fda workshop-external defibrillators quality systems practices and adverse reporting john collins...

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