Resources

FDA Human Factors Program

	Portal
	Overview of FDA's New Human Factors Program Plan
	Human Factors Implications of the New GMP Rules
	Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
	Do It By Design, Human Factors Guidelines

Human Factors Standards

	Human Factors in Medical Devices, Design, Regulation, and Patient Safety. AAMI/FDA Conference Report
	Human factors design process for medical devices.ANSI/AAMI HE74:2001
	Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices, HE-48:1993
	Graphical Symbols for Electrical Equipment in Medical Practice, ANSI/AAMI/IEC TIR 60878:2003.

Human Error in Medicine

	Institute of Medicine report, To Err is Human
	Making Healthcare Safer: A Critical Analysis of Patient Safety Practices. Agency for Healthcare Research and Quality. (See Section G)

Other Regulatory

	FDA/CDRH, USA
	MDD, Europe
	HPB/TPP, Canada

Research Programs

	The University of Texas Human Factors Research Project
	The University of Maryland Human Factors Research Program In Trauma, Anesthesia, and Critical Care

Articles on the Web

	Erika Brown. Human factors in medicine: Prospectives from 1-g to micro-g. Human Factors and Ergonomics, 2002
	Marcella J. Kogan. Human factors viewed as key to reducing medical errors. Monitor on Psychology, Volume 31, No. 11 December, 2000
	Michael E. Wiklund. Making medical device interfaces more user-friendly. MDDI, May 1998
	Michael E. Wiklund. Eleven keys to designing error-resistant medical devices. MDDI, May 2002
	Christine Engelke & Daniel Olivier. Putting human factors engineering into practice. MDDI, July 2002
	Safe, Comfortable, Attractive, and Easy to Use: Improving the Usability of Home Medical Devices, National Academies Press

Recommended Books

	Wiklund, Michael E. Medical Device and Equipment Design: Usability Engineering and Ergonomics. Interpharm Press, 1995.
	Bogner, Marilyn Sue (Ed). Human Error In Medicine. Lawrence Erlbaum Associates, 1994.
	Redmill, Felix & Rajan, Jane. Human Factors In Safety-Critical Systems. Butterworth-Heinemann, 1997.
	Reason, James. Human Error. Cambridge University Press. 1990.
	Park, Denise C., Morrell, Roger W., Shifren, Kim. Processing of Medical Information in Aging Patients: Cognitive & Human Factors Perspectives. Lawrence Erlbaum Associates, 1999.
	Casey, Steven. Set Phasers On Stun, And Other True Tales of Design, Technology, and Human Error. Aegean Publishing Company, 1998.

Top^