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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

www.baddesigns.com


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www.baddesigns.com

Introduction to Usability

www.baddesigns.com


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www.baddesigns.com

www.baddesigns.com

Introduction to Usability

X


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http://www.asktog.com/columns/042ButterflyBallot.html

Introduction to Usability

www.baddesigns.com


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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

Documentation

Reversible

actions

Minimize

memory

load

Consistency /

Standards

Visibility of system status

Informative

feedback

Illustration of HFE Principles


An easy to use system is l.jpg

Effective

Task completed, user’s goals met

Efficient

Task completed quickly without undue cognitive effort

Easy-to-learn

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

easy-to-use

  • User

  • Knowledge

  • Abilities

  • Expectations

  • Limitations

Device is not

easy-to-use

  • System

  • Operational requirements, procedures

  • Complexity

  • User interface characteristics

Why do users make errors?

Device

Use

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”

“Best-of-Breed”

  • 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

gginsburg@thc.on.ca

905-848-7580 x 3016

Questions?

Erin Barkel

EBarkel@niagarahealth.on.ca

905-684-7271 x 4420