An Introduction to Medical Device Adverse Event by run58134

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									 An Introduction to Medical Device
 Adverse Event Investigations
 A Biomedical Engineering Perspective




                             Ted MacLaggan, MScE, EIT
                             Clinical Engineer




Outline:
Introduction
      Hospitals & Hazards
      Purpose
      The Challenge
      Definitions
Quality Control & Risk Management
      Legal Considerations
Conducting an Investigation
      CSI Tool Box
      5 Investigational Phases
      Root Cause Analysis
Case Studies
Questions




Introduction – Hospitals &
Hazards
Complex Environment
     Many Systems
     Many Policies
     Many Procedures
Mission/Safety Critical Systems
     Life support Equipment
     Building Facilities
     Multiple Points & Modes of Failure




                                                        1
  Introduction – Hospitals &
  Hazards
Environmental:                                        Human Factors:
          Electrical                                         Use Errors
          Radiation                                          Misdiagnosis
          Chemical                                           Drug Dose Errors
          Biological
Facility:                                             Device:
          Power Failures                                           Entrapment & Falls
          Medical Gas Failures                                     Failures
          Smoke/Fire                                               Alarms




  Introduction – Hospitals &
  Hazards

      Recent empirical work has suggested that
      Canadian hospitals have an unsafe event
      rate of 7.5 percent of which 37 percent are
      preventable with a death rate of 0.66 percent.
       G. Baker et al., “The Canadian Adverse Events Study: The Incidence of Adverse Events Among
                                              Hospital Patients in Canada” (2004) 170 C.M.A.J. 1678.




    Hospitals are Inherently Hazardous Environments !!!




  Ask yourself, What can go
  wrong?




                                                   Some are very comical….




                                                                                                       2
Ask yourself, What can go
wrong?

                                         0.02 to 3 Tesla
                                         3 Tesla ~ 20 000 Times
                                       Stronger than the Earth Magnetic
                                       Field
                                         Accidental Firearm Discharge
                                          6 Year Old Paediatric Patient
                                       Killed by Steel Oxygen Tank


                            Many are very serious…




Introduction – Purpose
What it is not:
       Punitive
           Not to single out & blame individuals
       Protection from legal penalties

What it is:
       Patient & Staff Safety
       Prevention
            Identifying & resolving the root cause(s)
            Mitigation of risk
            Quality Control
       Education
            Learning from our mistakes
            Communication
                 Device & Process Problems
            Catalyst for change




Introduction – Purpose

  To Create an environment in which useful
  information is made available for open and
  frank discussion while recognizing the impact
  of legal and statutory obligations on quality
  review.
                 DHA/IWK Quality Review Framework
                  Nova Scotia Health, March 30, 2006

         The challenge is developing a new way of
         thinking, changing old school philosophies, &
         enabling culture change….




                                                                          3
Introduction – Definitions (1,2)

Adverse Event
       AKA (Occurrence, Sentinel Event, Incident)
       An unexpected and undesired incident directly associated
       with the care and services provided to the patient, or the
       environment in which the care was provided, which does, or
       can reasonably expected to negatively affect the patient’s
       physical and/or psychological health and quality of life.

Near Miss
       An Event/Circumstance which has not affected the patient
       nor caused harm but the potential for harm exists. It “almost
       happened” but may not have reached the patient due to
       chance, corrective action, and or timely intervention




Introduction – Definitions (1,2)

Latent Condition/Failure/Error
       Structural flaw in a system that predispose to adverse
       outcomes.
       May be present for many years before they combine with
       local circumstances and active failures to penetrate the
       system’s many layers of defenses.
       Poor design, gaps in supervision, undetected manufacturing
       defects, maintenance failures, unworkable procedures,
       clumsy automation, shortfalls in training, less than adequate
       tools and equipment, “work a rounds”
       They arise from strategic and other top level decisions made
       by government/regulators, manufacturers, designers, local
       managers etc..




