The Blood Transfusion Association (BTA) has responded to the European Chemicals Agency (ECHA) consultation on the proposed restriction of per- and polyfluoroalkyl substances (PFAS), raising significant concerns about the potential implications for blood transfusion systems, patient safety and healthcare resilience across Europe. The BTA also already submitted its position (#9329) in the previous consultation on the Annex XV restriction proposal in 2023.
While the BTA recognises the importance of reducing environmental emissions of PFAS and supports proportionate risk management measures, the association stresses that the proposed approach does not sufficiently account for the specificities of blood bags and medical devices.
Blood Bags Are Critical Medical Systems
A blood bag set is a disposable medical device used for the preparation and transfusion of blood and blood components. It typically consists of one or more bags connected through integrated tubing, along with components such as needles, clamps and protective elements, forming a closed and sterile system, as defined by the EDQM in its Blood Guide.
Blood bags are a highly specialised medical devices designed to collect, process, store and transport blood and blood components under extremely demanding conditions.
Every element of a blood bag system is carefully engineered to ensure:
Sterility and patient safety;
Preservation of blood quality and functionality;
Chemical and mechanical stability;
Resistance to sterilisation processes;
Compatibility with blood components during storage and transport;
Long shelf-life and supply reliability.
Why PFAS Are So Difficult to Substitute in Blood Bags
Currently, PFAS may be used across a range of processes and products involved in the manufacture and functioning of blood bag sets and related medical technologies, particularly in the collection, processing, storage, and safety control of blood.
Devices (equipment): PFAS can be present in various integral components such as coatings, wiring, sensors, seals, and lubricated parts. In many cases, their presence originates from upstream materials or processing aids within complex supply chains rather than direct addition by device manufacturers. This dependency on multi-tier suppliers is a key constraint, as PFAS use is often outside the immediate control of final manufacturers. These substances are used because they provide properties such as chemical resistance, durability and stability, which support consistent device performance and patient safety.
Disposables: PFAS are particularly relevant in filtration technologies, including leukoreduction filters. These are essential for removing unwanted elements from blood prior to transfusion. PFAS-based materials are used due to their ability to deliver reliable filtration performance and compatibility with medical requirements. At present, equivalent PFAS-free alternatives are not yet available.
PFAS are used where there are highly demanding technical requirements. In blood bags and associated transfusion systems, materials must maintain integrity, flexibility and performance throughout collection, processing, storage and transfusion.
Potential PFAS-free alternatives often fail to meet the functional requirements necessary for these applications.
The BTA stresses that substitution is not simply a matter of replacing one substance with another. Even small material changes can alter the performance of the entire medical device system, including:
Stability during sterilisation;
Interaction with blood components;
Storage performance and shelf-life;
Mechanical durability;
Barrier properties and contamination prevention.
In addition, any modification to the materials used in blood bags requires extensive validation, clinical assessment and regulatory approval under the EU Medical Devices Regulation (MDR).
This process can take years and must ensure that any alternative maintains the same level of safety and performance as existing systems.
BTA therefore warns that restricting PFAS before technically feasible alternatives are available could result in reduced product quality, increased costs, supply disruptions and risks to continuity of care.
Medical Devices Are Not a Sum of Their Parts
One of BTA’s principal concerns relates to the methodology underpinning the proposed restriction.
The BTA emphasises that medical devices cannot be assessed solely on the basis of individual chemical components. Blood bags and transfusion systems function as integrated medical systems whose safety and effectiveness depend on the interaction of multiple materials and components.
Treating medical devices as a “sum of their parts” risks overlooking the reality of how these products are designed, tested and approved.
The performance of a blood bag is not determined by one isolated material, but by the compatibility and interaction between polymers, tubing, films, connectors, coatings and sterilisation processes.
Any change to one component may affect the performance and safety of the device as a whole.
Additionally, blood filters currently referenced under “technical textiles” should be assessed within the “medical devices” context. These filters are not standalone textile articles, but fully integrated, functional components of blood bag sets used for blood collection and processing. Hence, such filters should not be assessed independently but as part of the blood bag set system.
Overall, PFAS are used because they enable the performance, reliability, and safety standards required in blood transfusion systems, where failure is not an option.
