- FDA has formally ended use of its Alternative Summary Reporting Program, disclosing more than six million medical device adverse event reports were filed under the program between 1997 and June 2019. Since it began, FDA said it granted 108 exemptions to medical device manufacturers, allowing them to not submit individual medical device reports for a device.
- The action announced Friday comes several months after Kaiser Health News reported at least 1.1 million reports had been captured since 2016 through the program, which allowed companies to file quarterly summary reports of certain adverse events instead of submitting them individually to the publicly available Manufacturer and User Facility Device Experience (MAUDE) database.
- Center for Devices and Radiological Health Director Jeff Shuren said FDA will keep in place its Voluntary Malfunction Summary Reporting Program, which continues to allow certain device malfunctions to be reported in summary form quarterly. However, serious injuries or deaths cannot be reported under the program and the data is available in MAUDE.
To formally end the Alternative Summary Reporting Program, FDA said it issued revocation letters to the remaining 13 manufacturers that had active exemptions in place for dental implants, implantable cardiac defibrillators and pacemaker electrodes.
“This program should never had been implemented and the data never been hidden, but we certainly welcome the fact that that data is now publicly available," Michael Carome, director of Public Citizen's Health Research Group, told MedTech Dive.
The agency said reports under the program were not publicly available "because they were not submitted in a format compatible with the public database," but noted a companion report to the MAUDE database that included the total number of events being summarized was required starting in 2017.
FDA will use new funding recently appropriated by Congress to make the MAUDE database more user friendly over the coming years by making Medical Device Reporting data "more usable and easier to find," according to Shuren.
In the final rule issued last August instituting the Voluntary Malfunction Summary Reporting Program, FDA disagreed with comments that argued the program would limit transparency and not provide critical information about the adverse events being summarized. Public Citizen, for example, requested FDA publicly post the product classification codes for the categories of medical devices eligible for the program.
"Allowing such summary reports for these moderate- and high-risk devices could allow device manufacturers to obscure — either intentionally or unintentionally — important information about individual device malfunction events, which could undermine the ability of the FDA and the public to fully understand the root causes and safety implications of these events," Carome wrote in February 2018.
But the device center chief argued the Voluntary Malfunction Summary Reporting Program is in the public interest.
It "enables the FDA to efficiently detect potential safety signals and free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices," Shuren said Friday.
"Medical device reports submitted to the FDA are only one source we use to monitor marketed medical devices. While such reports are a valuable source of information, this type of reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, duplicative, unverified or biased data."
Implementation of the National Evaluation System for health Technology will provide real-world data to "rapidly identify and help address safety signals" from medical devices more quickly, according to FDA.
Shuren said NEST will not be effective without unique device identification codes that are being phased into use, but once in place "these steps will improve our ability to identify and address device safety signals and provide patients and health care professionals with important information they can use to make better informed health care decisions."