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At FDA, Fewer Inspectors Trace More Device Complaints

Graphic: At FDA, Fewer Inspectors Trace More Device Complaints

by Dan Nguyen and Christina Jewett , ProPublica - June 7, 2009 12:00 a.m. EDT

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.

Return to main story: Tainted Syringes Slipped Past FDA's Watch

Graphic

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)

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
577 512 482 454 457 457 482 454 412 413 401

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

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
59,618 45,507 39,258 38,658 45,062 51,657 57,884 63,019 82,852 99,978 129,925