Navigating PFAS “Forever Chemicals” in Medical Devices

Per- and poly-fluoroalkyl substances (PFAS), "forever chemicals," are man-made fluorinated compounds. They are known for their strong carbon-fluorine bonds and unique properties, such as thermal and chemical stability, oil and water repellency, heat resistance, durability, lubricity, and biocompatibility. These properties make them essential in the manufacturing of various products across multiple industries.

However, their persistence in the environment and potential health risks have led to regulatory actions affecting various sectors, including the medical device industry.

The PFAS Family

PFAS encompasses thousands of chemicals, leading to debates about what constitutes this family of constituents. PFAS can be divided into two main classes: non-polymers (such as perfluorooctanoic acid, or PFOA) and polymers (such as Polytetrafluoroethylene, PTFE, or Teflon).

Non-polymers, often used in the manufacturing of polymers, are primarily detected in the environment and are bioavailable, making them a concern for human health and the environment. Until recently, the focus has been on the non-polymer side of the PFAS family from a human health perspective.

The inclusion of polymers in PFAS discussions began when addressing PFAS in products. There is ongoing discussion about whether polymers should be grouped with non-polymers as they are less bioavailable. This understanding is crucial when evaluating the increasing legislation at state, federal, and international levels and demonstrating compliance with these laws.

Polymers are large molecules formed by combining identical smaller molecules (monomers) in a repeating pattern. Fluoropolymers such as PTFE, FEP (Fluorinated Ethylene Propylene), ETFE (Ethylene Tetrafluoroethylene), and PFA (Perfluoroalkoxy) are sometimes referred to as "polymers of low concern" because they have high molecular weight, are extremely stable, and pose little environmental or health risk once in a consumer product. Like PTFE, some polymers are not bioavailable. Therefore, it is suggested that "polymers of low concern" should be evaluated separately from other PFAS when assessing risk.

PFAS in the Environment

PFAS are widely used and due to their strong bonds, they do not break down easily, leading to their ubiquitous presence in the environment. They enter the environment through various sources, including chemical producers, secondary manufacturing, and the use and disposal of consumer products.

Once released, PFAS can contaminate the air, soil, and water. They are not typically treated and can cycle through the environment, ending up in groundwater, drinking water, surface water, biosolids, and landfill leachate. They can transform into terminal dead-end products like PFOS and PFOA, which pose significant human health and regulatory concerns.

People are exposed to PFAS through ingestion, dermal contact, and inhalation due to exposure to food, water, dust, soil, and consumer products. The primary exposure has been through drinking water, with food and dust being secondary sources.

Extensive research has been conducted to understand the potential adverse health effects of different types of PFAS, which can include immunological, developmental, reproductive, hepatic, hormonal, and carcinogenic effects. However, more research is needed to fully understand the exposures to and health effects from PFAS. Most people have a form of PFAS in their blood, particularly PFOS and PFOA.

Industry Challenges

The medical device industry faces three main challenges when managing PFAS:

1. Inconsistent regulations and standards, or their absence
2. Oversimplifying PFAS as a class. PFAS are not, and should not be, treated equally
3. Lack of alternatives or substitutions, posing significant challenges, particularly for essential uses

When assessing PFAS across your organization, it's crucial to consider these challenges. Understanding PFAS and their relevance to your industry can be complex, so it's important to distinguish between general information and what specifically matters to your organization. Each of these challenges should be examined in more detail.

Regulatory Focus

Federal Level

PFAS regulations have been evolving for the last 10 years or more at the State-level and have only been gaining momentum in recent years at the Federal level.

The EPA (Environmental Protection Agency) published the PFAS Strategic Road Map that restricts PFAS from entering the environment, remediating PFAS contaminating environments, and investing in research to better understand analytical methods, human and ecological risk, and treatment technologies. ​

The EPA has committed to 25 actions across five different federal offices and six cross-program actions from 2021 to 2024. PFAS regulations have now impacted almost all EPA regulatory programs, from chemicals entering commerce and affecting products, to environmental releases and reporting at operational facilities, to the cleanup of historical and legacy releases.

Medical devices are not exempt from all EPA rules. While certain activities related to medical devices may be excluded from specific regulations under the Toxic Substances Control Act (TSCA) ¹, they can still be subject to other EPA regulations, especially if they involve hazardous materials or waste management.

State Level

States have had evolving PFAS regulations across environmental and product categories. Currently, over two dozen states have established PFAS regulations, initially focusing on water, responding to environmental releases, and drinking water impacts but transitioning more recently to product regulations.

A couple states, such as Minnesota and Maine, are broadly including all products in their regulations and specifically requiring reporting of PFAS in products, even in essential uses, such as in medical devices, by 2032. Companies will need to understand specific PFAS uses and advocate for exemptions with regulators.

Medical Device Industry Impact

As understanding and awareness of PFAS increase, so does the pressure for PFAS-free product alternatives. While not an exhaustive list, we have identified three key areas where the medical device industry could feel the impact.

Product

• Sourcing alternative materials
• Potential backlog due to requalification processes
• Development of new products and redesigning existing ones

Production

• Process and tooling redesign
• Potential disruption in the supply chain

Waste

• Handling and management of hazardous waste by users and patients

At each step, there will be demand for analytical testing facilities and services to determine PFAS presence, define and certify PFAS-free, and testing of alternative chemistries and materials.

How Battelle Can Help

From evaluating alternative chemistry formulations to chemical analysis and human health exposure studies to environmental investigation, clean-up, and destruction technologies, Battelle has supported clients across the life cycle for almost two decades.

Battelle offers scalable enterprise-wide vulnerability assessments to evaluate PFAS from a technical, functional, and business perspective, resulting in a strategic framework for both status and outlook. The assessment involves:

• Technical evaluation: current hazards, risks, and potential environmental impacts
• Functional evaluation: existing products and potential alternatives, as well as supply chain
• Business evaluation: regulatory reviews, litigation, and reputation risks to inform a risk management strategy

We are here to help clients understand the regulations and address concerns across the product lifecycle, from analysis to action. Battelle has provided a suite of services for PFAS risk mitigation and management, treatment, and alternative assessment since 2007.

To learn more about PFAS in medical devices, register for our “PFAS in Medical Devices: Ask the Expert” webinar featuring Shalene Thomas, or connect with our experts today.

Featured Expert

Shalene Thomas, R.E.P

Sr. Emerging Contaminants Program Manager

Shalene provides thought leadership, drives R&D and service offerings for Battelle’s growing PFAS and other potential emerging contaminant programs. She has more than 25 years of experience in environmental consulting that includes 15 years of experience providing PFAS strategic management services to government and commercial clients.

Sources:

1.  tsca-8a7-jan-2024-webinar.pdf