Risks for Healthcare and Blood Supply Resilience
Risk to medical procedures: Blood transfusions are essential for trauma care, cancer treatment, chronic conditions and major surgeries. Any disruption in the availability or quality of blood bags would immediately reduce access to life-saving treatments, delay urgent procedures and increase pressure on hospitals to prioritise care or postpone interventions.
Patient safety concerns: Immediate changes to device design or manufacturing processes could compromise the performance and reliability of blood transfusion systems. Product failure or performance variability is not acceptable, given the direct impact on patient outcomes.
Blood quality and adverse reactions: PFAS are potentially present in critical safety components, including filtration systems such as leukoreduction filters, which are essential to ensure blood quality and prevent adverse reactions. Without validated PFAS-free alternatives, there is a risk of reduced or inconsistent performance, product withdrawals or supply constraints.
Healthcare resilience: Impacts extend beyond product availability to healthcare system resilience, increasing operational uncertainty and risking disruption to coordinated transfusion services across Europe. Uneven implementation across Member States could lead to fragmentation and unequal availability of compliant products.
Challenges to European Strategic Autonomy and Preparedness
External dependencies: A substantial share of PFAS presence originates from upstream manufacturing processes and processing aids in components such as sensors, semiconductors, coatings, elastomeric parts and other integrated device elements. Compliance therefore depends not only on substitution within the blood bag set sector itself, but also on coordinated transition across multiple upstream industries.
Limited substitution potential: PFAS-free alternatives for key applications, particularly blood filtration materials such as leukoreduction filters, have not yet been developed or validated. It would take 20 years to develop alternatives to a stage where they can be implemented for the relevant use/application.
Regulatory and certification burden: Substitution would require extensive safety testing, regulatory assessment and clinical trials to ensure patient and donor safety is not compromised while maintaining continuous supply. Under the MDR, this would include full system-level redesign, extensive validation, clinical evaluation and regulatory re-certification of the entire device system.
Significant financial burden: Substituting PFAS would require major redesign of critical components, extensive R&D investment, and repeated testing and certification. These are aggregated industry-level impacts covering redesign, qualification and regulatory revalidation across interconnected devices and disposables, rather than a single company.
Risk to European production and supply chains: Without adequate derogation, impacts could include relocation or closure of production outside the EU, job losses across European supply chains, disruption of blood supply infrastructure and life-saving procedures, reduced innovation in the EU and increased dependence on non-EU supply chains, increasing healthcare vulnerability.
A Call for a Proportionate and Evidence-Based Approach
BTA acknowledges the EU’s objective to reduce and ultimately phase out the use of PFAS in the interest of environmental and public health protection and remains committed to engaging constructively in this process. However, environmental objectives must be pursued while safeguarding continuity of essential blood supply systems, which depend on highly integrated, regulated technologies with limited substitution options in the short to medium term.
Recommendation | Rationale |
Ensure a transition that maintains patient safety | The restriction should be implemented in a way that preserves the performance, reliability and availability of blood processing and transfusion medical devices used in life-saving procedures. |
Recognise blood bag sets under RO2-type time-limited derogations | Mmedical devices, including blood bag sets and integrated filters and tubing systems, should be explicitly recognised within the derogation framework. Alternatives may require 20 years to develop to implementation stage. |
Assess blood bag sets as complete medical systems | Blood filters and other integral components should be assessed as part of the complete blood bag set system, not as standalone articles or under unrelated sectoral classifications such as technical textiles. |
Reflect upstream dependency and supply-chain complexity | A significant proportion of PFAS presence originates from processing aids and component-level inputs in upstream industries, outside the direct control of blood bag set manufacturers. |
Include a formal review mechanism | The final restriction should include a clear review clause allowing newly identified PFAS uses to be assessed against criteria such as criticality of function, availability of alternatives and socio-economic impacts, with access to appropriate time-limited derogations where justified. |
Conclusion
BTA supports a harmonised EU approach to PFAS risk management, but stresses that implementation for blood bag sets must be proportionate, realistic and aligned with the realities of safety-critical medical device systems. Blood bag sets are essential medical devices with currently limited substitution potential. A premature or fragmented restriction could create disproportionate impacts on healthcare delivery compared to the environmental benefits achievable in the short term. A clear derogation pathway, system-level classification and adaptive review mechanism are therefore necessary to ensure both environmental protection and uninterrupted access to life-saving transfusion systems.