Abstract
The recently implemented European Council Basic Safety and Standards Directive (BSSD), 2013/59/Euratom lays down core radiation protection standards for European radiology departments, with a mandatory requirement for supporting clinical audit processes.A survey on behalf of the European Society of Radiology (ESR) was undertaken in November 2018 involving the ESR EuroSafe Imaging Star department network to assess compliance with selected key BSSD requirements, with emphasis also on clinical audit/re-audit.64% of invited departments participated and the survey results revealed a lack of compliance with BSSD requirements even when allowing for work in progress within departments. Justification processes showed the lowest rates of compliance overall, with varying results relating to dose limits, patient information and significant accidental exposure notification. Questions around implementation of diagnostic reference levels (DRLs) revealed generally far higher compliance with requirements.The survey findings confirm a lack of compliance with key BSSD radiation protection indicators and also a lack of supporting clinical audit structures. These findings are likely to be representative of the wider radiological community in Europe. There is a need for a co-ordinated response, involving relevant European agencies, national bodies and societies and also individual radiology departments to address these issues. ESR publications on clinical audit (Esperanto) and the 2018 EuroSafe Imaging Call for Action will be important components of this response.
Highlights
The European Basic Safety Standards Directive (BSSD) 2013/59/Euratom [1], laying down requirements for protection from the dangers associated with medical ionising radiation exposure, was adopted by the Council of the European Union (EU) in 2013, for transposition into the national legislation of EU Member States by February 2018
Implementation of the Directive will be underpinned by a process of external inspection, with European Union Member States determining how the Basic Safety and Standards Directive (BSSD) requirements are met via national legislation
The inferences are clear: as of February 2018 when the BSSD became a legal requirement, European Union Member States and their constituent radiology departments are required to comply with the BSSD, to have developed a supporting clinical audit programme, with the ability to evidence compliance and relevant audit processes at the time of potential inspection by an external agency
Summary
The European Basic Safety Standards Directive (BSSD) 2013/59/Euratom [1], laying down requirements for protection from the dangers associated with medical ionising radiation exposure, was adopted by the Council of the European Union (EU) in 2013, for transposition into the national legislation of EU Member States by February 2018. The BSSD directly impacts on all radiology departments and has been updated in light of new scientific evidence and guidelines. These changes from previous legislation are highlighted and summarised in a recent ESR publication [2]. Key aspects of the BSSD relevant to radiology departments include: available infrastructure amongst European National Radiology Societies [4]
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