Abstract
One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.
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Notes
- 1.
The models can be found at http://hcispecs.di.uminho.pt.
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Acknowledgements
This work has been funded by the EPSRC research grant EP/G059063/1: CHI+MED (Computer–Human Interaction for Medical Devices). J.C. Campos was funded by project NORTE-07-0124-FEDER-000062. We thank our reviewers for valuable and constructive feedback.
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Harrison, M.D., Masci, P., Campos, J.C., Curzon, P. (2017). Demonstrating that Medical Devices Satisfy User Related Safety Requirements. In: Huhn, M., Williams, L. (eds) Software Engineering in Health Care. SEHC FHIES 2014 2014. Lecture Notes in Computer Science(), vol 9062. Springer, Cham. https://doi.org/10.1007/978-3-319-63194-3_8
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