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Patient Safety & Usability of Medical Devices Part I 2004 Fall CESO Conference Gill Ginsburg, M.A.Sc Human Factors & Biomedical Engineer Trillium Health.

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Presentation on theme: "Patient Safety & Usability of Medical Devices Part I 2004 Fall CESO Conference Gill Ginsburg, M.A.Sc Human Factors & Biomedical Engineer Trillium Health."— Presentation transcript:


2 Patient Safety & Usability of Medical Devices Part I 2004 Fall CESO Conference 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

3 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

4 Introduction to Usability Mike’s New Car Monsters, Inc.

5 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”!

6 Introduction to Usability

7 Introduction to Usability

8 Introduction to Usability X

9 Introduction to Usability

10 Introduction to Usability Other Usability Examples ???

11 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

12 HFE Principles Easy-to-use systems incorporate these Human Factors Principles: Visibility of system status Consistency & standards Match between system & world Minimalist design Minimize memory load Informative feedback Flexibility & efficiency Good error messages Prevent errors Clear closure Reversible actions Use user’s language Users in control Help & documentation

13 Illustration of HFE Principles Consistency / Standards Minimize memory load Informative feedback Reversible actions Help and Documentation Visibility of system status Match between system & world

14 An Easy-to-Use System is… Effective –Task completed, user’s goals met Efficient –Task completed quickly without undue cognitive effort Easy-to-learn –System is predictable and consistent 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

15 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

16 Observations Task analysis Work domain analysis Questionnaires Surveys Interviews Focus groups HFE Techniques to Ensure Usability of Systems

17 Why do users make errors? human error Device is easy-to-use Device is not easy-to-use Device Use Work Environment Light, noise Distraction/Interruption Workload patient injury or death User Knowledge Abilities Expectations Limitations System Operational requirements, procedures Complexity User interface characteristics Adapted from Kaye & Crowley, 2000

18 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

19 “Computers allow us to make mistakes faster than any other invention in history” -Unknown

20 Canadian Adverse Events Study 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

21 Methodology 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”

22 Findings 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

23 Recommendations 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

24 Niagara Health System Last of the HSRC amalgamations, and the largest –7 sites –6 municipalities Population based of approximately 450,000

25 The Challenge 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

26 Standardize Data Collection 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

27 Continuing Efforts 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)

28 Cautionary Note 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

29 Medication Safety Committee Part of our Service Excellence Initiative –Reporting to the “Inspiring Excellence Council” Representatives from Risk Management, Pharmacy, Nursing, Human Resources and Finance

30 Medication Safety Committee 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

31 Other Projects “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

32 Projects at Trillium Health Centre Infusion pump selection Usability of bed alarms Usability of diagnostic imaging systems Incorporating human factors specifications into Request for Proposal process

33 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 IV Pump Selection

34 3 pumps after RFP 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

35 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 IV Pump Selection

36 Total Number of Usability Errors

37 IV Pump Selection Number of Critical Usability Errors

38 IV Pump Selection Number of Undetected Critical Usability Errors

39 IV Pump Selection Total # of Errors Across Clinical Areas

40 IV Pump Selection Usability Characteristic # Participants who preferred… Pump APump BPump C Easiest to program a basic infusion 4512 Easiest to program from a drug library 835 Easiest to program from a drug calc 1054 Easiest to loading a set 857 Easiest to transport 1226 Most user-friendly prompts 655 Most user-friendly keypad 569 Most user-friendly display 669 Overall preference 658

41 IV Pump Selection 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

42 Thank you! Gill Ginsburg 905-848-7580 x 3016 Erin Barkel 905-684-7271 x 4420 Questions?

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