Abstract

Blood transfusion represents a critical therapeutic intervention, and blood and blood components are increasingly recognised within biological product regulatory frameworks as regulated biological products. Nevertheless, maintaining blood transfusion safety in low- and middle-income countries (LMICs) remains a significant challenge due to persistent deficiencies in quality control, laboratory infrastructure, and regulatory governance. This review critically examines the safety challenges confronting blood transfusion systems in LMICs and evaluates their implications for public health, quality control, and government regulation. A narrative synthesis of evidence from peer-reviewed literature, World Health Organisation guidance, and international regulatory standards was undertaken. The analysis addresses three domains: transfusion-related safety risks, laboratory quality systems, and regulatory oversight structures. Key challenges identified include unsafe blood donor selection practices, inadequate screening for transfusion-transmissible infections, and weak haemovigilance systems. Laboratory-related constraints encompass limited implementation of quality control systems, restricted access to validated diagnostic technologies, and insufficient participation in external quality assessment schemes. Regulatory challenges, particularly weak government regulation, fragmented oversight, and limited enforcement capacity, further compromise transfusion safety. These systemic deficiencies contribute to increased adverse outcomes associated with blood transfusion and undermine overall health system performance. Enhancing blood safety in LMICs necessitates coordinated strengthening of laboratory quality systems, regulatory frameworks, and surveillance mechanisms. Integrating blood transfusion services within broader biological product regulation provides a strategic approach to improving safety, ensuring traceability, and safeguarding public health.

Keywords

Blood TransfusionBlood SafetyBiological ProductsQuality ControlGovernment RegulationLow- and Middle-Income Countries (LMICs)

