Overview
Hepatitis is inflammation of the liver that can be caused by different toxins, immunologic processes or infectious agents, including viruses. According to the CDC, the most common types of the disease are hepatitis A, hepatitis B and hepatitis C, each caused by a virus of the same name. While viral hepatitis can be spread in different ways, all forms have the potential to be transmitted through blood transfusions.
Implementation of improved tests and stringent screening criteria for donors has helped dramatically reduce the risk of transfusion or transplantation transmission of the virus in the United States. According to AABB's Technical Manual, 16th edition, the risk of HCV transmission is less than 1 in 800,000 units transfused.
On behalf of the transfusion medicine and cellular therapies community, AABB works with the FDA and other government agencies, either directly or through government advisory committees, as part of ongoing, collaborative efforts to protect against the transmission of hepatitis through blood and human cells, tissue, and cellular- and tissue-based products. In addition, AABB provides guidance to establishments while working with public health officials to monitor infection outbreaks.
Recent Actions
12/30/10
FDA updates a 2007 guidance that makes recommendations for complying with regulations that require blood establishments to search records of prior collections from donors whose test results have shown evidence of HCV.
5/1/10
FDA releases a guidance that provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories for testing individual or pooled samples from donations of blood and blood components for HIV-1 RNA and HCV RNA.
5/1/10
FDA releases a guidance that provides recommendations to establishments that collect whole blood or blood components intended for transfusion for requalifying or re-entering deferred donors into the donor pool based on a determination that previous tests that were repeatedly reactive for antibodies to hepatitis B core antigen were falsely positive and that there is no evidence of infection with HBV.
Archived Actions