Pathogen Reduction of Transfused Blood Components-The End of the Beginning Rather than the Beginning of the End.

Therapeutics derived from donated blood or its constituents are classifiable into blood components and plasma derivatives. The latter are defined as medicines/drugs/pharmaceuticals produced from the industrial fractionation of thousands of pooled plasma donations and characterised with relative precision to a pre-defined specification through sampling of a homogenous pharmaceutical batch. The former are defined as components/biologicals produced using relatively simple (but increasingly complex) technologies in blood centres from single or small pools of isolated components from whole blood and are pre-specified through regulatory standards with relatively wide limits because of the inherent biologic variability of individual donors. This review discusses the evolution of technology to reduce the risk of pathogen transmission by blood-derived therapeutics, assess the state of the approved technologies for pathogen-reduced blood components, and examine the features of the blood-provider and regulatory framework globally that have shaped, and in some instances impeded, the implementation of component pathogen reduction to an extent equivalent to that achieved for plasma derivatives. The ensuing risks to the public's confidence in the blood supply are discussed, and remedial actions are proposed. The features of a new paradigm for blood safety are outlined.