Perceived usefulness of a usability issues reporting form to help understand "usability-induced use-errors": a preliminary study.

The Medical Device regulation requires manufacturers to anticipate and prevent risks of use errors of their medical device. However, manufacturers experience difficulties to understand the concept of "usability-induced use-errors". Based on a "usability framework" aiming at describing the relationship between usability design principles, usability flaws, usage problems, and outcomes, a usability evaluation reporting form had been designed to support understanding the use-error concept. This paper reports the preliminary evaluation of the perceived usefulness of this form. Results show that manufacturers found helpful the presentation of the results of a usability evaluation through this form for it supports the understanding of the usability origins and the consequences of use-errors. Even if the use of this reporting form should be made easier as usability experts experience difficulties to fill it, it seems a promising way to clearly present "usability-induced use-errors" to manufacturers.