Report: FDA hiding millions of adverse event reports from docs, public

Thursday, March 7, 2019

Source: MassDevice

The FDA is hiding millions of medical device adverse event and malfunction reports from the public, according to a new report from Kaiser Health News.

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.

Summary reporting, which continues at the agency, can leave physicians without a solid knowledge of the risks associated with commonly used devices – like staplers, according to the report.

The number of malfunctions associated with staplers made them an “easy pick” for alternative summary reporting, Kessler told Kaiser Health News.

In the first 28 months of reporting through the alternative pathway, stapler makers filed more than 5,100 reports of malfunctions or injuries related to the devices, former FDA official Dr. S. Lori Brown said in the report.

Those numbers are much higher than the 112 publicly reported stapler-related deaths between 1994 and 2001, which Brown referred to as a “reason for concern,” according to Kaiser Health News.

But public filing of stapler-related issues has fallen significantly, with only 18 injury or malfunction reports filed in 2011 and 79 last year, making the devices appear safer than they are, according to the report.

Other devices, including pelvic mesh implants, have had numerous events and malfunctions masked behind exemptions, according to Kaiser Health News.

While pelvic mesh devices came under heavy scrutiny in 2011 that resulted in many makers discontinuing the devices, the FDA provided a “litigation compliant summary reporting” exemption to makers who continued to produce them. The exemption allows for a single injury report to be submitted for as many as 1,175 patient injury reports, according to the report.

Other prominent devices, ranging from robotic surgery systems to artificial heart valves and cardiovascular implants, have won exemptions that allow makers to report thousands of injuries on a single, hidden report, according to Kaiser Health News.

Intuitive Surgical (NSDQ:ISRG) was reportedly granted an exemption that allowed it to file a single report of approximately 1,400 injuries related to its da Vinci platform after it came under scrutiny for a lack of public reporting. The company now files hidden reports in smaller batches of between 99 and 130 injuries at a time, according to the report.

Intuitive Surgical isn’t the only prominent company picked out for their summary reporting in the Kaiser Health News report.

Edwards Lifesciences (NYSE:EW) was targeted for their use of registry exemptions for reporting on its Sapien 3 heart valve, which allows the company to submit as many as 297 deaths or 1,800 injuries in a secret, single filing. The company has filed more than 1,800 Sapien 3 valve patient deaths as summaries since 2016, according to the report.

Abbott (NYSE:ABT) similarly uses an exemption to keep from publicly reporting deaths or injuries related to its MitraClip device, Kaiser Health News reports. The company is allowed to report as many as 347 deaths or 1,000 injuries on a single, hidden filing.

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.

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