NDLI: A platform for implantable medical device validation

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A platform for implantable medical device validation

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A platform for implantable medical device validation

Content Provider	ACM Digital Library
Author	Mangharam, Rahul Pajic, Miroslav Dixit, Sanjay Connolly, Allison Jiang, Zhihao
Abstract	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.
Starting Page	418
Ending Page	419
Page Count	2
File Format	PDF
ISBN	9781605589886
DOI	10.1145/1791212.1791284
Language	English
Publisher	Association for Computing Machinery (ACM)
Publisher Date	2010-04-12
Publisher Place	New York
Access Restriction	Subscribed
Subject Keyword	Validation Medical devices Cyber-physical systems Real-time systems
Content Type	Text
Resource Type	Article

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