Abstract
This chapter gives a broad introduction of Human Factors (HF) and Human Computer Interaction (HCI) topics unique to the design and evaluation of medical devices. It covers medical device regulations that specify HF and HCI requirements, standards, and recommendations. It also highlights some of the user interface design challenges caused by the complexity and heterogeneity of healthcare. Specifically, we demonstrate how medical device usability and safety is a function of the nature and interplay of device use environments, patient characteristics, device users, care tasks, and device constraints. We also present two case studies: one showing how HF and HCI played a major role in reducing deaths related to the use of anesthesia machines, and another showing how simple changes to number entry interfaces can decrease the chance of serious medical errors.
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Additional Readings
Kaye, R., & Crowley, J. (2000). Medical device use-safety: Incorporating human factors engineering into risk management. Silver Spring: U.S. Food and Drug Administration, Center for Devices and Radiological Health. Retrieved from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094461.pdf
Sawyer, D. (1996). Do it by design – An introduction to human factors in medical devices. Rockville: U.S. Food and Drug Administration, Center for Devices and Radiological Health. Retrieved from http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm094957.htm
Weinger, M. B., Wiklund, M. E., & Gardner-Bonneau, D. J. (2011). Handbook of human factors in medical device design. Boca Raton: CRC Press.
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This work was partly funded by EPSRC grant [EP/L019272/1].
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Johnson, T.R., Thimbleby, H., Killoran, P., Diaz-Garelli, J.F. (2015). Human Computer Interaction in Medical Devices. In: Patel, V.L., Kannampallil, T.G., Kaufman, D.R. (eds) Cognitive Informatics for Biomedicine. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-319-17272-9_8
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