Before Life+ A prestudy
No PVC-free blood bag on the market
During the last years PVC have been systematically phased out of many products including medical devices. Blood bags are one of the remaining products. A major reason is that the manufacturers and suppliers who could develop such blood bags are not motivated to do so. They need more incentives, like indications of demand from the purchasers. Another reason is that PVC is cheap and works well.
Our demand is for a blood container that will not be harmful to health and the environment in accordance with specified requirements and which will also fulfill the existing regulatory requirements for performance, quality and safety. The Prestudy looked into EU regulations concerning medical devices and standards and tests linked to legislation. The objective was to set a realistic requirements specification aimed at non-toxic blood storage and blood handling.
Demand shown with petition and Letter of Intent
As a result of the Prestudy seven county councils i Sweden have signed a Letter of Intent to buy blood bags if they fulfil the requirements specification, after testing at Karolinska University Hospital.
The petition has been signed by 40 organisations worldwide and the petition will continue after the project ends.
It is possible in theory as shown in R&D
Hill H. R., Oliver C. K., Lippert L. E., Greenwalt T. J., Hess J. R. 2001.
The effects of polyvinyl chloride and polyolefin blood bags on red blood
cells stored in a new additive solution, Vox Sanguinis Volume 81, Issue 3,
pages 161–166, October 2001.
Economical and technical barrier exist
The main barriers are a combination of financial and technical factors, in which the financial barriers stand in the way of attempting to solve the technical barriers. However, suppliers are agreed that developing a non-PVC
product is theoretically technically feasible.
Technology procurement not possible since a market introduction is too far away!
In conclusion, the long development timeline makes technology procurement unsuitable. One opportunity is a joint demonstration project in the EU- programme Life+.
A collaborative project between consumers and suppliers.