In order to coordinate our message and establish our position in the subjects that matter the most, the BTA has developed two position papers. These work to define the BTA's position on relevant topics.
The first position paper addresses the use of DEHP in blood bag sets. The European Chemicals Agency’s (ECHA) has published a recommendation to remove the exemption from Authorisation for the use of DEHP in medical devices, particularly blood bag sets. Although the BTA members acknowledge that the Authorisation process aims at enhancing substitution when technically and economically viable alternatives are available, and are committed to contributing to identifying such alternatives, they are concerned that the envisaged timeframe for sunsetting the use of DEHP would hamper the availability of blood bag sets across the EU and therefore threaten blood supply, and ultimately, public health.
The second position paper refers to a potential up-classification of blood bag sets. As DEHP was labelled a Substance of Very High Concern (SVHC), ECHA has submitted a recommendation for consideration of the European Commission, which includes a proposed sunset date. This means that production of DEHP blood bag sets within the European Union would be banned, which would have a significant impact on blood supply and availability.
These position papers have been crucial, and have guided the BTA in its activities, such as in its contribution to the Public Consultation on Endocrine Disruptors opened by the European Commission.
BTA position papers on relevant topics
