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The release of long-private information in the FDA’s MAUDE database is changing lives

Medical Pharmaceutical Translations • Dec 11, 2019 12:00:00 AM

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Many people say that we live in an era of outrage, where groups and individuals are up in arms about everything from a controversial tweet, to an issue like global warming. And yet, despite our tendency to take notice of things we find wrong, a hugely significant one seems like it’s passed under the radar for a majority of the population.

For decades, the FDA kept records of medical device errors and issues confidential on its MAUDE database, through a system called the alternative summary reporting program. Not only did the public not have access to information such as high instances of issues related to specific types of implants, staples, and other devices; even medical professionals were in the dark.

Thanks to the Freedom of Information act, the FDA at last released most of this information to the public in June 2019. Read on for a look at the impact this information has had on those who study and report medical device injuries, as well as people suffering from such injuries, including former doctor Lorraine Bonner.

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