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FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices

By Kaiser Health News

In the wake of a KHN investigation, the agency will no longer let device makers file reports of harm outside a widely used public databaseRead full story

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  • Great to see this progress and the changes made by the FDA to bring transparency to the industry. The FDA previously allowed medical device companies to file reports of injuries and malfunctions outside the public process and database. The practice left doctors and patients in the dark. Great work by

    Great to see this progress and the changes made by the FDA to bring transparency to the industry. The FDA previously allowed medical device companies to file reports of injuries and malfunctions outside the public process and database. The practice left doctors and patients in the dark. Great work by Kaiser Health News for shining a bright light on this practice and driving the FDA to make this change.

  • Wait— this was legal.. for a very very long time?? “ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.”

  • What do you even say about this? Thank you for no longer concealing critical information that might help you the patient, or someone you love make a better life altering choice?

    If I am about to have a Jalopy of a pacemaker placed inside me, I’d appreciate the heads up from the FDA.

  • The amazing thing is that this level of malfeasance and misfeasance in the FDA could have gone on this long without a change and accountability. Kudos to KHN but still shame on the FDA.

  • This question was not directly addressed in the article but is just is important: why was the program initiated in the first place 20 years ago? Was it purely for profit measures on the part of the medical device companies? Or did it possibly start as a legitimate second arm of reporting device malfunctions

    This question was not directly addressed in the article but is just is important: why was the program initiated in the first place 20 years ago? Was it purely for profit measures on the part of the medical device companies? Or did it possibly start as a legitimate second arm of reporting device malfunctions that were TBD regarding if they were a device-wide flaw?

  • Outstanding work by the KHN reporters, bringing the light of truth to this horrible and indefensible practice.

    Shame on the FDA.

  • This has been an on going transparency issue for too long now. There have been cases of people dying, the underlying cause being said to be say a heart attack. After autopsies or further studies and investigations many of these deaths were caused by a faulty device that had been implanted. Most of these

    This has been an on going transparency issue for too long now. There have been cases of people dying, the underlying cause being said to be say a heart attack. After autopsies or further studies and investigations many of these deaths were caused by a faulty device that had been implanted. Most of these devices like pace makers etc. Are not regulated before sold to the public. It’s disgusting, more disgusting is the fact that it has taken so long to initiate putting a stop to it.

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