As the platelet shortage continues, whole blood-derived platelets (WBDPs) present an opportunity to help blood centers manage supply and demand. One historic challenge with manufacturing WBDPs is the U.S. Food and Drug Administration’s (FDA) 8-hour hold time limit when processing whole blood for platelets. In this article, we review the 8-hour hold time regulation and discuss potential advantages that may outweigh the challenges.
What is the 8-hour hold rule?The FDA currently requires that whole blood used to make components be held at ambient temperature (20 to 24 °C or 68 to 75.2 °F) for no more than 8 hours after collection. At that point, it must be cooled and stored at a temperature between 1 and 6 °C (33.8 to 42.8 °F).
1 Here’s the dilemma: Platelets are sensitive to temperature, making cooled blood unsuitable for platelet preparation.
2 Combine this with the 8-hour hold limit, and it means that platelets derived from whole blood must be obtained within the 8-hour window. Unfortunately, traditional processing procedures can be time-consuming, involving two centrifugations, each with an expression step, followed by red blood cell (RBC) leukoreduction. To allow time for these procedures, processing must begin within hours of collection.
3This limits the number of whole blood units collected by blood centers that can be processed into platelets. (Whole blood that is processed into RBCs and plasma can be refrigerated overnight and so does not have the same time constraint as making platelets.)
This logistical challenge may deter some blood centers from considering the WBDP option.
How is it different in Europe and Canada?Interestingly, outside the U.S., most countries allow for a 24-hour hold at room temperature. This "overnight" hold was first introduced in Europe and is now recognized by the Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components and by the Canadian Blood Services.
2,4 Studies have reported some impacts on the quality of red blood cells stored at ambient temperature overnight — mainly a slight increase in hemolysis. But the consensus is that the overnight hold is not clinically harmful.
2,5-7 In fact, it provides many logistical and economic advantages. For instance, blood centers may be able to reduce the number of trips between collection sites and processing centers, since all blood collected in a day could be transferred in a single trip.
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Why is it worth overcoming the challenges?Currently, almost 95% of the U.S. platelet supply is collected by apheresis.
9 But apheresis donors are becoming more difficult to recruit and retain. Blood centers consider WBDPs as a supplemental source of platelets for transfusion. Despite the 8-hour hold, U.S. blood centers may be able to take advantage of WBDPs to increase platelet supply. Let’s look at an example.
We’ll set the scene with results from a 2021 National Blood Collection and Utilization Survey (NBCUS). It revealed that U.S. blood centers processed 2.25 million units of whole blood within the 8-hour hold time limit to make cryoprecipitate.
10 Now let's assume that the same number of whole blood units were processed into RBCs, plasma, and intermediate platelet units (IPUs). Assuming IPUs from five collections are used to create a transfusable dose of platelets, U.S. blood centers could then collectively produce up to 450,000 additional platelet doses per year.
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In times when hospitals and blood centers report ongoing platelet shortages, the value of these additional platelet units cannot be overlooked.
Bottom lineDespite the 8-hour hold limit, whole blood-derived platelets represent an additional source of platelets for transfusion to meet patient needs. If you would like to discuss ideas and options,
please contact us — our experts are ready to help.
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Information in this article was provided by Aspen King, PhD, Scientific Marketing Associate, Terumo Blood and Cell Technologies.1U.S. Food and Drug Administration. 21CFR640. Accessed June 24, 2024.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=640&showFR=1.2Van der Meer PF, De Korte D. The effect of holding times of whole blood and its components during processing on in vitro and in vivo quality. Transfus Med Rev. 2015;29:24-34. 3Terumo Blood and Cell Technologies. Reveos™ Automated Blood Processing System U.S. Overview and Status Update. GB-REVE-00053. 2023.4Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components. 21st ed. Strasbourg: EDQM; 2023. 5Gulliksson H, Van der Meer PF. Storage of whole blood overnight in different blood bags preceding preparation of blood components: in vitro effects on red blood cells. Blood Transfus. 2009;7(3):210-215.6Högman CF, Meryman HT. Storage parameters affecting red blood cell survival and function after transfusion. Transfus Med Rev. 1999;13:275-296. 7Tinmouth A, Chin Yee I. The clinical consequences of red cell storage lesion. Transfus Med Rev. 2001;15:91-107.8Slichter SJ, et al. Platelet concentrates prepared after a 20 to 24 hour hold of the whole blood at 22 °C. Transfusion. 2012;52(9):2043-2048. 9Riley W, Cohn CS, Love K, McCullough J. Ensuring a reliable platelet supply in the United States. New Engl J Med. 2023;388(22):2017-2019. 10Free RJ, et al. Continued stabilization of blood collections and transfusions in the United States: Findings from the 2021 National Blood Collection and Utilization Survey. Transfusion. 2023;63(S4):S8-S18. 11Van der Meer PF. Platelet concentrates, from whole blood or collected by apheresis? Transfus Apher Sci. 203;48:129-131.