Significant incidents during X-ray exposures in humans – assessment and findings of the Federal Office for Radiation Protection

Abstract

Background

In Germany, significant incidents must be reported to the competent authority since 12/31/2018 (section 108 Radiation Protection Ordinance (StrlSchV)). After assessment and evaluation of the reports, the competent authority submits the relevant information via a web-based reporting system (BeVoMed) to the Federal Office for Radiation Protection (BfS), which publishes the results derived therefrom. The present paper evaluates significant incidents related to X-ray exposures on humans.

Methods

All reports on incidents in X-ray diagnostics and interventional radiology between 01/2019 and 10/2023, which were completed with detailed information until the reporting day (31/10/2023), were included. The following aspects were statistically evaluated: classification as an incident (section 1 subsection (22) StrlSchV), significance (section 108 StrSchV), classification to Annex 14 StrlSchV, assignment to the forms of care in the German healthcare system, and development of the reporting frequency over time. Furthermore, the content of the reports was systematically evaluated with regard to conspicuous clusters and typical problems.

Results and Conclusion

Until the reporting day, 383 reports (355 completed) were received. 252 reports (228 in X-ray diagnostics, 24 in interventional radiology) referred to significant incidents and were included in the detailed evaluation. Reporting frequency increased in X-ray diagnostics, whereas there was no trend in interventional radiology. Most of the significant incidents concerned examinations on an individual person (category I, criterion 2a or category II, criteria 2a and 3a) in the in-patient sector – especially in maximum care hospitals. Frequent errors concerned the inappropriate choice of parameters/protocols or were related to the administration of a contrast agent. Despite the overall positive trend, the establishment of awareness and error culture remains challenging.

Key Points

• In X-ray diagnostics, the reporting frequency of significant incidents increases.

• Most incidents concerned CT examinations in the in-patient sector.

• Main problems were selection of protocols/settings, contrast administration, and bolus-tracking.

• Uncertainties remain about the classification of an incident as significant and notifiable.

Citation Format

• Winter KS, Schweden M, Brix G et al. Significant incidents during X-ray exposures in humans – assessment and findings of the Federal Office for Radiation Protection. Rofo 2025; 197: 154–162

Keywords

significant incidents - incident reporting system - radiation safety - diagnostic radiology - interventional procedures

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