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 FDA database introduced on web site

Revisit Risk Assessment Physical Risk using FDA data

MAUDE RESULTS 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

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

Comparison of Physical Risk Scores

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

Comparison of Maintenance Risk Scores

What are the causes of medical device repairs?

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

Defibrillator Maude Reports

Defibrillator Recalls

Incident Report Findings Defibrillators malfunction86541 under investigation50092 failure replace shut down12615 fault defective55205 board3742

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