At FDA, Fewer Inspectors Trace More Device Complaints
Graphic: At FDA, Fewer Inspectors Trace More Device Complaints
AM2PAT, the North Carolina plant that shipped syringes contaminated with bacteria, was inspected by field staff in the Food and Drug Administration’s device division. The branch’s staffing reached a 10-year low in 2007. Meanwhile, reports from manufacturers about problem devices more than tripled. Manufacturers are required to report when a device may have malfunctioned or caused injury. It is believed that such adverse events are widely underreported.
Number of Full-Time Employees in the Food and Drug Administration's Medical Devices Field Division
Source: FDA Science Mission At Risk - 2007 Report of the Subcommittee on Science and Technology (Appendix B)
Number of Adverse Events Reports to the FDA By Device Manufacturers
The numbers below are the summation of the reports submitted by device manufacturers that have been classified as having an "event type" of injury, death, or malfunction.
Source: FDA Manufacturer and User Facility Device Experience Database (MAUDE) - File: MDRFOITHRU2008.ZIP