Accra: The Food and Drugs Authority (FDA) has expressed concern over persistent regulatory non-compliance in blood banking facilities, revealing that only 12 nationwide have met licensing standards despite years of audits and capacity-building. Dr Edwin Nkansah, Director of Vaccine Vigilance and Clinical Trials at the FDA, disclosed this at a stakeholder meeting on blood regulation, held on the theme 'Road to Compliance', held in Accra on Tuesday.
According to Ghana News Agency, Dr Nkansah explained that out of about 350 health facilities licensed by the Health Facilities Regulatory Agency (HeFRA), 112 blood banking facilities had undergone audits, while 78 had verification audits. However, only 12 of these facilities attained the compliance level required for licensing. Dr Nkansah noted that since the start of blood regulation activities in 2014, the FDA has been committed to ensuring that all blood and blood products collected, processed, stored, distributed, and transfused meet the highest safety and quality standards.
He highlighted significant milestones, such as the development of regulatory guidelines and inspection checklists in 2015 and benchmarking exercises by the World Health Organization (WHO) and the Blood Regulators Network in 2016. Despite receiving technical and financial support from WHO, the UK Blood Safety Programme, and the 4Life Research Institute for annual refresher training and capacity-building, logistical and financial constraints have recently impacted audits.
The FDA identified common non-compliance issues, including the use of unregistered blood-related medical devices, inadequate donor care systems, poor documentation, lack of dedicated personnel, insufficient training, improper waste disposal, and poor storage practices. Dr Nkansah noted concerns over many facilities relying solely on rapid diagnostic test kits without confirmatory testing, potentially compromising blood safety.
Additionally, he pointed out challenges in donor management, such as inadequate privacy during screening and insufficient post-donation care, warning that these practices could undermine voluntary blood donation. Despite these challenges, there have been improvements in compliance among facilities that underwent multiple inspections, with reductions in non-compliance rates in areas such as haemovigilance, quality management, and risk management.
Dr Nkansah commended facilities for embracing haemovigilance frameworks, noting fewer cases of non-compliance after verification audits. Data showed that transfusion-related adverse reactions fluctuated since 2016, with Greater Accra recording the highest number of cases, followed by the Eastern Region. Whole blood transfusions accounted for about 87 percent of reported adverse reactions.
Furthermore, more manufacturers and suppliers are registering blood-related medical devices, including screening reagents, rapid test kits, blood bags, and transfusion sets. However, Dr Nkansah expressed disappointment over the low number of license applications, noting that some facilities licensed in 2019 had failed to renew their licenses.
He urged blood banking facilities to prioritize compliance and apply for licensing to ensure safe, quality blood and blood products nationwide. Dr Nkansah reaffirmed the FDA's commitment to strengthening oversight and called for increased investment, logistics, and stakeholder collaboration to expand regulatory coverage and enhance blood safety standards.