fda workshop-external defibrillators quality systems practices and adverse reporting john collins...
TRANSCRIPT
![Page 1: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/1.jpg)
FDA Workshop-External Defibrillators
Quality Systems Practices and Adverse Reporting
John CollinsAHA/ASHE
![Page 2: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/2.jpg)
Nine Hospital Clinical Engineering Program
Started in 1997
![Page 3: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/3.jpg)
Risk Assessment Medical Devices
• Function• Physical risk• Maintenance
![Page 4: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/4.jpg)
Advent of the Internet
FDA database introduced on web site
![Page 5: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/5.jpg)
Revisit Risk Assessment
Physical Risk using FDA data
![Page 6: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/6.jpg)
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
![Page 7: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/7.jpg)
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
![Page 8: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/8.jpg)
Comparison of Physical Risk Scores
5 4 3 2 1Physical Risk
0
20
40
60
80
100
120
140
160
180
Scoring OldScoring New
![Page 9: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/9.jpg)
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
![Page 10: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/10.jpg)
Comparison of Maintenance Risk Scores
5 4 3 2 1 0Maintenance
0
20
40
60
80
100
120
140
Scoring OldScoring New
![Page 11: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/11.jpg)
What are the causes of medical device repairs?
![Page 12: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/12.jpg)
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
![Page 13: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/13.jpg)
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
![Page 14: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/14.jpg)
Defibrillator Recalls
• 2000 0• 2001 0• 2002 0• 2003 0• 2004 0• 2005 5• 2006 2• 2007 3• 2008 1• 2009 3• 2010 3
![Page 15: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/15.jpg)
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
![Page 16: FDA Workshop-External Defibrillators Quality Systems Practices and Adverse Reporting John Collins AHA/ASHE](https://reader036.vdocument.in/reader036/viewer/2022083005/56649f1e5503460f94c36655/html5/thumbnails/16.jpg)
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