References

  1. [1] Puerto-Meredith, S., Singogo, E., Chagomerana, M., et al., 2023. Systematic review of prevalence and risk factors of transfusion-transmissible infections among blood donors, and blood safety improvements in Southern Africa. Transfusion Medicine. 33(5), 355–371. DOI: https://doi.org/10.1111/tme.12988
  2. [2] Moreira-Soto, A., Postigo-Hidalgo, I., Tabares, X., et al., 2025. Transfusion-transmitted infections: Risks and mitigation strategies for Oropouche virus and other emerging arboviruses in Latin America and the Caribbean. The Lancet Regional Health – Americas. 46, 101089. DOI: https://doi.org/10.1016/j.lana.2025.101089
  3. [3] Amlak, A.W., Oljira, H., Tafa, B., et al., 2024. Magnitude of transfusion-transmissible infections and associated factors among blood donors at the Woliso Blood Bank, Oromia, Ethiopia: A cross-sectional study. Science Journal of Clinical Medicine. 13(3), 47–56. DOI: https://doi.org/10.11648/j.sjcm.20241303.12
  4. [4] Riley, W., Love, K., Saxon, M., et al., 2024. A model for estimating the burden of disease of transfusion-transmitted infection. International Journal of Public Health. 69, 1607165. DOI: https://doi.org/10.3389/ijph.2024.1607165
  5. [5] Sayed Ahmed, H.A., Kamel, N., Mahfouz, E.M., 2024. Insight into hazards and control of transfusion-transmitted infections in Egypt: A narrative review. Transfusion and Apheresis Science. 63(4), 103965. DOI: https://doi.org/10.1016/j.transci.2024.103965
  6. [6] World Health Organization, 1990. Blood Products and Related Biologicals: Aide-Mémoire. World Health Organization: Geneva, Switzerland. Available from: https://cdn.who.int/media/docs/default-source/biologicals/blood-products/aide-memoire-blood-products-and-related-biologicals.pdf
  7. [7] Igbe, M.I., Adepoju, E.-F., Amarachi, B.-J., et al., 2024. Implications of screening blood donors for selected transfusion-transmissible infections: Compromise in blood safety? Sokoto Journal of Medical Laboratory Science. 9(2), 45–53. DOI: https://doi.org/10.4314/sokjmls.v9i2.6
  8. [8] Barro, L., Drew, V.J., Poda, G.G., et al., 2018. Blood transfusion in sub-Saharan Africa: Understanding the missing gap and responding to present and future challenges. Vox Sanguinis. 113(8), 726–736. DOI: https://doi.org/10.1111/vox.12705
  9. [9] Nkengasong, J.N., Mbopi-Keou, F.-X., Peeling, R.W., et al., 2018. Laboratory medicine in Africa since 2008: Then, now, and the future. The Lancet Infectious Diseases. 18(11), e362–e367. DOI: https://doi.org/10.1016/S1473-3099(18)30120-8
  10. [10] World Health Organization, 2016. Global Status Report on Blood Safety and Availability 2016. World Health Organization: Geneva, Switzerland. Available from: https://www.who.int/publications/i/item/9789241565431
  11. [11] Barnes, L.S., Stanley, J., Bloch, E.M., et al., 2022. Status of hospital-based blood transfusion services in low-income and middle-income countries: A cross-sectional international survey. BMJ Open. 12(2), e055017. DOI: https://doi.org/10.1136/bmjopen-2021-055017
  12. [12] World Health Organization, 2026. Blood safety and availability. Available from: https://www.who.int/news-room/fact-sheets/detail/blood-safety-and-availability (cited 10 April 2026).
  13. [13] Petti, C.A., Polage, C.R., Quinn, T.C., et al., 2006. Laboratory medicine in Africa: A barrier to effective health care. Clinical Infectious Diseases. 42(3), 377–382. DOI: https://doi.org/10.1086/499363
  14. [14] Allain, J.P., Owusu-Ofori, S., Bates, I., 2004. Blood transfusion in sub-Saharan Africa. Transfusion Alternatives in Transfusion Medicine. 6(1), 16–23. DOI: https://doi.org/10.1111/j.1778-428X.2004.tb00108.x
  15. [15] Tagny, C.T., Owusu-Ofori, S., Mbanya, D., et al., 2010. The blood donor in sub-Saharan Africa: A review. Transfusion Medicine. 20(1), 1–10. DOI: https://doi.org/10.1111/j.1365-3148.2009.00958.x
  16. [16] Faddy, H.M., Osiowy, C., Custer, B., et al., 2024. International review of blood donation nucleic acid amplification testing. Vox Sanguinis. 119(4), 315–325. DOI: https://doi.org/10.1111/vox.13592
  17. [17] Pathak, A., Panda, D., Sharma, M., et al., 2022. Blood donation screening of transfusion-transmissible viral infection using two different nucleic acid testing platforms: A single tertiary care oncology centre experience. Indian Journal of Hematology and Blood Transfusion. 39(3), 456–463. DOI: https://doi.org/10.1007/s12288-022-01598-y
  18. [18] Stramer, S.L., Dodd, R.Y., 2013. Transfusion-transmitted emerging infectious diseases: 30 years of challenges and progress. Transfusion. 53(10), 2375–2383. DOI: https://doi.org/10.1111/trf.12371
  19. [19] Bolton-Maggs, P.H.B., Cohen, H., 2013. Serious Hazards of Transfusion (SHOT) haemovigilance and progress is improving transfusion safety. British Journal of Haematology. 163(3), 303–314. DOI: https://doi.org/10.1111/bjh.12547
  20. [20] Burnouf, T., 2007. Modern plasma fractionation. Transfusion Medicine Reviews. 21(2), 101–117. DOI: https://doi.org/10.1016/j.tmrv.2006.11.001
