山东省冠脉支架集中带量采购存在的问题与建议

Problems and suggestions of centralized banded purchasing of coronary stents in Shandong Province

介绍了冠状动脉药物洗脱支架系统(以下简称“冠脉支架”)的发展历程,回顾性分析了国家医疗器械不良事件监测系统中山东省上报的214例冠脉支架不良事件(包括集中带量采购前110例和集中带量采购后104例)的主要表现和原因,总结了冠脉支架集中带量采购实施过程中出现的问题,提出了规范医疗行为、落实主体责任、加强监管合力等建议,为冠脉支架安全使用和监管提供了参考。

The development history of the coronary artery drug-eluting stent system(hereinafter referred to as coronary stent)was introduced.The main manifestations and causes of 214 coronary stent adverse events(including 110 cases before centralized banded purchasing and 104 cases after)reported by Shandong Province in the National Medical Device Adverse Event Surveillance System were analyzed retrospectively.The problems were summarized during the centralized banded purchasing of the coronary stents,and some suggestions were proposed including standardizing medical behaviors,imple-menting the main responsibility and strengthening cooperative supervision.References were provided for the safe use and regulation of the coronary stents.