Pathogen Reduction in Platelets: A Review of the Proposed Draft Guidance

Abstract

Septic Transfusion Reactions, Biological Products, Transfusion Reaction, Pathogen Inactivation, Platelet transfusion Clin Lab Sci 2017;30(4):263 INTRODUCTION The increase in surgical procedures and patients receiving treatment for cancer, have led to an increased usage of platelet concentrates.1'2 Platelet transfusions are indicated for the treatment of many disorders, but especially for patients with thrombocytopenia and platelet dysfunction who are more prone to bleeding.2 Despite recent advances in donor screening and infectious disease testing, there is still a large risk for adverse transfusion reactions associated with platelets, such as bacterial contamination, transfusion-transmitted infections (TTIs), and sepsis. According to the Blood Products Advisory Committee in 2012, transfusion of platelets that have been stored for 4 or 5 days have been the source of all fatalities due to bacterial sepsis and most (95%) of platelet transfusionrelated septic reactions.9 To minimize TTIs, then, it would seem that shortening the duration of platelet storage to 3 or 4 days maximum would be the logical choice, but that would result in significantly decreased platelet availability, and is therefore not considered to be a feasible strategy. In a world of new and emerging pathogens such as Chikungunya Virus, Babesia, Dengue Virus,16 and most recently, Zika Virus,17 rapid bacterial detection is at a disadvantage to PRT. Since PRT interferes with nucleic acids, even emerging pathogens (for which the FDA may not have a detection test) will be rendered inactive. According to the current literature, both pathogen reduction technology and point-of-issue rapid bacterial detection prove to be safe and effective measures to reduce the transfusion of bacterially-contaminated platelet products.