Introduction – Definitions (1,2)
Active Condition/Failure
       An Event/Action/Process that is undertaken, or takes places,
       during the provision of direct patient care and fails to achieve its
       expected aims.
       Consequences & effects are apparent almost immediately, but
       may or may not contribute to patient injury.
Use Error
       a.k.a. User Error
       A device design that predisposes a user to Incorrect use,
       application, interpretation of results, etc… of a medical
       device/technology.
Contributing Factors
       Reasons, situational factors, latent conditions, that played a role
       in the genesis of an adverse event.




                                                                              4
  Introduction – Definitions (1,2)
Root Cause Analysis (RCA)
       A systematic process of investigating a critical incident or an
       adverse outcome or a near miss to determine the multiple,
       underlying contributing factors. The analysis focuses on identifying
       the latent conditions that underlie variation in performance and, if
       applicable, developing recommendations for improvements to
       decrease the likelihood of a similar incident occurring in the future.

Failure Mode Effect Analysis (FMEA)
       A proactive analysis that breaks a system or process into parts
       (human factors, medical device, environment, etc…) and then
       examines how and where things can fail within each part before they
       do. Recommendations are then made and enacted to prevent these
       failures.




                         DISCLAIMER




         Consult & Partner with Risk Management!!!




  Quality Control/Risk Management

  Legal Considerations:
        Different in each Province
        Evidence Acts
        Freedom of Information & Protection of Privacy Acts
        Others ???

  Seek Legal Counsel:
          Policies
          Procedures
          Quality Framework
          Terms of Reference




                                                                                5
Quality Control/Risk Management

Nova Scotia Law:
     Evidence Act
        Section 60[2]
     Freedom of Information & Protection of Privacy Act
     (FIOPOP)
        Section 19D[1]
     Protection of privileged documents from disclosure in legal
     proceedings

      Purpose: To allow & encourage individuals to
      freely participate and share information.




Quality Control/Risk Management (2)
Privilege – The Classification of info. which, though it may be
relevant to a legal proceeding, is protected from disclosure.

The Evidence Act - Provides protection hospitals against
disclosure of certain info. to a legal proceeding if the info. is
prepared for use by a duly constituted committee formed for the
ongoing process of education or improvement.

The Freedom of Info. & Protection of Privacy Act - Contains
protection from release of certain information by public bodies to
an applicant if the info. is prepared for use by a duly constituted
committee formed for the ongoing process of education or
improvement.




Quality Control/Risk Management (2)
Privileged does not apply to medical or hospital records
pertaining to the patient or factual info. contained in a record of
an incident regarding the provision of healthcare to the patient.
       Factual information or material facts
           Sequence of events
           Patient care
           Patient status
       Incident reports (not necessarily privileged)
       Work orders/Equipment histories & data
       Deidentified recommendations (not linked to cases)

Privilege is not applicable to an established ad-hoc review
committees




                                                                      6
 Quality Control/Risk Management (2)

 Privileged applies to documents prepared for quality
 review committees:
        Opinions
        Judgements pertaining to causative factors
        Audits
        Interview Reports
        Investigations
        Evaluations
        Root Cause Analysis
        Follow-up etc….

        Documents must be properly marked as
        “Quality Review Documentation”.




 Quality Control/Risk Management (2)

 Privilege is applicable to a Quality Review Committee that is
 part of an ongoing program with purpose and functions linked
 to the relevant sections of the Evidence and FIOPOP Acts
 clearly outlined in its terms of reference.

 Recommendations:
      CE/BE Quality Review Committee
      Do not put opinions etc… in work orders
      Do not reference Quality Review Documentation in
      work orders
      Establish Terms of Reference
         Critical Incidents Involving Medical Devices
         Selected Near Misses Involving Medical Devices
         Policies/Procedures for conducting investigation




 Conducting an Investigation –
 Introduction (3)
CSI Tool Box:
      Digital Camera
      Measuring Tape/Ruler
      Gloves
      Plastic Bags
      List of Prepared Questions
      Test Equipment/Tools
      Computer Interface Software/Equipment
      Pen & Notepad




                                                                 7
Conducting an Investigation –
Introduction (4,5,6,7,8,9,10)

Investigational Phases:
   1.    Initiation
   2.    Data Collection, Site Visit, & Survey
   3.    Interviews
   4.    Analysis
   5.              Follow-
         Reports & Follow-Up

        Keep in Mind: The Root Cause is often not what
        was initially suspected!!!




