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The FDA frees millions of records of incidents involving medical devices




On Friday, the US Food and Drug Administration published millions of previously unexplained reports of problems and post-surgical complications involving medical devices, including reports of implantable heart defibrillators, pacemaker electrodes, and dental implants.

The approximately 6 million reports released on Friday cover a wide range of units in reports that were secretly filed with the FDA from 1999 to April this year. From Allergan to Zimmer, dozens of medical device manufacturers have submitted reports of everything from breast implants and heart monitors to pediatric breathing machines. Minnesota decision-makers in the data include Boston Scientific, Coloplast, Medtronic and the former St. Jude Medical.

Proponents of public openness cheered Friday's announcement. The industry's largest trading group, AdvaMed, said that it supported the movement.

Medical equipment business is required by law to file such reports within 30 days after learning that a device may have caused a patient injury or death, even if the law contained a loopholes that allowed millions of files to remain hidden as "summary." The FDA said many of these reporting events were allowed because new files were duplicative and would not add knowledge of existing issues in the manufacturer and user facility experience (MAUDE), the FDA's public database of adverse reaction reports.

The Alternative Summary Program (ASR) "allowed the FDA to streamline the review of known, well-known side effects, so that we could focus on identifying and implementing new security signals and less understandable risks," said the FDA statement.

Star Tribune first wrote about the program in 201[ads1]6 after Medtronic, which I ran from offices in Fridley, said it had filed more than 1,000 reports of patient injuries related to the use of its infusing bone growth product as summaries instead of individual reports.

the program was formally completed this month as the result of a decision by the agency in 2017 to "gradually sunset" the program, according to an FDA statement published Friday.

Madris Tomes, a former FDA unit critic who left the agency and started an independent company to analyze the agency's published files, said Friday that the decision to revoke the ASR program Including recall of an even more unclear program called "Retrospective Summary Report", which was so secret that a Johnson & Johnson spokesman once claimed that the program did not exist – until the presentation of J & J's own submissions to the program.

"Consumers can now see what the FDA has seen over the years (ie, the true number of side effects), and doctors can make better informed decisions about which device to recommend to the patients," said Tomes, CEO of Device Events. e-mail

Medtronic, the world's largest medical company, said on Friday that while the company is working hard to reduce or eliminate product failures and incidents, employees also make every effort to tell regulators, clinicians, and the public about malfunctions when they

"Medtronic has used these various reporting programs and our reports and submissions are included in the reports published by the FDA today," said e-mail spokesman Jeffrey Trauring. "We applaud the FDA for their ongoing efforts to achieve transparency and transparency in medical performance, and we will continue to work with the FDA on future, modern reporting programs."

Submission of a side effect report is not even an admission that the device in the report caused the problem. Sometimes, the reports contain such concessions, but most often they only reveal a medical problem after using a medical device, as well as the manufacturer's conclusion that no direct link could be definitively defined. The same event can also be reported more than once in the MAUDE, and the files released Friday may also contain duplicate reports.

AdvaMed, a Washington-based co-tech industry trading group, said it was important to doctors and the public having access to medical device performance information, and the group supports the FDA's efforts to create old ASR archives.

"However, it is important to note that while the ASR information was not available in the FDA's MAUDE database, the Agency had access to all of this information and used the data in the analysis to determine the risk profile of the entities subject to ASR," AdvaMed spokesman Jim Jeffries Friday

Dr. Michael Carome, director of public health research group, said the FDA should never have created the program, saying that allows summaries that the FDA served the unit industry, not the public.

"It was easier for the industry to post these reports "instead of individual unwanted event reports, Carome said." But [summaries] hid information. Important safety information was not available to the public. What we need now is that the hidden information should be accessible and easily searchable. "

The newly released files are not easy to read. The summaries contain numeric codes that represent specific problems because it was how the devices reported the problems under the ASR program.

There are several different types of summary reporting, and at least one form is still allowed, known as the Voluntary Troubleshooting Summary Reporting Program.

Medical regulatory attorney Mark DuVal said on Friday that the move to publish the old summary data was an appropriate way to build public confidence in the reporting system, even though the system was not heavily used in the past. [19659002] "If the information will be useful to the public, I doubt it," said DuVal, CEO of DuVal & Associates in Minneapolis. "But the agency is increasingly criticized for things like this and they avoid perceptions."

ASR reports have come closer in recent months, as the International Consortium of Investigat ive Journalists and Kaiser Health News have published critical stories about the program's hidden reports of breast implants and surgical founders. The Star Tribune published a story in December on lengthy reports of problems resulting from the use of Medtronic's Infuse in upper spine fusion surgery.

The Washington-based non-profit National Center for Health Research welcomed the end of the Summary Reporting Program.

"While we are very pleased that the FDA has done the right thing by releasing the information as promised, this reporting program allowed thousands of serious side effects involving medical devices to remain hidden from public display," Government director Jack Mitchell said.

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