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

To bridge shortages of supply or serve patients with rare HLA antibodies, we must import PLTs that remain almost invariably produced without PRT. Their irradiation with 25 Gy is required before they can enter the inventory for release to patients. We do not provide bacterial testing upon release and retired our previous precaution to prevent bacterial contamination: 4 to 5 mL sampling within 24 hours of collection and release into inventory after 12 hours of negative culture in single standard aerobic bottles (BACTEC, Becton, Dickinson and Co.) while monitoring the culture for 7 days. With PRT products, the elimination of irradiation (possible without variance notification since March 17, 2016) 79 and bacterial culture resulted in substantial savings of consumables and handling, which were however exceeded by the costs of the new technologies and the increased hands-on time for the production staff. Reports of transfusion reactions ranged from nine to 19 annually without discernible trend, certainly no increase from 2015 to 2018; no severe transfusion reactions occurred.