Human Centered Strategies

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AAMI Webinar 2007
Standards & Guidances
RAPS Horizon 2008

Resources

AAMI Human Factors Webinar Material Now Available

Materials from the Association for the Advancement of Medical Intstrumentation's (AAMI) webinar on Implementing Human Factors Principles and Best Practices are now available through AAMI. The webinar was moderated by Bob North of Human Centered Strategies, with Edmond Israelski (Abbott Medical) and Ronald D. Kaye (FDA Office of Device Evaluation) lending perspectives on new standards and human factors regulatory expectations for manufacturers. A highlight of the webinar was discussion of a series of case studies involving use error incidents and how usability methods could have identified the design flaws leading to adverse events. See link to AAMI's announcement.

Papers and Presentations

Human Factors: A Methodology for Managing Risks of Use Error in Medical Device Design, R.A. North, and M.K. Peterson; presented to the Minnesota Medical Alley group, December 2003, Minneapolis, MN. (download)

UPCARE: An analysis, description, and educational tool for medical device use problems. R. D. Kaye, R. A. North, and M.K. Peterson (download)

Fitting Human Factors in the Product Development Process. P. A. Patterson and R. A. North, MD&DI, January, 2007.

In Plain Sight: The Benefits of Human Factors Analysis. P. A. Patterson and R. A. North. (Published in Focus, by Regulatory Affairs Professional Society, January, 2007)

Standards and Guidances

Human Factors Standards (AAMI, IEC) from FDA Human Factors Group (link)

FDA Guidance on Human Factors in Management of Use Error (2000)