Reasoning and Risk Assessment Based on Real-Time Physiological Simulations and Dependable Vital Parameter Monitoring

We present a novel approach for dependability analysis of medical devices. As focus, we considered vital parameter monitoring. The basic strategy relies on using methods from system theory. For the first time not only the technical device but also the patient is taken into consideration. Including the patient requires prediction of physiology which is achieved by a real-time physiological simulation in a continuous time domain, whereby one of the main ingredients is a temporal reasoning element. The quality of the reasoning is expressed by a dependability analysis strategy. Thereby, anomalies are expressed as differences between simulation and real world data. Deviations are detected for current and they are forecasted for future points in time. By this method, patient specific differences in terms of physiological reactions are described, allowing early detection of critical states. The interplay of the different elements and the consequences are explained in a realistic model.