Links to Resources

• FDA Releases Human Factors Draft Guidance
  The U.S. Food and Drug Administration (FDA) has developed a draft guidance document to help manufacturers make medical devices safer through the use of human factors engineering. "The recommendations are intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls," according to the introduction to the document, Applying Human Factors and Usability Engineering to Optimize Medical Device Design, which was released on June 22.The agency is now soliciting comments and suggestions on the draft. The document gives recommendations on the types of testing, validation, and verification the manufacturer should go through to meet FDA requirements.
• FDA Human Factors Program
• Information for Manufacturers and Distributors
• Information for Health Care Professionals and Engineers
• Information for Consumers
• Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
• Human Factors Points to Consider for IDE Devices
• Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System Regulation
• Design Control Guidance for Medical Device Manufacturers
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• Guidance on Medical Device Patient Labeling
• Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions

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• ISO 14971-1:2007 Medical Devices - Application of Risk Management to Medical Devices
• AAMI / ANSI HE75:2009, Human Factors Engineering - Design of Medical Devices (General)
• IEC 60601-1-6:2010 -- Medical Electrical Equipment Part 1-6: General requirements for basic safety and essential performance collateral standard: Usability
• IEC 60601-1-8 Ed. 1, Medical Electrical Equipment - Part 1-8: General Requirements for Safety - Collateral Standard: Alarm Systems - Requirements, Tests and Guidances - General Requirements and Guidelines for Alarm Systems in Medical Equipment (General)
• ISO 62366, Medical Devices - Application of Usability Engineering to Medical Devices

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• Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
• Labeling requirements from Device Advice

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• Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
• Human Factors Implications of New GMP Rule; Overall Requirements of the New Quality System Regulation
• Design Control Guidance For Medical Device Manufacturers
• Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
• Medical Devices with Sharps Injury Prevention Features

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• Human Factors: The Journal of the Human Factors and Ergonomics Society
• Other HFES Publications
• HFES Educational Resources

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• AAMI - Association for the Advancement of Medical Instrumentation
• FAA - Federal Aviation Administration - Human Factors Research and Engineering
• FAA -Human Factors Awareness Web Course
• HFES - Human Factors and Ergonomic Society
• Designing for Humans: Design Research - Ergonomics - Human Factors - Usability
• Trace Center - University of Wisconsin-Madison
• Usability Net
• What Makes a Pre-filled Syringe Usable and Ergonomic? Critical Human Factors Design Attributes and Interacting Factors

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• AAMI Human Factors for Medical Devices Course
• AAMI / ANSI HE75:2009, Human factors engineering - Design of medical devices
• ANSI/AAMI/IEC 62366:2007, Medical devices - Application of usability engineering to medical devices
• The Quality System Compendium, 2ed - the definitive text on FDA's Quality System regulation.
• Horizons: Human Factors, 2010
• AAMI/HE, Human Factors Engineering Committee
• AAMI/ID, Infusion Device Committee
• The Quality System Collection on CD
• AAMI/AL Medical Device Alarms Committee
• AAMI/HA, Medical Devices and Systems in Home Care Applications
• AAMI/DF, Defibrillator Committee
• AAMI/SW, Medical Device Software Committee
• AAMI/ST, Sterilization Standards Committee
• Human Factors Compilation

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• Human Factors News
• Biomeds Speak Out On Common Design Flaws
• A Roundtable Discussion...Increased Focus on Human Factors Drives Device Safety Improvement
• Using Data to Improve Smart Intravenous Infusion Pumps
• Quality, Safety of Home Healthcare and Role of Human Factors Addressed in New Report
• Using Human-Centered Systems Engineering to Reduce Nurse Stakeholder Dissonance

The Biomedical Instrumentation & Technology (BI&T) and Horizons articles were posted to this site with permission of the Association for the Advancement of Medical Instrumentation, Inc. (C) 2011 AAMI www.aami.org. All rights reserved. Further reproduction or distribution prohibited.

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• First Do No Harm: Making Infusion Pumps Safer (BI&T, Sept/Oct 2010)
• Guide to Navigating the Expanded Human Factors Standard (BI&T, May/Jun 2010)
• Using Human Factors Engineering Principles to Strengthen Technology Management (BI&T, May/Jun 2008)
• Improving Equipment Purchasing Decision through Human Factors Engineering (BI&T, Mar/Apr 2008)
• The Complexities of the Human-Medical Device Interface

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• The Design of Everyday Things
  Donald A. Norman
• Designing Usability into Medical Products
  Michael E. Wiklund, Stephen B. Wilcox
• Human Error in Medicine
  Marilyn Sue Bogner
• Field Guide to Human Error Investigations
  Sidney Dekker
• Usability Testing of Medical Devices
  Michael E. Wiklund, Jonathan Kendler, Allison Y. Strochlic
• Designing for older adults: Principles and creative human factors approaches
  Arthur D. Fisk, Wendy A. Rogers, Neil Charness, Sara J. Czaja, Joseph Sharit
• Designing Displays for Older Adults
  Richard Pak, Anne McLaughlin
• Designing Telehealth for an Aging Population: A Human Factors Perspective
  Neil Charness, George Demiris, Elizabeth Krupinski
• Handbook of Human Factors and Ergonomics in Health Care and Patient Safety
  Pascale Carayon
• Handbook of Human Factors in Medical Device Design
  Matthew Bret Weinger (Editor), Michael E. Wiklund (Editor), Daryle Jean Gardner-Bonneau (Editor)

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• Challenges for home health care providers: A needs assessment
• Human factors considerations in implementing telemedicine systems to accommodate older adults
• Age-related glucometer design and selection: Tools and principles for optimal solutions
• Learning to use a home medical device: Mediating age-related differences with training
• Analysis of a "simple" medical device
• The Use, Misuse, and Abuse of Design Controls
• Usability Testing is Not Enough: Integrating Human Factors the Right Way and at the Right Time

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• Health IT Workforce Curriculum
  Health IT Workforce Curriculum, funded by The Office of the National Coordinator for Health Information Technology (ONC) and available through the National Training and Dissemination Center (NTDC). Includes curriculum components dealing with Usability and Human Factors, Workflow Analysis and Redesign, and Healthcare Culture that are relevant to Health IT device design and implementation. The materials developed under this program are meant to be used by the member colleges of the regional Community College Consortia as well as be available to institutions of higher education across the country.

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• Center for Human-Machine Interaction is organized as a cross-disciplinary research network between some twenty scientists and PhD students at seven Danish sites with an engagement in the fundamental aspects of human-machine interaction and their implications for design.
• Cognitive "&" Psychological Sciences is sponsored by Stanford University and contains just about all the references to cognitive and psychological sciences on the net. It includes academic programs, journals/magazines, newsgroups, mailing lists, announcements, and has links to everything.
• Institute of Ergonomics & Human Factors homepage for ergonomics in the UK.
• Institute for Safe Medication Practices
• National Patient Safety Foundation
• VA National Center for Patient Safety
• U.S. National Library of Medicine: Patient Safety
• Agency for Healthcare Research and Quality: Patient Safety Network
• National Center for Human Factors Engineering in Healthcare Conference Proceedings
• UEMedical - Human Factor usable medicine

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