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

Approximately 65% of PLT products met the guard bands during the operational trial. Presplitting largely obviated the need for conducting volume reduction. The number of PR units currently labeled is less than 50% due to combination of demand, staffing, aggregates, and units exceeding 24 hours. Additional observations included a radical shift in type of PI kit used from predominantly dual-storage kits to small-volume kits; the use of large-volume kits remained the same. Before implementation of mitigations, the split rate of PI products fell to 1.30. After implementation of mitigations the split rate of PI products increased to 2.10. Programming of Amicus devices was standardized, and collection volume increased; triples became eligible and products were not downgraded.