Model-Driven Safety Analysis of Closed-Loop Medical Systems

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Real-Time and Embedded Systems Lab (mLAB)
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CPS Medical
closed-loop medical systems
model-based development
safety analysis
high-confidence medical device systems
Electrical and Computer Engineering
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In modern hospitals, patients are treated using a wide array of medical devices that are increasingly interacting with each other over the network, thus offering a perfect example of a cyber-physical system. We study the safety of a medical device system for the physiologic closed-loop control of drug infusion. The main contribution of the paper is the verification approach for the safety properties of closed-loop medical device systems. We demonstrate, using a case study, that the approach can be applied to a system of clinical importance. Our method combines simulation-based analysis of a detailed model of the system that contains continuous patient dynamics with model checking of a more abstract timed automata model. We show that the relationship between the two models preserves the crucial aspect of the timing behavior that ensures the conservativeness of the safety analysis. We also describe system design that can provide open-loop safety under network failure.

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IEEE Transactions on Industrial Informatics
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@ARTICLE{6341078, author={Pajic, M. and Mangharam, R. and Sokolsky, O. and Arney, D. and Goldman, J. and Lee, I}, journal={Industrial Informatics, IEEE Transactions on}, title={Model-Driven Safety Analysis of Closed-Loop Medical Systems}, year={2014}, month={Feb}, volume={10}, number={1}, pages={3-16}, keywords={automata theory;closed loop systems;hospitals;medical control systems;open loop systems;safety;abstract timed automata model;closed-loop medical device systems;continuous patient dynamics;cyber-physical system;drug infusion;hospitals;model checking;model-driven safety analysis;network failure;open-loop safety;physiologic closed-loop control;simulation-based analysis;Analytical models;Biomedical monitoring;Drugs;Heart rate;Principal component analysis;Safety;Software packages;Closed-loop medical systems;high-confidence medical systems;model-based development;safety analysis}, doi={10.1109/TII.2012.2226594}, ISSN={1551-3203},}