How to manage accidental and unintended exposure in radiology: an ESR white paper

Since February 2018, the Directive 2013/59/EURATOM (EU-BSS) requires all EU member states to implement a system for recording and analysis of all accidental or unintended medical exposures (Article 63). An ESR questionnaire in May 2018 among ESR member countries including all EU member states (MS) revealed a very heterogeneous and unsatisfactory situation in transposition of the EU-BSS. Some MS just translated this part of the directive, others used effective dose as reporting criteria and others used physical dose parameters from the modalities. This white paper will help national scientific organisations advice their national regulators and authorities on how to provide a simple and practicable implementation of the directive. ESR recommends notification and reporting criteria for significant events based on physical quantities and units and not on effective dose or text-based criteria like "significantly different" (EU-BSS, Article 4 (99)).