Authors:
Lorenzo Strigini
and
Marwa Gadala
Affiliation:
Centre for Software Reliability, City, University of London, Northampton Square, London, U.K.
Keyword(s):
Usability, Medical Devices, Usability of Standards, Automation Bias.
Abstract:
With increasing variety and sophistication of computer-based medical devices, and more diverse users and use environments, usability is essential, especially to ensure safety. Usability standards and guidelines play an important role. We reviewed several, focusing on the IEC 62366 and 60601 sets. It is plausible that these standards have reduced risks for patients, but we raise concerns regarding: (1) complex design trade-offs that are not addressed, (2) a focus on user interface design (e.g., making alarms audible) to the detriment of other human factors (e.g., ensuring users actually act upon alarms they hear), and (3) some definitions and scope restrictions that may create “blind spots”. We highlight potential related risks, e.g. that clear directives on “easier to understand” risks, though useful, may preclude mitigating other, more “difficult” ones; but ask to what extent these negative effects can be avoided by standard writers, given objective constraints. Our critique is moti
vated by current research and incident reports, and considers standards from other domains and countries. It is meant to highlight problems, relevant to designers, standards committees, and human factors researchers, and to trigger discussion about the potential and limits of standards.
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