医用电子直线加速器的可疑不良事件研究

Study on Suspicious Adverse Events Associated with Medical Electron Linear Accelerators

随着医用电子直线加速器在肿瘤治疗中的广泛使用,如何减少其在使用过程中对人体造成的伤害成为一个具有重要意义的研究课题。本文提出了可疑医疗器械不良事件产生的5种原因,并基于这5种原因,对医用电子直线加速器的可疑不良事件信息结合其产品特点进行了一些分析和探讨,以期对医用电子直线加速器的生产企业、使用单位控制其风险有所帮助,为相关监管部门有效实施对医用电子直线加速器的监管提供参考。

With the widespread use of medical linear accelerators in cancer therapy, how to reduce its damage to patients has become an important research topic. Five reasons caused by suspicious adverse events of medical equipment are put forward in this paper, and suspicious adverse events information of medical electron linear accelerators are analyzed and discussed combined with its characteristics, in order to provide references to regulatory of medical electron linear accelerator.