[Updated 8.18.16]
The science of Human Factors & Ergonomics is vital to assisting in the design, development, and deployment of safe, usable, and delightful medical devices.
Below are several resources that are relevant for individuals interested in learning about medical device human factors, companies looking to incorporate a comprehensive human factors program in their organization, and seasoned professionals that need a repository of readily accessible information.
This post will be updated as additional, relevant resources are identified. If you have suggestions, please contact me.
FDA Regulations
Standards
- ANSI/AAMI HE75:2009 (2010). Human factors engineering – Design of medical device. Arlington, VA: Association for the Advancement of Medical Instrumentation.
- IEC 60601-1 Ed. 3.1 (2012-08). Medical electronic equipment – Part 1: General requirements for basic safety and essential performance. Geneva, Switzerland: International Electrotechnical Commission.
- IEC 60601-1-12 Ed 1.0 (2014-06). Medical electronic equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. Geneva, Switzerland: International Electrotechnical Commission.
- IEC 62366-1 Ed 1.0 (2015-02). Medical devices – Part 1: Application of usability engineering to medical devices. Geneva, Switzerland: International Electrotechnical Commission.
- IEC/TR 62366-2 Ed 1.0 (2016-04). Medical devices – Part 2: Guidance on the application of usability engineering to medical devices. Geneva, Switzerland: International Electrotechnical Commission.
- ISO 14971:2007 (2010). Medical devices – Application of risk management to medical devices. Geneva, Switzerland: International Organization for Standardization.
Supplementary Information Sheets (SIS)
- IEC 62366-1 Edition 1.0 2015-02. Medical devices – Part 1: Application of usability engineering to medical devices [Recognition Number: 5-95]. Federal Register publication date: 08/14/2015.
- AAMI/ANSI/IEC 62366-1:2015. Medical devices – Part 1: Application of usability engineering to medical devices [Recognition Number: 5-96]. Federal Register publication date: 08/14/2015.
FDA Guidance Documents
- Guidance for Industry and Food and Drug Administration Staff – Applying human factors and usability engineering to medical devices (February 3, 2016).
- Draft Guidance for Industry and Food and Drug Administration Staff – List of highest priority devices for human factors review (February 3, 2016).
- Guidance for Industry and Food and Drug Administration Staff – Reprocessing medical devices in health care settings: Validation methods and labeling (March 17, 2015).
- Guidance for Industry and FDA Premarket and Design Control Reviewers – Medical device use-safety: Incorporating human factors engineering into risk management (July 18, 2000).
- Guidance for Industry and FDA Staff – Infusion pumps total product life cycle (December 2, 2014).
- Guidance for Industry and FDA Staff – Recognition and use of consensus standards (September 17, 2007).
- Guidance for Industry and Food and Drug Administration Staff – Design considerations for devices intended for home use (November 24, 2014)
- Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers (April 19, 2001)
- Sawyer, D. (1996). Do it by design: An introduction to human factors in medical devices. Silver Spring, MD: Food and Drug Administration.
Technical Information Reports
- AAMI TIR50:2014 (2014). Post-market surveillance of use error management. Arlington, VA: Association for the Advancement of Medical Instrumentation. [see here for additional details]
- AAMI TIR51:2014 (2014). Human factors engineering – Guidance for contextual inquiry. Arlington, VA: Association for the Advancement of Medical Instrumentation.
- AAMI TIR55:2014 (2014). Human factors engineering for processing medical devices. Arlington, VA: Association for the Advancement of Medical Instrumentation.
Books
- Carayon, P. (2011). Handbook of human factors and ergonomics in health care and patient safety. Boca Raton, FL: CRC Press.
- Tullis, T., & Albert, B. (2013). Measuring the user experience: Collecting, analyzing, and presenting usability metrics. Waltham, MA: Morgan Kaufmann.
- Weinger, M.B., Wiklund, M.E., & Garner-Bonneau, D.J. (2011). Handbook of human factors in medical device design. Boca Raton, FL: CRC Press.
- Wiklund, M., Dwyer, A., Davis, E. (2016). Medical device use error: Root cause analysis. Boca Raton, FL: CRC Press.
- Wiklund, M.E., Kendler, J., & Strochlic, A.Y. (2016). Usability testing of medical devices (2nd ed.). Boca Raton, FL: CRC Press.
Chapters
- Morrow, D.G., North, R., Wickens, C.D. (2005). Reducing and mitigating human error in medicine. In R. Nickerson (Ed.), Annual Review of Human Factors and Ergonomics, Vol .1 (pp. 254-296). Santa Monica, CA: Human Factors and Ergonomics Society.
Journals
Proceedings
- Proceedings of the 2015 International Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes
- Proceedings of the 2014 International Symposium on Human Factors and Ergonomics in Health Care: Leading the Way
- Proceedings of the 2013 International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause
- Proceedings of the 2012 Symposium on Human Factors and Ergonomics in Health Care
Trade Publications
Courses
Presentations – Conference
- HFES 2016 International Symposium on Human Factors and Ergonomics in Health Care: Shaping the Future
- HFES 2015 International Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes
- HFES 2014 International Symposium on Human Factors and Ergonomics in Health Care: Leading the Way
- HFES 2013 International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause
- HFES 2012 Symposium on Human Factors and Ergonomics in Health Care: Bridging the Gap
Presentations – FDA
- What’s new in human factors pre-market review (Ron Kaye, M.A., March 2013)
- Human factors engineering of combination products and the FDA (Molly Follette Story, Ph.D., July 2012)
- FDA perspectives on human factors in device development (Molly Follette Story, Ph.D., June 2012)
- FDA human factors draft guidance document: Agency expectations for human factors data in premarket submissions (Molly Follette Story, Ph.D., March 2012)
- Human factors review perspectives for premarket submissions FDA/CDRH: A tale of two submissions (Ron Kaye, M.A. and QuynhNhu Nguyen, B.S., March 2012)
- Identifying use errors and human factors approaches to controlling risks (Molly Follette Story, Ph.D. and QuynhNhu Nguyen, B.S., September 2011)
- Human factors/usability for medical devices: An historical perspective (Ron Kaye, M.A., June 2011)
- Enhancing the quality of device labeling (Molly Follette Story, Ph.D., April 2011)
Websites
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