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U.S. Department of Health and Human Services

Medical Devices

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AAMI/FDA Conference "Human Factors in Medical Devices: Design, Regulation, and Patient Safety"

In September 1995, the Association for the Advancement of Medical Instrumentation (AAMI) and FDA held a joint conference in Washington D.C. to discuss human factors and medical devices. Formal presentations were made by professional associations, representatives of industry, health and human factors professionals, academia, and FDA. The 111-page AAMI/FDA Conference Report of the presentations is available from the:

Association for the Advancement of Medical Instrumentation
3330 Washington Blvd., Suite 400
Arlington, Virginia 22201

The Conference Report includes the following presentations:

  • "Human Factors and the FDA’s Goals: Improved Medical Device Design" by D. Bruce Burlington, M.D., Director, Center for Devices and Radiological Health
  • "Human Factors: Success Stories and Current Challenges for Medical Devices" by Thomas B. Sheridan, Massachusetts Institute of Technology
  • "Human Factors in the Operating Room" by David M. Gaba, MD, Stanford University Medical Center; Palo Alto, CA Veterans Affairs Medical Center
  • "Perspectives and Experiences of Device Users: Human Factors and Home Care Devices" by Thomas H. French, Jr., APRIA Healthcare
  • "General Hospital and Critical Care Devices: Whose Faults is Human Error?" by William A. Hyman, PE, ScD, Texas A&M University
  • "The Costs and Benefits of Human Factors Design: A Manufacturer’s Perspective" by George Hutchinson, MSE, Marquette Electronics
  • "The Process of Human Factors Engineering: Human Factors in Product Design and Development" by Michael E. Wiklund, American Institutes for Research
  • "The Process of Human Factors Engineering: Usability Testing" by Joseph S. Dumas, PhD, American Institutes for Research
  • "The Process of Human Factors Engineering: User Product Evaluation" by Debra Myram, MSN, National Institutes of Health
  • "The IVAC Infusion Pump: User Centered Design" by Rodney Hasler, MME, IVAC Corporation
  • "Improving Ease of Use Through Automation and Design" by Thomas D. Kelly, Althin Medical, Inc.
  • "Designing User Instructions" by James R. Callan, PhD, Pacific Science & Engineering Group
  • "Overview of FDA’s New Human Factors Plan: Implications for the Medical Device Industry" by Peter B. Carstensen, Division of Device User Programs and User Analysis, Office of Communication, Education, and Radiation Programs (OCER), CDRH
  • "The Premarket Review Process: New Requirements for Manufacturers" by Susan Alpert, M.D., Director, Office of Device Evaluation, CDRH
  • "Human Factors in the GMP Inspection Process" by Gregory W. O’Connell, Office of Compliance, CDRH
  • "Human Factors and Postmarket Surveillance at FDA" by Thomas P. Gross, M.D., MPH, Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, CDRH
  • "Human Factors or Human Foibles?" James D. Stewardson, COBE Renal Care, Inc.
  • "Industry/FDA Exchange on Human Factors" by Glenn Pelikan, SpaceLabs Medical, Inc.
  • "Overview of the AAMI National Standard, Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices" by Frank E. Block, Jr., MD, University of Arkansas for Medical Sciences
  • "CDRH’s Approach to Providing Human Factors Information" by Dick Sawyer, PhD, Division of Device User Programs and Systems Analysis, Office of Communication, Education, and Radiation Programs (OCER), CDRH
  • "Resources for Human Factors Design: Additional Human Factors Resources" by Susan Meadows, Member, Executive Council of the Human Factors and Ergonomics Society