摘要
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.
作者
周敏靓
ZHOU Min-liang(Shanghai Center for Medical Device and Cosmetics Evaluation and Verification,Shanghai 200020)
出处
《中国医疗器械信息》
2024年第7期1-4,共4页
China Medical Device Information
关键词
机械解脱弹簧圈
风险因素
关注重点
体系核查
mechanical detachment coil
risk factors
focus
quality system inspection
