A low dose is better than no dose: Is it time to consider lowering the US minimum plateletpheresis yield?

Maintaining an adequate platelet supply in the United States (US) has become increasingly challenging due to stringent regulatory requirements, diminishing donor availability, and expanding clinical demand. Current US regulations require a minimum apheresis platelet yield of 3.0 × 10 ¹ ¹ per unit, a standard substantially higher than those used internationally. Implementation of bacterial risk mitigation strategies has further increased the proportion of plateletpheresis collections falling below this threshold, resulting in low-yield platelet units becoming a structurally important component of the national inventory. Analysis of US platelet utilization from 2022 to 2024 demonstrates that despite persistent supply pressures, the proportion of low-yield units remained relatively stable, while dividing of platelet units declined. Evidence from clinical studies indicates that low-yield platelets provide hemostatic efficacy comparable to standard-yield components in thrombocytopenic patients with marrow failure. However, single-center observations suggest an increase in overall platelet utilization when lower-yield units represent a larger proportion of available inventory, highlighting the influence of transfusion practices on product demand. Given ongoing supply constraints, the established availability of low-yield components, and international experience demonstrating safe use at lower minimum thresholds, reconsideration of the current US minimum plateletpheresis yield requirement is warranted. Harmonizing regulatory standards with global practice has the potential to enhance platelet availability, reduce donor burden, and strengthen national supply resilience without compromising patient safety. Further studies are needed to assess outcomes across diverse patient populations.