FDA Releases 20 Years of Data on Medical Device Adverse Event Reports
The US Food and Drug Administration (FDA) recently ended its Alternative Summary Reporting (ASR) program for medical devices, revoked the related exemptions and on Friday made available on its website all adverse event reports received under ASR exemptions from 1999 to 2019.
FDA said it initially indended the ASR program to be for “specific well-known and well-characterized events associated with specific devices,” and that exempted submissions excluded events where the device may have caused or contributed to a patient death, except for limited circumstances.
Jeff Shuren, director of FDA's Center for Devices and Radiological Health (CDRH), said in a statement that since the ASR program’s inception in 1997, FDA granted 108 exemptions to individual manufacturers.
"To formally end the program, we’ve issued revocation letters to the remaining 13 manufacturers with ASR exemptions, which covered three kinds of devices: dental implants, implantable cardiac defibrillators and pacemaker electrodes. Today, the agency also posted ASR data submitted to the FDA from 1999 to 2019," Shuren added.
And similar to the adverse event reports contained in FDA’s main Manufacturer and User Facility Device Experience (MAUDE) database, data in ASR reports cannot be used to determine “rates of adverse events due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use,” FDA said.
With the agency’s release of more than six million records of ASR data over the last 20 years, FDA also made clear that users of the data should be cautious.
Adverse events “may fluctuate over time for a variety of reasons that do not reflect a change in the actual rate of the events, such as changes in technology that impact rate of use in clinical practice, changes in a firm's reporting processes, and following a public communication or media reports about a technology. Moreover, the presence of an event or multiple events does not necessarily mean there is a problem with a device. Often additional investigation and data collection are necessary to make that determination,” FDA said.
As far as why ASR reports were not made public earlier, FDA added that, “They were not submitted in a format compatible with the public database” and that after the agency recognized public interest in this information, the agency “modified the conditions of the ASR Program in 2017 to require submission of a companion report on the official mandatory reporting form.”
The initial announcement in May on ending the alternative program followed a Kaiser Health News investigation that showed how FDA had collected 1.1 million reports through the program since 2016.
In addition to the ASR reports, CDRH also has Device Experience Network (DEN) reports on devices which may have malfunctioned or caused a death or serious injury and which were previously available on the website.
The DEN files contain information from a former CDRH database that was replaced by the MAUDE database in 1996. The files contain 600,000 reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 to 1996 and other voluntary reports up to June 1993.
Source : raps.org