由一起违规开展准分子激光屈光性角膜手术案引起对医疗技术临床应用监督执法的分析与探讨  

Analysis and Discussion on Supervision and Law Enforcement of Clinical Application of Medical Technology Caused by A Case of Excimer Laser Refractive Keratoplasty without Violation

作　　者：薛梅 徐果 邱敏 任洁 张文婷 韩佳煜 Xue Mei;Xu Guo;Qiu Min;Ren Jie;Zhang Wenting;Han Jiayu(Chaoyang Health and Family Planning Supervision,Beijing 100021)

机构地区：[1]北京市朝阳区卫生和计划生育卫生监督所

出　　处：《中国卫生监督杂志》2018年第6期580-583,共4页Chinese Journal of Health Inspection

摘　　要：通过对一起眼科门诊部未经卫生行政部门批准备案违规开展准分子激光屈光性角膜手术案例的分析,针对“限制临床应用”的医疗技术项目的认定,违规开展医疗技术的法律适用,尤其是对《医疗质量管理办法》是否适用该违法行为进行了深入探讨,为今后类似案件的办理提供参考。Through the analysis of the case that an eye clinic illegal practiced excimer laser photorefractive keratectomy(PRK),this assay takes an in-depth look at how to identify medical technologies of limited clinical application,which law or regulation is applicable,especially whether Medical Quality Management Approach is applicable for the illegal act, thus provides certain reference significance for such cases in future.

关 键 词：医疗技术 医疗质量管理办法 限制临床应用 

分 类 号：R197.1[医药卫生—卫生事业管理]