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Designing bug-free medical device software is difficult, especially in complex implantable devices that may be used in unanticipated contexts. Safety recalls of pacemakers and implantable cardioverter defibrillators due to firmware problems between 1990 and 2000 affected over 200,000 devices, comprising 41% of the devices recalled and are increasing in frequency. There is currently no formal methodology or open experimental platform to validate and verify the correct operation of medical device software. To this effect, a real-time Virtual Heart Model (VHM) has been developed to model the electrophysiological operation of the functioning (i.e. during normal sinus rhythm) and malfunctioning (i.e. during arrhythmia) heart. We present a methodology to extract timing properties of the heart to construct a timed-automata model. The platform exposes functional and formal interfaces for validation and verification of implantable cardiac devices. We demonstrate the VHM is capable of generating clinically-relevant response to intrinsic (i.e. premature stimuli) and external (i.e. artificial pacemaker) signals for a variety of common arrhythmias. By connecting the VHM with a pacemaker model, we are able to pace and synchronize the heart during the onset of irregular heart rhythms. The VHM has also been implemented on a hardware platform for closed-loop experimentation with existing and virtual medical devices. The VHM allows for exploratory electrophysiology studies for physicians to evaluate their diagnosis and determine the appropriate device therapy. This integrated functional and formal device design approach will potentially help expedite medical device certification for safer operation.
Real-time systems, medical devices, validation, verification, closed-loop control
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Date Posted: 30 March 2010