What is DEHP?
DEHP (di-ethyl-hexyl-phthalate) is a commonly used plasticizer that enhances the flexibility and durability of medical devices, including blood bags and transfusion tubing. It has been used safely and routinely in transfusion medicine for more than 50 years.
Why is it used in medical devices?
Blood bag systems are typically made using a polyvinyl chloride (PVC)-based material. DEHP has been a key ingredient in these systems because it makes rigid plastics, such as PVC, more pliable, which is essential for products like tubing sets and blood bags. It also has properties that help maintain the quality and storage life of red blood cell concentrates, which is essential to help prevent adverse transfusion events.
The transition:
As part of the European Union Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (EU REACH), the use of DEHP in medical devices is being phased out. The sunset date is 1 July 2030. This applies to medical devices within the European Economic Area (EEA).
Our commitment:
Patient safety, regulatory compliance, and quality are our highest priorities.
A program to transition our products to non-DEHP alternatives is active, and we are working diligently to adhere to the DEHP sunset date.
Our program includes the development, selection, testing, and release of non-DEHP plastics to replace DEHP-plasticized PVC in our existing CE marked products.
This commitment extends across our product lines, including:
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Trima Accel™ Automated Blood Collection System disposable sets
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Spectra Optia™ Apheresis System tubing sets
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Mirasol™ Pathogen Reduction Technology (PRT) System disposable sets
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Reveos™ Automated Blood Processing System collection sets and platelet pooling sets
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TERUFLEX™ and IMUFLEX™ blood bags
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TERUFLEX™ transfer bags
We recognize that this transition is critical for our customers and that their work is essential to supporting an adequate, safe, and sustainable blood supply.
We are committed to seamlessly integrating these changes while maintaining the quality and reliability that our customers expect from us.
Questions:
Speak with your Terumo Blood and Cell Technologies representative.
Trima Accel™, Spectra Optia™, Reveos™, and Quantum Flex™ are either registered trademarks or trademarks of Terumo BCT, Inc. in the United States and/or other countries. Mirasol™ is either a registered trademark or a trademark of Terumo BCT Biotechnologies LLC in the United States and/or other countries. TERUFLEX™, IMUFLEX™, and TACSI™ are either registered trademarks or trademarks owned by Terumo Corporation or its affiliates. See TerumoBCT.com/trademarks for details.