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

Quality variables are expected to change, as PRT affects all treated cells. The risks must be monitored and balanced while the technologies for PRT and PLT additive solution (PAS) continue to evolve. 64 PRT plasma from individual donors, although FDA-licensed devices are available, had not been introduced in patient care by the end of 2018. Similar to lyophilized plasma, which is not available from single-donor sources, 65 a PRT plasma alternative pooled from many donors does exist: S/D-treated plasma 66 has a history of worldwide use since 1992. Five randomized controlled trials showed no difference in efficacy, but trial sizes ranged from 49 to 293 patients for a total of only 552 patients. No TRALI has been reported from passively collected data, which may not reflect all incidence.