Phase 1: Initiation

Source:
         Risk Management
         Department Manager
         End User (eg. Nurse)
         Direct/Indirect Discovery
             Repairs
             Preventative Maintenance
             Word of Mouth




Phase 1: Initiation
 Initiate & Follow Established Procedures:
         Contact Risk Management
                                  etc…
         Complete Necessary Forms etc…

 Gather Initial Information:
         Who, What, Where, & When
         Incident Details
         Classification of Incident
             Injury/Death vs. Near Miss
                                                 etc…
         Gather necessary test equipment/manuals etc…




                                                         8
Phase 1: Initiation

 Important:
        Instruct Staff to Secure Medical Devices, Disposables
        Important not to state any opinions or comments with
        regards to the cause of the incident.
        Start to think about the types of Questions to ask staff.
        Consider a Multidisciplinary Team
            Occupational Health & Safety
            CE Technologist
            Nurses
            Risk Managers
            Maintenance
            Other Experts




Phase 2: Data Collection, Site Visit,
& Survey

Isolate Medical Device(s):
        Do not make repairs & adjustments
        Preserve Memory Logs

Record & Note Relevant Details:
       Control, Model, & Serial Number etc…
       Setup & Settings
       Date & Time
       Visible Damage
       Sketches




Phase 2: Data Collection, Site Visit,
& Survey
Take Photographs:(4)
       Device
       Setup
       Screen Shots
       Visible Damage

Retrieve & Isolate: (4)
       Accessories
       Disposables
       Documentation
            ECG Strips
            Trend Data
       Memory Logs




                                                                    9
Phase 3: Staff Interviews

   Conducted ASAP
          Be sensitive
   State the purpose
          Prevention, Non-punitive, Non-accusatory

   Use prepared Questions: (3)
         “In your own words can you describe what happened?”
         “Can you describe how the device was setup?”
         “Did you take notice of any device abnormalities?”
              Malfunctions
              Error Codes
              User Messages
         “Can you describe any corrective Actions?”




Phase 3: Staff Interviews
 Listen carefully & note details
 Carefully ask follow-up questions
     Do not give the 3rd degree!!!
     Do not pursue answers/truth
     Be prepared for resistance
 Thanks staff for participating
 Language to avoid:
     Fault
     Blame
     User error
     Negligent
     Liable
     Maintain confidentiality




Phase 4: Analysis
Develop Time Line:
      Interviews
      Memory Logs
      Patient Chart
      Recordings

Technical Evaluation:
      Review Service History
      Function check & other test
      Experimentation / trial & error
      Attempt to recreate event
      ECRI & MAUDE Database




                                                               10
 Root Cause Analysis (RCA) (5)
RCA is a structured investigation that aims to identify the
 cause of a problem.

It must be part of a larger problem-solving effort that
   involves a multidisciplinary team.

System Analysis Approach

RCA Teams Asks 3 Questions:
     What happened?
     Why did it happen?
     How do we prevent it from happening again?




 Root Cause Analysis (RCA)
     Identify & Define Problem/Event
     Break Event & Associated Processes into a series of
     small steps
         i.e. Connection of Patient to Defibrillator
         Identify All Contributing Factors (Brain Storming)
         Environmental
         Human
         Communications
         Device(s)
         Material(s)
         Training
         Processes
         Policies, Procedures, & Culture
         Service History
                                                  Think Outside the Box!!!




