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FDA Workshop-External Defibrillators

FDA Workshop-External Defibrillators. Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE. Nine Hospital Clinical Engineering Program. Started in 1997. Risk Assessment Medical Devices. Function Physical risk Maintenance. Advent of the Internet.

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FDA Workshop-External Defibrillators

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  1. FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE

  2. Nine Hospital Clinical Engineering Program Started in 1997

  3. Risk Assessment Medical Devices • Function • Physical risk • Maintenance

  4. Advent of the Internet FDA database introduced on web site

  5. Revisit Risk Assessment Physical Risk using FDA data

  6. MAUDE RESULTS 1997-2004 DEATH INJURY Anesthesia Unit 1 Blood Cell Processor 1 Dialysis Unit 3 Hypohyperthermia Unit 1 Laser, Excimer 1 Linear accelerator 1 Monitor, Physiological 1 Pacemaker, External 1 Phaecoemulsifier 5 Phototherapy Unit 1 Pump, Athrombic 1 Pump, IABP 3 Treadmill 2 Defibrillator 10 Heart Lung Unit 1 LVAD 1 O2 Regulator 1 Patient Lift 1 Pump, Infusion 2 Telemetry 2 Ventilator 4

  7. Maude Physical Risk Findings • Incidents concern specific models • Incidents for a model occur a single time (not recurrent) • Very few devices repeat with different mfg/model

  8. Comparison of Physical Risk Scores

  9. Maintenance Risks • Originally was manufacturer’s PM schedule • Revised to guess work on device repairs • Five years accumulated work requests for 9 hospitals/>50,000 devices • Revise risk based on data

  10. Comparison of Maintenance Risk Scores

  11. What are the causes of medical device repairs?

  12. Repair History -9 Hospitals-5years>50,000 Devices

  13. Defibrillator Maude Reports

  14. Defibrillator Recalls • 2000 0 • 2001 0 • 2002 0 • 2003 0 • 2004 0 • 2005 5 • 2006 2 • 2007 3 • 2008 1 • 2009 3 • 2010 3

  15. Incident Report FindingsDefibrillators 2008-2009 • malfunction 865 41 • under investigation 500 92 • failure 457 373 • replace 427 674 • shut down 126 15 • fault 103 255 • defective 55 205 • board 37 42

  16. Suggestion • Develop a design so that the device has a constant monitoring process at critical points on the circuit boards with the ability to send messages concerning imminent failure

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