Pretty much true. Human Factors Engineering has a goal of keeping all persons associated with the product safe from harm. Users include surgeon, support staff, and patient. It does take into consideration the training for each person in their intended role. It also looks at the potential for negative patient outcomes which could be derived from sub-optimal design of hardware, interfaces, etc. 15 trials suggested in document as a minimum, with trials being evaluated for how well the staff interact with the device. Participants are required to be US residents and in most cases, non-employees of the company (to reduce bias). Interface has to be clear and concise enough to avoid confusion for novice users and experienced users of other devices which may do some tasks in a different way.
I rather enjoyed reading the document, which repeatedly stated that Human Factors Engineering and Usability Engineering are synonymous and will be used interchangeably throughout the document, but they always called out both terms every time.
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