New AAMI TIR51 – Human Factors for Medical Devices

For Medical Device developers and other healthcare professionals, one challenge is to understand how people interact with their products in a “real world” context.  Now AAMI has provided you with guidance for this challenge – AAMI TIR51, “Human factors engineering – Guidance for contextual inquiry.”  If you’re in the healthcare business, this new Technical Information Report can help you design devices, systems or instructions in a more informed manner.  Here’s more details about this new document.

The goal of this report is to help you expand your concept of human factors from an interview-based methodology to a broader process based on both interviews and observation.  This will help you bridge the gap between what people say they do and their actual actions.  The protocol is intended to help you develop a deeper understanding of both users and the environments the device will be used in.  You’ll also be using this system to spot problems with existing design.  And you’ll also be getting insight into both the viewpoint of users as well as their capabilities and limitations.

Sections in AAMI TIR51 cover research methodology, data analysis, and reporting (including the use of video).   It also covers how to integrate your analysis into the design of devices, facilities and/or processes.  It covers troubleshooting, since the process is different from market research, for example.  And it also has a sample story board format for this type of process from the University of Cincinnati.  A 15-item bibliography finishes up the document.

This new publication is available from Document Center Inc. in both paper format and for pdf download.  You’ll be able to order the AAMI TIR51 (and all current AAMI standards) at our webstore, www.document-center.com.  Need more information?  Check in with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping people like you with standards and standards questions since 1982.  Make us your Standards Experts!

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Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

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