The impending phase-out of per- and polyfluoroalkyl substances (PFAS) presents a significant challenge for MedTech companies. After all, PFAS has been an integral component in manufacturing many MedTech devices. 

Two key events place pressure on manufacturers to replace PFAS. The first is 3M’s decision to cease manufacturing PFAS by 2025. As 3M is one of the most significant providers of PFAS for manufacturers and suppliers, access to PFAS will become severely limited in the short term. The second event is that the EU is considering a ban on PFAS under the REACH proposal by 2030. This requires that products manufactured through the use of PFAS are removed from the EU market.

To minimize business disruption, manufacturers must proactively and strategically adapt to a world without PFAS. This article shares a checklist of key considerations and steps to guide your PFAS phase-out project. These insights draw from the wealth of knowledge shared in our recent webinar on navigating PFAS challenges. Let’s start with the first step — documenting where PFAS are used. 

1. Identify PFAS Usage

PFAS are often employed throughout MedTech production, from core components to manufacturing aids. To effectively phase out PFAS, manufacturers must first have a clear understanding of where and how these substances are used across their product portfolio

Identifying PFAS requires a comprehensive audit of the entire supply chain, scrutinizing every stage of production and every material source. This process includes:

  • Supply Chain Collaboration — engage with your suppliers to understand the material composition and manufacturing processes of the components they provide. 
  • Comprehensive Material Review — conduct a detailed review of all materials used in your devices. This includes active ingredients, ancillary substances, and even the materials used in packaging and shipping.
  • Advanced Testing and Analysis — employ advanced analytical techniques to test for the presence of PFAS, particularly in cases where supplier information may be incomplete or uncertain.
  • Documentation and Record Keeping — maintain detailed records of your findings. This documentation will aid in compliance and serve as a reference point for future product development and supply chain management.

2. Perform an Impact Assessment

Once PFAS usage has been identified in your portfolio, you’re able to conduct an impact assessment to understand how phasing out PFAS will affect your products. The impact assessment is key to determining whether supplier changes are feasible or if there's a need for alternative materials and potential redesigns of your devices.

An effective impact assessment will evaluate:

  • Feasibility of Supplier Changes — whether current suppliers can provide PFAS-free alternatives that meet your quality and performance standards. This may involve exploring new supplier relationships or working with existing suppliers to develop new solutions.
  • Alternative Materials Evaluation — if material changes are required, evaluate potential alternatives for their performance, safety, and compatibility with existing device designs.
  • Design Modification Requirements — determine whether material changes will necessitate design alterations. Assess the scope of such modifications and their impact on device performance, safety, and effectiveness.
  • Supply Chain Controls — revisit your controls for supplier vetting, quality agreements, and continuous monitoring. Controls need to ensure that alternative materials or supplier changes do not compromise device quality or lead to supply chain disruptions.
  • Stakeholder Insights — the impact assessment should engage key stakeholders, including R&D, quality assurance, regulatory affairs, and procurement. Their insights will provide a holistic view of the potential implications of PFAS removal.

3. Develop a Proactive Strategy

The strategy you craft to guide PFAS phase-out is vital for navigating the complex challenges of material substitution. Don’t discount this step. The more sound your strategy, the better position you’ll be in to complete the next steps in the process. As such, your strategy should encompass device performance, biological safety, and clinical evaluation. 

This comprehensive strategy should prioritize maintaining or enhancing device functionality and user experience, while rigorously reassessing biological safety in line with ISO standards. Additionally, updates in clinical evaluations, including new trials or data analysis, are vital if material changes significantly alter the device. The strategy must also include detailed plans for regulatory engagement, involving cross-functional teams for a holistic approach, and implementing risk management measures to mitigate potential disruptions. 

Setting clear timelines and milestones is crucial to keep progress on track. By integrating these elements, manufacturers can ensure a smooth transition from PFAS. 

4. Assess the Global Competitive and Regulatory Impact

Substituting PFAS materials affects how you position your products in the market and how they align with international regulatory standards. 

Are there alternative materials that, for instance, provide a competitive edge? What about the effects of replacing PFAS on product certifications, labeling, and market access across the regions you operate in?

With a clear, global picture of the market and the diverse requirements of different regulatory bodies, manufacturers can make informed decisions that strengthen their market position and ensure sustainable growth.

5. Materials Testing and Verification

An in-depth approach to materials testing and verification is essential to securing regulatory approval and ensuring that any device modifications maintain the integrity of the final product. Testing and verification involves:

  • Thorough Chemical Characterization — chemical analysis is needed to understand the full spectrum of chemical properties and potential interactions within the device. This characterization helps ensure the materials are PFAS-free and effective for their intended use.
  • Verification and Validation Testing — once new materials are identified, they must undergo rigorous verification and validation testing. This process ensures that the materials meet all the necessary performance standards and regulatory requirements. It's a critical step to confirm that modified devices retain their intended functionality and efficacy.
  • Guaranteeing Device Integrity — includes testing for durability, biocompatibility, and overall performance. Any change in materials could potentially alter the device's interaction with the body or its environment, making these tests essential for patient safety.
  • Creating Documentation for Regulatory Compliance — all testing and validation results form a critical part of the documentation required for regulatory submissions. Ensuring these tests meet regulatory standards will streamline market approval. 

6. Regulatory Documentation and Submission

The final step in the PFAS phase-out process involves the meticulous preparation and submission of technical documentation to global regulatory bodies. The more effectively you execute the previous steps, the easier this process will be. 

Your documents and submission strategy must be tailored to the unique requirements of the regulatory bodies you submit to. Generally, your process should include:

  • Preparing Complete Documentation — technical documents must detail all the changes made, the results of materials testing and verification, and any other relevant data. This documentation should clearly outline the rationale behind the substitution of PFAS materials, the impact assessments conducted, and the steps taken to ensure device safety and efficacy.
  • Effective Communication of Changes — submissions should clearly and effectively communicate all changes made to the device. This includes detailed descriptions of the new materials used, the testing processes, and the outcomes. Regulatory bodies need to understand what changes were made and why they were necessary.
  • Clear Demonstration of Compliance — the documentation must prove compliance with the relevant regulatory standards and guidelines. This includes showing that the device meets requirements in the absence of PFAS and adheres to any new guidelines that may have been established regarding PFAS substitutes.
  • Responding to Feedback — after submission, manufacturers need to actively monitor the review process and be ready to provide additional information or clarification as requested by regulatory bodies. Quick and effective responses can help expedite the approval process.

Your Roadmap for Replacing PFAS in Your Products

Successfully phasing out PFAS in medical devices is a complex but essential process. The steps shared here should help simplify your journey and ensure device safety, regulatory compliance, and market competitiveness.

For more insights and tips on replacing PFAS, sign up to watch our free webinar: Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers.

How RQM+ can help

Comprehensive planning, strategic foresight, and extensive testing are crucial to transitioning away from PFAS. 

As a full-service CRO, RQM+ has the regulatory and product testing expertise needed to streamline your PFAS journey. With decades of experience in polymers, including expertise dealing with PFAS materials, we understand the unique challenges and intricacies involved in replacing PFAS in medical devices.

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

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation


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