Other guidances of interest include AAMI/IEC 62366-1:2015 and IEC 60601-1-6 third edition. AAMI/IEC 62366-1:2015 provides a structured approach to conducting human factor studies. Specific features include an overview of the design process for human factor studies, planning of human factor stud...
Human factors and usability engineering principles should be applied in the design process. The IEC 62366 standard describes the application of usability engineering to medical devices. The onus is on the design team to develop an inherently safe product, designed in such a way as to minimize the...
The next consequence to consider is whether or not the error has effectiveness implications. In other words, “does the error reduce or eliminate the intended medical effects of the product?” If a user can’t remove the cap on an auto-injector, it’s not going to be very...