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Research Letter
October 7, 2019

Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database

Author Affiliations
  • 1Bates College, Lewiston, Maine
  • 2School of Medicine, University of California, San Francisco
  • 3Device Events, York, Pennsylvania
  • 4Department of Medicine, University of California, San Francisco
  • 5Editor, JAMA Internal Medicine
JAMA Intern Med. Published online October 7, 2019. doi:10.1001/jamainternmed.2019.4030

As the US Food and Drug Administration (FDA) moves to hasten approval of medical devices, data from postmarketing studies and registries are increasingly relied on to inform decision-making. With less time for premarketing clinical studies, postmarketing data are the principal way adverse events and risks become apparent. Even for high-risk implanted devices, premarketing trials are usually small and have short-term follow-up.1 The process of reporting adverse events is cumbersome, and reporting rates are low.2

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    1 Comment for this article
    Non-reporting of adverse events
    Harald Aanning, MD | Retired general surgeon
    Perhaps a contributing obstacle to obtaining accurate data on deaths from "injury or malfunction events" from medical devices is the lack of documentation of fatal medical/surgical complications on death certificates.

    I have not encountered a death certificate (or discharge diagnosis) that documents the specific complication causing a patient's death in my review of a dozen medical charts of fatalities from medical/surgical complications in my state.
    CONFLICT OF INTEREST: None Reported
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