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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http://ifmbe.org/

MORE INFORMATION?

patricia.trbovich@utoronto.ca

THANK YOU!