Blood Components Resources

WHO model for costing of blood products

Guideline

25 Jul 2025

Updated EUROGTP II Risk Assessment Guide

Faecal microbiota and breast milk chapters

Guideline

16 Feb 2024

The page lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

Guideline

16 Feb 2023

Circular of information for the use of human blood and blood components (AABB)

The Circular of Information (the Circular) is made available through the important work of the AABB's Circular of Information Task Force. This webpage provides the background information for compliance with FDA requirements under 21 CFR 606.122 for use of the Circular, including information on purchase options, implementation, and updated language. AABB encourages you to review the information for important changes.

Guideline

16 Feb 2023

Australian Red Cross Lifeblood Blood Component Information

Blood and blood components are biological products, and in the form of cellular products are living human tissue intended for use in the treatment of patients

Guideline

01 Mar 2022

ANZSBT Guidelines

Australia and New Zealand transfusion medicine guidelines, position papers and consensus statements

Guideline

01 Mar 2022

European Blood Alliance (EBA)

EBA position papers and fact sheets

Guideline

01 Feb 2021

Guidance on increasing the supply of plasma-derived medicinal products (PDMPs) in LMICs through the fractionation of domestic plasma

World Health Organisation, (2021)

Guideline

1. Platelet Cryopreservation

Ehn et al. Cryopreserved platelets in a non-toxic DMSO-free solution maintain hemostatic function in vitro. International Journal of Molecular Sciences 2023; 24:13097. DOI: 10.3390/ijms241713097 PMID: 37685902 Weblink: https://www.mdpi.com/1422-0067/24/17/13097
Waters et al. Strategies to improve platelet cryopreservation: A narrative review. Transfusion 2025; 65:740-749. DOI: https://doi.org/10.1111/trf.18204 PMID: 40059666 Weblink: https://pmc.ncbi.nlm.nih.gov/articles/PMC12005584/
Reade et al. A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial. Transfusion 2019; 59:2794-2804. DOI: https://doi.org/10.1111/trf.15423 PMID: 31290573 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.15423
Johnson et al. In vitro comparison of cryopreserved and liquid platelets: potential clinical implications. Transfusion 2015; 55:838-847. DOI: https://doi.org/10.1111/trf.12915 PMID: 25371169 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.1291

2. Cold-stored platelets

Neal et al. Early cold-stored platelet transfusion following traumatic brain injury: A randomized clinical trial. Annals of Surgery 2025; 281:796-805. DOI: https://doi.org/10.1097/SLA.0000000000006640 PMID: 39840438 Weblink: https://pmc.ncbi.nlm.nih.gov/articles/PMC11974628/
Braathen et al. In vitro quality of cold and delayed cold-stored platelet concentrates from interim platelet units during storage for 21 days. Vox Sanguinis 2023; 118:463-470. DOI: 10.1111/vox.13437 PMID: 37166405 Weblink: https://onlinelibrary.wiley.com/doi/epdf/10.1111/vox.13437
Nash et al. Quantitative increases of extracellular vesicles in prolonged cold storage of platelets increases the potential to enhance fibrin clot formation. Transfusion Medicine 2023; 33:467‑477. DOI: https://doi.org/10.1111/tme.12989 PMID: 37553476 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/tme.12989
Warner et al. Transition from room temperature to cold-stored platelets for the preservation of blood inventories during the COVID-19 pandemic. Transfusion 2021; 61:72-77. DOI: https://doi.org/10.1111/trf.16148 PMID: 33029791 Weblink: https://pmc.ncbi.nlm.nih.gov/articles/PMC7675729/
Wood et al. Maximising platelet availability by delaying cold storage. Vox Sanguinis 2018; 113:403‑411. DOI: https://doi.org/10.1111/vox.12649 PMID: 29633290 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/vox.12649

3. Irradiation (Gamma and X-ray) of Blood Components

de Korte et al. Timing of gamma irradiation and sex of blood donor influences in vitro characteristics of red cell concentrates. Transfusion 2019; 58:917-926. DOI: https://doi.org/10.1111/trf.14481 PMID: 29341199 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.14481
Johnson et al. The in vitro quality of x-irradiated platelet components in PAS-E is equivalent to gamma-irradiated components. Transfusion 2021; 61:3075-3080. DOI: https://doi.org/10.1111/trf.16647 PMID: 34482545 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.16647
Davis et al. X-irradiation and gamma-irradiation inactivate lymphocytes in blood components. Transfusion 2021; 61:3081-3086. DOI: https://doi.org/10.1111/trf.16674 PMID: 34554562 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.16674
Marks et al. X- and gamma-irradiation have similar effects on the in vitro quality of stored red cell components. Transfusion 2021; 61:3214-3223 DOI: https://doi.org/10.1111/trf.16656 PMID: 34510450 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.16656

