FDA releases millions of records of incidents involving medical devices

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

Published in Business News

AdvaMed, a Washington-based trade group for the med-tech industry, said it was important for physicians and the public to have access to information about medical device performance, and the group supports the FDA's efforts to make old ASR filings public.

"It is important to note, however, that while the ASR information was not accessible in FDA's MAUDE database, the agency had access to all this information and used that data in its analysis to determine the risk profile of the devices subject to ASR," AdvaMed spokesman Jim Jeffries said Friday.

Dr. Michael Carome, director of Public Citizen's health research group, said FDA should never have created the program. He said allowing summaries gave the appearance that FDA was serving the device industry, not the public.

"It was easier for the industry to file these reports (rather than individual adverse event reports)," Carome said. "But (summaries) hid information. Important safety information was not available to the public. What we need now is for the hidden information to be available and easily searchable."

The newly released files are not easy to read. Traditional adverse event reports filed in MAUDE include narratives describing what happened, but the 6 million summary files released Friday don't contain narrative accounts. Rather, the summaries include numerical codes that represent specific problems, because that's how the device companies were reporting the problems under the ASR program.

For example, some breast-implant files contain the code 2682, which corresponds to "Patient-Device Incompatibility." One common code involving dental implants is 1863, which is "failure to osteointegrate."

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

ASR reports have come under close scrutiny in recent months, as the International Consortium of Investigative Journalists and Kaiser Health News have published critical stories about the program's hidden reports regarding breast implants and surgical staplers. The Star Tribune published a story in December about long-lost reports of problems following the use of Medtronic's Infuse in upper-spine fusion surgery.


The Washington-based not-for-profit National Center for Health Research welcomed the end of the summary reporting program.

"While we're very pleased that the FDA has done the right thing by releasing the information as promised, this summary reporting program allowed thousands of serious adverse events involving medical devices to remain hidden from public view," government affairs director Jack Mitchell said. "No one outside FDA would have known had it not been for the journalists who uncovered the hidden reporting plan."

Hiding adverse events "needlessly delayed regulatory action on a number of fronts," Mitchell added. "This entire episode was unfair to patients and the medical community alike."

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