17 April marks the 28th World Haemophilia Day, a day turning the spotlight on this rare bleeding disorder that affects approximately 1 out of 10,000 people in the world. Haemophilia is a bleeding disorder that slows the blood clotting process and can be treated by replacing missing blood clotting factors. Clotting factor concentrates can be made of blood plasma and aim at killing any potential viruses that might affect the plasma.
As any treatment that involves human blood, the plastic material PVC (or vinyl) is essential for the plasma-based treatment of haemophilia. PVC is the only material that can meet the strict requirements for blood containers and sets for blood transfusions. Blood transfusion sets are used to collect blood from donors and therefore play a key role to secure blood availability during surgical operations and medical emergencies, as well as for the long-term treatment of diseases. PVC’s unique characteristics such as resistance, flexibility and softness but also its cost-effectiveness make it the most commonly used material for blood transfusion.
The first time PVC blood bags proved their efficiency was during the Korean War where they replaced breakable glass containers. As a result, the lives of thousands of soldiers were saved. Since the 1950s, PVC blood containers and sets for blood transfusions have enabled several medical breakthroughs, not least in the treatment of haemophilia.
The European Pharmacopeia (Ph. Eur.) sets Europe’s legal and scientific standards to delivering high quality medicines in Europe and beyond. To make PVC blood containers soft, a so-called plasticiser (US: plasticizer) is added to the PVC compound. The phthalate DEHP used to be the main plasticiser in medical PVC due to its technical properties and cost-efficiency. The substance has been under increasing scrutiny by regulatory and medical authorities, and its use in medical devices in the EU after 2020 will require robust justification.
Yet a breakthrough for PVC blood bags without phthalates of concern is imminent. Two of the PVCMed Alliance’s member companies have helped develop DEHP-free blood bags, which meet the criteria for collection and storage of blood, ensuring the same quality of the device as well as patient’s safety, which remains the priority. To find out more about these stories, read more about new plasticisers in blood bags and the push for non-phthalates plasticisers.
Five new plasticisers have recently been approved by the European Pharmacopeia some of which for use in the manufacturing of blood containers and sets for blood transfusions, which means patients can continue to benefit from PVC’s unique properties while avoiding DEHP phthalate.
Follow the hashtag #WHD2018 and learn more about haemophilia on 17 April.