  21. [21] World Health Organization, 2011. Laboratory Quality Management System: Handbook, Version 1.1. World Health Organization: Geneva, Switzerland. Available from: https://apps.who.int/iris/handle/10665/44665
  22. [22] de Vries, R.R.P., Faber, J.-C., Strengers, P.F.W., 2011. Haemovigilance: An effective tool for improving transfusion practice. Vox Sanguinis. 100(1), 60–67. DOI: https://doi.org/10.1111/j.1423-0410.2010.01442.x
  23. [23] Hmida, M.A., Mahjoub, S., Ben Hamed, L., et al., 2024. Transfusion safety: Is there a difference between reported reactions in low-to-middle-income and high-income countries? Transfusion and Apheresis Science. 63(3), 103916. DOI: https://doi.org/10.1016/j.transci.2024.103916
  24. [24] Yao, K., Maruta, T., Luman, E.T., et al., 2014. The SLMTA programme: Transforming the laboratory landscape in developing countries. African Journal of Laboratory Medicine. 3(2), a194. DOI: https://doi.org/10.4102/ajlm.v3i2.194
  25. [25] Staves, J., Ashford, P., Bullock, T., et al., 2024. Guidelines for the specification, implementation and management of IT systems in hospital transfusion laboratories: A British Society for Haematology guideline. Transfusion Medicine. 34(2), 83–111. DOI: https://doi.org/10.1111/tme.13027
  26. [26] Say, L., Chou, D., Gemmill, A., et al., 2014. Global causes of maternal death: A WHO systematic analysis. The Lancet Global Health. 2(6), e323–e333. DOI: https://doi.org/10.1016/S2214-109X(14)70227-X
  27. [27] Gilson, L., 2003. Trust and the development of health care as a social institution. Social Science & Medicine. 56(7), 1453–1468. DOI: https://doi.org/10.1016/S0277-9536(02)00142-9
  28. [28] European Parliament, 2003. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 Setting Standards of Quality and Safety for the Collection, Testing, Processing, Storage and Distribution of Human Blood and Blood Components and Amending Directive 2001/83/EC. European Parliament: Strasbourg, France. Available from: https://eur-lex.europa.eu/eli/dir/2002/98/oj/eng
  29. [29] U.S. Food and Drug Administration, 2025. Blood & Blood Products. Available from: https://www.fda.gov/vaccines-blood-biologics/blood-blood-products (cited 10 April 2026).
  30. [30] U.S. Food and Drug Administration, 2026. Part 606—Current Good Manufacturing Practice for Blood and Blood Components. Available from: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-606 (cited 10 April 2026).
  31. [31] Soutar, R., McSporran, W., Tomlinson, T., et al., 2023. Guideline on the investigation and management of acute transfusion reactions. British Journal of Haematology. 201(5), 832–844. DOI: https://doi.org/10.1111/bjh.18789
  32. [32] Liu, H., Wang, X., 2021. Pathogen reduction technology for blood component: A promising solution for prevention of emerging infectious disease and bacterial contamination in blood transfusion services. Journal of Photochemistry and Photobiology. 8, 100079. DOI: https://doi.org/10.1016/j.jpap.2021.100079
  33. [33] Cohn, C., Delaney, M., Johnson, S.T., et al. (Eds.), 2023. Technical Manual, 21st ed. AABB: Bethesda, MD, USA. Available from: https://www.aabb.org/aabb-store/product/technical-manual-21st-edition---print-16919010
  34. [34] Barzilai, M., Cohen, O., 2025. AI applications in transfusion medicine: Opportunities, challenges, and future directions. Acta Haematologica. 148(5), 516–523. DOI: https://doi.org/10.1159/000546303
  35. [35] Anstey, C., Ullman, D., Su, L., et al., 2024. The practical use of artificial intelligence in transfusion medicine and apheresis. Transfusion and Apheresis Science. 63(6), 104001. DOI: https://doi.org/10.1016/j.transci.2024.104001
  36. [36] Al-Riyami, A.Z., Gammon, R.R., Seheult, J., et al., 2026. Artificial intelligence and transfusion education, research and practice: The view from the ISBT Clinical Transfusion Working Party. Vox Sanguinis. 121(4), 481–487. DOI: https://doi.org/10.1111/vox.13793
  37. [37] Giansanti, D., Cosenza, C., 2025. AI-driven innovations in transfusion medicine: A narrative synthesis of current reviews. Medical Sciences. 14(1), 10. DOI: https://doi.org/10.3390/medsci14010010
  38. [38] Carson, J.L., Stanworth, S.J., Guyatt, G., et al., 2023. Red blood cell transfusion: 2023 AABB International Guidelines. JAMA. 330(19), 1892–1902. DOI: https://doi.org/10.1001/jama.2023.12914
  39. [39] O’Brien, S.F., Yi, Q.-L., Fan, W., et al., 2012. Current incidence and residual risk of HIV, HBV and HCV at Canadian Blood Services. Vox Sanguinis. 103(1), 83–86. DOI: https://doi.org/10.1111/j.1423-0410.2012.01584.x

How to Cite

Moses Dabah Lugos, Darshna Yagnik, Addi Danjuma Masokano, Peter Ubah Okeke, Grace Kuje Ogbor, Dapus Obadiah Damulak. Safety Challenges in Blood Transfusion Systems in Low- and Middle-Income Countries: Implications for Public Health, Laboratory Quality, and Regulatory Oversight. Food and Drug Safety. https://doi.org/10.55121/fds.v3i2.101824
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Copyright © 2026 Moses Dabah Lugos, Darshna Yagnik, Addi Danjuma Masokano, Peter Ubah Okeke, Grace Kuje Ogbor, Dapus Obadiah Damulak. Published by Japan Bilingual Publishing Co..

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