Device AEs Exceed Drug AEs in 2008

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The Government Accounting Office issued a report on Monday, 20 July 09, stating that the number of adverse events reported to FDA for medical devices outnumbered the number of adverse events for drugs for the first time in 2008. The number increased to 588,161 from 189,450 since 2004.

So many adverse event reports go to FDA that their tracking system is overwhelmed; they cannot track which individual reports have been reviewed and which have not. Ask us for a free copy of the GAO Report.

The incredible increase in medical device reports speaks loudly to the increase in medical device use, the increase in device complexity, and the increase in device importance in our healthcare system.