How Human Factors Lead to Medical Device Adverse Events
MedSun: Newsletter #26, July 2008

By Suzanne Rich, RN, CT, MA
FDA Medical Device Safety Website

Human factors is the science that focuses on understanding and supporting how people interact with technology. To minimize human factors problems, devices should be designed according to users' needs, abilities, limitations, and work environments. This includes the design of the device's user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device…

Additional Information:

How Human Factors Lead to Medical Device Adverse Events. Rich, Suzanne; RN, CT, MA. FDA Medical Device Safety Website. June 9, 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070185.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun