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E-raamat: Medical Device Use Error: Root Cause Analysis

(UL-Wiklund, Concord, Massachusetts, USA), (UL-Wiklund, Concord, Massachusetts, USA), (UL-Wiklund, Concord, Massachusetts, USA)
  • Formaat: 267 pages
  • Ilmumisaeg: 06-Jan-2016
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781498705806
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  • Formaat: 267 pages
  • Ilmumisaeg: 06-Jan-2016
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781498705806

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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 errora mistakethat 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.

Arvustused

"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

Foreword xi
Acknowledgments xv
Who Should Read This Book xvii
Limitations of Our Advice xix
Authors xxi
Chapter 1 Introduction
1(4)
Chapter 2 Our Root Cause Analysis Process
5(10)
Introduction
5(3)
Step 1: Define the Use Error
8(1)
Step 2: Identify Provisional Root Causes
9(1)
Step 3: Analyze Anecdotal Evidence
10(1)
Step 4: Inspect Device for User Interface Design Flaws
11(1)
Step 5: Consider Other Contributing Factors
11(1)
Step 6: Develop a Final Hypothesis
12(1)
Step 7: Report the Results
13(1)
Next Steps
13(2)
Chapter 3 The Regulatory Imperative to Perform Root Cause Analysis
15(6)
FDA Regulations
15(3)
European Union Regulations
18(1)
Other Regulators
19(2)
Chapter 4 Applicable Standards and Guidelines
21(8)
Summary
27(2)
Chapter 5 The Language of Risk and Root Cause Analysis
29(10)
Introduction
29(10)
Chapter 6 Types of Use Errors
39(8)
Perception, Cognition, and Action Errors
39(4)
Slips, Lapses, and Mistakes
43(1)
Errors of Commission and Omission
44(1)
Safety-Related and Non-Safety-Related Use Errors
45(2)
Chapter 7 Detecting Use Errors
47(8)
Detecting Use Errors during Usability Tests
47(3)
Detecting Use Errors during Clinical Studies
50(1)
Detecting Use Errors during the Device's Life Cycle
51(4)
Chapter 8 Interviewing Users to Determine Root Causes
55(6)
Introduction
55(2)
Interview Timing
57(1)
Interviewing Participants during Formative Usability Tests
57(1)
Interviewing Participants during Summative Usability Tests
58(2)
Interview Tips
60(1)
Chapter 9 Perils of Blaming Users for Use Errors
61(6)
Don't Blame the User
61(4)
Reporting Test Artifact as a Root Cause of Use Error
65(2)
Chapter 10 User Interface Design Flaws That Can Lead to Use Error
67(22)
Introduction
67(5)
General User Interface Design Flaw Examples
72(1)
Inadequate Feedback (or Delayed Feedback)
72(1)
Insufficient User Support
72(1)
Similar Names
72(1)
Too Many Procedural Steps
73(1)
Hardware User Interface Design Flaw Examples
73(6)
Closely Spaced Buttons
73(1)
Complex Connection
73(1)
Display Glare
73(1)
Inaudible Alarm
74(1)
Inconspicuous Placement
74(1)
Insufficient Touch Screen Sensitivity
75(1)
Limited Display Viewing Angle
75(1)
Muffled Sound
75(1)
Narrow and Shallow Handles
75(1)
No Functional Grouping
76(1)
No Safeguard
76(1)
No Spotlighting
77(1)
No Strain Relief
77(1)
Pinch Point
77(1)
Requires Too Much Dexterity
77(1)
Sharp Edge
77(1)
Similar Colors
78(1)
Widely Compatible Connectors
79(1)
Software User Interface Design Flaw Examples
79(3)
Abbreviation
79(1)
Information Density
79(1)
