Medical Device Injuries: FDA Data Reveals Increasing Risk

    Expert Institute Expert
    By Updated on June 23, 2020
    Medical Device Injuries: FDA Data Reveals Increasing Risk

    FDA Adverse Event ReportingThe FDA receives thousands of reports each year detailing the deaths, serious injuries, and malfunctions associated with medical devices. This is in order to monitor the safety and performance of medical devices. As a service to device manufacturers, physicians, patients, and researchers, the FDA has collected the data retrieved in these reports. They have made it available through its Manufacturer and User Facility Device Experience, or MAUDE, database. The data can be complicated by the submission of incomplete or inaccurate information. As well as by the potential for events to go unreported. However, the database does offer some significant insights into the way medical devices are interacting with the patients they are made to help.

    We took a look at MAUDE data with a leading medical device expert, as well as additional reports produced by the FDA. This was to obtain a snapshot of how the medical device industry has changed over the past decade. We discovered an increasing trend towards major negative events (such as death, injury, and disabilities). These are being caused by failures in medical devices.

    Expert Witness Bio E-007962

    E-007962This highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in Mathematics from Oregon State University and an MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory documentation and applications.

    Location: California
    BS, Mathematics, Oregon State University
    MS, Medical Device and Diagnostic Engineering, University of Southern California
    Certified, Quality Auditor
    Former, Sales and Account Manager, IBM Data Network
    Former, Insulin Pump Sales, Medtronic Diabetes
    Current, President, Medical Device Consulting Firm

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