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Trima Accel Automated Blood Collection System Reveos Automated Blood Processing System Welders & Sealers Reliable, sterile connections using cost-effective tubing welders and sealers Whole Blood Bag Systems Whole blood collection, component processing and storage Mirasol Pathogen Reduction Technology (PRT) System
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TOMEs Terumo Operational Medical Equipment Software Trima KPI Dashboard Data visualization and KPIs Cadence Data Collection System Veda Solutions Service | Analytics | Consulting Vista Information System
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Spectra Optia Apheresis System Therapeutic Plasma Exchange (TPE) Exchange protocols available on the Spectra Optia Apheresis System Red Blood Cell Exchange Therapeutic Apheresis Red Blood Cell Exchange Cell Collections Comprehensive cell collection solutions Vascular Access Your resource for optimizing vascular access for each and every patient Sickle Cell Disease Transfusion Therapy for Sickle Cell Disease
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Cell Collection Services Spectra Optia Cell Collection Services Veda Solutions Service | Analytics | Consulting
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Quantum Flex Cell Expansion System FINIA Fill and Finish System Welders & Sealers Reliable, sterile connections using cost-effective tubing welders and sealers
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Cell Collection Services Comprehensive cell collection solutions Veda Solutions Service | Analytics | Consulting
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Welders & Sealers Reliable, sterile connections using cost-effective tubing welders and sealers Accessories for Blood Centers Collection, processing, and storage needs
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To maintain the highest level of blood safety while keeping costs down, our technologies and software can be implemented and integrated at each step along your supply chain from collection and processing to pathogen reduction and storage.

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As a global leader in therapeutic apheresis and cell collections, Terumo Blood and Cell Technologies is dedicated to advancing apheresis to help provide more treatment options for the patients you serve.

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Non-DEHP Commitment

Background on 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.1,2

Blood bag systems are typically made using a polyvinyl chloride (PVC)-based material.1 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.2,3

The use of DEHP in medical devices is being phased out as part of the European Union Registration, Evaluation, Authorization and Restriction of Chemicals regulation (EU REACH). The sunset date is July 1, 2030. This applies to medical devices within the European Economic Area (EEA).4,5 However, due to the risk of cross contamination and the cost of manufacturing dual production lines, Terumo BCT intends to sunset all DEHP products worldwide.

Our non-DEHP commitment

Patient safety

Our products use plasticizers approved in the European Pharmacopoeia for use in containers intended for human blood and blood components, as well as for sterile containers of plasticized PVC for human blood containing anticoagulant solutions.

Regulatory compliance

We are working to comply with the REACH regulation regarding the use of DEHP in medical devices and to comply with all applicable regulatory requirements across all our product lines.

Stable RCC supply

We are committed to non-DEHP products that will maintain 42-day storage for red blood cell concentrates stored in the Erythromate™ RBC storage bag.

Customer support

We are dedicated to robust support and training to help a smooth customer transition to non-DEHP products.

Our Global Non-DEHP Program is working diligently to adhere to the European DEHP sunset date of July 1, 2030. This program includes the development, selection, testing, and release of non-DEHP devices to replace DEHP-plasticized PVC in our existing CE-marked products.

This commitment extends across our product lines, including:

  • Trima Accel™ Automated Blood Collection System disposable tubing sets
  • Spectra Optia™ Apheresis System disposable tubing sets​
  • Reveos™ Automated Blood Processing System collection sets and pooling sets
  • Whole blood collection sets
  • Transfer bags
  • Solutions*
  • TACSI™ System (sets)*
  • Quantum Flex™ Cell Expansion System*
  • Finia™ Fill and Finish System

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.

Customer validation

What customer validation work needs to be done?

We are encouraging customers to follow internal standard operating procedures (SOPs) to validate material changes. While there are several existing guidelines and recommendations for validating blood products processed with new non-DEHP disposables containing alternative plasticizers, these guidelines are not legally binding. However, we strongly recommend and encourage customers to perform appropriate validation activities.6,7

We are committed to supporting this process by providing relevant data and material information to help facilitate necessary validation efforts.

Questions?

Speak with your Terumo Blood and Cell Technologies representative.

Contact us

Disclaimers and notes

*Already converted to non-DEHP.

  1. van Wonderen SF, Vermeulen C, Lagerberg J, Vlaar APJ, Klei TRL. Combinations of non-di(2-ethylhexyl) phthalate collection sets, storage bags and additive solutions for red blood cells. Transfus Med Rev. 2025;39(3):150904. doi:10.1016/j.tmrv.2025.150904
  2. Walter CW. Invention and development of the blood bag. Vox Sang. 1984;47(4):318-324. doi:10.1111/j.1423-0410.1984.tb01603.x
  3. Larrson L, Ohlsson S, Derving J, et al. DEHT is a suitable plasticizer option for phthalate‑free storage of irradiated red blood cells. Vox Sang. 2022;117(2):193-200. doi:10.1111/vox.13177 
  4. European Union. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Official Journal of the European Union. December 30, 2006;L 396:1-849. Accessed July 30, 2025. https://eur-lex.europa.eu/eli/reg/2006/1907/oj
  5. European Commission. Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards synthetic polymer microparticles. Official Journal of the European Union. November 17, 2023;L 2023/2482:1-32. Accessed July 30, 2025. https://eur-lex.europa.eu/eli/reg/2023/2482/oj
  6. European Directorate for the Quality of Medicines & HealthCare (EDQM). The Ph. Eur. revised its general chapters on plasticised PVC materials. Published January 18, 2018. Accessed July 31, 2025. https://www.edqm.eu/en/-/the-ph.-eur.-revised-its-general-chapters-on-plasticised-pvc-materials
  7. European Society of Human Reproduction and Embryology (ESHRE). Good Practices Guideline to Authorization on Preparation Processes in Blood, Tissue and Cells Establishments. January 2022. Accessed July 9, 2025. https://www.gapp-ja.eu/wp-content/uploads/2022/01/GAPP-volume-Guide-and-Technical-Annexes.pdf

Products are available in selected areas subject to regulatory approval in each country

CO-NONP-00533

 

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