Heuristic evaluation of portable pulse oximeters for domiciliary use: Implications for its use in assessing medical device usability

Abstract

Medical Device manufacturers must consider usability during medical device design to minimise the risk of harm associated with user error. However, devices are increasingly being incorporated into home care pathways and may be adopted in contexts unforeseen by manufacturers. In situations where devices are being used without supervision of a healthcare professional, device usability is more important. The first objective of this research was to use heuristic evaluation to assess the usability of pocket pulse oximeters used in National Health Service home pathways. The second objective was to investigate the value of heuristic evaluation as a tool to assess medical device usability. 10 heuristic evaluators independently assessed 5 portable pulse oximeters using 15 heuristics. The value of the heuristic evaluation in evaluating device usability was assessed. A total of 42 unique use problems were identified across all devices. 76% of use problems received the lowest severity score (1). We identified limitations in the methodology used and suggested modifications to improve the evaluation process. Heuristic evaluation pre-empted use problems and allowed for quantitative usability comparisons between devices. We found value in heuristic evaluation used to objectively identify device design flaws, particularly with the minor modifications suggested.