The Association for the Advancement of Medical Instrumentation (AAMI) is revamping its Human Factors for Medical Devices course—the latest of which will take place from August 29-31 in Baltimore. The course, which has educated 1,200 students over a seven-year period, will be completely revised in November and will incorporate additional investigation techniques, including class exercises. where participants use data to identify device design flaws.
The most recent evolution of the course—which is aimed at quality and design engineers, research and development managers, and risk managers—includes an increased focus on combination products and ties in with changes stemming from the FDA’s February 2016 guidance document, Applying Human Factors and Usability Engineering to Medical Devices, as well as revisions to American National Standards Institute/AAMI/IEC 62366-1, Medical Devices?Part 1: Application of usability engineering to medical devices.
“Many participants were coming to our course with the new guidance in their hands, and we know they want us to be up to date with the FDA’s published position on human factors,” says Bob North, chief scientist at Colorado Springs, Colo-based Human Centered Strategies, who directs the course. “We also present material from the newly updated international guidance, IEC 62366, which has undergone an upgrade to make it harmonize more with the FDA’s guidance.
“The course now has an integrated agenda that includes both of the FDA’s devices and drug centers,” North adds. “We have officials from those FDA centers giving co-presentations in the course now.”
Information about this month’s AAMI course can be found here.