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Human factors analysis and design support in medical device development.

The last issue of BI&T explored the nature and role of human factors engineering (HFE) in health care. That column examined how the "root cause" of an accident is often simply labeled "human error" and how human error can be a convenient way to explain away a system-wide problem. HFE is highly effective in designing and operating systems that consider human strengths and weaknesses and do not "set up" users to commit errors. Still, people will continue to commit errors, no matter how hard we try. Yet we can design systems that, if not "fail-safe", are at least "fault tolerant." In these systems errors are more difficult to commit and are more easily detected, corrected, and mitigated. Human factors engineering can be of value to the health care industry in at least three highly critical areas: Developing new systems to enhance safety, efficiency, and usability; Evaluating whether to purchase particular equipment and how to effectively integrate it into hospital systems; and Investigating accidents. This article will review the HFE analysis and design activities undertaken in developing a new system. The article in the next issue of BI&T will explore HFE developmental and usability and evaluation activities.