Human Factors Engineering for Medical Devices and Equipment · Human Factors Engineering for...
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Human Factors Engineering for Medical Devices and Equipment 2017 CADTH Symposium Patricia Trbovich, PhD Badeau Family Research Chair in Patient Safety and Quality Improvement North York General Hospital Associate Professor, University of Toronto April 24, 2017
Transcript of Human Factors Engineering for Medical Devices and Equipment · Human Factors Engineering for...
Human Factors Engineering for Medical Devices and Equipment
2017 CADTH Symposium
Patricia Trbovich, PhD
Badeau Family Research Chair in Patient Safety and Quality ImprovementNorth York General Hospital
Associate Professor, University of Toronto
April 24, 2017
“Medicine has become the act of managing extreme complexity- and a test of whether such complexity can, in fact, be
humanely mastered”
-Atul Gawande, The Checklist Manifesto,
2009
“Low health value per dollar spent”
Impact
• Most frequent reason for device recalls are related to design and software (Medical Recall Report FY2003 to FY2012”; CDRH Office of Compliance, Division of Analysis and Program Operations)
• Medical error: third leading cause of death in the US (BMJ 2016;353:i2139)
• Many medical errors related to medical devices
What is Human Factors?
• The study of how people interact physically and psychologically with products, tools, procedures, and processes
• Working to make the environment function in a way that seems natural to people
FormativeEvaluations
SummativeEvaluations
Hazard/risk assessment
•Risk assessment (ANSI/AAMI/ISO 14971)•Human factors hazard/risk assessment: Heuristic Evaluation
Hazard/risk assessment
Focuses on risk management and whether clinical benefits outweigh risk to patients and users
Consistency and standards
Flexibility and efficiency
Visibility of system state
Match between system and world
Control
Minimalist
Error prevention
Informative feedback
Error messages
Clear closure
Reversible actions
Minimize memory load
Language
Help
Usability Heuristics
J Zhang, et al., Journal of Biomedical Informatics, Vol. 36, No. 1-2. (April 2003), pp. 23-30,
Hazard/risk assessment
Answers the question “What potential hazards/risks exists?
Next question: “How will you try to mitigate these hazards/risks?
FormativeEvaluations
Evaluates an intervention by having representative users perform representative tasks
Usability Testing
LOW FIDELITY USABILITY TESTINGAsk questions and think aloudDocument performanceRecord video and audio
How many participants?
h"p://www.nngroup.com/ar0cles/why5you5only5need5to5test5with555users/:
Formative: 5 - 7 representative users
Answers the question “How did you try to mitigate the hazards/risks?”
Next question: “ Can you prove that you mitigated the hazards/risks?”
FormativeEvaluations
Summative Evaluation
Include objective (performance-based) evaluations of task success. Focus on high-priority tasks and on use errors that could result in harm to a patient or a user.
HIGH FIDELITY USABILITY TESTING
How many participants?
Formative: 5 - 7 representative users
h"p://www.nngroup.com/ar0cles/why5you5only5need5to5test5with555users/:
Summative: 15-20 representative users
Answers the question “Have you mitigated the hazards/risks?”
SummativeTesting
FormativeEvaluations
SummativeEvaluation
Hazard/risk assessment
“What potential hazards/risks exists?
“How did you try to mitigate the hazards/risks?”
“Have you mitigated the hazards/risks?”
XValley ofDeath
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