1st Edition

Medical Device Use Error Root Cause Analysis

    267 Pages 130 Color Illustrations
    by CRC Press

    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.


    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    Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design, Issued on June 22,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
    UPCARE Model
    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


    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