ENER/D3/2022-402: SAMIRA study

This new call intends to achieve a SAMIRA study on reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology. This work is part of the SAMIRA actions in the area of Quality and Safety of medical applications of ionising radiation. It will contribute to the overall SAMIRA objective of supporting the implementation of high standards for quality and safety of medical radiation applications into Member States’ health systems.

The SAMIRA Action Plan foresees generating high quality evidence and developing evidence-based guidance and practical tools to improve the quality and safety of medical applications of ionising radiation and to support the implementation of Council Directive 2013/59/Euratom (Basic Safety Standards, BSS). The Plan further aims to ensure that good practices in quality and safety of medical radiation applications are shared among Member States.

The various uses of ionising radiation in medicine involve different levels of radiation exposure and associated risk of incidents that may cause harm to patients. In general, the complexity of the procedure will determine the probability of errors and incidents, and the potential harm to patients will depend on the magnitude of the radiation doses involved. While errors in radiotherapy are very rare, when they do occur the consequences for the patient can be significant, bringing harm and even death in the worst cases. Radiotherapy is also a highly complex multi-step process, which requires careful treatment planning and inputs from several professionals. On the other hand, the risk of incidents and harm to patients is considerably lower in diagnostic radiological procedures. Consequently, the principle of “graded approach” applies to the regulatory control and radiation safety procedures for these practices.

Link to the call