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Formal verification of software-based medical devices considering medical guidelines

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International Journal of Computer Assisted Radiology and Surgery Aims and scope Submit manuscript

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Abstract

Objective

    Software-based devices have increasingly become an important part of several clinical scenarios. Due to their critical impact on human life, medical devices have very strict safety requirements. It is therefore necessary to apply verification methods to ensure that the safety requirements are met. Verification of software-based devices is commonly limited to the verification of their internal elements without considering the interaction that these elements have with other devices as well as the application environment in which they are used. Medical guidelines define clinical procedures, which contain the necessary information to completely verify medical devices. The objective of this work was to incorporate medical guidelines into the verification process in order to increase the reliability of the software-based medical devices.

Materials and  methods

   Medical devices are developed using the model-driven method deterministic models for signal processing of embedded systems (DMOSES). This method uses unified modeling language (UML) models as a basis for the development of medical devices. The UML activity diagram is used to describe medical guidelines as workflows. The functionality of the medical devices is abstracted as a set of actions that is modeled within these workflows. In this paper, the UML models are verified using the UPPAAL model-checker. For this purpose, a formalization approach for the UML models using timed automaton (TA) is presented.

Results

    A set of requirements is verified by the proposed approach for the navigation-guided biopsy. This shows the capability for identifying errors or optimization points both in the workflow and in the system design of the navigation device. In addition to the above, an open source eclipse plug-in was developed for the automated transformation of UML models into TA models that are automatically verified using UPPAAL.

Conclusions

    The proposed method enables developers to model medical devices and their clinical environment using clinical workflows as one UML diagram. Additionally, the system design can be formally verified automatically.

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Acknowledgments

This research is supported by the European Union, European Regional Development Fund (ERDF) and the federal state of Baden-Wuerttemberg, Germany.

Conflict of Interest

Zamira Daw, Rance Cleaveland, and Marcus Vetter declare that they have no conflict of interest.

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Authors and Affiliations

  1. EMB-Lab, Hochschule Mannheim, University of Applied Sciences, Mannheim, Baden-Württemberg, Germany

    Zamira Daw & Marcus Vetter

  2. Department of Computer Science, University of Maryland, College Park, MD, USA

    Rance Cleaveland

Authors
  1. Zamira Daw
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  2. Rance Cleaveland
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  3. Marcus Vetter
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Correspondence to Zamira Daw.

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Daw, Z., Cleaveland, R. & Vetter, M. Formal verification of software-based medical devices considering medical guidelines. Int J CARS 9, 145–153 (2014). https://doi.org/10.1007/s11548-013-0919-2

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  • DOI: https://doi.org/10.1007/s11548-013-0919-2

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