点。

This study summarizes the clinical application,technical characteristics,and production process of intravascular shockwave catheters.It collects statistics on adverse events of related products from the MAUDE database,analyzes the causes of adverse events and failure modes of intravascular shockwave catheters,and identifies risk points.Based on the whole life cycle management method of medical devices,combined with product risks and the requirements of Good Manufacturing Practice for Medical Devices and related appendices,the critical control points of such products in the design and development,manufacturing,sales,and use stages are discussed.