Risk management process in a microwave thermal ablation system for CE marking

Abstract

Microwave thermal ablation (MWA) is a promising technique capable of achieving larger ablation zones quicker than other energy forms. The aim of this work is the risk management of a brand new microwave thermal ablation system, for the purpose of CE marking. The risk analysis will be driven by a multidimensional Failure Mode, Criticality and Effect analysis, which will take into account the effects on the patient, the operator and the hospital facility. All the principal mitigation interventions found will be described. © Springer International Publishing Switzerland 2014.