The role of patient simulation and incident reporting in the development and evaluation of medical devices and the training of their users

We describe how simulation and incident reporting can be used in combination to make the interaction between people, (medical) technology and organisation safer for patients and users. We provide the background rationale for our conceptual ideas and apply the concepts to the analysis of an actual incident report. Simulation can serve as a laboratory to analyse such cases and to create relevant and effective training scenarios based on such analyses. We will describe a methodological framework for analysing simulation scenarios in a way that allows discovering and discussing mismatches between conceptual models of the device design and mental models users hold about the device and its use. We further describe how incident reporting systems can be used as one source of data to conduct the necessary needs analyses - both for training and further needs for closer analysis of specific devices or some of their special features or modes during usability analyses.