Institute of Medical Physics, Klinikum Nurnberg, Paracelsus Medical University, Nurnberg, Germany.
Institute for Diagnostic and Interventional Radiology, University Medical Center Gottingen, Gottingen, Germany.
Rofo. 2022 Apr;194(4):400-408. doi: 10.1055/a-1665-6988. Epub 2021 Dec 21.
According to the German legislation and regulation of radiation protection, i. e. Strahlenschutzgesetz und Strahlenschutzverordnung (StrlSchG and StrlSchV), which came into force on 31 December 2018, significant unintended or accidential exposures have to be reported to the competent authority. Furthermore, facilities have to implement measures to prevent and to recognize unintended or accidental exposures as well as to reduce their consequences. We developed a process to register incidents and tested its application in the framework of a multi-center-study.
Over a period of 12 months, 16 institutions for x-ray diagnostics and interventions, documented their incidents. Documentation of the incidents was conducted using the software CIRSrad, which was developed, released for testing purposes and implemented in the frame of the study. Reporting criteria of the project were selected to be more sensitive compared to the legal criteria specifying "significant incidents". Reported incidents were evaluated after four, eight, and twelve months. Finally, all participating institutions were interviewed on their experience with the software and the correlated effort.
The rate of reported incidents varied between institutions as well as between modalities. The majority of incidents were reported in conventional x-ray imaging, followed by computed tomography and therapeutic interventions. Incidents were attributed to several different causes, amongst others to the technical setup and patient positioning (19 %) and patient movement or insufficient cooperativeness of the patient (18 %). Most incidents were below corresponding thresholds stated in StrlSchV. The workload for documenting the incidents was rated as appropriate.
It is possible to monitor and handle incidents complient with legal requirements with an acceptable effort. The number of reported incidents can be increased by frequent trainings on the detection and the processing workflow, on the software and legal regulation as well as by a transparent error handling within the institution.
· The software CIRSrad was developed to enable the present study and as prototype platform for a future radiological incident management system.. · 586 exceedances of thresholds were recorded by 16 facilities in a period of one year.. · Frequent trainings of all users increase the number of reported cases..
· Müller BS, Singer J, Stamm G et al. Handling of Incidents in the Clinical Application of Ionizing Radiation in Diagnostic and Interventional Radiology - a Multi-center Study. Fortschr Röntgenstr 2022; 194: 400 - 408.
根据德国辐射防护法规和条例（StrlSchG 和 StrlSchV），自 2018 年 12 月 31 日起生效，必须向主管部门报告重大非故意或意外照射。此外，设施必须采取措施预防和识别非故意或意外照射，并减少其后果。我们开发了一个登记事件的流程，并在一项多中心研究中测试了其应用。
在 12 个月的时间里，16 家 X 射线诊断和介入机构记录了他们的事件。使用 CIRSrad 软件对事件进行记录，该软件是为测试目的开发的，在研究框架内发布并实施。选择报告标准比规定“重大事件”的法律标准更敏感。在四个、八个和十二个月后对报告的事件进行了评估。最后，对所有参与机构进行了关于他们对软件和相关工作的使用经验的采访。
报告事件的发生率在机构之间以及在不同模式之间有所不同。大多数事件发生在常规 X 射线成像中，其次是计算机断层扫描和治疗干预。事件归因于多种不同的原因，包括技术设置和患者定位（19%）以及患者移动或患者配合度不足（18%）。大多数事件低于 StrlSchV 规定的相应阈值。记录事件的工作量被评为适当。
使用可接受的工作量，可以根据法律要求对事件进行监测和处理。通过对检测和处理工作流程、软件和法律规定的频繁培训，以及在机构内透明的错误处理，可以增加报告事件的数量。
· CIRSrad 软件是为了进行本研究而开发的，也是未来放射事故管理系统的原型平台。· 在一年的时间里，16 个设施共记录了 586 次超过阈值的情况。· 对所有用户进行频繁培训可以增加报告案例的数量。
