Preparing for the Phase-Out of PFAS in MedTech Manufacturing

Major per- and polyfluoroalkyl substances (PFAS) suppliers are beginning to exit the market due to significant environmental, health, regulatory, and legal concerns. That’s mostly a good thing! While PFAS are used in an incredible array of consumer products, including medical devices and in vitro diagnostics, they can pollute the environment and endanger health.

Globally, regulatory bodies are responding to these environmental and health concerns. The European Union is leading the charge, with Denmark, Germany, the Netherlands, Norway, and Sweden proposing that PFAS be restricted under the REACH regulation. America is also taking strides toward minimizing the use of PFAS. The US Environmental Protection Agency, for instance, recently ruled that PFAS are subject to the same reporting requirements as other chemicals of special concern.

These regulatory changes reflect a growing global consensus on reducing PFAS usage, with countries like Canada, Australia, and several Asian nations actively engaging in the discussion. As the world is concerned about PFAS and crucial suppliers are ceasing the manufacture of PFAS, MedTech manufacturers must find a way to adapt and innovate. 

In this article, we unpack steps manufacturers can take to phase out PFAS and safeguard their product lines and profitability. For an even deeper dive and the ability to ask us your own questions, please RSVP for our January 2024 expert panel event.

To start, let’s explore how dwindling supplies may accelerate the timeline to abandon FPAS.

Will PFAS Supplies Dwindle by 2025?

Along with regulations, supply chain issues will play a critical role in removing PFAS from use. 3M, a leading manufacturer of PFAS, will completely stop manufacturing the chemical by 2025. This decision came in the wake of mounting legal challenges. In June 2023, for instance, 3M settled approximately 300 lawsuits for $10.3 billion. DuPont, another leading PFAS manufacturer, is facing similar legal woes. 

Collectively, DuPont and 3M are facing over 4,000 lawsuits by states and municipalities and another 6,000 personal injury lawsuits — all due to their PFAS manufacturing. These lawsuits reflect the increasing legal and financial pressures associated with PFAS production and use.

The response from 3M is just a precursor to a larger industry trend. As regulatory bodies tighten restrictions on PFAS, other manufacturers are likely to follow suit, further constricting the supply of these materials. The dwindling PFAS supply will have a knock-on effect, limiting the availability of parts that make use of PFAS.

This scenario poses a challenge for MedTech companies, compelling them to reassess their material sourcing strategies and hasten their search for sustainable and compliant alternatives. 

So, when should MedTech secure a PFAS alternative? 3M gives us a clear deadline: by 2025.

Steps for Phasing Out PFAS

The move away from PFAS represents a significant shift in MedTech, especially as these substances have been a cornerstone in the design and manufacture of so many medical devices. 

Along with being resistant to heat, water, and oil, PFAS chemicals do not degrade easily. A viable substitute will need to have similar properties and their use should, ideally, enhance and not detract from device quality. Here are five key steps for phasing PFAS out of your products:

• Perform a PFAS Gap Assessment — the first step involves a comprehensive assessment of existing product lines to pinpoint where PFAS are used. This detailed analysis requires collaboration with suppliers and a thorough understanding of the material composition in the manufacturing process. Lab testing may be needed to verify the information given by suppliers.
  
  
• Identify PFAS Alternatives — manufacturers must consider potential redesigns to accommodate new materials while maintaining device functionality and performance. Identifying suitable alternatives requires exploring various sources and materials, and understanding their implications in terms of device design, application, and patient safety.
  
  
• Testing and Validation — once alternatives are identified, the focus shifts to rigorous materials testing and validation. This includes biocompatibility testing, chemical characterization, and ensuring the new materials meet the technical and safety standards for medical devices. Documenting these tests is crucial for submitting complete safety evaluations.
  
  
• Design and Implement the Right Regulatory Strategy — successfully finding a suitable source to replace PFAS in product materials demands a strategic approach to regulatory compliance. This includes preparing and submitting detailed documentation to regulatory bodies and aligning with global regulatory changes, such as the significant updates in the EU. Understanding and navigating these regulatory landscapes are essential for a smooth market transition.
  
  
• Strategic Planning and Execution — effective project management is key to a successful transition. Manufacturers need to adopt best practices for planning and execution, ensuring minimal disruption to supply chains and operations. This step involves proactive risk management, contingency planning, and stakeholder communication to maintain continuity and competitiveness in the market.

Navigating a Future Without PFAS

Replacing PFAS with a suitable alternative requires careful navigation, informed decision-making, and strategic adaptation. The complete phasing out of PFAS will take time — enough to accommodate the product life of most current designs. However, PFAS manufacturers will likely continue exiting the market. Another issue is that PFAS’ unique properties lack a current substitute.

The challenges ahead are considerable, but they also present an opportunity for innovation and leadership in developing safer, more sustainable medical devices.

As a full-service CRO, RQM+ can help your MedTech company adapt to a future without PFAS. With over 40 years of expertise in polymers, including a decade of focused experience with PFAS materials, we understand the unique challenges and intricacies involved in replacing PFAS in medical devices.

Our Lab Services team can help you with chemical characterization, mechanical property evaluation, and ensuring the biocompatibility of alternative materials. Of course, transitioning from PFAS is as much a regulatory challenge as it is a technical one. Our Regulatory Consultants offer support in developing documentation, aligning with regulatory agencies' expectations, and ensuring that the transition to PFAS alternatives is smooth and compliant.

Speak with our experts to find out how we can support you in substituting PFAS in your products.

Exclusive Opportunity to Learn More About the PFAS Phase-Out

Gain a deeper understanding of the PFAS phase-out and how it impacts your operations. RSVP for our free expert panel: Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers.

RSVP today to hear a panel of MedTech experts share their roadmap for overcoming PFAS challenges.