Despite the fact that medical device malfunctions often lead to severe patient injury or even death, the U.S. Food and Drug Administration (FDA) is seeking to relax the adverse event reporting requirement, further slowing down an already slow process of recognizing device problems and potentially putting patients at greater risk.
The 2017 draft of the Medical Device User Fee Amendments, which is renegotiated every five years, would allow device manufacturers to report malfunctions to the U.S. Food and Drug Administration (FDA) quarterly instead of within the current 30-day requirement. The House has already reauthorized the new agreement, which now awaits Senate approval.
Who Currently Reports Device Malfunctions?
Currently, only device manufacturers and user facilities are required to notify the FDA of suspected medical device malfunctions leading to serious injuries and deaths. The Medical Device Guardians Act, legislation to require individual physicians to report adverse events, was introduced in the U.S. House in 2016, but the measure was not included into the 21st Century Cures Act. The failed measure sought to allow anyone who observes an adverse event – doctors, nurses, institutions, or patients – to be able to easily make the event public, available, and accessible.
GAO Says Adverse Events Underreported
In February 2017, a report issued by the Government Accountability Office stated that adverse event reports to the FDA are often underreported, incomplete, erroneous, and not timely. This is in agreement with a 2015 survey of reporting standards at 17 hospitals by the FDA, which concluded that the majority of the hospitals studied did not file timely reports of injuries and deaths due to malfunctioning medical devices. But despite the findings, the FDA did not impose penalties against hospitals that failed to comply with the reporting requirements.