1. 1 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 Batteries & Medical Devices: A Managed Approach to Risk Reduction

2. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 2 What does this mean? Good Poor

3. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 3 Agenda Introduction Introduction Medical Battery Background Information Medical Battery Background Information Glossary Glossary Capacity Analysis Capacity Analysis Protocol Protocol Case Study: Infusion Pumps Case Study: Infusion Pumps Life Cycle Management Philosophy Life Cycle Management Philosophy Benefits Benefits Questions Questions

4. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 4 University of Ottawa Heart Institute The University of Ottawa Heart Institute is a 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. 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. 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. Resource to the province, the rest of Canada, and the international community.

5. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 5 University of Ottawa Heart Institute The University of Ottawa Heart Institute is a 140 Bed Cardiac Care Academic Health Care Organization The University of Ottawa Heart Institute is a 140 Bed Cardiac Care Academic Health Care Organization Therapeutic Therapeutic 4 Cardiac Operating Rooms 4 Cardiac Operating Rooms 4 Catheterization Laboratories 4 Catheterization Laboratories 1 Electrophysiology Laboratory 1 Electrophysiology Laboratory Rehabilitation Rehabilitation Diagnostic Diagnostic Echocardiography Echocardiography Nuclear Medicine Nuclear Medicine Cardiac Imaging Cardiac Imaging ECG and Holter ECG and Holter Stress Testing Stress Testing Research Research Cardiac PET Cardiac PET Canadian Cardiovascular Genetics Centre Canadian Cardiovascular Genetics Centre

6. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 6 Biomedical Engineering Cardiovascular Devices Division 1 Clinical Engineering Manager 1 Clinical Engineering Manager 5 Biomedical Engineering Technologists 5 Biomedical Engineering Technologists Biomedical Engineering Services provides equipment maintenance, planning, and consultation services to the University of Ottawa Heart Institute. Biomedical Engineering Services provides equipment maintenance, planning, and consultation services to the University of Ottawa Heart Institute. Asset Management Asset Management Project Management Project Management Equipment Planning Equipment Planning Maintenance Management Maintenance Management Standards & Regulation Standards & Regulation Risk Analysis Risk Analysis Quality Improvement Quality Improvement Training & Education Training & Education Research & Development Research & Development

7. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 7 Background Information Batteries can perform two functions Batteries can perform two functions Primary / Secondary power source Primary / Secondary power source Retain critical parameters, data, information in the event of power disruption Retain critical parameters, data, information in the event of power disruption Variety of medical devices use batteries Variety of medical devices use batteries All portable equipment All portable equipment Infusion pumps Infusion pumps Defibrillators / Pacemakers Defibrillators / Pacemakers Ventilators Ventilators Transport Physiological Monitors Transport Physiological Monitors Intra-Aortic Balloon Pumps Intra-Aortic Balloon Pumps Ventricular Assist Devices / Artificial Hearts Ventricular Assist Devices / Artificial Hearts Stationary Equipment Stationary Equipment Uninterruptible power supplies (UPS) Uninterruptible power supplies (UPS)

8. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 8 Battery Glossary Battery Chemistry Battery Chemistry Nickel-Cadmium Nickel-Cadmium Nickel-metal-hydride Nickel-metal-hydride Lead-acid Lead-acid Lithium-ion Lithium-ion Reusable alkaline Reusable alkaline Capacity 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. 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) Equipment Load (Current Drain) Desired Run Time Desired Run Time For a 1.0 Ahr For a 1.0 Ahr @ 100% capacity = 1 hour of 1.0 A draw @ 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 @ 25% capacity = 15 min of 1.0 A draw OR 1 hour of 0.25 A

9. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 9 Capacity Analysis Capacity Analysis Capacity rating in ampere-hours (Ahr) Capacity rating in ampere-hours (Ahr) Life Expectancy Life Expectancy Tolerance to prolonged charge times Tolerance to prolonged charge times Tolerance to deep discharges Tolerance to deep discharges 14.4 v 10.5 v 14.4 v 12.5 v 200 ~ 300 Cycles 1500 Cycles Capacity Analysis SLA Batteries

10. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 10 Protocol “Treat medical batteries in the context of the equipment that is utilizing them.” Usage profile Usage profile Desired runtime Desired runtime Medical Directors consulted Medical Directors consulted Determine allowable limits for runtime for equipment Determine allowable limits for runtime for equipment Determine allowable cutoffs for battery replacement / disposal Determine allowable cutoffs for battery replacement / disposal Configuration of battery circuit Configuration of battery circuit Parallel Vs Series Parallel Vs Series Load, current draw from the equipment Load, current draw from the equipment Scheduled maintenance intervals Scheduled maintenance intervals Equipment management program Equipment management program Recommendations / Guidelines from Manufacturer Recommendations / Guidelines from Manufacturer

11. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 11 Assessment Protocol

12. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 12 Protocol Cont’d Initiates a Discharge Cycle Initiates a Discharge Cycle What is current status of the battery What is current status of the battery Capacity is recorded as Initial Capacity Capacity is recorded as Initial Capacity Charge Cycle Charge Cycle Discharge Cycle Discharge Cycle Additional information of the current battery state Additional information of the current battery state Eg. Discharged, charged state upon initial presentation Eg. Discharged, charged state upon initial presentation Repeated Charge / Discharge Cycle Repeated Charge / Discharge Cycle Is change in capacity greater than 5% Is change in capacity greater than 5% If yes, repeat cycle If yes, repeat cycle If no, end of assessment If no, end of assessment End of Assessment Capacity is recorded as Final Capacity End of Assessment Capacity is recorded as Final Capacity

13. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 13 UOHI Battery Assessment Setup

14. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 14 Case Study: Infusion Pumps Compare Battery Capacity with Runtime Compare Battery Capacity with Runtime Assessed 100 infusion pump batteries Assessed 100 infusion pump batteries Based on infusion rate of 100 mL/hr as per the service manual. Based on infusion rate of 100 mL/hr as per the service manual. Measured battery capacity Measured battery capacity Determined Time to Alarm Determined Time to Alarm Determined Total Run Time Determined Total Run Time

15. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 15 Case Study: Infusion Pumps

16. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 16 Case Study: Infusion Pumps Acceptance Criteria for infusion pump operation was 3 hours Acceptance Criteria for infusion pump operation was 3 hours Safe time for patient transfer to and from CT Scan across campus Safe time for patient transfer to and from CT Scan across campus Transport Time + Safety Margin Transport Time + Safety Margin Battery Rating # of Batteries Capacity Range Runtime(Minutes) (N)(%)MinMeanMax Very Low 32 0 – 19 573192 Low32 20 – 39 79162287 Acceptable36 > 40 182278397 Performance thresholds for 100 Sealed Lead Acid Batteries Battery Rating # of Batteries Capacity Range Runtime(Minutes)(N)(%)MinMeanMax Very Low 32 0 – 19 573192 Low32 20 – 39 79162287 Acceptable36 > 40 182278397

17. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 17 Life Cycle Management Philosophy Treat Batteries as Medical Devices Treat Batteries as Medical Devices

18. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 18 Philosophy Cont’d Log procurement information Log procurement information Purchase date, PO Number, cost, supplier Purchase date, PO Number, cost, supplier Date of Battery serves as Serial Number Date of Battery serves as Serial Number Monitor where these batteries are utilized Monitor where these batteries are utilized Parent – Child relationships Parent – Child relationships Perform an initial assessment Perform an initial assessment Initial and final capacities Initial and final capacities Many batteries are not monitored from the vendor / supplier end. Many batteries are not monitored from the vendor / supplier end. Log all inspection / assessment data Log all inspection / assessment data Isolate trends etc. Isolate trends etc. Part of Equipment Management Program Part of Equipment Management Program Scheduled Inspections / Preventive Maintenance Scheduled Inspections / Preventive Maintenance Part of the Day-to-Day operation of the department

19. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 19 Benefits Staff Awareness Staff Awareness Nursing Inservice Nursing Inservice Intensive Care Newsletter Intensive Care Newsletter Staff confidence in equipment operation Staff confidence in equipment operation Potential Cost Savings Potential Cost Savings Prolonged use of previously considered “poor” batteries Prolonged use of previously considered “poor” batteries Environmental Protection Environmental Protection Reduce unnecessary disposal of batteries Reduce unnecessary disposal of batteries Battery recycling Battery recycling Recycling program generates some funds Recycling program generates some funds Normalize Suppliers (Cost Vs Quality) Normalize Suppliers (Cost Vs Quality)

20. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 20 Measured Capacity of New Batteries < 65%, N = 46 > 65%, N = 80 Source: Cleland et al. Journal of Emerg Med 2000 Apr, 18(3) N = 126 Batteries

21. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 21 Benefits (cont’d) Predictability of Equipment use and Function Predictability of Equipment use and Function Force analysis of equipment design Force analysis of equipment design Over charge and bloating Over charge and bloating Poor battery orientation, placement Poor battery orientation, placement Determine End of Life based on non-destructive means Determine End of Life based on non-destructive means Premature disposal / replacement Premature disposal / replacement # of cycles (deep discharges, shocks) # of cycles (deep discharges, shocks) Vendors states to replace after 1 year Vendors states to replace after 1 year Some battery lasts 1 year Some battery lasts 1 year

22. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 22 Battery Replacement

23. T.Zakutney, M.Cleland University of Ottawa Heart Institute, Biomedical Engineering 23 Benefits (cont’d) !!!! IMPROVED PATIENT CARE !!!! Minimize failures due to batteries, leads to a improvement of patient care.

24. 24 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 Questions Batteries & Medical Devices: A Managed Approach to Risk Reduction