journalist investigated medical device safety
How Global Journalists Investigated Medical Device Safety
AP and ICIJ used the FDA's Manufacturer and User Facility Device Experience database, or MAUDE, to analyze device problems, going back more than three decades. They eliminated reports that stemmed from academic literature reviews or studies, and largely focused on reports from 2008 through 2017. For some devices, they also analyzed the most-recent data available for the first half of 2018. To analyze the MAUDE data, the partners standardized as much as possible the names of device manufacturers - correcting misspellings, fixing irregularities and tracing back subsidiaries to their parent companies. Cases were tracked by the date they were reported to the U.S. health agency.