Despite FDA regulations, fatalities do occur as a result of blood transfusions.
According to the FDA’s annual summary for 2012, there were 65 reported transfusion-related, or potentially related, fatalities. This was more than the 58 fatalities recorded in 2011 and the 64 recorded in 2010.
Of the fatalities from 2008 through 2012, 37 percent were transfusion-related acute lung injury. Of the 17 of such cases in 2012, the associated blood was from 39 different donors.
Despite the testing and screening, the common concern for blood transfusion is the exposure to AIDS/HIV. But, according to the World Health Organizations, blood in the United States is among the safest in the world, and most HIV-infections were transmitted before 1985, when blood was not tested for the virus.
Now, the FDA reports that about one in 450,000 to 660,000 blood donations each year contain HIV antibodies. And the safety continues, as it was estimated that in 2003, the risk of acquiring HIV was between one in 1.4 million to 1.8 million units of blood. This was up from 1995, when the estimate was between 1 in 450,000 to 660,000 units of blood.
The CDC reported that the number of persons acquiring AIDS through blood transfusion was 284 in 2000, which was down from 1098 in 1993
The American Red Cross, the largest blood collector and distributer in the United States, was fined $9.6 million for unsafe blood management practices in Jan. 2012.
The Adverse Determination Letter, released by the FDA, said the investigators inspected 16 American National Red Cross Blood Service facilities in 2010, documenting violations of laws and regulations.
Among the violations was the failure to comply with reporting requirements, the failure to attain accurate and complete lists of donors, and inadequate staff training.
About Matt Dotray
