A cross-sectional study of prevalence, distribution, cause, and impact of blood product recalls in the United States

Abstract

AbstractDefective blood products that are recalled because of safety or potency deviations can trigger adverse health events and constrict the nation’s blood supply chain. However, the underlying characteristics and impact of blood product recalls are not fully understood. In this study, we identified 4700 recall events, 7 reasons for recall, and 144 346 units affected by recalls. Using geospatial mapping of the newly defined county-level recall event density, we discovered hot spots with high prevalence and likelihood of blood product recall events. Distribution patterns and distribution distances of recalled blood products vary significantly between product types. Blood plasma is the most recalled product (87 980 units), and leukocyte-reduced products (34 230 units) are recalled in larger numbers than non-leukocyte-reduced products (8076 units). Donor-related reasons (92 382 units) and sterility deviations (22 408 units) are the major cause of blood product recalls. Monetary loss resulting from blood product recalls is estimated to be $17.9 million, and economic sensitivity tests show that donor-related reasons and sterility deviations contribute most to the overall monetary burden. A total of 2.8 million days was required to resolve recall events, and probabilistic survival time analysis shows that sterility deviations and contamination took longer to resolve because of their systemic effect on blood collection and processing. Our studies demonstrate that better donor screening procedures, rigorous sterility requirements, improved containment methods, and mitigation of recall events in high-prevalence regions will enable a more robust blood supply chain.