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FDA releases millions of records of incidents involving medical devices

Joe Carlson and Jim Spencer, Star Tribune (Minneapolis) on

Published in Business News

The U.S. Food and Drug Administration on Friday published millions of previously undisclosed reports of problems and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants.

The roughly 6 million reports released Friday cover a wide array of devices in reports that were secretly filed with the FDA over a 21-year period, from 1999 to April of this year. From Allergan to Zimmer, dozens of medical device makers have filed reports on everything from breast implants to heart monitors to pediatric breathing machines. Device makers with Minnesota ties in the data include Boston Scientific, Coloplast, Medtronic, and the former St. Jude Medical.

Advocates for public transparency cheered Friday's announcement, and the industry's biggest trade group, AdvaMed, said it supported the move.

Medical device companies are required by law to file such reports within 30 days of learning that a device may have caused a patient injury or death, though the law contained a loophole that allowed millions of files to remain hidden as "summaries." The FDA said many of these summary reporting arrangements were allowed because new files were duplicative and wouldn't add to the body of knowledge about existing problems in MAUDE, the FDA's public database of adverse event reports.

"Since the program's inception in 1997, the FDA granted 108 such exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to health care professionals and patients. The ASR Program allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks," the FDA statement said.

The Star Tribune first wrote about the program in 2016, after Medtronic, run from offices in Fridley, disclosed that it had filed more than 1,000 reports of patient harm associated with the use of its Infuse bone-growth product using a program called "Alternative Summary Reporting."

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The ASR program was formally ended 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 device reviewer who left the agency and started an independent company to analyze the FDA's public-facing files, said Friday that the decision to revoke the ASR program apparently includes the revocation of an even more obscure program called "retrospective summary reporting," which was so secret that a spokesperson for Johnson & Johnson once claimed the program did not exist -- until presented with a J & J subsidiary's own filings in the program.

"The revocation of the alternative and retrospective summary reporting is a huge step in transparency of medical device data. Consumers can now see what the FDA has seen over the years (i.e. the true numbers of adverse events), and physicians can make better informed decisions about which device(s) to recommend to their patients," said an e-mail from Tomas, CEO of the firm Device Events.

The filing of an adverse event report is not itself an admission that the device in the report caused the problem. Sometimes they include such admissions, but more commonly the reports simply disclose a medical problem following the use of a medical device, plus a manufacturer's conclusion that no direct link could be definitively established. Also, the same event may be reported more than once in MAUDE, and the files released Friday may also contain duplicative reports.

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