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Patient Safety & Usability of Medical Devices Part I. Gill Ginsburg , M.A.Sc Human Factors & Biomedical Engineer Trillium Health Centre. Erin Barkel , B.A.Sc Patient Safety/Risk Management Specialist Niagara Health System. 2004 Fall CESO Conference. Outline – Part I. Intro to usability

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Patient safety usability of medical devices part i l.jpg

Patient Safety & Usability of Medical DevicesPart I

Gill Ginsburg, M.A.Sc

Human Factors & Biomedical Engineer

Trillium Health Centre

Erin Barkel, B.A.Sc

Patient Safety/Risk Management Specialist

Niagara Health System

2004 Fall CESO Conference

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Outline – Part I

  • Intro to usability

  • Intro to Human Factors Engineering

  • Why do users make mistakes?

  • Intro to patient safety & medical error

  • Canadian Adverse Events Study

  • Examples

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Introduction to Usability

Mike’s New CarMonsters, Inc.

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Introduction to Usability

  • Usability issues with Mike’s new car:

    • Complex dashboard

      • Too many buttons / switches

      • Functions are not obvious

      • No logical grouping

    • Hood is too high for Mike

    • Sully doesn’t fit

    • New & exciting features are too complicated to use…Mike “wants his old car back”!

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Introduction to Usability

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Introduction to Usability

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Introduction to Usability


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Introduction to Usability

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Introduction to Usability

Other Usability Examples


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Introduction to HFE

  • Human Factors Engineering (HFE) ensures that systems are easy-to-use

  • Multidisciplinary: engineering, medicine, psychology, computing, statistics…etc.

  • Design of systems according to Human Factors Principles…iterative process incorporating user feedback

  • Evaluation of systems for usability, safety, efficiency & effectiveness

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HFE Principles

Easy-to-use systems incorporate these Human Factors Principles:

  • Good error messages

  • Prevent errors

  • Clear closure

  • Reversible actions

  • Use user’s language

  • Users in control

  • Help & documentation

  • Visibility of system status

  • Consistency & standards

  • Match between system & world

  • Minimalist design

  • Minimize memory load

  • Informative feedback

  • Flexibility & efficiency

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Match between

system & world

Help and







Consistency /


Visibility of system status



Illustration of HFE Principles

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Task completed, user’s goals met


Task completed quickly without undue cognitive effort


System is predictable and consistent

An Easy-to-Use System is…

  • Engaging

    • User experiences pleasant interaction with the system

    • User satisfied with how system supports completion of task

  • Error tolerant

    • System prevents errors and assists in error recovery

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HFE Techniques to Ensure Usability of Systems

  • Heuristic evaluation

    • How does the system violate the HFE principles?

    • What is the severity of the violations?

  • User testing

    • Real users

    • Realistic tasks

    • What mistakes are made?

    • What is the severity of the mistakes?

    • Other performance measures: task completion time, mental workload, user preference

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HFE Techniques to Ensure Usability of Systems

  • Observations

  • Task analysis

  • Work domain analysis

  • Questionnaires

  • Surveys

  • Interviews

  • Focus groups

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Device is


  • User

  • Knowledge

  • Abilities

  • Expectations

  • Limitations

Device is not


  • System

  • Operational requirements, procedures

  • Complexity

  • User interface characteristics

Why do users make errors?



human error

patient injury

or death

Adapted from Kaye & Crowley, 2000

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Examples of Medical Error

  • Incorrectly sterilizing equipment

  • Administering wrong medication

  • Administering wrong dose

  • Administering wrong blood type

  • Wrong site surgery

  • Making an incorrect diagnosis

  • Burning a patient

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Canadian Adverse Events Study invention in history”

  • Principal Investigators Ross Baker and Peter Norton

  • Released May 2004

  • Based on a review of 3,700 charts from 20 acute care facilities

  • Year 2000 data

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Methodology invention in history”

  • Nurses reviewed the charts looking for any of the 18 “triggers” that might indicate that an AE had occurred

    • 40.8% of charts had at least one trigger

  • Charts were then reviewed by Doctors

    • Looking for evidence that an injury that caused disability, death or a prolonged LOS was present

      • Injury caused by “health care management”

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Findings invention in history”

