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Other Human Factors Resources

If this is your first time visiting the Human Factors section of FDA’s web site, we encourage you to read the Frequently Asked Questions on this site for general information about the program and to help direct you to documents of interest.

• FDA Information
• Other Government Reports about Patient Safety and Human Factors
• Human Factors Training
• Special Population Considerations
• Human Factors and Medical Device Sources

FDA Information

FDA investigates and develops information for the public on safe use of medical devices. Some reports of our findings and recommendations can be found by clicking on the links below:

• Do It By Design: An Introduction to Human Factors in Medical Devices a primer on Human Factors for medical devices PDF
• Reuse of Single Use Devices
• Hospital Bed Safety
• Reducing Use Error
• Managing The Risks From Medical Product Use: Creating A Risk Management Framework

You can check these FDA sources for information about devices that you use now or are considering for your facility:

• CDRH Public Health Notifications
• CDRH Medical Device Recalls List
• CDER: Medication Errors
• Medical Device Safety (Alerts/Recalls, Patient Safety News)

Other Government Reports about Patient Safety and Human Factors

• To Err Is Human - Building a Safer Health System, Institute of Medicine report, 1999
• Preventing Medication Errors, Institute of Medicine report, 2006)
• Making Health Care Safer: A Critical Analysis of Patient Safety Practices Agency for Research Healthcare Research and Quality (AHRQ) report, 2001

Human Factors Training

• Veterans Health Administration Virtual Learning Center (Workshops and online training about Human Factors and Patient Safety, with examples and description of Human Factors and Root-Cause Analysis)
• U.S. Air Force’s Ergonomics Course Modules (Tool Design and Basic Anatomy/Biomechanics may be most useful general modules)
• FAA’s Human Factors Awareness Web Course (Human Factors Model is overview of discipline, Usability module discusses usability testing, Visual Display, Non-Visual Displays, Controls, Cognition modules discuss human factors considerations for each design area)

Special Population Considerations

• FDA’s Pediatric Medical Devices (note that the guidance has special labeling requires for these devices)
• Making Your Web Site Senior Friendly, checklist from the National Institute on Aging (NIA) and National Library of Medicine
• Section 508 of the US Rehabilitation Act
• DisabilityInfo.gov
• Assistive Technology section of Standards.gov
• ABLEDATA, National Institute on Disability and Rehabilitation Research (NIDRR) information/resources on accessing and maintaining accessibility
• Guidelines: Making Health Settings & Information Accessible, The Center for Disease Control’s (CDC)
• Center for Universal Design, North Carolina State University
• Trace Center, University of Wisconsin website on Designing a More Usable World; contains many links on additional resources, including guidelines based on disability type (e.g., Blindness) and extensive reference listings
• AARP’s Older Adults Online: Useful Resources on Usability
• National Public Website on Assistive Technology

Human Factors and Medical Device Sources

• American Society of Anesthesiologists Recommendations for Pre-Anesthesia Checkout Procedures
• Association for the Advancement of Medical Instrumentation (AAMI)
• Human Factors and Ergonomic Society (HFES)
• Human Factors Professional Interest section, Industrial Design Society of America
• Medical DeviceLink (the monthly magazine often has human factors articles)
• Usability Net
• Usability Professionals Association Body of Knowledge

Updated January 22, 2008