Toward patient safety in closed-loop medical device systems

Authors:
David Arney;Miroslav Pajic;Julian M. Goldman;Insup Lee;Rahul Mangharam;Oleg Sokolsky
Affiliations:
University of Pennsylvania;University of Pennsylvania;Massachusetts General Hospital & CIMIT;University of Pennsylvania;University of Pennsylvania;University of Pennsylvania
Venue:
Proceedings of the 1st ACM/IEEE International Conference on Cyber-Physical Systems
Year:
2010

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Abstract

A model-driven design and validation of closed-loop medical device systems is presented. Currently, few if any medical systems on the market support closed-loop control of interconnected medical devices, and mechanisms for regulatory approval of such systems are lacking. We present a system implementing a clinical scenario where closed-loop control may reduce the possibility of human error and improve safety of the patient. The safety of the system is studied with a simple controller proposed in the literature. We demonstrate that, under certain failure conditions, safety of the patient is not guaranteed. Finally, a more complex controller is described and ensures safety even when failures are possible. This investigation is an early attempt to introduce automatic control in clinical scenarios and to delineate a methodology to validate such patient-in-the-loop systems for safe and correct operation.