  • 1 in 13 patients will experience an AE

    • 255 of these AEs required an additional 1521 days in hospital

    • About 1 million bed days nation wide

  • 5% of AEs resulted in permanent disability

  • 16,500 deaths

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Recommendations invention in history”

  • Near Miss/Close Catch Reporting

    • “Accident Ratio Study”

  • Incident Reporting

    • Renewed efforts to promote incident reporting

  • Using Root Cause Analysis to investigate incidents

    • Ask why 5x

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Niagara Health System invention in history”

  • Last of the HSRC amalgamations, and the largest

    • 7 sites

    • 6 municipalities

  • Population based of approximately 450,000

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The Challenge invention in history”

  • Regionalization

  • 7 Distinct Site Cultures

    • Different levels of awareness of patient safety

    • Different attitudes towards reporting

    • Different methods of reporting

  • Need to standardize reporting

    • Consistent data set

    • Consistent, conscientious reporting

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Standardize Data Collection invention in history”

  • In June 2004, 3 of 7 sites were using the Encon Incident Reporting system

    • The remaining 4 were using homemade forms

  • Inservice sessions were run at the remaining 4 sites

    • As of September, all NHS sites are using Encon

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Continuing Efforts invention in history”

  • Need for continuous inservicing

    • Maintain staff awareness

    • Develop awareness of Near Miss/Close Catch situations

    • Increase visibility of Risk Management initiatives and demonstrate accountability

    • Address staff fear (e.g. that reporting is punitive)

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Cautionary Note invention in history”

  • Increased volume is not reflective of a higher error rate

    • Incidents are presently under reported at most facilities

    • Education of staff will lead to an increase in reporting

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Medication Safety Committee invention in history”

  • Part of our Service Excellence Initiative

    • Reporting to the “Inspiring Excellence Council”

  • Representatives from Risk Management, Pharmacy, Nursing, Human Resources and Finance

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Medication Safety Committee invention in history”

  • First Year Goals

    • Increase incident reporting

      • Complete/Revise the Regional Medication Administration Policy

      • Provide education to frontline staff on the policy and the importance of reporting

      • Work on developing the framework for a “Just Culture” (Marx, 2001)

    • Creating a list of “Look-a-like, Sound-a-like” drugs in our facilities

      • Implement a education strategy to reduce errors associated with these drugs

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Other Projects invention in history”


  • Joint effort by Finance, Information Technology and Biomedical Departments

  • Standardize purchasing – only the best products, that are well supported and are usable, will be purchased

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Projects at Trillium Health Centre invention in history”

  • Infusion pump selection

  • Usability of bed alarms

  • Usability of diagnostic imaging systems

  • Incorporating human factors specifications into Request for Proposal process

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IV Pump Selection invention in history”

  • Background

    • Over 500 general-purpose IV pumps in hospital

    • Existing contract expiring

    • Need for “smart” features for patient safety

      • Dose-error reduction

      • Automated programming

    • Need for standard pump across hospital

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3 pumps after RFP invention in history”

Similar functionality & features

Initial selection process not successful

Used HFE to evaluate usability of pumps to:

Choose best pump for end users

Enhance patient safety

IV Pump Selection

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IV Pump Selection invention in history”

  • Heuristic Evaluation

    • Based on Human Factors principles

    • Revealed usability issues

    • Revealed information about causes of errors

  • User testing

    • 5 clinical areas, 14 nurses & 3 anaesthetists

    • Realistic scenarios

    • Observed & recorded # of errors & severity

      • Usability errors

      • Critical usability errors

      • Critical undetected usability errors

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IV Pump Selection invention in history”

Total Number of Usability Errors

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IV Pump Selection invention in history”

Number of Critical Usability Errors

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IV Pump Selection invention in history”

Number of Undetected Critical Usability Errors

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IV Pump Selection invention in history”

Total # of Errors Across Clinical Areas

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IV Pump Selection invention in history”

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IV Pump Selection invention in history”

  • Benefits of using HFE to evaluate usability:

    • Structured & objective approach

    • User involvement

    • Feedback to vendors

    • Customize user training

    • User familiarity & preference not always an indicator of device usability

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Thank you! invention in history”

Gill Ginsburg

905-848-7580 x 3016


Erin Barkel

905-684-7271 x 4420