Medical Device Use Error: Root Cause Analysis

This book offers practical guidance on how to methodically discover and explain the root cause of a use error-a mistake-that occurs when someone uses a medical device. From home-use products to devices used in clinical environments, the text presents case studies that show how root cause analysis leads from understanding a use error's causes and consequences to the development of design-based preventions. Using clear illustrations and simple narrative explanations, the text covers the fundamentals, language, and regulatory expectations of root cause analysis.

Author: Michael Wiklund,Andrea Dwyer,Erin Davis
Publisher: CRC Press
Published: 12/16/2015
Pages: 245
Binding Type: Hardcover
Weight: 1.28lbs
Size: 9.30h x 6.30w x 0.70d
ISBN: 9781498705790

About the Author

Michael E. Wiklund is general manager of the human factors engineering (HFE) practice at UL-Wiklund, as well as professor of the practice at Tufts University, where he teaches courses on HFE. He has more than 30 years of experience in HFE, much of which has focused on medical technology development. His work has involved optimizing the safety, effectiveness, usability, and appeal of various products. Widely published, he is a certified human factors professional and one of the primary contributors to today's most pertinent guidelines on the HFE of medical devices: AAMI HE75 and IEC 62366.

Andrea M. Dwyer is a managing human factors specialist at UL-Wiklund, where she leads some of the team's most challenging user research and usability testing projects. She has authored numerous usability test reports that involve root cause analysis of medical device use errors. She also frequently composes usability engineering (i.e., human factors engineering, or HFE) program plans, administers usability tests, and develops HFE reports. She earned her BS in human factors engineering from Tufts University, where she received two prizes that honor achievement and excellence in human factors studies. She is currently a part-time graduate student in engineering management at Tufts University.

Erin M. Davis is a managing human factors specialist at UL-Wiklund, where she develops and implements human factors engineering (HFE) programs and leads projects requiring expertise in user research, design, and usability testing of medical devices. She received her MS in HFE from Tufts University, and her BS in biomedical engineering from Marquette University. Erin is a published researcher and serves as the 2015 president of the Human Factors and Ergonomics Society's New England chapter.