Medical Device Use Error : Root Cause Analysis book cover
1st Edition

Medical Device Use Error
Root Cause Analysis

ISBN 9781498705790
Published December 16, 2015 by CRC Press
267 Pages 130 Color Illustrations

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USD $170.00

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Book 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.

Table of Contents


Our Root Cause Analysis Process
Step 1: Define the Use Error
Step 2: Identify Provisional Root Causes
Step 3: Analyze Anecdotal Evidence
Step 4: Inspect Device for User Interface Design Flaws
Step 5: Consider Other Contributing Factors
Step 6: Develop a Final Hypothesis
Step 7: Report the Results
Next Steps

The Regulatory Imperative to Perform Root Cause Analysis
FDA Regulations
European Union Regulations
Other Regulators

Applicable Standards and Guidelines
U.S. Food and Drug Administration (Silver Spring, Maryland USA)
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design, Issued on June 22, 2011
International Standards Organization (Geneva, Switzerland)
ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes
International Standard Organization (Geneva, Switzerland)
ISO 14971:2007 Medical devices -- Application of risk management to medical devices
International Electrotechnical Commission (Geneva, Switzerland)
IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
International Electrotechnical Commission (Geneva, Switzerland)
IEC 62366-1:2015 Medical devices -- Part 1: Application of usability engineering to medical devices

The Language of Risk and Root Cause Analysis
Risk analysis
Hazardous situation
Intended use
Use error
Risk evaluation
Risk control
Residual risk

Types of Use Errors
Perception, Cognition, and Action Errors
Slips, Lapses, and Mistakes
Errors of Commission and Omission
Safety-Related and Non-Safety-Related Use Errors

Detecting Use Errors
Detecting Use Errors during Usability Tests
Detecting Use Errors during Clinical Studies
Detecting Use Errors during the Device’s Life Cycle

Interviewing Users to Determine Root Causes
Interview Timing
Interviewing Participants during Formative Usability Tests
Interviewing Participants during Summative Usability Tests
Interview Tips

Perils of Blaming Users for Use Errors
Don’t Blame the User
Reporting Test Artifacts as a Root Cause of Use Error

User Interface Design Flaws That Can Lead to Use Error
General User Interface Design Flaw Examples
Hardware User Interface Design Flaw Examples
Software User Interface Design Flaw Examples
Document User Interface Design Flaw Examples
Packaging User Interface Design Flaw Examples

Reporting Root Causes of Medical Device Use Error
Residual Risk Analysis
Presenting the Results of a Residual Risk Analysis

Root Cause Analysis Examples
About the root cause analysis examples
Insulin Pen Injector
Drug Bottle
Automated External Defibrillator (AED)
Handheld Tonometer
Lancing Device
Transdermal Patch
Electronic Health Record (EHR)
Syringe Infusion Pump
Surgical Warming Blanket
Urinary Catheter
Hemodialysis Machine
Ultrasonic Nebulizer
Ventricular Assist Device (VAD)
Smartphone Application: Insulin Bolus Calculator
Naloxone Nasal Spray
Enteral Feeding Pump
Metered Dose Inhaler
Drug Patch Pump
Patient Monitor
Jet Nebulizer
Electrosurgical Generator and Handpiece
Large-Volume Infusion Pump
Hospital Bed
Pen Injector
Blood Gas Analyzer
Dialysis Solution Bag
Ultrasound Scanner

Guide to Designing an Error-Resistant User Interface
Text Readability
Pushbutton Feedback
Component Visibility
"Undo" Control
Data Entry
Protection against Inadvertent Actuation
Instructional Content and Format
Package Design

Other Root Cause Analysis Methods
The 5 Whys
Ishikawa Diagramming
The Joint Commission’s Framework for Conducting a Root Cause Analysis
Matrix Diagrams
Critical Decision Method (CDM)
Systems-Theoretic Accident Model and Processes (STAMP)
The Human Factors Analysis and Classification System (HFACS)
Event Analysis for Systemic Teamwork (EAST)

Articles and Reports
US Food and Drug Administration (FDA) Publications

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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.


"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