Transitioning to ericshaver.com

January 2, 2014 by · Leave a Comment
Filed under: general 

ericshaver.com

After 5 years blogging at The Human Factor Advocate, I’ve decided it’s time to transition to a new home.  Thus, all future posts will occur at ericshaver.com.

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Five Facts about Human Factors for Health Care Professionals

December 1, 2013 by · Leave a Comment
Filed under: health care, human factors 

Earlier this year, the BMJ Quality & Safety journal published an article that sought to “…describe the scientific discipline of human factors and provide common ground for partnerships between healthcare and human factors communities” (p. 802).

Among many important points, the authors highlighted five facts – and their corresponding fictions – that needed clarification. They include:

  • Fact 1: Human factors is about designing systems that are resilient to unanticipated events.
  • Fact 2: Human factors addresses problems by modifying the design of the system to better aid people.
  • Fact 3: Human factors work ranges from the individual to the organizational level.
  • Fact 4: Human factors is a scientific discipline that requires years of training; most human factors professionals hold relevant graduate degrees.
  • Fact 5: Human factors professionals are bound together by the common goal of improving design for human use, but represent different specialty areas and methodological skills sets.

Overall, this is a great introductory article for those in the health care profession that are just learning about the discipline of human factors. Interested readers can download and read the entire article here.

References

Russ, A.L., Fairbanks, R.J., Karsh, B., Militello, L.G., Saleem, J.J., & Wears, R.L. (2013). The science of human factors: Separating fact from fiction. BMJ Quality & Safety, 22, 803-808.

 

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Ben Goldacre on Battling Bad Science

November 17, 2013 by · Leave a Comment
Filed under: business, research 

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Are Zombie Doctors Taking Over America?

October 26, 2013 by · Leave a Comment
Filed under: health care 

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Human Factors and Medical Device Resources

The science of Human Factors & Ergonomics is vital to assisting in the design, development, and deployment of safe and usable 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 ideas for resources to include, please contact me.

FDA Regulations

21 CFR 800 – Medical Devices

21 CFR 820.30 – Design Controls

Standards

ANSI/AAMI/IEC 62366:2007 (R2013). Medical devices – Application of usability engineering to medical devices. Arlington, VA: Association for the Advancement of Medical Instrumentation.

ANSI/AAMI HE75:2009 (2010). Human factors engineering – Design of medical device. Arlington, VA: Association for the Advancement of Medical Instrumentation.

IEC 60601-1 3rd Ed. (2012). Medical electronic equipment – Part 1: General requirements for basic safety and essential performance. Geneva, Switzerland: International Electrotechnical Commission.

ISO 14971:2007 (2010). Medical devices – Application of risk management to medical devices. Geneva, Switzerland: International Organization for Standardization.

Guidance

Draft Guidance for Industry and Food and Drug Administration Staff – Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)

Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (May 2, 2011)

Guidance for Industry and FDA Premarket and Design Control Reviewers – Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management (July 18, 2000)

Sawyer, D. (1996).  Do it by design: An introduction to human factors in medical devices.  Silver Spring, MD: Food and Drug Administration.

Books

Tullis, T., & Albert, B. (2013).  Measuring the user experience: Collecting 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.E., Kendler, J., & Strochlic, A.Y. (2011). Usability testing of medical devices. 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

Biomedical Instrumentation & Technology

Journal of Medical Engineering & Technology

Proceedings

Proceedings of the 2013 International Symposium on Human Factors and Ergonomics in Health Care

Proceedings of the 2012 Symposium on Human Factors and Ergonomics in Health Care

Trade Publications

Horizons

MD+DI

Courses

Association for the Advancement of Medical Instrumentation (AAMI): Human Factors for Medical Devices (3 Day Course)

Conferences

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 – General

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., 2013)

FDA Perspectives on Human Factors in Device Development (Molly Follette Story, Ph.D., 2012)

FDA Human Factors Draft Guidance Document: Agency Expectations for Human Factors Data in Premarket Submissions (Molly Follette Story, Ph.D., 2012)

HF Review Perspectives for Premarket Submissions FDA/CDRH: A Tale of Two Submissions (Ron Kaye, M.A. and QuynhNhu Nguyen, B.S., 2012)

Identifying Use Errors and Human Factors Approaches to Controlling Risks (Molly Follette Story, Ph.D. and QuynhNhu Nguyen, B.S., 2011)

Human Factors/Usability for Medical Devices: An Historical Perspective (Ron Kaye, M.A., 2011)

Websites

FDA General Human Factors Information and Resources

AAMI Human Factors Resources

MedicalDeviceHumanFactors.org

HFES Health Care Technical Group

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