Adverse events on the rise
This article was originally published in The Gray Sheet
Executive Summary
Medical device adverse event reports continue to increase, FDA says. In FY 2006, they rose to 210,706, surpassing the 176,351 reported in 2005. Susan Gardner, director of CDRH's Office of Surveillance & Biometrics, suggests that the increase could be due to the device industry's growth. During a Nov. 1 Regulatory Affairs Professionals Society webcast, Gardner noted that "the ratio or percent of deaths, malfunctions and injuries - in spite of increasing reports - remains about the same," adding that the "number of injuries is increasing somewhat in proportion to malfunctions." For 2006, there were 2,735 deaths, 119,070 injuries, 82,493 malfunctions, and 6,408 adverse events classified as "other." Stats for 2005 were 2,347 deaths, 100,158 injuries, 67,183 malfunctions, and 6,663 events classified as other...