Strengthening incident learning in radiotherapy practice: insights from the MARLIN study.

BACKGROUND AND PURPOSE: Incident Learning Systems (ILSs) are central to patient safety in radiotherapy, enabling learning from adverse events and near misses. Despite EU regulatory requirements, substantial variability persists across Europe in the implementation and effectiveness of ILSs in radiotherapy. This paper presents radiotherapy-specific recommendations derived from the MARLIN study to support harmonised, risk-informed implementation of ILSs.

METHODS

The 24-month MARLIN study, conducted under the SAMIRA Action Plan, employed a structured literature review, an online European survey of clinical facilities, competent authorities and professional societies, expert interviews, and a multi-stakeholder consensus workshop. Survey data from 172 respondents in 28 countries were analysed to identify current practices, barriers and enabling factors for ILS implementation in radiotherapy.

RESULTS

Although all responding countries reported transposition of the Directive, substantial variability was observed in criteria for reporting significant radiotherapy events, feedback mechanisms and use of international databases. Fear of punitive actions, limited resources, lack of training in incident analysis, and insufficient dissemination of lessons learned were identified as key barriers. External-beam radiotherapy showed more mature ILS implementation than brachytherapy. Findings from the MARLIN study informed recommendations on category-based event classification, radiotherapy-specific taxonomies, multidisciplinary incident-learning committees, and collaboration between clinical facilities, competent authorities and professional societies.

CONCLUSION

The MARLIN recommendations provide a practical framework to strengthen ILS implementation in radiotherapy, promote a just culture, enhance learning from incidents and support regulatory compliance, ultimately improving patient safety and quality of care across Europe, while the broader RP-208 report extends these principles to all medical fields using ionising radiation, supporting cross-disciplinary harmonisation.