FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions

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. […]

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