Periodic Reporting for period 4 - ACORN-BP (Development and Commercialisation of PVC- DEHP Free Blood Packs To Ensure Appropriate Control Of Red Cells)
Reporting period: 2022-05-01 to 2022-10-31
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.
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.
Excellent progress has been achieved towards fulfilment of each listed objective & in readiness for the next phase of the work. Main results achieved in the current period:
Design requirements assessed with respect to functionality of prototype bag material, material constraints & manufacturability (D2.2,19 Aug 22)
Key performance criteria satisfied with respect to material properties, processability, mechanical strength, oxygen permeability, transparency & manufacturability (D2.2 19 Aug 22)
ACORN-BP blood bag prototypes were produced using Haemotronic’s manufacturing process for PVC-free blood bag systems (D2.3 20 June 23)
The certification level of Haemotronic & Ducit Medical, as well as notified body requirements for CE Certification were identified (D2.3 20 June 23)
ACORN prototypes were produced using Haemotronic’s manufacturing process for PVC-free blood bag systems (D2.4 20 June 23)
Relevant Sterilisation Method & dosage determined (D2.4 20 June 23)
ACORN-BP film of ABA construct, combination 3, has been successfully manufactured. All films produced were of excellent quality & satisfied the acceptance criteria (D4.2 20 June 23).
Overall, the purpose-built line exceeded the capabilities & achievable tolerances on the original multilayer co-extrusion process. Additionally, there was a significant reduction in the amount of trimmed recyclate generated (D4.1 01 June 23)
ACORN-BP blood bags were successfully manufactured using the final material selection & assembled into blood bag sets according to Haemotronic’s process for PVC-free blood bag systems
An overview of commercial, environmental, technical, scientific & collaborative outcomes is provided in Tech. Report, Part B.
Design requirements assessed with respect to functionality of prototype bag material, material constraints & manufacturability (D2.2,19 Aug 22)
Key performance criteria satisfied with respect to material properties, processability, mechanical strength, oxygen permeability, transparency & manufacturability (D2.2 19 Aug 22)
ACORN-BP blood bag prototypes were produced using Haemotronic’s manufacturing process for PVC-free blood bag systems (D2.3 20 June 23)
The certification level of Haemotronic & Ducit Medical, as well as notified body requirements for CE Certification were identified (D2.3 20 June 23)
ACORN prototypes were produced using Haemotronic’s manufacturing process for PVC-free blood bag systems (D2.4 20 June 23)
Relevant Sterilisation Method & dosage determined (D2.4 20 June 23)
ACORN-BP film of ABA construct, combination 3, has been successfully manufactured. All films produced were of excellent quality & satisfied the acceptance criteria (D4.2 20 June 23).
Overall, the purpose-built line exceeded the capabilities & achievable tolerances on the original multilayer co-extrusion process. Additionally, there was a significant reduction in the amount of trimmed recyclate generated (D4.1 01 June 23)
ACORN-BP blood bags were successfully manufactured using the final material selection & assembled into blood bag sets according to Haemotronic’s process for PVC-free blood bag systems
An overview of commercial, environmental, technical, scientific & collaborative outcomes is provided in Tech. Report, Part B.
Novel, patentable, multilayer coextruded advanced polyolefin film
Unique value proposition for customers seeking to model, formulate, make & test cast film materials with tailored gas barrier properties, especially those seeking to benefit from a new generation of advanced polyolefins & related blends.
Through this 24 months FTI project Ducit Medical, Ireland along with our development partners Global Polymer Consulting, Ireland, Haemotronic, Italy & Scottish National Blood Transfusion Service Scotland have developed a complete blood pack system ‘ACORN-BP’, which is PVC & DEHP free. Once accredited, ACORN-BP will be commercialised as a direct replacement of PVC bags.
Using the direct sales force model, we will target capturing 10.9% of the global PVC-DEHP blood pack market through cumulative sales of >27million blood bags. This will generate cumulative revenues of >€216 million in the first five years, with a cumulative net profit of ~€65.60 million across the consortium. The ROI against total project costs of €3.53 million is ~18:1.
Now more than ever, the world depends on the medical polymers, products & services that the consortium members are delivering. Through the manufacture & development of Advanced Polyolefins (PP Compounds) it is envisaged that further new products based on leading-edge olefin resin technology can be produced, using EU sourced compounds, thereby addressing an identifiable gap in the market.
The impact of ACORN-BP is becoming an ever-increasing requirement in the marketplace, with the oncoming sunset date for the removal of DEHP from blood bags by June 2025. As new tenders come on stream and go beyond the 2025 deadline, it will be a requirement for procuring bodies to have accessed the availability of such technologies to facilitate their introduction. The ACORN technology is already ear-marked to be included in a large tender for over 3 million units per annum. From a wider impact perspective, it is envisaged that the key enabling technologies being developed here will have an important role to play in the development of gas barrier systems for sustainable & recyclable packaging in general.
Unique value proposition for customers seeking to model, formulate, make & test cast film materials with tailored gas barrier properties, especially those seeking to benefit from a new generation of advanced polyolefins & related blends.
Through this 24 months FTI project Ducit Medical, Ireland along with our development partners Global Polymer Consulting, Ireland, Haemotronic, Italy & Scottish National Blood Transfusion Service Scotland have developed a complete blood pack system ‘ACORN-BP’, which is PVC & DEHP free. Once accredited, ACORN-BP will be commercialised as a direct replacement of PVC bags.
Using the direct sales force model, we will target capturing 10.9% of the global PVC-DEHP blood pack market through cumulative sales of >27million blood bags. This will generate cumulative revenues of >€216 million in the first five years, with a cumulative net profit of ~€65.60 million across the consortium. The ROI against total project costs of €3.53 million is ~18:1.
Now more than ever, the world depends on the medical polymers, products & services that the consortium members are delivering. Through the manufacture & development of Advanced Polyolefins (PP Compounds) it is envisaged that further new products based on leading-edge olefin resin technology can be produced, using EU sourced compounds, thereby addressing an identifiable gap in the market.
The impact of ACORN-BP is becoming an ever-increasing requirement in the marketplace, with the oncoming sunset date for the removal of DEHP from blood bags by June 2025. As new tenders come on stream and go beyond the 2025 deadline, it will be a requirement for procuring bodies to have accessed the availability of such technologies to facilitate their introduction. The ACORN technology is already ear-marked to be included in a large tender for over 3 million units per annum. From a wider impact perspective, it is envisaged that the key enabling technologies being developed here will have an important role to play in the development of gas barrier systems for sustainable & recyclable packaging in general.