Abstract
BackgroundThe design complexity of critical care ventilators (CCVs) can lead to use errors and patient harm. In this study, we present the results of a comparison of four CCVs from market leaders, using a rigorous methodology for the evaluation of use safety and user experience of medical devices.MethodsWe carried out a comparative usability study of four CCVs: Hamilton G5, Puritan Bennett 980, Maquet SERVO-U, and Dräger Evita V500. Forty-eight critical care respiratory therapists participated in this fully counterbalanced, repeated measures study. Participants completed seven clinical scenarios composed of 16 tasks on each ventilator.Use safety was measured by percentage of tasks with use errors or close calls (UE/CCs). User experience was measured by system usability and workload metrics, using the Post-Study System Usability Questionnaire (PSSUQ) and the National Aeronautics and Space Administration Task Load Index (NASA-TLX).ResultsNine of 18 post hoc contrasts between pairs of ventilators were significant after Bonferroni correction, with effect sizes between 0.4 and 1.09 (Cohen’s d). There were significantly fewer UE/CCs with SERVO-U when compared to G5 (p = 0.044) and V500 (p = 0.020). Participants reported higher system usability for G5 when compared to PB980 (p = 0.035) and higher system usability for SERVO-U when compared to G5 (p < 0.001), PB980 (p < 0.001), and V500 (p < 0.001). Participants reported lower workload for G5 when compared to PB980 (p < 0.001) and lower workload for SERVO-U when compared to PB980 (p < 0.001) and V500 (p < 0.001). G5 scored better on two of nine possible comparisons; SERVO-U scored better on seven of nine possible comparisons. Aspects influencing participants’ performance and perception include the low sensitivity of G5’s touchscreen and the positive effect from the quality of SERVO-U’s user interface design.ConclusionsThis study provides empirical evidence of how four ventilators from market leaders compare and highlights the importance of medical technology design. Within the boundaries of this study, we can infer that SERVO-U demonstrated the highest levels of use safety and user experience, followed by G5. Based on qualitative data, differences in outcomes could be explained by interaction design, quality of hardware components used in manufacturing, and influence of consumer product technology on users’ expectations.Electronic supplementary materialThe online version of this article (doi:10.1186/s13054-016-1431-1) contains supplementary material, which is available to authorized users.
Highlights
The design complexity of critical care ventilators (CCVs) can lead to use errors and patient harm
The findings explore the design of the ventilators in two dimensions of interest: use safety and user experience
Within the boundaries of this study, we can infer that the SERVO-U ventilator demonstrated the highest levels of use safety and user experience, followed by the G5
Summary
The design complexity of critical care ventilators (CCVs) can lead to use errors and patient harm. Ventilators are a fundamental technology in critical care, with their use expected to increase in demand in the 10 years [1]. The use of ventilators is not without risk to the patient, with potential harm arising from infections, pneumothorax, ventilator-associated lung injury, and oxygen toxicity [6,7,8,9]. Other significant ventilator-related risks are the associated use errors with the device [10,11,12,13,14]. Use errors could cause patient harm in their operation if devices are not properly designed to mitigate such risks [11, 15, 16]. The design of ventilators can negatively affect user performance through poor user interfaces, interaction modes, or difficulties during the physical setup of the equipment [17]
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