Welcome to Human Factors Resources
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.
Human Factors Education
- Human Factors Engineering — Design of Medical Devices: A Review of ANSI/AAMI HE75:2009
- Human Factors Approaches to Ensuring Safe Medical Devices
- Implementing Human Factors Principles and Best Practices in Medical Device Design: Lessons Learned
- Linking Human Factors with FDA's Quality System Regulation: A Critical Component to the Design and Manufacturing Process
Publications
- Handbook of Human Factors in Medical Device Design — Written as a compliment to HE75, this handbook includes expanded discussions of design issues, product design case studies, and supporting illustrations. Order Code: HFMDD
- Handbook of Human Factors and Ergonomics in Health Care and Patient Safety — This book focuses on the need for collaboration between human factors professionals and health care providers. Order Code: HFEH
- Patient Safety: A Human Factors Approach — This discusses the latest human factors/ergonomics research applicable to patient safety and includes with examples to connect theory to actual practice. Order Code: HFA
Human Factors Standards
- ANSI/ANSI HE75:2009, 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. Order Code: HE75 or HE75-CD
- ANSI/AAMI/IEC 62366:2007, 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. Order Code: 62366 or 62366-PDF
- AAMI TIR49:2013, Design of training and instructional materials for medical devices used in non-clinical environments Order Code: TIR49 or TIR49-PDF Coming Soon
- AAMI Standards on CD — Human Factors — This CD collection contains more than 30 documents including AAMI standards, FDA guidance, and articles from industry experts. Order Code: HFCOL-CD
- 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
- E-mail standards@aami.org or
- Apply online at www.aami.org/standards/tc_join.html.
FDA Human Factors Resources
- 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)