Overall, FDA received twice as many adverse event reports for medical devices in 2007 than in 2003; however, some types of reports decreased. Manufacturers, user facilities, and other reporters submitted 72,866 medical device adverse event reports in 2003, which doubled to 150,210 reports in 2007. Manufacturers submitted the vast majority of these reports. Thirty-day reports of death, serious injury, and malfunction accounted for almost all manufacturer reports and drove the overall increase in adverse event reports.
Five-day reports made up less than 1 percent of manufacturer reports. Although the total number of manufacturer reports increased substantially, 5-day reports fell from 432 to 54 reports per year over the 5-year period.
Manufacturers submitted most adverse event reports on time, but many 5-day manufacturer and user facility reports were late. In 2007, manufacturers submitted 89 percent of all 30-day reports on time. This percentage has remained relatively unchanged since 2003. Although manufacturers submitted only 54 5-day reports in 2007, 31 percent of them were late. This was a decrease from a high of 64 percent in 2003 but an increase from 7 percent in 2005.
In 2007, user facilities submitted 39 percent of both death and injury adverse event reports late to FDA. From 2003, the percentage late ranged from 30 percent to 45 percent. Likewise, user facilities submitted at least 42 percent of adverse event reports late to manufacturers in each year from 2003 to 2007.
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. Outcomes of adverse events can result in a variety of postmarket surveillance activities; 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’s Office of Compliance does not document which reports resulted in inspections when analysts refer the reports. CDRH also does not document onsite inspections in its adverse event database (MAUDE).
CDRH does not consistently read adverse event reports for the first time in a timely manner. Analysts read fewer than one-third of adverse event reports for the first time within 30 days and less than half within 60 days in every year from 2003 to 2007. CDRH’s procedures require that high-priority adverse event reports be in MAUDE and ready for analysts to review within 96 hours of receipt; however, 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 inability to obtain complete and usable information in adverse event reports hinders analysts’ review of reports. Analysts also pointed to MAUDE as an impediment because they cannot easily conduct trend analysis and MAUDE does not connect with other CDRH databases.
CDRH makes limited use of annual reports. We identified at least 526 user facilities that should have submitted annual reports for 2006, but CDRH could provide only 220 annual reports for that year. We could not determine whether facilities did not submit reports or whether CDRH was unable to supply copies.