Fatalities Reported to FDA Following Blood Collection and Transfusion

Background: As previously mentioned in the annual summary of fatalities reported to the FDA in Fiscal Years (FY) 2005 through FY2008, the blood supply is safer today than at any time in history. Due to advances in donor screening, improved viral marker tests, automated data systems, and changes in transfusion medicine practices, the risks associated with blood transfusion continue to decrease. Overall, the number of transfusion related fatalities reported to the FDA remains small in comparison to the total number of transfusions. In 2006, for example, there were approximately 30 million components transfused.1 During the proximate period of FY2006, there were 73 reported transfusion related and potentially2 transfusion related fatalities, with subsequent reports of 63 in FY2007, 54 in FY2008, and 66 in FY2009. CBER is distributing this summary of transfusion fatality reports received by the FDA to make public the data received in FY2009, to provide the combined data received over the last five fiscal years, and to compare the FY2009 reports to the fatality reports received in the previous four fiscal years. We also include information on the infrequent reports of post-donation fatalities. Throughout this report we note changes over time, but the reader should interpret these changes cautiously, given the small numbers of reports and inherent variations in reporting accuracy. The significance of shifts in numbers derived from small populations may appear to be greater than they really are.