Presented by: Timothy J. Zakutney, M.H.Sc., P.Eng. Mark Cleland, Biomedical Technologist Biomedical Engineering Card

1. 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

2. What does this mean? Good Poor

3. Agenda • Introduction • Medical Battery Background Information • Glossary • Capacity Analysis • Protocol • Case Study: Infusion Pumps • Life Cycle Management Philosophy • Benefits • Questions

4. 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.

5. 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

6. 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

7. 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)

8. 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

9. 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

10. 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

11. Assessment Protocol

12. 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

13. UOHI Battery Assessment Setup

14. 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

15. Case Study: Infusion Pumps

16. 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

17. Life Cycle Management Philosophy • Treat Batteries as Medical Devices

18. 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

19. 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)

20. 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)

21. 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

22. Battery Replacement

23. Benefits (cont’d) !!!! IMPROVED PATIENT CARE !!!! Minimize failures due to batteries, leads to a improvement of patient care.

24. 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