Council Directive 2013/59/Euratom (the BSSD) mandates establishing a framework to ensure that unintended and accidental medical radiation exposures are reported, analysed and findings disseminated to mitigate future risks. This is a crucial element of enhancing patient safety in medical application involving radiation. In many countries, incident learning systems (ILSs) are used by clinical staff, management and regulators to report incidents and near misses, collect information, analyze the findings and develop safety measures and guidelines for improvement in fields such as radiotherapy, interventional cardiology, nuclear medicine, and interventional and diagnostic radiology. But how are ILSs designed and used? How do all these different parties cooperate in investigation, dissemination and training? How are incidents treated with respect for the patient, reporter and clinic? How does European legislation vary across the EU Member States?
The MARLIN study was a 2-year project comprising experts from the European Institute for Biomedical Imaging Research (EIBIR), European Federation of Organisations for Medical Physics (EFOMP), and European Society for Radiotherapy and Oncology (ESTRO), who with the help of advisors from clinical facilities, competent authorities and professional organisations surveyed the implementation of the European legal requirements on reporting and learning from patient-related incidents and near misses. After analysis, the consortium developed guidelines and recommendations to support the implementation of ILSs for incident reporting in the medical application of ionising radiation across Europe. Feedback and best practices were gathered in consultation with a range of external experts and organizations and at a workshop in 2024, leading to the publication of the the study’s final report in the Radiation Protection Series.
The report is a valuable resource for clinicians in the study fields, patient advocates, and medical and radiation protection regualtors and may be read and downloaded from the website of the EU Publications Office.