 Root Cause Analysis (RCA) (11)

Environment         Measurement           Method/ Process
                 Sub-cause            Sub-cause           Sub-cause
                          Sub-cause                            Sub-cause
                                              Sub-cause
                                                                      Problem
                                            Sub-cause
                   Sub-cause                                Sub-cause
                                      Sub-cause
              Sub-cause                            Sub-cause
 Materials          Equipment            People




                                                                                11
Phase 5: Report & Follow-Up
Reports:
 Include:
      Device Information
      Occurrence Details
      Background Information
      Investigation
      Conclusions
      Recommendations
 Do’s:
         Maintain Confidentiality
         Target Document to Audience
 Don’ts
         Patient Information
         Staff Member Names




Phase 5: Report & Follow-Up(9)
Questions:
 What can be done, and what factors can be changed?
 What can be implemented in the short and long term?
 Who is responsible for the activities to prevent recurrence of
 the incident?
 What resources can be committed to reduce the likelihood
 of recurrence of the incident?
 The effectiveness of the activities in preventing recurrence
 of the incident?




Phase 5: Report & Follow-Up

Recommendations & Changes:

 Strong -> Greatly Reduce Risks
      Physical Plant or System Fixes
      Application of Human Factors

 Weak -> Little reduction in Risk
     Rely on policies, procedures, & training
     Avoid Individualized Solutions

 Review & Analyse Effectiveness




                                                                  12
Phase 5: Report & Follow-Up

Follow-Up:
 Health Canada
      Hospitals -> Voluntary Problem Report
      Manufacturer -> Mandatory Problem Report

 ECRI
     Confidential Medical Device Problem Report

 Manufacturer
    Recommendations & Findings

 Patient Safety & Quality Review Committees




Case Studies

 Lifepak 20
 Paceart




Lifepak 20

Occurrence:
     Medical staff in process of preparing patient with
     Bradycardia for transport.
     Lifepak 20 attached to patient to verify operation
     during transport.
     Lifepak 20 displayed pacing pulses on ECG display
     but failed to deliver therapy to patient.
     Medical staff varied current & rate with no effect.
     Lifepak 20 swapped with LP 12, neuromuscular
     stimulation confirmed.




                                                           13
      Lifepak 20
      Medical Staff Interview:
           Confirmed “Quick Combo” electrodes were not exchanged
           Communicated need for additional training
      Technical Evaluation:
              Pacing Checked OK
              Printed patient ECG recordings
              Contacted MEMS to retrieve memory logs
              Obtained evaluation software
              Extracted complete beat to beat ECG recording
                  Included therapy cable impedance




      Lifepak 20 – Memory Log
   Incident
Analyzer
 Defib.




                Therapy cable impedance was found to be 0 Ohms




      Lifepak 20

        Conclusion:
              Root Cause ≠ Suspected Cause
              Patient therapy cable impedance is normally
              between 30 and 300 Ohms.
              Patient therapy cable of 0 Ohms =
                   Attached to self test shorting plug & not the
                   “Quick Combo” Electrodes.
              Experimentally repeatable scenario
                   Pacing
                   Defibrillation
              Device not designed to alert user.




                                                                   14
Lifepak 20 - ???




Lifepak 20

 Recommendations:
     Follow up reports to
         Manufacturer
         ECRI
         Health Canada
     Communication
         Device Hazard
         Steps to preserve Lifepak 20 Memory logs
     Additional regular training
     Reminder to verify leads, cables & connections




Paceart Event Recorder


  Occurrence:
        Patient fitted with King of Hearts Express
        3x Recorder
        Transmits ECG to hospital
        Received by Paceart System Software
        ECG reviewed by three ECG Techs &
        Cardiologists.
            Diagnosed arrhythmia
            Patient admitted to hospital




                                                      15
Paceart Event Recorder




Paceart Event Recorder




 Occurrence:
       After examination of patient in hospital it was noted
       that the time scale in Paceart Chart was distorted
       Calibration pulse spanned three 5mm/sec blocks
       instead of one 5 mm/sec blocks.
       Hospital staff began independent & self directed
       investigation with manufacturer -> Root cause not
       found/incorrect




