The FDA's Center for Devices and Radiological Health (CDRH) does not use adverse event reports in a systematic manner to detect and address safety concerns about medical devices, according to an October report from the Office of Inspector General (OIG).
The CDRH is responsible for regulating medical devices within the FDA. Adverse reporting enables the FDA to take corrective action on problem devices and to prevent injury and death by alerting the public when potentially hazardous devices are discovered. The adverse event reporting system enables the CDRH to gather information about potentially hazardous devices that could cause either injury or death.
Current regulations require medical device manufacturers to report to the FDA:
- Within 30 calendar days of acquiring information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury or malfunction; and
- Within five working days if an event requires action other than routine maintenance or service to prevent a public health issue.
The OIG report stated that the extent to which CDRH uses adverse event reporting information to identify and address problems with medical devices is not clear.
According to the report, between 2000 and 2003 only 5 percent of onsite inspections specifically referenced adverse event numbers in their files and that that the reporting was hardly followed up with another review. “We identified at least 526 user facilities that should have submitted annual reports for 2006, but CDRH could only provide 220 annual reports for that year,” the study read.
This practice of scant documentation makes it difficult to trace the response to an individual event, according to OIG.
In addition to a failure to use adverse event reports in a systematic manner, the report found that, overall, the FDA received twice as many adverse event reports for medical devices in 2007 than in 2003, although some types of reports decreased. However, the increase in 30-day manufacturer reports drove the overall increase.
The report also found that manufacturers submitted most adverse event reports on time but many five-day manufacturer and user facility reports (those required to report within five days of adverse event) were late.
The OIG acknowledged its report was limited by the fact that it did not verify information in the adverse event reports from the user facilities or manufacturers or calculate the magnitude of underreporting from either user facilities or manufacturers.
The study used the Manufacturer and User Device Experience (MAUDE) database, the alternative summary reports database, annual user facility reports, CDRH files on regulatory actions, structured interviews with CDRH analysts and interviews with CDRH senior officials.