“We found that CDRH has not documented follow-up on adverse events, nor does it consistently read adverse-event reports for the first time in a timely manner,” an HHS spokesman said in the report. “In addition, CDRH rarely acts when manufacturers and user facilities submit reports late.”
Specifically, the OIG found that CDRH:
- does not use adverse event reports in a systematic manner to detect and address safety concerns about medical devices;
- does not consistently consult the reports in a timely manner;
- rarely takes action against facilities that submit reports late; and
- does not appear to collect annual reports from all facilities, having reports on file from only 220 out of an estimated universe of 526 facilities.
The OIG recommended that CDRH:
- document its follow-up actions on adverse events;
- ensure it is meeting its guidelines for reviewing adverse event reports;
- follow up with facilities that routinely submit late or incomplete reports;
- enhance outreach strategies to reduce underreporting by user facilities; and
- seek authority to eliminate the requirement for annual reports, because information in the annual reports is redundant to the originally submitted reports.
Read the HHS Office of the Inspector General’s report on FDA’s Center for Devices and Radiological Health (pdf).
