ABSTRACT
The role of human factors in the device use-hazard risk control process is the systematic identification and elimination of use errors during user-device interaction that lead to patient or user harm. Eliminating use error risk begins in the earliest stages of design by applying techniques such as task analysis, contextual inquiry, heuristic evaluations and inspections, and formative usability evaluations. Examining the history of use errors for similar devices is also essential in identifying use hazards and eliminating these problems through design. Throughout this process, the standard practices of the human factors, usability engineering, and ergonomic research disciplines are essential for designing unbiased evaluations, recording and analyzing data, and developing subjective and objective performance measures.
