PFAS: How ‘Forever Chemicals’ Impact Medical Devices

Using specific PFAS material types has various benefits for medical device manufacturers. Because of its anti-inflammatory properties, cell adhesion in surgical wounds can be safely promoted, improving the effectiveness of surgical therapy. Catheter replacements are performed less frequently because the blockage happens less often. Although PFAS are extensively utilised, there is a greater chance of long-term hazardous exposure due to their persistence—these elements are hard to break down. These chemicals accumulate over time, posing a potential health risk. As the world shifts toward minimizing PFAS usage, medical device manufacturers must prepare for the challenges and opportunities that lie ahead.

The switch away from products that depend on PFAS might raise demand for alternative materials, which could result in a shortage and higher prices. Manufacturers will have to have strong supply chain plans. Some common products that contain PFAS:

• Stain Resistant Products
• Non-Stick Cookware
• Shampoo
• Paints
• Pesticides
• Fast Food Packaging
• Photography

According to research by the Centers for Disease Control and Prevention, 97% of Americans have PFAS in their blood, which used data from the National Health and Nutrition Examination Survey (NHANES).

Why PFAS are a growing concern?

• Widespread occurrence: Scientists are investigating if PFAS are linked to health issues after finding them in human blood and urine.
• Numerous exposures: Around the world, PFAS are present in hundreds of items, providing numerous chances for human exposure.
• Growing numbers: According to the U.S. Environmental Protection Agency's CompTox chemicals database, PFAS are a class of about 15,000 manufactured compounds.
• Persistence: The amount of time that PFAS are present in the environment is unclear.
• Bioaccumulation: Diverse PFAS compounds may come into contact with people. The process of substances being ingested at a higher rate than they are eliminated over time causes bioaccumulation in the body.

Types of PFAS

• Polymeric PFAS: Large molecules consisting of repeating units are seen in. They are less likely to be dangerous and less movable in the surroundings. Examples of polymeric PFAS are Polytetrafluoroethylene (PTFE), Fluorinated ethylene propylene (FEP), Perfluoroalkoxy alkanes (PFA), etc.
• Non-polymeric PFAS: Smaller, flame retardants, soluble in the environment, more mobile, and pose a greater risk of environmental pollution and human health hazards. Examples of non-polymeric PFAS are Perfluorooctanoic acid (PFOA), Perfluorooctanesulfonic acid (PFOS).

Benefits of PFAS used in medical devices

• A greater emphasis on product efficacy and patient safety drives rapid improvements in the medical technology sector. More significantly, PFAS (per- and polyfluoroalkyl compounds) have been key players in the significant regulatory changes that have occurred in the medical device industry to allow for the adoption of safer materials. PFAS are found in a variety of products because of their remarkable qualities, such as chemical stability, high heat capacity, inertness, and biocompatibility
• Their involvement in manufacturing processes is vital since they play a crucial part in producing a broad range of devices, including surgical devices, pacemakers, artificial heart pumps, inhalers, dental floss, and more.
• The use of fluoropolymers is growing in areas such as gene delivery, cytosolic protein delivery, drug delivery, magnetic resonance imaging, photodynamic therapy, and tissue engineering, showcasing their versatility and effectiveness in improving patient care and treatment outcomes.
• The PFAS regulation environment is complicated and differs significantly between nations and regions. The United States (US), the European Union (EU), and other countries have taken action to limit the use of some PFAS compounds, although strategies and levels of control vary.

PFAS Regulation in the United States

The Comprehensive Environmental Response, Compensation, and Liability Act, or Superfund, allows for the classified of two commonly used PFAS, PFOA and PFOS, as hazardous compounds. The EPA finalised this necessary regulation in April 2024. By taking this action, PFAS pollution in communities will be cleaned up with greater accountability and transparency.

To protect populations from exposure to dangerous PFAS, the EPA released the first-ever nationwide drinking water regulation in April 2024 that is legally enforceable. About 100 million people will have less exposure to PFAS because of the final regulation, which will also stop thousands of deaths and tens of thousands of severe illnesses. Concurrently, the EPA announced an additional $1 billion to assist states, territories, and private well owners in addressing PFAS contamination and implementing PFAS testing and treatment at public water systems.

PFAS Regulation in the EU

The European Commission decided to impose restrictions on perfluorinated carboxylic acids (C9–14 PFCAs), their salts, and precursors in the EU/EEA starting in February 2023 in response to a request put up by the Swedish and German governments.

A further ban on undecafluorohexanoic acid (PFHxA), its salts, and similar chemicals has been recommended by Germany. The scientific committees of ECHA assessed this proposal in December 2021. In February 2024, the EU Member States approved the Commission's plan. The European Parliament and Council will now review the limitation before it is approved.

Other countries and regions

Restrictions on PFAS have also been suggested or put into effect by other nations, including Canada, Australia, and the Nordic region. These include thorough evaluations of PFAS use and environmental discharge and targeted prohibitions on PFAS in food packaging materials. Furthermore, global action on specific PFAS has been made easier by international accords like the Stockholm Convention on Persistent Organic Pollutants.

Consequences of PFAS prohibition on the medical device market

Medical device companies may soon begin to feel the effects of changing laws. Reformulating products to remove or minimize PFAS levels without sacrificing functionality or safety may challenge manufacturers. Businesses may incur more expenses for testing, certification, and maybe even product redesign because of compliance. Finally, if people's awareness and concerns regarding PFAS grow, there may be a danger to one's image among healthcare practitioners and customers.

• Identification and Assessment
• Supply Chain Management
• Reputational Risk
• Regulatory Complexity
• Increased Cost

The skilled scientists and researchers at Battelle have been researching per- and polyfluoroalkyl substances (PFAS) for almost twenty years, and they have created novel approaches to improve PFAS testing, analysis, and elimination. They have put out a list of tactics that medical device manufacturers should consider in advance of industry-wide regulation.

Decos can help determine the potential effects of PFAS regulation on your biocompatibility evaluation and medical device development planning.

References

• https://www.epa.gov/pfas/key-epa-actions-address-pfas
• https://echa.europa.eu/hot-topics/perfluoroalkyl-chemicals-pfas
• https://inside.battelle.org/blog-details/the-impact-of-pfas-regulations-on-the-medical-device-industry
• https://www.federalregister.gov/documents/2024/06/11/2024-12645/pfas-national-primary-drinking-water-regulation-correction
• https://www.mass.gov/info-details/per-and-polyfluoroalkyl-substances-pfas