FMECA Application in Tomotherapy: Comparison between Classic and Fuzzy Methodologies

Accident analysis in radiotherapy highlighted the need to increase quality assurance (QA) programs by the identification of failures/errors with very low probability (rare event) but very severe consequences. In this field, a Failure Mode, Effects and Criticality Analysis (FMECA) technique, used in various industrial processes to rank critical events, has been met with much interest. The literature describes different FMECA methods; however, it is necessary to understand if these tools are incisive and effective in the healthcare sector. In this work, comparisons of FMECA methodologies in the risk assessment of patients undergoing treatments performed with helical tomotherapy are reported. Failure modes identified for the phases "treatment planning" and "treatment execution" are classified using the Risk Priority Number (RPN) index. Differences and similarities in the classification of failures/errors of the examined FMECA approaches are highlighted.