November 07, 2022
In a time of increasing blood supply pressures and donor recruitment challenges, the United States has among the highest per capita platelet use and highest minimum platelet content in the world1. With these challenges in mind, some in the blood community have begun discussing whether low-yield platelets could help extend the supply in the U.S.
A Monday session at the 2022 Virtual Annual Meeting expanded on that discussion, focusing on potential strategies to provide low-yield platelets and highlighting the experience of Canadian Blood Services (CBS), which introduced low-yield platelets in 2017.
P. Dayand Borge, MD, PhD, chief, Transfusion Medicine and Cell Therapy Section, at Memorial Sloan Kettering Cancer Center, began the session with a review of findings from a 2019 report that compared international platelet usage per capita and minimum content.
He also provided an overview of the current Food and Drug Administration regulations that address platelet content for various platelet products, including the December 2007 FDA guidance “Collection of Platelets by Automated Methods.” Borge described how the guidance includes a provision for low-yield platelets under the “labeling” category: “When special circumstances warrant their use, platelets, pheresis components containing less than 3.0 x 1011 should be labeled with the actual platelet count,” the guidance states. However, Borge emphasized that, based on this guidance, these products would be unlicensed with limited distribution.
Borge also focused on the impact of the December 2020 guidance on bacterial risk control strategies for platelets. While the guidance has reduced the risk of bacterial contamination, Borge said it also requires the blood community to think carefully about how these process changes (such as large-volume delayed sampling and pathogen-reduction technology) may affect the ability to get usable platelet products at the end of processing.
He continued by sharing the experience of the New York Blood Center (NYBC) the American Red Cross (ARC), describing the processes that these institutions used to offer low-yield platelets as licensed products.
So, will low-yield platelets help address future platelet shortages? Borge emphasized his belief that “low yield is better than no yield,” but stated that additional data on platelet recipients and practices is necessary. As FDA has announced plans to update the December 2007 guidance, Borge said, “perhaps now is a good time to consider lowing the minimum standard content and making that something that’s more accessible to all of us in the future.”
Following Borge’s presentation, Dana Devine, PhD, FCAHS, chief scientist at CBS and director of the University of British Columbia’s Centre for Blood Research, shared her institution’s experience.
In August 2017, CBS introduced a minimum platelet count of 2.4 x 1011 platelets per unit (a decrease from 3.0 x 1011) following approval from Health Canada. The following year, CBS undertook a monitoring study to understand whether these platelets were meeting demand in the country.
In the first full year with a minimum platelet count of 2.4 x 1011 per unit, platelet content decreased by 23% while utilization increased 1.6%. According to Devine, this transition did not increase platelet demand or customer complaints.
Benjamin, Richard J. “The Argument(s) for Lowering the US Minimum ... - Wiley Online Library.” The argument(s) for lowering the US minimum required content of apheresis platelet components. TRANSFUSION, November 21, 2018. https://onlinelibrary.wiley.com/doi/10.1111/trf.15036.