Reports Of Patients’ Deaths Linked To Heart Devices Lurk Below Radar

Christina Jewett, Kaiser Health News, December 24, 2019

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.

The FDA carved out the exemption in 2010 and it covers six devices, a spokeswoman said. Doctors tend to report extensive data on patients for certain medical devices that are closely monitored in registries. Private medical societies tend to administer the registries and act as gatekeepers to the data.

The registry leaders, in turn, have reported data to device makers, who sent the FDA spreadsheets detailing what they know about more than 8,000 patient deaths. Those spreadsheets are also inaccessible to the public.

Under standard FDA reporting rules, the device maker is bound to investigate and send the agency a detailed public report about each patient death believed to be device-related.

Device makers say the registries strip key data they need to fully investigate each death, most of them related to heart valves threaded through a catheter and implanted in faulty hearts.

“It’s crazy,” said Diana Zuckerman, president of the National Center for Health Research. “I have to say, there’s not a particular reason I can think of why you put [summary reports] behind some kind of firewall where no one can see it.”

An FDA spokeswoman said the agency just got additional funding from Congress that it plans to use to make “more information readily available and easier to access.”

“We agree that the public should have access to more information about reports of adverse events for medical devices,” the agency said in an email, noting that its current public device database called MAUDE is outdated and “has limited functionalities.”

Earlier this year, the FDA shut down other so-called exemptions to its device-reporting rules that put millions of device harm or malfunction reports out of public reach. Doctors, researchers and even device-safety experts were unaware that for 20 years the FDA accepted 5.7 million reports through its “alternative summary reporting” program.


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