Julian Malicki1, Ritva Bly2, Mireille Bulot3, Jean-Luc Godet4, Andreas Jahnen5, Marco Krengli6, Philippe Maingon7, Carlos Prieto Martin8, Kamila Przybylska9, Agnieszka Skrobała10, Marc Valero4, Hannu Jarvinen2. 1. Department of Electroradiology, University of Medical Sciences, Poznan, Poland; Greater Poland Cancer Centre, Poznan, Poland. Electronic address: julian.malicki@wco.pl. 2. Radiation and Nuclear Safety Authority, Helsinki, Finland. 3. SECTOR, Paris, France. 4. Nuclear Safety Authority - ASN, Paris, France. 5. Luxembourg Institute of Science and Technology (LIST), Esch/Alzette, Luxembourg. 6. Department of Translational Medicine, University of "Piemonte Orientale", Novara, Italy(1). 7. Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix, Paris, France(1). 8. Fundación Investigación Biomédica Hospital Clínico San Carlos, Madrid, Spain. 9. Greater Poland Cancer Centre, Poznan, Poland. 10. Department of Electroradiology, University of Medical Sciences, Poznan, Poland; Greater Poland Cancer Centre, Poznan, Poland.
Abstract
PURPOSE: To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. MATERIAL AND METHODS: The original data were collected as part of the ACCIRAD project through two online surveys. RESULTS: Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. CONCLUSIONS: Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons.
PURPOSE: To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. MATERIAL AND METHODS: The original data were collected as part of the ACCIRAD project through two online surveys. RESULTS: Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. CONCLUSIONS: Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons.
Authors: Andrea Baehr; Daniel Hummel; Tobias Gauer; Michael Oertel; Christopher Kittel; Anastassia Löser; Manuel Todorovic; Cordula Petersen; Andreas Krüll; Markus Buchgeister Journal: Strahlenther Onkol Date: 2022-08-05 Impact factor: 4.033
Authors: Michelle Lis; Wayne Newhauser; Marco Donetti; Moritz Wolf; Timo Steinsberger; Athena Paz; Marco Durante; Christian Graeff Journal: Front Oncol Date: 2021-03-19 Impact factor: 6.244