The rationale for pathogen-inactivation treatment of blood components.

Blood transfusion provides an ideal portal of entry for microorganisms. Although current residual risks of microbial infection by transfusion are extremely low in the developed world, the requirements for even safer blood are paradoxically increasing. Such requirements are partly a legacy of the tragic transmissions of human immunodeficiency virus (HIV) by blood early in the acquired immunodeficiency syndrome pandemic and are legally expressed in consumer protection laws imposing strict product liability. Enhanced safety is called for, not only for recognized agents (especially bacteria, which cause most current transfusion-transmissible infections [TTIs]and have only recently been addressed) but also for potential future "emerging" TTIs. These possibilities are not merely theoretical. TTIs of HIV-1, HIV-2, hepatitis B virus vaccine escape mutants, human herpesvirus 8, West Nile fever virus, and variant Creutzfeld-Jakob disease amply demonstrate the continual emergence of such threats. For recognized agents, the possibilities of test errors, misreporting, process-control failures, and false-negative results (although rare with modern automation) remain. In principle, an all-embracing, pan-effective microbe-inactivation procedure offers a potential solution to blood safety concerns. Such procedures may also allow the removal of several existing antimicrobial interventions. However, blood services remain to be convinced that the various prerequisites for safe and effective pathogen inactivation have been met. Not the least of these prerequisites is that all blood components can be inactivated to provide a single streamlined alternative blood safety strategy. Furthermore, the huge potential value of effective pathogen-inactivation systems for developing countries should not be forgotten once such systems are perfected.