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A Hazard Analysis Method for Systematic Identification of Safety Requirements for User Interface Software in Medical Devices

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Part of the book series:Lecture Notes in Computer Science ((LNTCS,volume 10469))

Abstract

Formal methods technologies have the potential to verify the usability and safety of user interface (UI) software design in medical devices, enabling significant reductions in use errors and consequential safety incidents with such devices. This however depends on comprehensive and verifiable safety requirements to leverage these techniques for detecting and preventing flaws in UI software that can induce use errors. This paper presents a hazard analysis method that extends Leveson’s System Theoretic Process Analysis (STPA) with a comprehensive set of causal factor categories, so as to provide developers with clear guidelines for systematic identification of use-related hazards associated with medical devices, their causes embedded in UI software design, and safety requirements for mitigating such hazards. The method is evaluated with a case study on the Gantry-2 radiation therapy system, which demonstrates that (1) as compared to standard STPA, our method allowed us to identify more UI software design issues likely to cause use-related hazards; and (2) the identified UI software design issues facilitated the definition of precise, verifiable safety requirements for UI software, which could be readily formalized in verification tools such as Prototype Verification System (PVS).

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Acknowledgments

Sandy Weininger (FDA), Scott Thiel (Navigant Consulting, Inc.), Michelle Jump (Stryker), Stefania Gnesi (ISTI/CNR) and the CHI+MED team (www.chi-med.ac.uk) provided useful feedback and inputs. Paolo Masci’s work is supported by the North Portugal Regional Operational Programme (NORTE 2020) under the PORTUGAL 2020 Partnership Agreement, and by the European Regional Development Fund (ERDF) within Project “NORTE-01-0145-FEDER-000016”.

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Authors and Affiliations

  1. INESC TEC, Universidade Do Minho, Braga, Portugal

    Paolo Masci & José C. Campos

  2. US Food and Drug Administration, Silver Spring, USA

    Yi Zhang & Paul Jones

Authors
  1. Paolo Masci

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  2. Yi Zhang

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  3. Paul Jones

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  4. José C. Campos

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Corresponding author

Correspondence toPaolo Masci.

Editor information

Editors and Affiliations

  1. University of Trento, Trento, Italy

    Alessandro Cimatti

  2. Mälardalen University, Västerås, Sweden

    Marjan Sirjani

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Masci, P., Zhang, Y., Jones, P., Campos, J.C. (2017). A Hazard Analysis Method for Systematic Identification of Safety Requirements for User Interface Software in Medical Devices. In: Cimatti, A., Sirjani, M. (eds) Software Engineering and Formal Methods. SEFM 2017. Lecture Notes in Computer Science(), vol 10469. Springer, Cham. https://doi.org/10.1007/978-3-319-66197-1_18

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