机械解脱弹簧圈生产环节风险因素及现场体系核查关注点

Analysis of Risk Factors in Production Process of Mechanical Detachment Coil and the Focus on Site Quality Management System Inspection

机械解脱弹簧圈是治疗动脉瘤的有效手段之一,但手术过程中不良事件时有发生,究其原因其中产品质量问题占有较大的比例。通过分析此类产品生产人员、机器设备、原材料、过程方法、生产环境等方面在产品实现过程中可能存在的风险因素,文章针对性地提出机械解脱弹簧圈产品现场体系核查的关注重点,对医疗器械检查员在检查该类产品时有一定的指导作用。

One of the most effective therapies for aneurysm is to use mechanical detachment coil.However,the adverse events occurd by product quality problems during the surgical process are at high level.Through the analysis of risk factors in personnel,machine,material,process,environment during production,this article focus on the site inspection in the mechanical detachment coil production process.It is also a good guidance for medical device inspectors in inspecting mechanical detachment coil.