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What Could a PFAS Phase-out Mean for Medical Product Manufacturers?

Apr 5, 2024 | General, Manufacturing, Medical Device, Medical Device Testing, Technical Expertise

At the end of 2022, one of the world’s largest manufacturers of PFAS (per- and polyfluoroalkyl substances) announced it would stop making the compounds and discontinue using them across its entire product portfolio by the end of 2025. The company explained that PFAS are critical in manufacturing many standard products—i.e., batteries, phones, automobiles, airplanes, semiconductors, medication and medical devices—but that significant questions exist about their long-term impact to humans and the environment.

PFAS boasts some of the strongest carbon-fluorine bonds in organic chemistry, creating an almost unparalleled durability and resistance to degradation. While useful in applications, this stability also makes PFAS highly persistent in the environment and biological organisms, leading to their nickname, “forever chemicals.” This persistence, combined with the widespread use of PFAS, has led to significant environmental contamination and growing concerns about potential health effects.

Health studies have linked certain PFAS (specifically, PFOA and PFOS) to various adverse health outcomes, including, but not limited to, cholesterol changes, immune system effects, cancer (for PFOA), and developmental effects or delays in children. These concerns have increased regulatory scrutiny and reduction efforts for certain PFAS. However, scientists agree that additional research is needed to fully understand PFAS substances’ impacts.

It’s apparent that an abrupt phasedown or phase-out of PFAS could have a significant and multifaceted impact on medical device manufacturers and biopharma product companies. The repercussions could range from immediate supply chain disruptions to long-term product development and manufacturing challenges. But let’s start at the beginning.

How is PFAS currently used in medical devices and biopharma products?

PFAS’ unique properties allow for several applications in medical devices and biopharmaceutical products. Their chemical stability, resistance to heat and chemicals and non-stick characteristics make them valuable in some specialized fields. Specific applications include:

  • Coatings for medical devices: PFAS coatings can reduce friction and improve durability in catheters and guidewires, making them easier and safer.
  • Implantable devices: Implantable medical devices, including heart patches, vascular grafts and stents, may use PFAS materials because of their biocompatibility and durability inside the human body.
  • Drug delivery: In biopharmaceutical applications, PFAS may be used in controlled drug delivery systems like transdermal patches, implantable pumps and intramuscular depot injections. Their chemical stability ensures the drug’s integrity is maintained, and their biocompatibility allows for safer interaction with bodily tissues.
  • Containers & packaging: PFAS might be found in containers or packaging used in pharmaceutical manufacturing due to their resistance to corrosive substances and ability to create barrier layers. This is particularly important for ensuring the purity and effectiveness of medications.
  • Respiratory devices: Membrane filtration systems and reactor components can contain PFAS because of their ability to repel moisture and resist thermal degradation.

It’s clear that PFAS provides significant advantages in some applications, but their potential environmental and health impacts should give the industry pause. Medical device and biopharma product manufacturers who are not considering alternatives or at least looking more closely at their PFAS usage could be left behind. The need to balance performance with safety and environmental sustainability is real, but the scrutiny these substances receive cannot be ignored. Luckily, these industries have options.

PFAS alternatives

PFAS’ unique properties make reformulating or replacing them challenging. But getting a head start on possible alternatives now is a smart move. The suitable option depends on several factors, including the project’s timeline, a device’s specific application and the biophysical qualities required. Each of these strategies requires a nuanced understanding of the functional requirements of the original PFAS application and the implications of any changes.

The most straightforward strategy is bypassing PFAS altogether by opting for materials that don’t require PFAS’ high-performance characteristics. This might involve switching to natural materials or other synthetic alternatives. Either way, finding materials that meet all the functional requirements of the original PFAS-containing product without compromising on quality or performance will require time and additional research.

Shorter-chain PFAS compounds are not entirely risk-free, but they are generally believed to be less harmful than their longer-chain counterparts. They tend to have a lower potential for bioaccumulation and are more rapidly excreted from the body. Manufacturers can reformulate products using shorter-chain PFAS, which may still provide some of the desirable properties of the traditional PFAS but with potentially reduced environmental and health impacts.

Innovating entirely new materials or chemistry is the most promising route for long-term success and the most difficult. This approach may offer a sustainable and safe alternative to PFAS, addressing environmental and health concerns while still fulfilling necessary functional roles. The challenge here is the extensive R&D needed to create novel compounds or explore new combinations of existing materials.

Ultimately, the goal in reformulating or replacing PFAS is not just to find a direct substitute but to rethink the material requirements of products and processes, potentially leading to more innovative, sustainable, and safe solutions. A shift of this magnitude requires collaboration among manufacturers, scientists, regulatory agencies and lab partners to ensure that the solutions developed are effective and responsible.

How to prepare for a PFAS phasedown or phase-out

Preparing for the discontinued use of PFAS requires a thoughtful, detailed strategy from medical device and biopharma product manufacturers. Here are nine actions leaders in these industries are already taking to stay ahead of the shift. These can be done in tandem or in a different order; it’s just important that these actions are taken:

  • Action 1: Conduct a comprehensive material audit. Inventory all products and components in your portfolio that use PFAS to understand the scope of impact. This will help identify which products need immediate attention and can help prioritize strategies.
  • Action 2: Assess supply chain vulnerabilities and product availability. This will help identify critical dependencies and bottlenecks, allowing for creating backup plans and minimizing disruptions.
  • Action 3: Begin researching alternative materials. Finding reliable alternatives ensures product quality and safety are maintained and helps avoid potential regulations banning PFAS.
  • Action 4: Find trusted external partners. Collaborations can accelerate the development of viable alternatives and provide access to cutting-edge research and technologies.
  • Action 5: Engage early with regulatory bodies. Early engagement can help navigate the complex regulatory landscape efficiently and reduce the time to market for redesigned products. This can also generate important regulatory feedback on any new materials.
  • Action 6: Diversify suppliers and look for alternative materials. Diversification reduces the risk of supply chain disruptions and potential monopolies or unfair price hikes. Remember, with any regulatory ban, there will undoubtedly be a grace period. Be sure to maintain enough PFAS-based products to provide stability during the transition.
  • Action 7: Educate staff about new processes and materials. Training ensures a skilled workforce capable of handling new materials and processes effectively. Also keep customers, suppliers, and other partners informed about changes.
  • Action 8: Monitor market developments and technological advances. Pay attention to how competitors manage the phase-out. This will help in strategic planning and alleviate market-based surprises or risks.
  • Action 9: Assess the environmental and health impacts of PFAS use. Be sure this assessment aligns with broader corporate social responsibility goals and contributes to internal and external messaging.

Each action toward a PFAS-free future is critical in mitigating the immediate challenges its discontinuation poses. Proactive steps also prepare companies for long-term success in a rapidly changing regulatory environment. It’s about maintaining product integrity, ensuring regulatory compliance and preserving customer trust.

A final word

The real possibility of a phasedown or phase-out of PFAS compounds poses a big challenge for medical device and biopharma product manufacturers. This shift requires a reassessment of manufacturing processes and materials and a fundamental rethink of industry norms and safety standards. This evolution is imperative for environmental sustainability and public health, but it may also be overwhelming for organizations navigating these waters alone.

This is where the value of a trusted laboratory partner becomes clear. Such collaborations highlight shared knowledge, specialized expertise and innovative technologies essential for significant transitions. A lab partner can help dissect the intricate web of material specifications, regulatory landscapes and environmental impacts, providing bespoke solutions that align with customer goals. This collaboration isn’t just about adapting to a PFAS-free era; it’s about seizing an opportunity to innovate and ethically advance toward a safer and more sustainable future.

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