Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

Atreya, Chintamani; Glynn, Simone; Busch, Michael; Kleinman, Steve; Snyder, Edward; Rutter, Sara; AuBuchon, James; Flegel, Willy; Reeve, David; Devine, Dana; Cohn, Claudia; Custer, Brian; Goodrich, Raymond; Benjamin, Richard J.; Razatos, Anna; Cancelas, Jose; Wagner, Stephen; Maclean, Michelle; Gelderman, Monique; Cap, Andrew; Ness, Paul

The first session titled "Blood-Borne Infectious Agents and Their Impact on Blood Safety" provides a state-of-the-science overview of the risks to blood safety posed by infectious agents. Additionally, this session addresses the strategies used to mitigate these risks in the United States including the introduction of increasingly sensitive laboratory screening testing platforms and PRTs for PLTs and plasma products. In a first part, the session includes a general overview of the evolution of responses to established, emerging, and reemerging transfusion-transmitted infectious diseases in the past 50 years. Further, it addresses the need for ongoing surveillance for and systematic responses to emerging infectious diseases (EIDs), optimally with sensitive metagenomics, multiplexed nucleic acid amplification technology (NAT) and serologic testing strategies in sentinel global donor populations. This is followed by a review of the major policy issues pertaining to the development and implementation of PRTs, which if successfully adopted will provide insurance against known and unknown pathogens that may enter the blood supply. It will be noted that these technologies, if applied to all blood components or WB, may allow for the relaxation of redundant donor laboratory screening, modified donor questioning and/or deferral, and simplified handling of postdonation information while preserving or enhancing the safety of the blood supply. The session ends with an overview of the current status of approved pathogen-reduced (PR) PLT and plasma products in the United States with attention provided to their current effectiveness and safety profile. Major reasons for the slow adoption of the currently approved PR products in the United States are discussed including cost-effectiveness (CE) considerations.