FDA proposes allowing medical device makers to summarize malfunctions

WASHINGTON – A Food and Drug Administration (FDA) proposal to let medical device makers summarize malfunctions of certain products instead of filing a report for each incident has kicked off a debate over the public's ability to judge safety.

Regulators and device industry representatives say the proposal is an efficiency measure limited to malfunctions that do not threaten lives or health and only involves the least risky devices on the market. Summaries that bundle "like events" into summary reports as the FDA proposes let the government, businesses and the public pick up on trends sooner, they say.

"I think it will be very good and not just for our members," said Shaye Mandle, CEO of Medical Alley, the trade group representing Minnesota's massive medical technology sector. "I think everybody wins."

Currently, device makers must file individual reports of device problems with detailed narratives. Depending on the severity of the malfunction, those reports are due within five days or 30 days of a company learning about them from any source.

The move to quarterly filings of single report summaries concerns some patient advocates and those seeking more detailed public disclosure of device problems. They base their worry on existing FDA summary reporting programs that they say keep too many details secret.

"FDA already has difficulty keeping up with device reports that would generate corrective action in a timely manner," said Jack Mitchell, director of health policy at the National Center for Health Research. "When companies have submitted summary reports in the past, it has resulted in less transparency, with neither FDA nor the public able to have access to adequate information about patients who have been seriously harmed by medical devices. This proposal would further weaken the current post-market safety surveillance system for devices, which is already passive and inadequate."

Star Tribune investigations into current FDA summary reporting practices found that the agency allowed Medtronic to summarize a study that revealed more than 1,000 malfunctions of its Infuse bone graft in three sentences within a single "marker report" more than five years after the law required the company to reveal those adverse events individually. The FDA also redacted the total number of injuries and complications as a "trade secret" until the newspaper appealed the decision.

Medtronic says that it should have filed the data sooner, but says it misplaced the study for several years and reported it as soon as it was found. The company says it then complied with all requests the FDA made for information about the study.

Medtronic declined to comment on the new FDA summary program, deferring to its national trade group, the Advanced Medical Technology Association (AdvaMed).

In addition to letting Medtronic summarize overdue malfunction reports, the Star Tribune investigation discovered that the FDA has allowed other companies to offer limited, consolidated and sometimes redacted data on thousands of late individual malfunction reports through an informal process called "retrospective summary reporting."

An FDA spokeswoman did not respond to a question about redactions. She said she could not speculate on whether individual products such as Infuse would qualify for the new summary reporting program, which lets companies that make products with certain device codes file quarterly reports in a summary format. Nor would she say how or if malfunctions resulting from non-FDA-approved uses of devices would be cataloged. Off-label use can be an issue. For instance, research has estimated that Infuse is used off-label 85 percent of the time.

"Once the comment period for this [summary program] closes on February 26th, FDA will take into consideration the comments, including a specific request for comments [on] combination products, for finalizing the conditions of this program," the spokeswoman said in a statement. "No manufacturer will be allowed to participate in this voluntary program until a final notice has been published in the Federal Register and a list of eligible device product codes, including Class II implantable devices and Class III devices, are issued. We can't comment on specific devices or manufacturers … But as noted in the [Federal Register], the FDA may 'may revoke or modify in writing an exemption, variance, or alternative reporting requirement if it determines that revocation or modification is necessary to protect the public health.' "

The FDA has included what it considers safeguards in the new summary program. It is supposed to be limited to the least dangerous devices, is standardized in delivery and still requires death and serious injury reports to be filed within five or 30 days of a company learning about them, depending on circumstances.

In a statement to the Star Tribune, AdvaMed stressed this backstop.

"AdvaMed is supportive of FDA's proposal to move toward quarterly summary reporting for certain malfunction incidents — which by definition did not result in a serious injury. It is important to understand that quarterly summary reporting is only allowed for malfunction incidents that are well-understood and familiar to the agency; any new type of malfunction incident not previously reported to FDA would still have to be reported to the agency as an individual report. Furthermore, FDA retains the authority to require an individual malfunction report from a specific manufacturer or for a specific device if the agency deems it necessary to protect the public health."

But the program also notes that "information contained in a summary malfunction report that is protected from public disclosure under applicable disclosure laws would be redacted prior to release of the report."

That provision does not satisfy individuals and groups that have been pushing for more public access to product safety information.

Madris Tomes is a former FDA contractor whose company, Device Events, tracks product malfunctions. She points to the current FDA practice of redacting numbers of malfunctions in summaries as "trade secrets."

Wording is also important to Tomes, who uncovered hundreds of fetal deaths and injuries among users of the Essure contraceptive device that were buried in FDA data. She found serious injuries leading to revision surgeries caused by Allergan breast implants that the FDA allowed to be summarized under its current system.

"There are quite a few examples of where companies have misbehaved," she told the Star Tribune.

The FDA has already expanded its Alternative Summary Reporting program, Tomes said, and the agency already offers retrospective summary reporting to rule breakers, even though a formal description of the program does not seem to exist on the FDA website.

For Tomes, a new summary program that continues to limit data and include redactions is a move in the wrong direction.

"If you put [malfunctions] in summary form and are redacting," she said, "I don't see how this rule will be better than current rules that are misused by industry."

Jim Spencer • 202-662-7432