This area has been designed specifically for human factors professionals in the medical device community. It serves as a resource on educational offerings, standards and publications, and contacts for other groups involved in medical device human factors activities. The site also provides information on FDA and regulations affecting medical device manufacturers.
AAMI Human Factors Standards
- ANSI/AAMI/IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical devices
This standard partially replaces 62366:2007/(R)2013. It specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety.
- ANSI/ANSI HE75:2009(R)2013, Human factors engineering—Design of medical devices— A virtual encyclopedia, this 445 page document is filled with illustrations, making the content practical and relevant to all readers.
- ANSI/AAMI/IEC 62366:2007(R)2013, Medical devices - Application of usability engineering to medical devices — This standard defines a usability-engineering process that ensures the basic safety and essential performance of medical devices related to usability.
- AAMI TIR49:2013, Design of training and instructional materials for medical devices used in non-clinical environments
- AAMI TIR50:2014 Post-market surveillance of use error management
- eSubscription — Human Factors — This CD collection contains more than 30 documents including AAMI standards, FDA guidance, and articles from industry experts.
- Get involved in AAMI’s Human Factors Committee
Committees of volunteers are the heart of the AAMI Standards Program. Committee members make recommendations on the need for new standards and other technical publications, determine when a document needs to be revised, draft new documents, and develop committee and public consensus on drafts. To join: Call +1 703 525-4890 x 1250 OR email firstname.lastname@example.org OR apply online.
AAMI Human Factors Publications
- Handbook of Human Factors in Medical Device Design — Written as a complement to HE75, this handbook includes expanded discussions of design issues, product design case studies, and supporting illustrations.
- Human Factors and Ergonomics in Health Care and Patient Safety — This book focuses on the need for collaboration between human factors professionals and healthcare providers.
- Patient Safety: A Human Factors Approach — This discusses the latest human factors/ergonomics research applicable to patient safety and includes examples to connect theory to actual practice.
AAMI Human Factors Training
FDA and Human Factors
- Applying Human Factors and Usability Engineering to Medical Devices (February 2016)
- Human Factors and Medical Devices
- General Human Factors Information and Resources
- Human Factors Engineering of Combination Products and the FDA (July 2012)
- FDA Perspectives on Human Factors in Device Development (June 2012)
- FDA Human Factors Draft Guidance Document: Agency Expectations for Human Factors Data in Premarket Submissions (March 2012)