The regulatory pendulum in transfusion medicine

Abstract

Blood banking and the manufacture of blood products have been relatively outside the influence of regulatory authorities. Several developments contributed to a revision of this environment. The transmission of acquired immunodeficiency syndrome by blood products changed the perception of blood product safety and also spawned litigation and governmental inquiries. The blood banking industry has embraced, with varying degrees of enthusiasm, the principles of systematic quality management and good manufacturing practice, which has created a substantial subindustry and has contributed to a disproportionate focus on product quality. Conventional market forces have also gradually penetrated the traditional blood economies. The public and political focus has resulted in regulatory and policy efforts being concentrated on inappropriate areas. Several of the safety efforts can be arguably described as cost-ineffective while diverting attention and resources from more important issues. An improved integration into mainstream public health policy and incorporation of objectively measured risks into regulatory policy would do much to enhance the quality of the transfusion system. This can be achieved if regulators themselves are overseen through a process that ensures performance and accountability against objective and predefined standards. A further beneficial outcome from this approach could be the harmonization of blood safety and policy measures, the need for which is being felt increasingly worldwide.