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CBER Reports on Safety of Blood Transfusions in 2010


With summer upon us and the recent weather related events, Joplin, MO and Tuscaloosa, Alabama tornadoes, there is a great need for blood donations. It is comforting to know if you or a loved one is injured or has surgery and needs a blood transfusion, the blood supply is safer today than at any time in history. This safety is due to advances in donor screening, improved testing, automated data systems, and changes in transfusion medicine practices.

The Food and Drug Administration (FDA) notes the overall number of transfusion related fatalities reported remains small in comparison to the total number of transfusions. In 2008, there were approximately 24 million components transfused and only 54 reported transfusion related and potentially transfusion related fatalities. There were 64 reported transfusion related deaths in 2010.

Center for Biologics Evaluation & Research (CBER) released it’s summary of transfusion fatality reports received by the FDA in 2010. The summary report is the work of a team of CBER medical officers who reviewed the documentation submitted by the reporting facilities and obtained by FDA investigators who followed up on the report to determine if any relationship existed between the blood donation or transfusion and the reported fatality.

CBER received 76 fatality reports during FY2010 (October 1, 2009, through September 30, 2010) -- 71 were transfusion recipient fatalities and 5 were post-donation fatalities. Of the 71 transfusion recipient fatality reports, 64 were determined to be transfusion related. More specifically -- 40 were definitely transfusion-related, 24 were cases that transfusion could not be ruled out as the cause of the fatality, and 7 were unrelated to the transfusion.

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Of the 40 definitive transfusion-related deaths, 18 (45%) were transfusion related acute lung injury (TRALI), 7 (18%) hemolytic transfusion reactions (HTR), 2 (5%) complications of microbial infection, 8 (20%) transfusion associated circulatory overload (TACO), 4 (10%) anaphylactic reactions, and 1 (3%) graft vs host disease (GVHD). Of the 7 HTR, 5 were non-ABO and 2 were ABO incompatibilities.

CBER reports a continued decrease in the number of reported fatalities following donation of plasma or blood. In 2010, there were 2 deaths following plasma donation and 3 following whole blood donation. One of the plasma donation deaths was definitively ruled out as related to the donation, the other 4 deaths could not be definitively ruled out as being implicated in the donor’s death, but the medical reviewers found no evidence to support a causal relationship between the donation and subsequent death of the donor.

More than 38,000 blood donations are needed every day. The American Red Cross states every two seconds, someone in the United States needs blood.

Consider making an appointment today with your local American Red Cross to donate blood as their supplies are low.

FDA: Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2010 (May 31, 2011)