fda workshop-external defibrillators quality systems practices and adverse reporting john collins...
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FDA Workshop-External Defibrillators
Quality Systems Practices and Adverse Reporting
John CollinsAHA/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 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
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
5 4 3 2 1Physical Risk
0
20
40
60
80
100
120
140
160
180
Scoring OldScoring New
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
5 4 3 2 1 0Maintenance
0
20
40
60
80
100
120
140
Scoring OldScoring New
What are the causes of medical device repairs?
Repair History -9 Hospitals-5years>50,000 Devices
0
50
100
150
200
250
300
350
400
Quantity
boardpower supply
tubem
otor
cablepum
pvalve
monitor
driveswitch
Component
Number of Repairs
Defibrillator Maude Reports
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
DefibAED
Defibrillator Recalls
• 2000 0• 2001 0• 2002 0• 2003 0• 2004 0• 2005 5• 2006 2• 2007 3• 2008 1• 2009 3• 2010 3
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
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