DEHP-Free

When CHANGE means
NO COMPROMISE

Macopharma is committed to addressing the health concerns related to the DEHP plasticizer used in medical devices.

Our priority is to support healthcare professionals by providing reliable solutions designed to ensure high-quality blood components, for the benefit of both donors and patients. As part of this commitment, we offer blood bag systems in compliance with Regulation (EC) No 1907/2006 (REACH).

Moving from P to T: changing one letter, making a meaningful difference

In its search for alternative plasticizers, Macopharma selected DEHT as a solution aligned with its commitment.

No compromise on…

HEALTH AND SAFETY

Patients transfused using PVC-DEHT devices are significantly less exposed to plasticizers than when using a PVC-DEHP devices, regardless of the blood component transfused. For RBCs, regardless of the preservative solution used, the DEHP-equivalent concentrations are 50% higher than those of DEHT, throughout the storage at Day 49¹.

BUSINESS CONTINUITY

More than 4 DEHT suppliers operate worldwide reducing the risk of material shortage and ensuring operational continuity. We collaborate closely with our suppliers to ensure a seamless transition from DEHP to DEHT, while guaranteeing uninterrupted product availability throughout the process.

PERFORMANCES

Whole blood-derived RBC, collected and stored in DEHT/PAGGSM collection bags, maintained acceptable quality through 42 DAYS of storage. 100% of DEHT/PAGGSM units were compliant with the EDQM requirements².

SUSTAINABILITY

DEHT has been shown to be less environmentally toxic than DEHP, demonstrating that switching to this new plasticizer will improve its environmental performance. Macopharma will continue its efforts to minimize its environmental impact by working on raw material sourcing and processing³.

(1) Thelliez M, et al. Migration of di(2-ethylhexyl) phthalate, diisononylcyclohexane-1,2-dicarboxylate and di(2-ethylhexyl) terephthalate from transfusion medical devices in labile blood products: a comparative study. Vox Sang 2023; 118(7):533-42. DOI: 10.1111/vox.13446

(2) Walsh GM, Howell A, Stephenson T, Olafson C, Blake J, Sumian C, et al. In vitro quality of red cell concentrates in PAGGSM additive solution derived from a whole blood collection set plasticized with di(2-ethylhexyl) terephthalate. Vox Sang 2025; 120(11):1103-1112. doi: 10.1111/vox.70087.

(3) Brebant Q, Lagrange A, Pinon S, Delorme B. Life cycle assessment (LCA) of a DEHT/PAGGSM reference: a step toward sustainable practices. Vox Sang 2025; 120: 8-537. https://doi.org/10.1111/vox.70030

DEHT x PAGGSM performances

EFS/SFS study

All plasma and RBC units were compliant with the EDQM requirements (21 Ed.), at D1

During the storage of plasma, at 6 and 12 months, Fibrinogen Factor VIII, and Total Proteins, were compliant with the EDQM.

When comparing DEHT/PAGGSM and DEHT/SAGM, the parameters controlled during RBC storage, from D1 to D49, were similar (pH, glucose, lactate and potassium).

For haemolysis, at d49, 100% of RBC/PAGGSM units were compliant with the EDQM requirements, versus 87% of RBC/SAGM (p < 0.05). Nevertheless, all RBCs were compliant until D42.

ATP results improved with the PAGGSM solution (D35, D42, D49; p < 0.05).

(1) Wirnitzer U, Rickenbacher U, Katerkamp A, Schachtrupp A. Systemic toxicity of di-2-ethylhexyl terephthalate (DEHT) in rodents following four weeks of intravenous exposure. Toxicology Letters 2011; 205 (1): 8-14.

(2) Carlson KR. U.S. Consumer Product Safety Commission (CPSC). Toxicity Review for Di-2-ethylhexyl Terephthalate (DEHT). Risk Science Center Department of Environmental Health, University of Cincinnati, 2018.

(3) SCENIHR (Scientific Committee on Emerging and Newly-Identified Health Risks), Scientific Opinion on the safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk. 2015.

(4) Kambia N, Séverin I, Farce A, Dahbi L, Dine T, Moreau E, Sautou V, Chagnon MC. Comparative Effects of Di-(2-ethylhexyl)phthalate andDi-(2-ethylhexyl) terephthalate Metabolites on Thyroid Receptors: In Vitro and In Silico Studies. Metabolites 2021; 11:94.

CBS/NETCAD study

Whole blood-derived red blood cell concentrates, collected and stored in prototype DEHT/PAGGSM collection sets, show acceptable quality until expiry at 42 days

Overall, in vitro quality of “warm” RCCs in DEHT/PAGGSM indicated:

No failures against current Canadian Blood and Blood Components Quality Control criteria, for LR-RCC in DEHP/SAGM, at expiry.

No significant difference in haemolysis between RCCs in DEHP/SAGM and DEHT/PAGGSM at day 43.

Differences seen in ATP and MCV, in line with observations from others and likely due to additive solution change, rather than plasticizer change.

Deformability changes observed, likely related to the absence of DEHP at the RBC membrane.

Walsh GM, Howell A, Stephenson T, Olafson C, Blake J, Sumian C, Reichenberg S, Brebant Q, McTaggart K. AABB 2024, P-BC-38.

Impact of Weekly Mixing of Red Cell Concentrates on Storage Quality: a Comparative study

Non DEHP transition requires materials optimizations as well as process and storage conditions

Gentle mixing 1/ week during 42 days shows optimised results for hemolysis

No significant difference for hematocrit and hemoglobin parameters

References:
A LAGRANGE 1, Q BREBANT 1
1 R&D, Macopharma, Tourcoing, France

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