The BTA has convened scientific experts to find a common approach to a Benefits Risk Assessment for the justification of the use of DEHP in medical devices in accordance with the Scientific Committee on Health, Environmental and Emerging Risk (SCHEER) guidelines. The BTA's internal Working Group on this Benefit Risk Assessment has been working to define a common approach that is in line with competition law.
Details on the SCHEER Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties can be found here.
The BTA are also in contact with key stakeholders in this field to prepare for an Application for Authorisation for the continued use of DEHP in blood bag sets. This could help ensure the availability of sufficient blood supply within Europe in the event that no exemption is made for the use of DEHP in medical devices. Should authorisation be granted, this would extend the use of DEHP to sunset by some years, thus allowing the continued use of DEHP in blood bag sets. In order for authorisation to be granted, it has to include a substitution plan detailing the process and timeline of the stages of developing an alternative to a blood bag set containing DEHP. This emphasises, therefore, that while the BTA supports the increased protection in human health and the environment, the timeline for sunsetting of DEHP proposed is not viable for blood bag set manufacturers, as to date there is no viable alternative.
Non-DEPH | Leveraging BTA members' expertise
