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."
CDRH rarely acts when manufacturers and user facilities submit reports late. "Analysts told us they generally forward concerns about timeliness only when they notice pervasive problems, and they usually handle concerns informally by calling the manufacturers."
The OIG recommended that the agency:
- Document follow-up of adverse events and develop a tracking system.
- Ensure and document that CDRH is meeting its guidelines for reviewing all 5-day and Code Blue (reports of pediatric, multiple deaths, exsanguinations, explosions, fires burns, electrocutions, and anaphylaxis) reports as its highest priority.
- Follow up with manufacturers that routinely submit reports late or with incomplete information.
- Enhance outreach strategies to reduce underreporting by user facilities.
- Seek legislative authority to eliminate the requirement for user facilities to submit annual reports, which would decrease regulatory burden.
The FDA requires that product quality problems, therapeutic inequivalence (when a dosage or strength of a drug is not as labeled) or failure, product use errors with human medical products, such as drugs and medical devices, all be reported.
If there is the potential for repetition or continuation of harm from these devices, the FDA can recall or suspend the device, require the manufacturer to conduct postmarket surveillance, levy a civil monetary penalty not to exceed $150,000 per event and $1 million per proceeding, issue a warning of FDA's intent to seek criminal prosecution, file a proceeding to seize a device, seek an injunction or refer the matter to the U.S. Attorney for prosecution.