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Batteries & Medical Devices: A Managed Approach to Risk Reduction. Presented by: Timothy J. Zakutney, M.H.Sc., P.Eng. Mark Cleland, Biomedical Technologist Biomedical Engineering Cardiovascular Devices Division. Presented to the Medical Product Surveillance Network, MedSun

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slide1

Batteries & Medical Devices:A Managed Approach to Risk Reduction

Presented by:

Timothy J. Zakutney, M.H.Sc., P.Eng.

Mark Cleland, Biomedical Technologist

Biomedical Engineering

Cardiovascular Devices Division

Presented to the Medical Product Surveillance Network, MedSun

December 13, 2005

agenda
Agenda
  • Introduction
  • Medical Battery Background Information
    • Glossary
  • Capacity Analysis
  • Protocol
  • Case Study: Infusion Pumps
  • Life Cycle Management Philosophy
  • Benefits
  • Questions
university of ottawa heart institute
University of Ottawa Heart Institute
  • The University of Ottawa Heart Institute is a
    • Bilingual academic health centre dedicated to promoting heart health through integrated cardiac services including: primary and secondary prevention, state-of-the-art diagnostics, and therapies and rehabilitation.
    • Regional facility serving our local communities within the Champlain District and Western Quebec. This is a population of roughly 1.8 Million people.
    • Resource to the province, the rest of Canada, and the international community.
university of ottawa heart institute5
University of Ottawa Heart Institute
  • The University of Ottawa Heart Institute is a 140 Bed Cardiac Care Academic Health Care Organization
    • Therapeutic
      • 4 Cardiac Operating Rooms
      • 4 Catheterization Laboratories
      • 1 Electrophysiology Laboratory
      • Rehabilitation
    • Diagnostic
      • Echocardiography
      • Nuclear Medicine
      • Cardiac Imaging
      • ECG and Holter
      • Stress Testing
    • Research
      • Cardiac PET
      • Canadian Cardiovascular Genetics Centre
biomedical engineering cardiovascular devices division
Biomedical EngineeringCardiovascular Devices Division
  • 1 Clinical Engineering Manager
  • 5 Biomedical Engineering Technologists
    • Biomedical Engineering Services provides equipment maintenance, planning, and consultation services to the University of Ottawa Heart Institute.
      • Asset Management
      • Project Management
      • Equipment Planning
      • Maintenance Management
      • Standards & Regulation
      • Risk Analysis
      • Quality Improvement
      • Training & Education
      • Research & Development
background information
Background Information
  • Batteries can perform two functions
    • Primary / Secondary power source
    • Retain critical parameters, data, information in the event of power disruption
  • Variety of medical devices use batteries
    • All portable equipment
      • Infusion pumps
      • Defibrillators / Pacemakers
      • Ventilators
      • Transport Physiological Monitors
      • Intra-Aortic Balloon Pumps
      • Ventricular Assist Devices / Artificial Hearts
    • Stationary Equipment
      • Uninterruptible power supplies (UPS)
battery glossary
Battery Glossary
  • Battery Chemistry
      • Nickel-Cadmium
      • Nickel-metal-hydride
      • Lead-acid
      • Lithium-ion
      • Reusable alkaline
  • Capacity
    • The total number of ampere-hours or watt-hours that can be withdrawn from a fully charged cell or battery under specified conditions of discharge.
  • Equipment Load (Current Drain)
  • Desired Run Time
      • For a 1.0 Ahr
        • @ 100% capacity = 1 hour of 1.0 A draw
        • @ 25% capacity = 15 min of 1.0 A draw OR 1 hour of 0.25 A
capacity analysis
Capacity Analysis
  • Capacity Analysis
    • Capacity rating in ampere-hours (Ahr)
  • Life Expectancy
        • Tolerance to prolonged charge times
        • Tolerance to deep discharges

14.4 v

14.4 v

SLA Batteries

12.5 v

1500 Cycles

10.5 v

200 ~ 300 Cycles

protocol
Protocol

“Treat medical batteries in the context of the equipment that is utilizing them.”