Paceart Event Recorder



 Theory of operation:
      3 system components
      3 manufacturers
 Technical Evaluation:
      King of Hearts Express 3x:
          Functioned correctly at time of incident
      Reproduced incident by retransmitting into original
      patient record
      Examination of software, no problems found
      Attempted to recreate incident using two different
      types of recorders -> Not able to reproduce distortion




                                                               16
Paceart Event Recorder




Conclusion:
     Medtronic/Paceart Test Results
        Demonstrated 3 possible distortion scenarios where
        software & device transmission speeds where
        mismatched
        Question of Speed Markers?
        Root cause undetermined….
        Device configuration & testing practices
        Suspected currently practiced setup process




Paceart Event Recorder




  Recommendations:
       Modification of setup practices
       Medtronic's/Paceart setup/data entry
       recommendations
       Obtain current software version
       Additional Paceart system software training
       Creation of a standard practice manual
       Reminder to verify calibration pulse




Paceart Event Recorder



 Reoccurrence:
      Calibration pulse found to be incorrect
      Identified software/hardware device setting mismatch
           Software = 3x
           Device = 1x
      Determined device transmit speed could be accidentally
      changed by patient
      Permanently Removed devices from service
      Discovery of previous occurrences


       Latent Conditions that failed to produce Active
       Conditions




                                                               17
Questions?




                                                       occur…
FMEA – Sometimes others can foresee events before they occur…




Resources:
Canadian Patient Safety Institute    http://www.patientsafetyinstitute.ca/index.htmL


Health Canada – Medical Device       http://www.hc-sc.gc.ca/dhp-mps/compli-
Problem Reporting by Health Care     conform/prob-report-rapport/md_prob_rep-
Facilities, Medical Professionals,   rap_incident_im_e.html
and other device users
Health Canada – Voluntary            http://www.hc-sc.gc.ca/dhp-mps/compli-
Problem Reports                      conform/prob-report-rapport/rep_md_prob-
                                     rap_prob_im_vol_e.html

                                     http://www.hc-sc.gc.ca/dhp-mps/compli-
                                     conform/prob-report-rapport/index_e.html

                                     http://www.hc-sc.gc.ca/dhp-mps/compli-
                                     conform/prob-report-rapport/rep_md_prob-
                                     rap_inc_im_tc-tm_e.html
ECRI Medical Device Problem          http://www.ecri.org/Problem_Reporting/Reportin
Reports                              g_Prob_ECRI.aspx




References:
1.    “The Canadian Patient Safety Dictionary”, Canadian Patient
      Safety Institute, October 2003
2.    “DHA/IWK Quality Review Understanding the Legal Framework”,
      NS Health, July 2006
3.    “Called to Testify?, Biomedical Instrumentation &Technology”,
      November/December 2006.
4.    “Adverse Event Reporting: Making the System Work”,
      Biomedical Instrumentation &Technology, March/April 2005.
5.    “Clinical Engineering Toolkits for Patient Safety Focus
      Investigations”, Biomedical Instrumentation &Technology,
      November/December 2006.
6.    “Improving Patient Safety: More Than Repairs for Today’s
      Biomeds”, Biomedical Instrumentation &Technology,
      September/October 2006.




                                                                                       18
References:
7.  “Four Case Studies of Biomeds Who Went Above and Beyond”,
    Biomedical Instrumentation &Technology, September/October
    2006.
8. “Human Factors and the Control of Medical Error”, Biomedical
    Instrumentation &Technology, July/August 2005.
9. “Taking a Proactive Role in Adverse Event Investigations”,
    Biomedical Instrumentation &Technology, March/April 2005.
10. “Using Human Factors Engineering to Improve Patient Safety”,
    Biomedical Instrumentation &Technology, November/December
    2005.
11. “QUALITY WORKBOOK #1” Capital District Health Authority.




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