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Modeling and integrating physical environment assumptions in medical cyber-physical system design

Published: 27 March 2017 Publication History

Abstract

Implicit physical environment assumptions made by safety critical cyber-physical systems, such as medical cyber-physical systems (M-CPS), can lead to catastrophes. Several recent U.S. Food and Drug Administration (FDA) medical device recalls are due to implicit physical environment assumptions. In this paper, we develop a mathematical assumption model and composition rules that allow M-CPS engineers to explicitly and precisely specify assumptions about the physical environment in which the designed M-CPS operates. Algorithms are developed to integrate the mathematical assumption model with system model so that the safety of the system can be not only validated by both medical and engineering professionals but also formally verified by existing formal verification tools. We use an FDA recalled medical ventilator scenario as a case study to show how the mathematical assumption model and its integration in M-CPS design may improve the safety of the ventilator and M-CPS in general.

References

[1]
Lui Sha and Jose Meseguer. Analytical system composition. In The First Analytic Virtual Integration of Cyber-Physical Systems Workshop, 2010.
[2]
U.S. Food and Drug Administration. Medical device databases. http://www.fda.gov/medicaldevices/deviceregulationandguidance/databases/.
[3]
U.S. Food and Drug Administration. Medical ventilators - faulty batteries. http://www.fda.gov/MedicalDevices/Safety/ucm460951.htm.
[4]
Charles W. Kerechanin II, Protagoras N. Cutchis, Jennifer A. Vincent, Dexter G. Smith, and Douglas S. Wenstrand. Development of field portable ventilator systems for domestic and military emergency medical response, 2004.
[5]
U.S. Food and Drug Administration. Applying human factors and usability engineering to medical devices. http://www.fda.gov/downloads/MedicalDevices/.../UCM259760.pdf.
[6]
J. Goldmann. Medical device interoperability to enable system solutions at the sharp edge of healthcare delivery. In White House Homeland Security Council Biodefense Directorate Conference, Apr 2010.
[7]
Medical Device "Plug and Play" Interoperability Program. Ice standard: Integrated clinical environment. http://www.mdpnp.org/mdice.html.
[8]
Medical Device "Plug and Play" Interoperability Program. Device clock synchronization. http://www.mdpnp.org/devicesynchronization.html.
[9]
Cheolgi Kim, Mu Sun, Sibin Mohan, Heechul Yun, Lui Sha, and Tarek F. Abdelzaher. A framework for the safe interoperability of medical devices in the presence of network failures. In Proceedings of the 1st ACM/IEEE International Conference on Cyber-Physical Systems, pages 149--158, 2010.
[10]
Tirumala A.S. An assumptions management framework for systems software. In Doctoral Thesis. University of Illinois at Urbana-Champaign, 2006.
[11]
S. Leue. Baby death due to software-controlled air bag deactivation? In ACM Risks Digest, March 1999.
[12]
N. Leveson and C. Turner. An investigation of the therac-25 accidents. IEEE Computer, 26:1841, July 1993.
[13]
Patricia Lago and Hans van Vliet. Explicit assumptions enrich architectural models. In In Proceedings of the 27th international Conference on Software Engineering, 2005.
[14]
Lewis, T. A. G., Mahatham, and Wrage L. Assumptions management in software development. In Technical Report. CMU, 2004.
[15]
Cadex Electronics. Battery university. http://batteryuniversity.com/.
[16]
European Hearing Instrument Manufacturers Association. Ehima recommendations for zinc-air hearing aid batteries. http://www.ehima.com/wp-content/uploads/2014/03/EHIMA-Battery-Recommendations_V2.0.pdf.
[17]
Zhicheng Fu, Chunhui Guo, Shangping Ren, YuJiang, and Lui Sha. Modeling and integrating physical environment assumptions in medical cyber-physical system design. Technical report, Department of Computer Science, Illinois Institute of Technology, 2016. http://gauss.cs.iit.edu/~code/techreports/Fu2016DATEtechreport.pdf.
[18]
Chunhui Guo, Shangping Ren, Yu Jiang, Po-Liang Wu, Lui Sha, and Richard Berlin. Transforming medical best practice guidelines to executable and verifiable statechart models. In 2016 ACM/IEEE 7th International Conference on Cyber-Physical Systems (ICCPS), pages 1--10, April 2016.

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cover image Guide Proceedings
DATE '17: Proceedings of the Conference on Design, Automation & Test in Europe
March 2017
1814 pages

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European Design and Automation Association

Leuven, Belgium

Publication History

Published: 27 March 2017

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