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FDA Review of Adverse Events Caused By Medical Devices Is Inadequate

Cheryl Clark, for HealthLeaders Media, October 26, 2009

The U.S. Food and Drug Administration division that regulates medical devices does not systematically review adverse event reports to address safety concerns that hospitals, nursing homes or manufacturers are required to file, according to a review issued Friday by the Office of Inspector General.

The number of these reports, which are filed through the FDA's MedWatch program, doubled between 2003 and 2007, from 72,886 adverse events involving medical devices to 150,210, the OIG said. The vast majority were submitted by manufacturers in compliance with a requirement such reports be submitted within 30 days of the realization that a device caused or contributed to a death, injury or malfunction.

The incident must be reported within five working days if an event requires action other than routine maintenance to prevent a public health issue. And about 1% of the reports came under this requirement.

But the Inspector General's report found the following problems with the FDA's required review of those reports, which are the responsibility of the Center for Devices and Radiological Health (CDRH).

Manufacturers submitted most adverse event reports on time, but many 5-day manufacturer and user facility reports were late. "Although manufacturers submitted only 54 (of the) 5-day reports in 2007, 31% of them were late, a decrease from 64% in 2003."

Hospitals and nursing homes submitted to the FDA 39% of both death and injury adverse event reports late in 2007. From 2003 to 2007, such facilities submitted "at least 42% of adverse event reports late to manufacturers."

The CDRH does not use adverse event reports in a systematic manner to detect and address safety concerns about medical devices. "Analysts have documented little of their reviews, which can make it difficult to trace the response to an individual event," the OIG said.

It added that postmarket surveillance might follow adverse events, "however, at this time CDRH cannot link these activities to particular adverse events. CDRH also lacks an established system to document when adverse event reports result in onsite inspections."

CDRH does not consistently read adverse event reports for the first time in a timely manner and, in fact, analysts read fewer than one-third for the first time within 30 days and less than half within 60 days. Though procedures require that high-priority adverse events be ready for review within 96 hours of receipt, "we were unable to verify CDRH's compliance with these procedures through its documents."

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