Insufficient Visual Hierarchy
79(1)
Low Contrast
80(1)
No Confirmation
81(1)
No Data Validity Checks
81(1)
Poor Information Layout
81(1)
Small Decimal Point
81(1)
Small Text
82(1)
Toggle Ambiguity
82(1)
Document User Interface Design Flaw Examples
82(3)
Binding Does Not Facilitate Hands-Free Use
82(1)
Black and White Printing Limits Comprehension
82(1)
No Graphical Reinforcement
83(1)
No Index
83(1)
No Troubleshooting Section
83(1)
Poor Information Coding
83(1)
Poor Information Placement
84(1)
Unconventional Warnings
84(1)
Unfamiliar Language
84(1)
Visual Interference
84(1)
Packaging User Interface Design Flaw Examples
85(4)
"Hidden" Instructions
85(1)
Inconspicuous and Difficult-to-Read Expiration Date
86(1)
Limited Finger Access
86(1)
Sharp Edge
87(1)
Small Text
87(2)
Chapter 11 Reporting Root Causes of Medical Device Use Error
89(10)
Introduction
89(6)
Distinguishing Facts and Hypotheses
95(1)
Residual Risk Analysis
96(1)
Presenting the Results of a Residual Risk Analysis
97(2)
Chapter 12 Root Cause Analysis Examples
99(108)
About the Root Cause Analysis Examples
99(3)
Insulin Pen-Injector
102(4)
Drug Bottle
106(4)
Automated External Defibrillator (AED)
110(3)
Handheld Tonometer
113(4)
Lancing Device
117(3)
Transdermal Patch
120(3)
Electronic Health Record (EHR)
123(4)
Syringe Infusion Pump
127(4)
Surgical Warming Blanket
131(4)
Urinary Catheter
135(3)
Hemodialysis Machine
138(3)
Ultrasonic Nebulizer
141(4)
Ventricular Assist Device (VAD)
145(3)
Auto-Injector
148(4)
Stretcher
152(3)
Smartphone Application: Insulin Bolus Calculator
155(4)
Naloxone Nasal Spray
159(3)
Enteral Feeding Pump
162(3)
Metered Dose Inhaler
165(3)
Drug Patch Pump
168(4)
Patient Monitor
172(4)
Jet Nebulizer
176(4)
Syringe
180(4)
Electrosurgical Generator and Handpiece
184(3)
Large Volume Infusion Pump
187(3)
Hospital Bed
190(4)
Pen-Injector
194(4)
Blood Gas Analyzer
198(3)
Dialysis Solution Bag
201(3)
Ultrasound Scanner
204(3)
Chapter 13 Guide to Designing an Error-Resistant User Interface
207(10)
Introduction
207(1)
Perceptions
208(4)
Text Legibility
208(2)
Text Readability
210(1)
Text Conspicuity
210(1)
Alarm Detection
211(1)
Pushbutton Feedback
212(1)
Component Visibility
212(1)
Cognition
212(2)
Mental Calculations
212(1)
Unit Conversion
213(1)
Information Recall
213(1)
Action
214(3)
Device Orientation
214(1)
"Undo" Control
215(1)
Data Entry
215(1)
Protection against Inadvertent Actuation
215(1)
Instructional Content and Format
215(1)
Package Design
216(1)
Chapter 14 Other Root Cause Analysis Methods
217(16)
Introduction
217(1)
The Five Whys
218(1)
Ishikawa Diagramming
219(1)
AcciMap
220(3)
The Joint Commission's Framework for Conducting a Root Cause Analysis
223(3)
UPCARE Model
226(4)
Unmet User Needs
227(1)
Perception
227(1)
Cognition
228(1)
Actions
229(1)
Results
229(1)
Evaluation
230(1)
Matrix Diagrams
230(1)
Critical Decision Method (CDM)
231(1)
Systems-Theoretic Accident Model and Processes (STAMP)
231(1)
The Human Factors Analysis and Classification System (HFACS)
231(1)
Event Analysis for Systemic Teamwork (EAST)
232(1)
Resources 233(4)
Index 237
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 todays 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 teams 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 Societys New England chapter.