Safety challenges in blood transfusion systems in low- and middle-income countries: implications for public health, laboratory quality, and regulatory oversight

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.