4. Washed Red Blood Cell Components

Acker et al. Introduction of a closed system cell processor: Post-implementation monitoring of safety and efficacy. Transfusion 2016; 56:49-57. DOI: https://doi.org/10.1111/trf.13341 PMID: 26444143 Weblink: https://pubmed.ncbi.nlm.nih.gov/26444143/
Hansen et al. Quality of red blood cells washed using a second wash cycle in an automated cell processor. Transfusion 2015; 55:2415-2421. DOI: https://doi.org/10.1111/trf.13166 PMID: 25988774 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.13166
Hansen et al. Quality of red blood cells washed using an automated cell processor with and without irradiation. Transfusion 2014; 54:1585-1594. DOI: https://doi.org/10.1111/trf.12489 PMID: 24224608 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.12489
Hansen et al. Quality of red blood cells washed using the ACP-215 cell processor: Assessment of optimal pre- and post-wash storage times and conditions. Transfusion 2013; 53:1772-1779. DOI: https://doi.org/10.1111/trf.12170 PMID: 23521180 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.12170

5. Whole blood

Shea et al. Doing more with less: low-titer group O whole blood resulted in less total transfusions and an independent association with survival in adults with severe traumatic hemorrhage. Journal of Thrombosis and Haemostasis 2023; S1538-7836(23)00727-4. DOI: https://doi.org/10.1016/j.jtha.2023.09.025 PMID: 37797692 Weblink: https://linkinghub.elsevier.com/retrieve/pii/S1538-7836(23)00727-4
Reddoch-Cardenas et al. Novel anticoagulant-preservative solution maintained the hemostatic function of cold stored whole blood for 56 days. Transfusion 2025: 65(S1):S185-S192. DOI: https://doi.org/10.1111/trf.18207 PMID: 40134105 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.18207
Rosetto et al. Comparison of whole blood versus red blood cells and plasma to correct trauma-induced coagulopathy ex vivo. Transfusion 2025; 65:624-636. DOI: https://doi.org/10.1111/trf.18143 PMID: 39908221 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.18143
Huish et al. A comparison of platelet function in cold-stored whole blood and platelet concentrates.Transfusion 2021; 61:3224-3235. DOI: https://doi.org/10.1111/trf.16657 PMID: 34622949 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.16657
Sayre et al. Providing whole blood for an urban paramedical ambulance system. Transfusion 2021; 62:82-86 DOI: https://doi.org/10.1111/trf.16749 PMID: 34787330 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.16749
Yazer et al. How do I implement a whole blood program for massively bleeding patients? Transfusion 2018; 58:622-628. DOI: https://doi.org/10.1111/trf.14474 PMID: 29332316 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/trf.14474

6. Alternatives to DEHP for blood bags

Thelliez et al. Migration of di(2-ethylhexyl) phthalate, diisononylcyclohexane-1,2-dicarboxylate and di(2-ethylhexyl) terephthalate from transfusion medical devices in labile blood products: A comparative study. Vox Sanguinis 2023; 118:533-542. DOI:https://doi.org/10.1111/vox.13446 PMID: 37246454 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/vox.13446
Klei et al. Recommendations for in vitro evaluation of blood components collected, prepared and stored in non-DEHP medical devices. Vox Sanguinis 2023; 118:165-177. DOI: https://doi.org/10.1111/vox.13384 PMID: 36510371 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/vox.13384
Vermeulen et al. Clinical and in vitro evaluation of red blood cells collected and stored in a non-DEHP plasticized bag system. Vox Sanguinis 2022; 117:1163-1170. DOI: https://doi.org/10.1111/vox.13344 PMID: 36102116 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/vox.13344
Larsson et al. DEHT is a suitable plasticizer option for phthalate-free storage of irradiated red blood cells. Vox Sanguinis 2022; 117:193-200. DOI: https://doi.org/10.1111/vox.13177 PMID: 34268809 Weblink: https://onlinelibrary.wiley.com/doi/full/10.1111/vox.13177
Larsson et al. Non-phthalate plasticizer DEHT preserves adequate blood component quality during storage in PVC blood bags. Vox Sanguinis 2021; 116:60-70. DOI: https://doi.org/10.1111/vox.12982 PMID: 32918773 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/vox.12982
Morishita et al. Pilot study on novel blood containers with alternative plasticizers for red cell concentrate storage. PLoS One 2017;12:e0185737. DOI: https://doi.org/10.1371/journal.pone.0185737 PMID: 28957448 Weblink: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0185737

7. State of the art

Shih et al. Not all red cell concentrate units are equivalent: international survey of processing and in vitro quality data. Vox Sanguinis 2019; 114:783-794. DOI: https://doi.org/10.1371/journal.pone.0185737 PMID: 31637738 Weblink: https://onlinelibrary.wiley.com/doi/full/10.1111/vox.12836
Hansen et al. The effect of processing method on the in vitro characteristics of red blood cell products. Vox Sanguinis 2015; 108:350-358. DOI: https://doi.org/10.1111/vox.12233 PMID: 25678039 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/vox.12233
Acker et al. Quality assessment of established and emerging blood components for transfusion. Journal of Blood Transfusion vol 2016, Article ID 4860284, 28 pages (2016). DOI: https://doi.org/10.1155/2016/4860284 PMID: 28070448 Weblink: https://pmc.ncbi.nlm.nih.gov/articles/PMC5192317/
Jordan et al. Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data. Vox Sanguinis 2016; 111(1):8-15. DOI: https://doi.org/10.1111/vox.12378 PMID: 26991891 Weblink: https://onlinelibrary.wiley.com/doi/10.1111/vox.12378