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A platform for implantable medical device validation

Publication ,  Conference
Pajic, M; Jiang, Z; Connolly, A; Dixit, S; Mangharam, R
Published in: Proceedings of the 9th ACM/IEEE International Conference on Information Processing in Sensor Networks, IPSN '10
July 16, 2010

Designing bug-free medical device software is difficult, especially in complex implantable devices that may be used in unanticipated contexts. In the 20-year period from 1985 to 2005, the US Food and Drug Administration's (FDA) Maude database records almost 30,000 deaths and almost 600,000 injuries from device failures [8]. 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 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.

Duke Scholars

Published In

Proceedings of the 9th ACM/IEEE International Conference on Information Processing in Sensor Networks, IPSN '10

DOI

Publication Date

July 16, 2010

Start / End Page

418 / 419
 

Citation

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Pajic, M., Jiang, Z., Connolly, A., Dixit, S., & Mangharam, R. (2010). A platform for implantable medical device validation. In Proceedings of the 9th ACM/IEEE International Conference on Information Processing in Sensor Networks, IPSN ’10 (pp. 418–419). https://doi.org/10.1145/1791212.1791284
Pajic, M., Z. Jiang, A. Connolly, S. Dixit, and R. Mangharam. “A platform for implantable medical device validation.” In Proceedings of the 9th ACM/IEEE International Conference on Information Processing in Sensor Networks, IPSN ’10, 418–19, 2010. https://doi.org/10.1145/1791212.1791284.
Pajic M, Jiang Z, Connolly A, Dixit S, Mangharam R. A platform for implantable medical device validation. In: Proceedings of the 9th ACM/IEEE International Conference on Information Processing in Sensor Networks, IPSN ’10. 2010. p. 418–9.
Pajic, M., et al. “A platform for implantable medical device validation.” Proceedings of the 9th ACM/IEEE International Conference on Information Processing in Sensor Networks, IPSN ’10, 2010, pp. 418–19. Scopus, doi:10.1145/1791212.1791284.
Pajic M, Jiang Z, Connolly A, Dixit S, Mangharam R. A platform for implantable medical device validation. Proceedings of the 9th ACM/IEEE International Conference on Information Processing in Sensor Networks, IPSN ’10. 2010. p. 418–419.

Published In

Proceedings of the 9th ACM/IEEE International Conference on Information Processing in Sensor Networks, IPSN '10

DOI

Publication Date

July 16, 2010

Start / End Page

418 / 419