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Ergonomics, or human factors, is the scientific discipline concerned with understanding the interactions among humans and other elements of a system. It is also the profession that applies theory, principles, data, and design methods needed to optimize system performance. In the medical device field, this translates to increased patient safety.
Human factors will capture headlines in the medical device arena in 2005, as standards development activities, the current regulatory environment, industry practices, and an increased body of knowledge have all contributed to a greater awareness of the discipline.
AAMI activities in the human factors arena will be two-fold-first, as host of the Human Factors, Ergonomics, and Patient Safety for Medical Devices Conference, which is scheduled on June 28-30 in Washington, D.C. (Go to www.aami.org/meetings/hf/index. html to learn more.) AAMI has invited internationally recognized leaders in human factors and patient safety for a dialogue that will focus on important developments in U.S. and international human factors standards; regulatory expectations and requirements; implementing, validating, and maintaining a human factors program; legal and liability risks; usability; and more. The conference will appeal to design and research engineers, quality system and risk managers, human factors managers, product managers, customer advocates, and others interested in or responsible for advancing human factors and patient safety as it relates to medical devices.
AAMI's second contribution to the field in 2005 comes in the form of standards development. The AAMI Human Factors Engineering (HFE) Committee, which oversees development of human factors standards for the association, is developing a new standard, Human factors design principles for medical devices (HE75).
BI&T recently sat down with the co-chairs of the committee, Edmond W. Israelski, PhD, Program Manager-Human Factors at Abbott Laboratories' Corporate Regulatory & Quality Science Department, and Matthew B. Weinger, MD, who is a professor of anesthesiology at Vanderbilt University Medical Center, to discuss AAMI's new standard and other activities taking place in this...