Ensuring Safety of the Blood Supply in the United States: Donor Screening, Testing, Emerging Pathogens, and Pathogen Inactivation

Safety of the blood supply has been a critical aspect of the transfusion medicine field since its inception, including infections that can be passed to a blood product recipient. Reactive efforts to identify potentially infected blood products are used throughout the blood donation process and afterward. Before donation, potential donors are provided educational materials about infection risks, examined and then screened through a series of questions that help temporarily, permanently, or indefinitely defer donors who could harbor acute and/or chronic infections. During donation, aseptic technique and diversion pouches reduce the potential to introduce bacteria into the blood product. Before transfusion, the blood products are tested for several infectious diseases by serology, nucleic acid testing, or a combination. During transfusion, the patient is monitored closely, and suspected transfusion reactions should be reported and investigated. The FDA regularly publishes guidance documents to incorporate knowledge gained regarding transfusion-transmitted infections, so that information can be shared and practices updated so that transfusion-related patient care can be optimized over time. Pathogen reduction processes are being developed and deployed that provide a proactive approach to both recognized and emerging pathogens.