Per- and Poly- fluoroalkyl Substance Exposure, Emissions, and End of Life Management in Healthcare Sector

Aims

• The overall aim of this IHI JU topic is to provide world-leading, fully integrated and globally applicable solutions to address PFAS emission and exposure concerns, for example by substitution.

Objectives

• Objective 1: Cross-sector solutions to develop PFAS alternatives
  • Activities:
    • Establish public-private collaboration to increase knowledge about PFAS applications and alternatives with a focus on prioritised PFAS chemicals;
    • Document key performance characteristics for PFAS used in healthcare products, manufacture, and testing;
    • Exploit industry, academic and manufacturing collaborations, incorporating skills such as chemical synthesis, material sciences and analytics to develop PFAS alternatives;
    • Test and validate PFAS alternatives generated by this project and, in addition, PFAS alternatives developed through research external to this project against performance characteristics and applications.
  • Outputs:
    • Reporting system to label PFAS-containing raw materials or medical device components;
    • Technology on optimised materials capable of replacing PFAS in specific applications;
    • Reliable data on alternative materials that could replace PFAS and corresponding design and performance characteristics;
    • Technology for replacing PFAS chemicals in chemical synthesis or excipients in drug manufacturing;
    • Replacements for trifluoroacetic acid (TFA) in chromatography and other analytical methods;
    • Development of PFAS-free process aids (tubing, gaskets, fittings);
    • Searchable database of validated PFAS alternatives.
• Objective 2: Understanding PFAS in the medtech sector
  • Activities:
    • Identify and map PFAS types and applications in the medtech sector and align with those already identified in previous mappings of PFAS in the pharmaceutical industry;
    • Develop a methodology for risk-benefit analysis of PFAS use;
    • Establish public-private collaboration to gain knowledge about PFAS applications, alternatives, risks, and risk management options;
    • Identify suppliers to raise awareness of PFAS alternatives and secure continuous supplies of raw materials and parts;
    • Collect data on PFAS materials used in the supply chain, emissions, and mitigation options.
  • Outputs:
    • Increased knowledge of PFAS types and applications throughout the medtech and diagnostic process supply chain;
    • Robust evaluation of PFAS alternatives;
    • Enhanced stakeholder information sharing between medtech and the manufacturers of equipment, devices, disposables, PPE manufacturers and other activities identified by this mapping exercise.
• Objective 3: Sector-specific solutions to reduce and reuse PFAS materials
  • Activities:
    • Map and calculate PFAS exposure from different categories of applications;
    • Develop end-of-life management options across the sector in line with the SSbD framework;
    • Evaluate and leverage PFAS removal technologies;
    • Evaluation of sector specific circular economy principles for applications where removal is not yet possible;
    • Evaluate sector-specific solutions to minimise PFAS exposure in partnership with healthcare facilities and waste management companies.
  • Outputs:
    • End-of-life management guidelines for PFAS components/chemicals, including circularity aspects and waste treatment;
    • PFAS-specific removal, decontamination or environmentally responsible disposal technologies for TFA from wastewaters.

Scope

• To replace PFAS in medical technologies without risking human health, input from supply chain actors, scientists, and engineers is crucial. This includes assessing material availability, feasibility, and testing. Where current technology falls short, understanding PFAS environmental exposure and mitigation must improve. Standardised testing protocols and quantification methodologies are needed to measure exposure accurately. Effective mitigation requires knowledge of exposure routes and environmentally sensitive disposal methods. A scientific, data-driven approach that aligns with the safe and sustainable by design (SSbD1) framework is essential for lifecycle exposure management and ensuring alternative materials are safe and effective. Collaboration among scientists, policymakers, regulators, healthcare providers, chemical manufacturers, patient groups and trade associations and waste managers is vital to address technical, legal, and practical considerations. Proper scientific assessment of alternatives is necessary to maintain safety and quality.
• The key challenges in the field include:
  • obtaining information on PFAS uses in healthcare due to a complex global supply chain and limited data sharing;
  • many specific use requirements and potential exposure routes exist due to the ubiquitous nature of PFAS use in the healthcare sector, including in production equipment, consumables, packaging, delivery devices, medical devices, complex machinery and cleaning agents;
  • identifying alternatives for high-performing PFAS like polytetrafluoroethylene (PTFE) while ensuring product quality and safety;
  • end-of-life management of healthcare products is underdeveloped, with inconsistent approaches to multi-component waste management;
  • current wastewater treatment technologies struggle to eliminate complex PFAS;
  • consideration of PFAS guidelines and regional policy disparities that may impact the global utility of this study.

Expected Impact

• This IHI JU topic will enable and directly contribute to the EU health priorities, initiatives, and policies. Healthcare products containing PFAS are often essential for the health of citizens in Europe and worldwide. The proposed IHI JU topic would strengthen collaboration between healthcare system stakeholders to reduce emissions of, and exposure to PFAS, evaluate alternatives and therefore, contribute to the EU Chemicals Strategy for Sustainability of the EU Green Deal.
• The action under this topic is expected to achieve the following impacts:
  • contribute to IHI JU SRIA objectives, driving cross-sectoral health innovation for a competitive European health industry. Contribute to the objectives of the Industrial Strategy for Europe and Pharmaceutical Strategy for Europe;
  • understanding human health and environmental risks from PFAS in healthcare from a life cycle perspective, i.e. mapping where PFAS is introduced in the healthcare industry and removal, where possible;
  • manage PFAS risks with novel mitigation measures, including safe disposal, reuse, and recycling;
  • develop methodologies and solutions for PFAS replacement that meet regulatory requirements without compromising efficacy, quality, safety, or environmental performance;
  • position the EU as a leader in safe, sustainable PFAS alternatives through industry-academia collaboration; foster medicine supply in the EU, avoid non-EU dependencies, and keep R&D activities in Europe for active substances to address societal and political needs;
  • strengthen stakeholder collaboration to reduce emissions and exposure until alternatives are found;
  • share industry knowledge and best practices to inform future PFAS policy;
  • improve business planning certainty for medical technology manufacturers, ensuring long-term sustainability and patient access.
• Possible target groups: medical technology and medicines manufacturers and their supply chains, stakeholders involved in regulatory approval process (i.e., notified bodies, policy makers); waste management companies; hospitals and other healthcare settings and providers.

For more information, visit European Commission.