Balancing Sustainability, Safety and Global Equity in Transfusion Medicine

A profound and rapidly evolving shift is underway in transfusion medicine. Sustainability policies, once distant from day-to-day blood operations, are now actively influencing how blood is collected, processed and stored. At the center of this transition lies the global movement to restrict or replace di(2-ethylhexyl) phthalate (DEHP), a plasticizer long used in polyvinyl chloride (PVC) blood bags.

This is no longer theoretical. In the European Union (EU), DEHP is classified as a “Substance of Very High Concern” under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulatory framework due to its potential endocrine-disrupting properties.¹ The EU Medical Devices Regulation (MDR 2017/745) further requires explicit justification for the continued use of such substances above defined thresholds.² In practice, this has translated into procurement shifts: blood services and group purchasing organizations are increasingly favoring or mandating DEHP-free systems. Manufacturers, in turn, have accelerated the development of alternatives such as dioctyl terephthalate (DEHT) and 1,2-cyclohexane dicarboxylic acid diisononyl ester (DINCH).

The transition away from DEHP is not a simple material substitution. It requires comprehensive revalidation of blood systems, including storage performance, processing workflows and clinical outcomes. The scientific evidence continues to evolve. DEHP exposure has been documented, particularly in vulnerable populations, and concerns regarding its toxicological profile are well established. At the same time, decades of clinical use have demonstrated a functional safety profile for red blood cell storage. DEHP is known to leach into blood components and contribute to measurable patient exposure.³Alternative plasticizers, such as DEHT, have shown promising in vitro results, but long-term clinical outcomes remain limited.⁴

At its core, this is a question of balance: how to act responsibly when evidence is still evolving and when decisions carry consequences beyond individual patients.

This places the field in a challenging position. The transition is being driven not solely by scientific evidence, but also by regulatory and societal forces. This intersection is what makes the DEHP transition a defining bioethical moment for transfusion medicine.

A Real-World Scenario: When Sustainability Meets Supply

Consider a national blood service implementing DEHP-free systems in response to sustainability-driven procurement requirements. The transition involves the qualification of new materials, the retraining of staff and the coordination with suppliers operating under constrained global manufacturing capacity.

Even minor disruptions—whether related to validation timelines, supply chain delays or regulatory approvals—can affect inventory levels. The downstream consequences are immediate: elective procedures may be postponed, trauma readiness may be strained and reliance on imported components may increase.

Although such pressures may be manageable in high-resource settings, they can have far more significant consequences in low- and middle-income countries. Limited budgets, reduced procurement flexibility and fragile supply chains may transform a sustainability initiative into a barrier to access. What begins as a well-intentioned environmental decision may inadvertently create inequities in blood availability.

Three Competing Ethical Imperatives

The DEHP transition requires the transfusion medicine community to navigate three equally legitimate, yet often competing, priorities:

• Patient safety remains paramount. Any transition must ensure that alternative materials do not introduce unforeseen risks or compromise the quality of blood components.
• Environmental and toxicological responsibility is essential. Reducing exposure to substances classified as harmful to human health and the environment is a necessary objective.
• Equity and access must be preserved. Changes in materials, processes or supply chains should not reduce the availability of blood products, particularly in resource-limited settings.

These priorities are interdependent. Advancing one without considering the others risks unintended consequences.

Why Is This a Bioethics Issue?

The DEHP transition expands the scope of bioethics in transfusion medicine. Traditionally focused on consent, allocation and safety, the field must now also address questions of environmental responsibility, global equity and decision-making under uncertainty.

This transition highlights the growing influence of regulatory frameworks and societal expectations in shaping clinical practice. It challenges the assumption that technological change is driven solely by evidence and instead underscores the role of policy and public health priorities.

At its core, this is a question of balance: how to act responsibly when evidence is still evolving and when decisions carry consequences beyond individual patients.

A Path Forward: Ethics-Informed Implementation

The issue is no longer whether the transition will happen, but whether it will be managed effectively. Efforts should focus not on delaying change, but on ensuring it is implemented responsibly. A coordinated, risk-based strategy, grounded in phased adoption and aligned with evolving evidence, is essential. Transparent reporting of exposure and performance data must become standard practice, while cross-institutional collaboration will be key to accelerating validation and avoiding fragmented efforts.

Procurement strategies should be designed with global supply dynamics in mind, ensuring that transitions do not compromise equitable access. Sustainability must be integrated into patient-centered care as an ethical imperative, not treated as an external constraint.

The transition beyond DEHP is more than a materials issue. It is a test of how the transfusion community navigates complexity in an environment where science, policy and ethics are increasingly intersecting. The decisions made today will shape not only the composition of blood systems but also their resilience, accessibility and fairness in the future

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References

1. European Chemicals Agency (ECHA). Candidate list of substances of Very High Concern for Authorisation: Bis(2-ethylhexyl) phthalate (DEHP). Helsinki: ECHA; 2023. Available from: https://chem.echa.europa.eu/100.003.829/obligations/authorisationList/details
2. European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. Off J Eur Union. 2017;L117:1–175.Available from:  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
3. Tickner, J.A., Schettler, T., Guidotti, T., McCally, M., and Rossi, M. (2001), Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: A critical review. Am. J. Ind. Med., 39: 100-111. https://doi.org/10.1002/1097-0274(200101)39:1<100::AID-AJIM10>3.0.CO;2-Q
4. Larsson, L., Sandgren, P., Ohlsson, S., Derving, J., Friis‐Christensen, T., Daggert, F., ... & Uhlin, M. (2021). Non‐phthalate plasticizer DEHT preserves adequate blood component quality during storage in PVC blood bags. Vox Sanguinis, 116(1), 60-70. https://doi.org/10.1111/vox.12982