Why everyone working in a radiology department should be aware of the Euratom Basic Safety Standards Directive

The European Directive 2013/59/Euratom lays down Basic Safety Standards for protection against the arising dangers from exposure to ionizing radiation. With less than one year left for the implementation deadline, time is ticking for radiology departments to undertake action. However, ignorance prevails in lots of radiology departments about the precise content of this directive.

Exposure to ionizing radiation involves detrimental health risks for patients, which is why patient protection in medical imaging should be priority. Keeping dose as low as reasonably achievable (ALARA) is therefore the moral duty of every radiology professional. However, radiation dose management can be jeopardized because of problems with communication and justification, or mistakes of human or technological nature. Besides, not every radiology department succeeds to manage its radiation dose in the most efficient way.

Therefore, the European Union obligates every radiology department to implement a culture that ensures patient protection and quality. The foundations are laid by several, already existent, separate directives about radiation protection (for example the directive 97/43/Euratom on medical exposures): after a significant revision, they are unified into one overarching legislative piece. In 2013 the European Basic Safety Standards Directive (BSS) 2013/59/Euratom was born.

By February 2018 the five years of transposition period will have ended, which means that all EU member states must have implemented the directive on radiation protection in national legislation. For radiology departments, the requirements are strengthened for recording and reporting dose, population dose evaluation (based on age and gender distribution), the use and regular review of diagnostic reference levels, and the availability of dose-indicating devices. Radiology departments should ensure radiation protection education and training, and provide dose-related information. Further on, the directive sets out rules regarding justification of medical exposure and the requirements for patient information. All of this should lead to the optimisation of dose management.

Besides dose management, clinical auditing is also underlined in the European Directive. From February 2018 onwards, conducting each year internal clinical audits will be obligatory for every European radiology department, for which the objective should be set by the management of the department. Besides, external clinical audits will be conducted on a regular base. Here, the objectives should be agreed between the auditing organization and the health care institutions to be audited. The guideline on which these audits are based are the questions of QUAADRIL (Quality Assurance Audit for Diagnostic Radiology) of the IAE (International Atomic Energy Agency). The aim is to improve the quality of patient care, the effective use of resources to enhance the provision and organization of clinical services, and to organize professional education and training.

The impact of the European Directive in medical imaging is undeniable. Changes will be needed on the part of dose management as well as for auditing, so radiological departments have to start preparing themselves and think about various ways to work towards this culture change. Therefore, it is important to enforce the medical imaging environment with tools to assist as best as possible to work towards these goals in an efficient way.