Lohr F, Baus W, Vorwerk H, Schlömp B, André L, Georg D, Hodapp N
Klinik für Strahlentherapie und Radioonkologie, Universitätsmedizin Mannheim, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Deutschland.
Strahlenther Onkol. 2012 Jul;188(7):545-50. doi: 10.1007/s00066-012-0119-y. Epub 2012 May 16.
Radiotherapy is an essential and reliable element of the treatment armamentarium in oncology. Numerous rules, regulations, and protocols minimize the associated risks. It can, however, never be excluded that errors in the treatment delivery chain result in inadequate tumor doses or unnecessary damage to organs at risk. A legal framework governs the management of such incidents. The most important European and North American regulations are reported.
Various directives issued by the European Union are differently implemented nationally. This applies particularly to the characterization of incidents that must be reported to authorities. Reporting thresholds, audit systems, and the extent of the integration of voluntary reporting systems vary.
Radiotherapy incidents are dealt with differently on an international level. Changes are to be expected based on the European Basic Safety Standards Directive that is currently being prepared and will have to be implemented nationally in due course.
放射治疗是肿瘤学治疗手段中不可或缺且可靠的要素。众多规则、法规和方案将相关风险降至最低。然而,治疗交付链中的错误导致肿瘤剂量不足或对危及器官造成不必要损伤的情况绝不能被排除。有一个法律框架来管理此类事件。报告了欧洲和北美的最重要法规。
欧盟发布的各项指令在各国的实施方式有所不同。这尤其适用于必须向当局报告的事件的特征描述。报告阈值、审核系统以及自愿报告系统的整合程度各不相同。
放射治疗事件在国际层面的处理方式各异。基于目前正在制定且将在适当时候在各国实施的欧洲基本安全标准指令,预计会有变化。