Regulatory requirements for testing the donor blood supply

Abstract

Abstract Over the last 30 years, there have been tremendous advances made in protecting the nation's blood supply from dangerous pathogens. From serologic testing to antigen detection to the application of nucleic acid testing, developments in technology have contributed to the reduction in the risk of transfusion transmission of hepatitis, human immunodeficiency virus (HIV), and West Nile virus. The Centers of Biologics Research of the Food and Drug Administration (FDA) has legal enforcement power and is responsible for oversight of the collection and manufacture of blood and blood products. The American Association of Blood Banks is a major voluntary standard setting organization that publishes standards, some going beyond the requirements of the FDA, to ensure blood safety. This report will highlight the major topics in blood safety and the regulatory and quality requirements that shape transfusion medicine.