Document Type

Journal Article

Subject Area

CPS Medical

Date of this Version

10-2012

Publication Title

IEEE Transactions on Industrial Informatics

Volume

10

Issue

1

First Page

3

Last Page

16

DOI

10.1109/TII.2012.2226594

Comments

An earlier version of this article can be found here.

Abstract

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.

Permission Statement

© 2012 IEEE. Personal use of this material is permitted. Permission from IEEE must be obtained for all other uses, in any current or future media, including reprinting/republishing this material for advertising or promotional purposes, creating new collective works, for resale or redistribution to servers or lists, or reuse of any copyrighted component of this work in other works.

Keywords

closed-loop medical systems, model-based development, safety analysis, high-confidence medical device systems

 

Date Posted: 21 October 2012

This document has been peer reviewed.