Updated headline from ‘adverse events’ to ‘malfunctions’ after receiving clarity on the wording of the MDUFA agreement from AdvaMed.
The newly House-passed medical device FDA user fee agreement could allow medical device makers to delay reporting malfunctions, according to a New York Times report.
While makers would still be required to quickly report injuries or deaths related to their products, they would be given more time to file reports on device malfunctions which have the potential for injuries, according to the report.
The draft, which passed the House yesterday, looks to speed medical devices to the market faster than before, and includes a provision which says the FDA should permit companies to report technical errors every months, rather than the current practice of reporting within 30 days.
The change comes after the FDA has acknowledged that medical device malfunctions are vastly underreported – something that industry executives dispute, according to the paper. Executives argue that the new proposal won’t affect their responsibility to notify the agency of adverse events.
“All of our companies report adverse events quickly and as clearly as they can. It’s in our interest to do it. We want safe, effective products more than anyone else,” AdvaMed prez Scott Whitaker told the Times.
Some consumer advocates disagree, pointing out issues like those associated power morcellators, which were designed to remove uterine fibroids but were found to spread cancer through patient’s bodies when used on cancerous tumors. Other issues, such as the superbug-housing duodenoscopes and their reprocessing woes, were also referenced in the report.
“It often takes months or even years for the FDA to detect patterns of failure. Post-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices,” National Center for Health Research health policy director Jack Mitchell told the paper.
FDA Center for Devices and Radiological Health called the current system “passive surveillance,” according to the report, as the regulators rely on manufacturers and hospitals to notify them of the events.
Both the FDA and the Government Accountability Office cannot directly quantify the amount of problems that go unreported, according to the Times.