Medical Device Use Error: Root Cause Analysis

By Michael E. Wiklund, Andrea M. Dwyer, Erin Davis

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.

• Format: Hardcover
• Language: English
• ISBN: 1498705790
• ISBN13: 9781498705790
• Release Date: January 2016
• Publisher: CRC Press
• Length: 245 Pages
• Weight: 1.28 lbs.
• Dimensions: 0.7" x 6.3" x 9.3"