Medical Device Use Error: Root Cause Analysis, 1st Edition (Hardback) book cover

Medical Device Use Error

Root Cause Analysis, 1st Edition

By Michael Wiklund, Andrea Dwyer, Erin Davis

CRC Press

245 pages | 130 Color Illus.

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pub: 2015-12-16
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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.


"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

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



About the Authors

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.

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Biotechnology
TECHNOLOGY & ENGINEERING / Industrial Health & Safety