Since 2016, at least 1.1 million such reports have been ingested into the FDA’s “alternative summary reporting” repository, a system inaccessible to the public and so obscure that former agency head Dr. Robert Califf said he’d “never heard anything about it,” according to the report.
The summary reporting repository was originally created as an alternative for issues “well-known and well-documented with the FDA” and covers approximately 100 medical devices, according to the Kaiser Health News report. The FDA declined to provide a complete list of the approximately 100 devices that have been granted reporting exemptions.
More than 480,000 injuries or malfunctions were reported in 2017 through the publicly inaccessible pathway, according to the report, with over 2 million events reported through it since 2014.
While the reports are still hidden, a new push for transparency at the agency has allowed public individuals to submit Freedom of Information Act requests to obtain information about the incidents – but the wait can take up to two years, Kaiser Health News reports.
FDA spokesperson Alison Hunt said that the program “has allowed the FDA to more efficiently review adverse events … and take action where warranted without sacrificing the quality of our review or the information we receive,” according to the report.
But for healthcare professionals outside the FDA, the hidden records make it harder to assess the safety of the devices they use, Kaiser Health News reports.
“The FDA is basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of those devices,” former FDA manager Madris Tomes said, according to the report.
The alternative summary reporting program began approximately 20 years ago, with the goal of cutting down redundant paperwork, according to Kaiser Health News.
The program was created after scandals of under-reporting device events sparked changes that allowed criminal penalties to be levied against device companies, former FDA official and current University of Washington health services provider Larry Kessler said, according to the report.
Kessler told Kaiser Health News that with only 15 staff members dedicated to reviewing thousands of injury and malfunction reports each month, the task at hand became “mind-numbing,” and that he went to the agency’s legal department and to device makers to propose a solution – exemptions.
The exemptions were intended to streamline the process, with manufacturers sending quarterly or bi-annual reports to the FDA noting all related issues, according to the report, allowing reviewers to quickly identify trending or spiking issues.
“I don’t know why it’s not [made public] now. I’m surprised about that,” Kessler told Kaiser Health News.
Such summary exemptions, as well as a number of other newly created exemptions, such as registry exemptions, still remain in place at the agency, according to the report.
Companies that receive such exemptions tend to be “tight-lipped,” former device firm manager and med device consultant Christine Posin told Kaiser Health News. She added that the relative secrecy of the program can give those companies an advantage against competitors, whose device malfunctions may be part of the public record.
The summary reporting pathway was reformed in 2017, with a new voluntary summary reporting program put in place for up to 5,600 devices, according to Kaiser Health News.
Under the newly implemented system, device makers will no longer have to seek an exemption or notify the FDA that they are filing a public summary report in the MAUDE database. These exemptions apply to devices including cardiac stents, headless pacers and mechanical heart valves, according to the report.
Last November, a report from the Honolulu Star Advertiser raised concerns that the number of medical device reports concerning breast implants was kept artificially low through the use of summary reporting.