Rules and regulations applying to incidents in radiotherapy

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.