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Medical Device Design Standards: Necessary But Not Sufficient

Medical Device Design Standards: Necessary But Not Sufficient. Chris Vincent & Ann Blandford. UCLIC, University College London, Gower Street, London, WC1E 6BT, UK c.vincent@ucl.ac.uk, a.blandford@ucl.ac.uk. There are many standards, applied to support infusion pump design and manufacture:.

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Medical Device Design Standards: Necessary But Not Sufficient

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  1. Medical Device Design Standards: Necessary But Not Sufficient Chris Vincent & Ann Blandford UCLIC, University College London, Gower Street, London, WC1E 6BT, UK c.vincent@ucl.ac.uk, a.blandford@ucl.ac.uk There are many standards, applied to support infusion pump design and manufacture: • WE HAVE BEEN SUPPORTING MANUFACTURERS AND CONSULTANCIES IN THE FOLLOWING WAYS • www.chi-med.ac.uk • Personas and scenarios: Avoid designing in isolation by considering hypothetical users and usage [3]. • Number entry guidance: Conducting experiments to reveal the pros and cons of candidate design options. • Design rationale: Provide techniques to articulate trade-offs and make apparent the reasoning behind design [4]. • Guidance for standards: Provide an overview of the pros and cons of different approaches. • BUT…. There are reasons why we need more than just standards: • Devices are being used outside hospitals, and in ways that are hard to anticipate [1]. • 2) Despite standards, design and development occurs in isolation [2]. • 3) Guidance / standards can be contradictory. Care outside of the hospital Care in the hospital “In many cases, the development landscape resembled multiple islands of individuals, maintaining they had little influence over the device UI…” “UE/HFE practitioners still reported discipline specific silos.” “So everything that fosters communication helps. and stuff that prevents communication doesn’t.” A guide to the design of electronic infusion devices: NPSA / NHS England. Human factors engineering –Design of medical devices: AAMI/ANSI HE75. Example: Number Entry Keypads: Where to put the decimal point? For more examples, have a look at the handout, and/or get in contact: c.vincent@ucl.ac.uk +44(0)20 7679 0694. We want to hear about your experiences using medical device design standards. This work forms part of the UK EPSRC funded CHI+MED project (EP/G059063). [1] O'Kane, A. A., & Blandford, A. (2013). Patients’ situated affective experience with mobile medical devices. Paper presented at MediCHI, CHI Paris. [2] Vincent, C.J., Li, Y, & Blandford, A. (2014). Integration of human factors and ergonomics during medical device design and development: It's all about communication. Applied Ergonomics, 45(3), 413-419. [3] Vincent, C.J., & Blandford, A. (In Press) The challenges of delivering validated personas for medical equipment design. Applied Ergonomics. [4] Vincent, C.J., Blandford, A., & Li, Y. (2012). QOC-E: A mediating representation to support the development of shared rationale and integration of Human Factors advice. Paper presented at the HFES 2012 Symposium on Human Factors and Ergonomics in Health Care.

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