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 Defibrillator 10 Heart Lung Unit 1 LVAD 1 O2 Regulator 1 Patient Lift 1 Pump, Infusion 2 Telemetry 2 Ventilator 4 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

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 20000 20010 20020 20030 20040 20055 20062 20073 20081 20093 20103

15. Incident Report Findings Defibrillators 2008-2009 malfunction86541 under investigation50092 failure457373 replace427674 shut down12615 fault103255 defective55205 board3742

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