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  • Press Release

UL and AAMI collaborate on Book: "Writing Human Factors Plan and Reports"

January 30, 2018

NORTHBROOK, Ill., Jan. 30, 2018 —UL (Underwriters Laboratories) and AAMI (Association for the Advancement of Medical Instrumentation) have collaborated on a new book to help medical professionals apply human factors engineering (HFE) methods needed to create safer and more effective health care products.

HFE is an applied science that aligns the design of devices, systems and physical use conditions with the capacities and requirements of the user. Its application to design improves ease of use, system performance and reliability, and user satisfaction, while reducing operational errors and operator stress. The application of HFE in the medical field, for example, can produce an X-ray machine that enables efficient and effective use, while protecting against potentially harmful errors. As such, the application of HFE directly serves to make products safer to use.

There is a regulatory imperative for medical technology developers to apply HFE methods in the design and function of their products. This book offers medical device manufacturers a head start on matching their product development processes to regulators’ HFE expectations by providing ideal work products. Topics covered in the book include guidance in developing an HFE project plan, a formative usability test plan and report, a summative (i.e., validation) usability test plan and report, and an HFE report. These plans and reports will help medical technology developers create high-quality HFE work products and expedite the development process.

“This book speaks to the importance of HFE Standards, principles and, demonstrates UL’s technical thought leadership and safety science expertise,” said Anil Patel, Director of Strategy, UL.

The book was co-written by UL’s Michael Wiklund, UL HFE General Manager, and Laura Birmingham and Stephanie Larsen, UL Human Factors Specialists.

“This book will better help technical manufacturers understand human behavior and manufacture easy-to-use products,” said Wiklund, HFE General Manager, UL.

“We’re very proud of this book and grateful to Michael Wiklund and his team. At AAMI, we’re committed to developing resources that support the medical device industry, and this guide does just that. By sharing their expertise in human factors engineering, Mr. Wiklund and his team are helping to make medical devices as safe and effective as possible. Everyone wins when that happens, most especially the patients,” said Sean Loughlin, Vice President of Communications and Marketing at AAMI.

The book can be ordered by calling 1-877-249-8226 or by visiting

About UL

UL fosters safe living and working conditions for people everywhere through the application of science to solve safety, security and sustainability challenges. The UL Mark engenders trust enabling the safe adoption of innovative new products and technologies. Everyone at UL shares a passion to make the world a safer place. We test, inspect, audit, certify, validate, verify, advise and train and we support these efforts with software solutions for safety and sustainability. To learn more about us, visit

About AAMI

AAMI is a nonprofit organization founded in 1967. It is a diverse community of approximately 7,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective healthcare technology. To learn more, please visit