The European Institute for Biomedical Imaging Research (EIBIR), in cooperation with the European Society for Radiotherapy and Oncology (ESTRO) and European Federation of Organisations for Medical Physics (EFOMP), is proud to have been awarded the European Commission Tender ‘Safety in Medicine by Incident Learning in Ionising Radiation Applications in Europe’ (acronym: SAMILERA).

This 2-year project is led by Ms. Monika Hierath (EIBIR, AT), with scientific coordination by Dr. Carlos Prieto (ESTRO, BE) and aims to improve reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine, and interventional and diagnostic radiology.

Project objectives:

  • Collect and analyse up-to-date information on the implementation of Council Directive 2013/59/Euratom requirements for reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology
  • Develop best-practice consensus guidelines on the implementation of the above Directive in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology
  • Discuss the results of the work with representatives of Member States and relevant stakeholders, with the view of stimulating further national and EU-wide efforts in this area

The use of ionising radiation is important in both the diagnosis and treatment of diseases. However, it is important that the use of ionising radiation is carefully monitored, and measures are taken to minimise both the frequency and harm caused by accidental or non-intended exposures to patients. The use of Incident learning systems (ILSs) as a risk management procedure to maintain safety and quality in the use of ionizing radiation in medicine by learning from incidents and near misses has been recommended by many international and European bodies, although experience in their use varies by field, from being relatively common in external radiotherapy to practically non-existent in diagnostic radiology. This project will attempt to understand the current state of ILSs, including current practices and associated successes and barriers to implementation. This information will facilitate the drafting of clear consensus guidelines to facilitate the smooth implementation of ILSs in Member States and ultimately improve the quality and safety of patient care.

The project will support the implementation of Council Directive 2013/59/Euratom by providing a comprehensive description of the status of incident reporting and elaborating consensus guidelines with recommendations on reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine, and interventional and diagnostic radiology in Europe. The project consortium will bring together experts in the various clinical areas where ionising radiation is used and relevant stakeholders in the Advisory Board.

SAMILERA consists of 5 work packages, which begin with research on the current implementation of European legal requirements regarding patient-related incidents and near misses in the selected fields. These activities will provide the necessary input to formulate general and patient-specific guidelines, which will be evaluated by European competent authorities, professional societies and the project’s Advisory Board before dissemination at a project workshop for further discussion.

Contact:

SAMILERA is led by the European Institute for Biomedical Imaging Research

ESR Office
Am Gestade 1
1010 Vienna, AT
Phone: +43 (1) 533 40 64 -20
E-mail: Monika Hierath, monika [.] hierath [@] myesr [.] org

Facts and figures

Coordinator: European Institute for Biomedical Imaging Research (EIBIR)
Number of Partners: 3
Start Date: January 1, 2023
End Date: December 31, 2024
Total Funding: € 249,950.00

This project has received funding from the European Commission under Service Contract N°ENER/2022/NUCL/SI2.869532.