  • Usage profile
    • Desired runtime
      • Medical Directors consulted
      • Determine allowable limits for runtime for equipment
  • Determine allowable cutoffs for battery replacement / disposal
  • Configuration of battery circuit
    • Parallel Vs Series
  • Load, current draw from the equipment
  • Scheduled maintenance intervals
    • Equipment management program
    • Recommendations / Guidelines from Manufacturer
protocol cont d
Protocol Cont’d
  • Initiates a Discharge Cycle
    • What is current status of the battery
    • Capacity is recorded as Initial Capacity
  • Charge Cycle
  • Discharge Cycle
    • Additional information of the current battery state
      • Eg. Discharged, charged state upon initial presentation
  • Repeated Charge / Discharge Cycle
    • Is change in capacity greater than 5%
      • If yes, repeat cycle
      • If no, end of assessment
    • End of Assessment Capacity is recorded as Final Capacity
case study infusion pumps
Case Study: Infusion Pumps
  • Compare Battery Capacity with Runtime
  • Assessed 100 infusion pump batteries
    • Based on infusion rate of 100 mL/hr as per the service manual.
      • Measured battery capacity
      • Determined Time to Alarm
      • Determined Total Run Time
case study infusion pumps16
Case Study: Infusion Pumps
  • Acceptance Criteria for infusion pump operation was 3 hours
    • Safe time for patient transfer to and from CT Scan across campus
      • Transport Time + Safety Margin

Performance thresholds for 100 Sealed Lead Acid Batteries

life cycle management philosophy
Life Cycle Management Philosophy
  • Treat Batteries as Medical Devices
philosophy cont d
Philosophy Cont’d
  • Log procurement information
    • Purchase date, PO Number, cost, supplier
    • Date of Battery serves as Serial Number
  • Monitor where these batteries are utilized
    • Parent – Child relationships
  • Perform an initial assessment
    • Initial and final capacities
    • Many batteries are not monitored from the vendor / supplier end.
  • Log all inspection / assessment data
    • Isolate trends etc.
  • Part of Equipment Management Program
    • Scheduled Inspections / Preventive Maintenance

Part of the Day-to-Day operation of the department

benefits
Benefits
  • Staff Awareness
    • Nursing Inservice
    • Intensive Care Newsletter
    • Staff confidence in equipment operation
  • Potential Cost Savings
    • Prolonged use of previously considered “poor” batteries
  • Environmental Protection
    • Reduce unnecessary disposal of batteries
  • Battery recycling
    • Recycling program generates some funds
  • Normalize Suppliers (Cost Vs Quality)
measured capacity of new batteries
Measured Capacity of New Batteries

N = 126 Batteries

< 65%, N = 46

> 65%, N = 80

Source: Cleland et al. Journal of Emerg Med 2000 Apr, 18(3)

benefits cont d
Benefits (cont’d)
  • Predictability of Equipment use and Function
  • Force analysis of equipment design
    • Over charge and bloating
    • Poor battery orientation, placement
  • Determine End of Life based on non-destructive means
    • Premature disposal / replacement
    • # of cycles (deep discharges, shocks)
    • Vendors states to replace after 1 year
      • Some battery lasts < or > 1 year
benefits cont d23
Benefits (cont’d)

!!!! IMPROVED PATIENT CARE !!!!

Minimize failures due to batteries, leads to a improvement of patient care.

slide24

Questions

Batteries & Medical Devices:A Managed Approach to Risk Reduction

Presented by:

Timothy J. Zakutney, M.H.Sc., P.Eng.

Tzakutney@ottawaheart.ca

613.798.5555 Ext. 1.6773

Mark Cleland, Biomedical Technologist

Mcleland@ottawaheart.ca

613.798.5555 Ext. 1.3826

Biomedical Engineering

Cardiovascular Devices Division

Presented to the Medical Product Surveillance Network, MedSun

December 13, 2005