SU‐C‐137‐06: What Was the Impact Of European Medical Exposure Directive On Regulation On Clinical Practice Associated with Accidental Exposures, Reporting and Risk Analyses in Radiotherapy?

Abstract

Purpose: The objective of the study was to perform an EU‐wide study on the implementation of the MED requirements aimed at the reduction of the probability and the magnitude of accidents in radiotherapy. Methods: The two‐step questionnaire was carried out using internet‐based facility (Lime survey, www.limesurvey.org) and was sent out to establish the overall status and the legal and practical arrangements in EU Member States. Results: The General questionnaire was sent to 38 countries, from which 21 have replied. 10 more countries have provided some data, but have not finished the questionnaire. The second questionnaire covered more details of the available risk analysis systems, results of such analyses, as well as incident classification, reporting and registration systems. The second questionnaire was completed by respective number of countries: detailed questionnaire ‐ 10, description of local proactive risk assessment/ and retrospective risk analysis ‐ 13, radiotherapy event report ‐ 5, incident reporting systems‐20. More than half of the countries already implemented the legal basis for risk analysis and classification of events, recording and reporting. However, the lack of this basis in many countries and the lack of practical implementation in most of the countries highlight the need for further European guidelines. The factor that influences the current situation in Europe is its diversity, variety of legal systems and different radiotherapy care organizations. Conclusion: Fifteen years that passed since the introduction of EU Directive made it clear that next step on European level has to be made. The requirement for legal framework for risk analysis, classification of events, recording and reporting systems has not been addressed in some EU countries, and thus, the practical implementation of the systems in many countries is still incomplete.