ABSTRACT
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Human factors engineering, also called ergonomics, can trace its roots to early
industrial engineering studies of work efficiency and task performance using,
for example, time-motion techniques. Human factors engineering emerged as
a recognized discipline during the Second World War, while focusing primar-
ily on military system performance, including problems in signal detection,
workspace constraints, and optimal task training. The widespread recognition
of the importance of applying human factors engineering in the design of
tools, devices, tasks, and other human activities is reflected in the increasing
number of disparate professionals interested in human factors. Their work
products can be found in lay and professional publications, standards, and
other documents. Human factors activities have improved the quality of
personal and professional life across many domains. Public and professional
interest in patient safety issues has promoted increased application of human
factors engineering to the medical domain. Numerous medical device companies have established human factors
engineering programs to ensure the usability and safety of their devices. These
companies also believe that their human factors engineering efforts enhance
the marketability of their products. National and international regulations
with respect to the safety of medical devices now require that human factors
engineering principles be applied to the design of medical devices, and that
this process be documented.
