Full Description
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.
Contents
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.
