Resources

FDA Human Factors Program

	Human Factors and the FDA's Goals: Improved Medical Device Design.
	Do It By Design, Human Factors Guidelines
	Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management

Human Factors Related Standards for Medical Devices

	Medical devices -- Application of usability engineering to medical devices. IEC 62366:2007
	Human Factors Engineering - Design of Medical Devices. ANSI/AAMI HE75:2009
	Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
	Human factors design process for medical devices. ANSI/AAMI HE74:2001
	Graphical Symbols for Electrical Equipment in Medical Practice, ANSI/AAMI/IEC TIR 60878:2003.

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.

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