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Medical Device Use Error
ISBN-13:
9781498705806
Veröffentl:
2016
Seiten:
267
Autor:
Michael Wiklund
eBook Typ:
PDF
eBook Format:
EPUB
Kopierschutz:
2 - DRM Adobe
Sprache:
Englisch
Beschreibung:
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.
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.
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