Blood transfusion saves lives & improves health, but many patients requiring transfusion do not have timely access to safe blood. In 2018 alone, ~117million blood donations were recorded globally with ~49million donations coming from high-income countries who account for only 16% of the global population. Europe has the highest blood donation rates globally. Blood is transfused as individual blood components (red blood cells, platelets, & plasma) after separation from whole blood.
Red Blood Cell (RBC) concentrate is the most commonly transfused blood component across the world today. Following the production of red cells, using separation procedures, RBC concentrates can be stored for up to 42 days in DEHP/PVC bags, however, it is accepted that DEHP leaches out of the PVC & is taken up by the RBCs thereby providing a conservatory benefit to the RBC storage quality for the 42 day period. Therefore, RBCs, have a longer shelf life than those in containers made of alternative materials & meet the international norms whereby the degradation of red blood cells cannot be higher than 0.8% for the storage timeframe. However, DEHP’s use is of particular concern, as exposure increases dramatically in patients undergoing multiple medical interventions, such as bypass, hemodialysis or long-term use of tubing in ICU. This is because DEHP is not covalently bound to the PVC polymer, making it susceptible to leaching when in contact with blood, plasma, & other lipophilic fluids.
The rate at which DEHP migrates from the blood bag & the related tubing is dependent upon storage conditions (temperature, volume of solution, contact time, & extent of shaking or flow rate of the fluid) & the lipophilicity of the fluid. DEHP leaching has been reported to vary between 0.25–0.40 mg/100 mL/day for whole blood stored more than 21 days at 4°C, to 6mg/unit of platelet concentrate stored at room temperature.
ACORN-BP’s major benefit is the delivery of a solution to the use of DEHP in blood processing that, whilst acknowledged as posing a significant health threat, has remained unaddressed due to the fact that DEHP’s effect on red cells has been to conserve the cell structure during storage.
Importance for Society: The ACORN-BP is the first blood bag to achieve this & will allow blood banks to realise the value of a healthcare component that is less harmful to patients than PVC blood bags. We therefore expect that PVC-free blood bags will not cost more than the current PVC blood bags (€8/pack) in a life-cycle perspective. Phasing-out PVC in blood bags also has the potential to achieve 30% waste reduction due to the lower density of our polyolefin-based materials. In the EU, ~26 million blood bags affect ~30 million people every year. This equals 2.7million kg of plastics in the EU. ~1.7 million kg are PVC while a million kg are phthalates. Replacing PVC bags in the EU with non-PVC will yield a reduction of ~750tons in waste due the lower density of polyolefins vs PVC.
Overall Objectives: To develop ACORN-BP to meet customer expectations for both patient safety & reduction in harm as well as processing centre requirements for component separation & storage. Clinical acceptance through clinical studies for ACORN-BP processing & storage have been selected to maximise health benefits & the continued ability to meet regulatory requirements in the creation of blood components. The clinical studies will also provide the clinical data for regulatory CE Mark approval as a Class IIb Medical Device & as Class II for the FDA approval.
