At FDA, Fewer Inspectors Trace More Device Complaints — ProPublica

At FDA, Fewer Inspectors Trace More Device Complaints

June 8, 2009, 10:33 a.m. EDT

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

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

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