Reports of Patients’ Deaths Linked to Heart Devices Lurk Below Radar

upstart writes in with an IRC submission for chromas:

Reports of patients' deaths linked to heart devices lurk below radar:

The Food and Drug Administration continues to file thousands of reports of patients' deaths related to medical devices through a reporting system that keeps the safety data out of the public eye.

The system is similar to a vast program exposed earlier this year by KHN that kept device-injury reports effectively hidden within the agency. The FDA shuttered the program after the article about it was published and released millions of records.

The result of this remaining so-called registry exemption program is that key death data about heart devices sits in inaccessible FDA reports that can take up to two years for the public to see under open-records laws. Device-related death reports are typically open, allowing researchers to track and alert their peers about safety concerns.

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