The FDA has followed through with plans to formally end its Alternative Summary Reporting program, making 20 years’ worth of medical device safety data publicly available.
The once-obscure program had granted device manufacturers exemptions to the standard reporting rules related to disclosing harms—for “certain well-known events associated with specific devices” often described in product labeling, the agency’s device center director, Jeffrey Shuren, said in a statement.
This included 108 exemptions given to individual device makers since the program’s launch in 1997, which allowed them to instead submit summaries of adverse event reports on a quarterly basis.
But now the FDA has revoked the last remaining allowances granted to the program’s final 13 manufacturers, covering three categories of devices: dental implants, implantable cardiac defibrillators and pacemaker electrodes.
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An investigation earlier this year by Kaiser Health News detailed the vast and growing scope of the program over the years, which had collected 1.1 million reports of harm and device malfunctions since 2016 alone—including more than half of safety reports related to surgical staplers.
Over 56,000 stapler malfunctions were reported to the agency from 2011 through 2018. Earlier this year, the FDA proposed to reclassify the devices as higher-risk, Class II products, following an agency review that found more than 32,000 malfunctions, over 9,000 serious injuries and 366 related deaths. Those reports included misfirings, malformed staples or reopenings in the wound—as well as user errors, such as selecting the wrong cartridge size during a procedure.
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Going forward, the archive of more than 6 million alternative summary reports from 1999 to April 2019 will be hosted separately from the FDA’s main public device safety database, known as MAUDE, which is designed for mandatory reporters such as manufacturers, as well as voluntary reporters, including healthcare professionals and patients.
In addition, the FDA said it plans to make MAUDE more user-friendly and accessible over the next few years, as the agency and its device center modernize their IT systems.