Major milestone in the development of PVC-free blood bags

The members of the “PVC-free blood bag” project have announced a major milestone in the development of alternatives to PVC-containing blood bags. At Karolinska University Hospital in Sweden in-vitro testing with the first PVC-free blood bags has started with donor blood. Danish company Melitek manufactures the soft polyolefin materials for these new blood bags and its tubings at its dedicated plant south of Copenhagen.

“We are very excited that this major milestone is reached after several years of close work with the partners on this project and are optimistic based on our initial trials made earlier this year with water, that the bags will perform well in actual use - now we are anxious to see the outcome of the actual testing with blood and hearing the feedback from hospital staff”, says Jesper Laursen, Melitek’s Business Director.

Hans Gulliksson, Associate professor in Experimental Transfusion Medicine at Karolinska University Hospital, supervised the first blood donations for the in vitro evaluations. Donors gave blood at Skanstull donation centre in Stockholm and donors who had given their informed consent donated the blood used for the tests.

“Introducing new medical devices is a long and thorough process. I am very happy that we’re now starting in vitro testing - it is a huge milestone in the project,” says Lena Stigh, project manager from Region Jämtland Härjedalen in Sweden.

The physical performance of the bags has already been tested with water. The bags were deemed to fulfil essential requirements when factors such as impact during centrifugation, leakages and suitable length of tubes were tested. The same tests will be carried out using blood.

The study is taking place at Karolinska University Hospital and will be conducted by a team managed by professor Petter Höglund. “It will be exciting to see the results of the evaluation in March next year,” says Hans Gulliksson.

Concurrently, the PVC-free blood bags will also undergo a test at Östersund hospital and four other Swedish hospitals. These tests are planned to start before Christmas and will simulate and evaluate the practical handling of the blood bags by medical staff.

According to Melitek, there are currently no PVC-free blood bags for red blood cells on the market. The most commonly used plasticisers for this application are phthalates that are classified as a reproductive disruptors.

“This project has two objectives: firstly to increase demand from healthcare organisations; and secondly to demonstrate that it is possible to make a PVC-free blood bag that fulfils the relevant requirements specification,” says Lena Stigh.

“We have over the years supplied materials for many applications replacing soft PVC in medical products, and now set our goal to demonstrate that our material platform will work and offer environmental and health benefits also for blood bags. We hope this project will prove to healthcare providers, industry and the public that it is possible to substitute PVC one of the last few applications where PVC containing DEHP phthalates still remain in use”, says Jesper Laursen.

PVCfreeBloodBag (www.pvcfreebloodbag.eu) is a project within the EU’s Life+ Environmental Programme. The full title is “Public healthcare and plastic makers demonstrate how to remove barriers to PVC-free blood bags in the spirit of REACH”. The cooperation between industry and European healthcare started in the autumn of 2011.

Melitek at CompaMed 2015
Hall 08B, stand L09