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Adverse Event Reports on Automatic External Defibrillators from 1996 - 2003 Oscar H Tovar MD and Beverly Gallauresi RN, MPH Food and Drug Administration Office of Surveillance and Biometrics Office of Device Evaluation
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Medical Device Reporting Beverly Gallauresi RN, MPH Division of Postmarket Surveillance Office of Surveillance and Biometrics
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3 Oscar H Tovar CDRH / FDA/ DHHS MDR – A Brief Description ● Nationwide passive surveillance mandatory and voluntary reports ● Reporters manufacturers, importers user facilities voluntary ● Types of reports deaths serious injuries malfunctions
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4 Oscar H Tovar CDRH / FDA/ DHHS What is an Adverse Event ? An event whereby a medical device has, or may have, caused or contributed to a death or serious injury. Includes events associated with: - device failure- improper / inadequate design - device malfunction- manufacturing (problems) - use error- labeling (problems)
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5 Oscar H Tovar CDRH / FDA/ DHHS MAUDE Manufacturer and User Facility Device Experience
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6 Oscar H Tovar CDRH / FDA/ DHHS Methodology for Data Retrieval ● Product code ● August 1996 - December 2003
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7 Oscar H Tovar CDRH / FDA/ DHHS Manufacturer Reports August 1996 - December 2003 ● DEATH 590 ● INJURY 10 ● MALFUNCTION 7044 ● TOTAL 7644
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8 Oscar H Tovar CDRH / FDA/ DHHS Limitations of MDR ● Underreporting ● No incidence data ● Biased reporting ● Uncertain causality
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Oscar H Tovar MD Food and Drug Administration Office of Device Evaluation Office of Surveillance and Biometrics
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10 Oscar H Tovar CDRH / FDA/ DHHS ● The benefits of early defibrillation in public places have been shown in numerous studies ● There is a steady increase in deployment of automatic external defibrillators (AEDs) ● The estimated AED growth rate for the USA was 8.2% for 2000 and 2001, 11.5% for 2002 and 22.0% for 2003. It is estimated to be about 20% per year in the next 5 years* * Frost & Sullivan, September 2003 Background
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11 Oscar H Tovar CDRH / FDA/ DHHS ● The success of early defibrillation implies that the AED works in the first attempt and consistently in the following attempts if necessary ● An AED failure to deliver a defibrillation shock decreases significantly the probability of survival of a patient in ventricular fibrillation ● There is scarce information about adverse events associated with AED use Background
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12 Oscar H Tovar CDRH / FDA/ DHHS Goals of the Study To assess adverse event reports – particularly deaths- associated with AED failure from 1996 to 2003 To determine AED component failure or factors that resulted in failed defibrillation associated with deaths
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13 Oscar H Tovar CDRH / FDA/ DHHS ● We reviewed Medical Device Reports (MDR) submitted by AED manufacturers to the FDA for AED-related adverse events. ● MDRs were received from 8-19-1996 to 12-31-2003. ● We analyzed MDRs using the Manufacturer and User Facility Device Experience (MAUDE) database from the FDA. Methods
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14 Oscar H Tovar CDRH / FDA/ DHHS Methods ● The manufacturer results and conclusion codes (following failure analyses) were used to assess the association of device and component failure with a patient death. Both results and conclusions were grouped in categories.
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15 Oscar H Tovar CDRH / FDA/ DHHS Adverse Events 1996-1999
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16 Oscar H Tovar CDRH / FDA/ DHHS Adverse Events 2000-2003
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17 Oscar H Tovar CDRH / FDA/ DHHS Adverse Events 2000-20031996-1999
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18 Oscar H Tovar CDRH / FDA/ DHHS AED Malfunctions 1996-2003
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19 Oscar H Tovar CDRH / FDA/ DHHS AED Injuries 1996-2003
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20 Oscar H Tovar CDRH / FDA/ DHHS AED-Associated Deaths
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21 Oscar H Tovar CDRH / FDA/ DHHS Manufacturers’ Conclusions 1996-1999 Percent
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22 Oscar H Tovar CDRH / FDA/ DHHS Manufacturers’ Conclusions 2000-2003 Percent
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23 Oscar H Tovar CDRH / FDA/ DHHS Manufacturers’ Conclusions 1996-2003 2000-2003 1996-1999 Percent
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24 Oscar H Tovar CDRH / FDA/ DHHS Component Failure 1996-1999 Percent
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25 Oscar H Tovar CDRH / FDA/ DHHS Component Failure 2000-2003 Percent
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26 Oscar H Tovar CDRH / FDA/ DHHS Component Failure 1996-2003 2000-2003 1996-1999 Percent
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27 Oscar H Tovar CDRH / FDA/ DHHS AED Recalls 1996-2003
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28 Oscar H Tovar CDRH / FDA/ DHHS Conclusions The results suggest that: ● The number of reported deaths associated with AED failure is markedly more frequent than injuries ● Reported AED failure is increasing, along with increase in AED deployment
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29 Oscar H Tovar CDRH / FDA/ DHHS Conclusions ● There is a relative decrease in reported electrical component failure ● There is relative decrease in reported device operation outside specifications (which includes use error)
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