Medical Device Use Error: Root Cause Analysis

ISBN-13: 9781498705790 / Angielski / Twarda / 2015 / 245 str.

P.E. Michael E. Wiklund; Andrea M. Dwyer; Erin Davis

Opis

Medical Device Use Error: Root Cause Analysis 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. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors (mistakes) that people make when using a medical device, the potential consequences, and design-based preventions. Using clear illustrations and simple narrative explanations, the text:

• Covers the fundamentals and language of root cause analysis and regulators expectations regarding the thorough analysis of use errors
• Describes how to identify use errors, interview users about use errors, and fix user interface design flaws that could induce use errors
• Reinforces the application of best practices in human factors engineering, including conducting both formative and summative usability tests

Medical Device Use Error: Root Cause Analysis delineates a systematic method of analyzing medical device use errors. The book provides a valuable reference to human factors specialists, product development professionals, and others committed to making medical devices as safe and effective as possible."

Recenzje

"In a simple but lucid manner, this book addresses medical device use error, utilizing root cause analysis as a structured method to examine serious adverse events. It is an excellent resource for human factors practitioners, medical device manufacturers and designers, clinicians at the bedside, biomedical engineers, caregivers at home, and students interested in understanding effective and safe design aspects of typical medical devices."
—Ergonomics in Design, October 2017

Spis treści

Introduction. Our Root Cause Analysis Process. The Regulatory Imperative to Perform Root Cause Analysis. Applicable Standards and Guidelines. The Language of Risk and Root Cause Analysis. Types of Use Errors. Detecting Use Errors. Interviewing Users to Determine Root Causes. Perils of Blaming Users for Use Errors. User Interface Design Flaws That Can Lead to Use Error. Reporting Root Causes of Medical Device Use Error. Root Cause Analysis Examples. Guide to Designing an Error-Resistant User Interface. Other Root Cause Analysis Methods. Resources.