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Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices.

Paolo Masci, Sandy Weininger

    Biomedical Instrumentation & Technology
    |November 2, 2021
    PubMed
    Summary

    This study developed usability engineering recommendations for integrated medical devices using model-based hazard analysis. These findings informed the ANSI/AAMI/UL 2800-1:2019 standard for medical device interoperability.

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    Area of Science:

    • Medical Device Engineering
    • Human-Computer Interaction
    • Systems Safety

    Background:

    • Next-generation medical devices require robust interoperability.
    • Usability is critical for safe and effective use of integrated medical systems.
    • Existing standards need enhancement for interoperability usability.

    Purpose of the Study:

    • To develop usability engineering recommendations for integrated interoperable medical devices.
    • To apply a model-based hazard analysis method to identify use-related design anomalies.
    • To inform the development of medical device interoperability standards.

    Main Methods:

    • Utilized a model-based hazard analysis to identify potential design anomalies in interoperability functions.
    • Focused on reasoning about use errors stemming from design flaws.
    • Developed specific design recommendations to mitigate identified risks.

    Main Results:

    • Generated a set of usability engineering recommendations for medical device interoperability.
    • Demonstrated the application of the method using a prototype system for postoperative care.
    • The analysis results directly informed Annex J of the ANSI/AAMI/UL 2800-1:2019 standard.

    Conclusions:

    • The model-based hazard analysis is effective for early-stage usability assessment of medical systems.
    • The developed recommendations contribute to safer medical device interoperability.
    • This work provides a valuable framework for future standard revisions and manufacturer practices.