Understanding the Impact of PFAS "Forever Chemicals" on Medical Devices

In recent years, the presence of per- and poly-fluoroalkyl substances (PFAS), commonly known as "forever chemicals," in medical devices has become a growing concern. Used for their durability, these man-made compounds are integral to many industries, including healthcare. However, their persistence in the environment and potential health risks have prompted increased regulatory scrutiny. 

In this blog, we’ll answer frequently asked questions about the complexities of PFAS in medical devices, exploring their uses, environmental impact, health implications, and the challenges faced by the medical device industry. 

What are PFAS?

PFAS are man-made fluorinated compounds known for their strong carbon-fluorine bonds. These bonds give PFAS unique properties such as thermal and chemical stability, oil and water repellency, heat resistance, durability, lubricity, and biocompatibility. These characteristics make PFAS useful in manufacturing various products across multiple industries, including medical devices.

How do PFAS enter the environment?

PFAS enter the environment through various sources, including chemical production, secondary manufacturing, and via use and disposal of consumer products. Their strong bonds prevent them from breaking down easily, leading to their widespread presence in the environment. PFAS can contaminate many environmental media such as air, groundwater, drinking water, surface water, soil, biosolids, and landfill leachate.

How are people exposed to PFAS?

People are exposed to PFAS through ingestion, dermal contact, and inhalation, primarily via food, water, dust, and consumer products. Drinking water is the primary exposure source, with food and dust as secondary sources.

What are the health risks associated with PFAS exposure?

Not all PFAS are equally harmful. Some PFAS pose higher potential health risks, including immunological, developmental, reproductive, hepatic, hormonal, and carcinogenic effects. Most people have some form of PFAS in their blood, particularly PFOS and PFOA. While research continues to understand the full extent of these risks, the persistence of PFAS in the environment and their bioavailability make them a significant concern.

What medical devices contain PFAS?

PFAS are used in various medical devices, including personal protective equipment (PPE), healthcare equipment like catheters and tubing, surgical devices, and implants like stents and joint replacements. 

What challenges does the medical device industry face?

The increasing public awareness of the impact on human health could affect patient safety and adherence among those with concerns. Obsolescence and supply chain challenges are a concern as some manufacturers discontinue the fluorochemistry business while others may be shifting focus to specific markets. Customer concerns continue to evolve as new demands for PFAS-free products arise. Liabilities associated with environmental releases during manufacturing and waste handling are developing with continued increase in Federal and State regulations.  

Are there any regulations regarding PFAS?

Yes, PFAS regulations have been evolving at both state and federal levels. The EPA's PFAS Strategic Road Map outlines actions to restrict PFAS from entering the environment, remediate contamination, and invest in research. While medical devices may be exempt from some regulations, they are still subject to others, especially concerning hazardous materials or waste management. Over two dozen states have established PFAS regulations, initially focusing on water but now expanding to product regulations.

What impact could PFAS regulation have on the medical device industry?

The medical device industry could face significant impacts from PFAS regulations, including sourcing alternative materials, potential backlogs due to requalification processes, and redesigning existing products. Production processes and tooling may also require redesign and supply chains could be disrupted. Additionally, waste management challenges may arise, requiring analytical testing to determine PFAS presence and certify PFAS-free alternatives.

How can Battelle help?

Battelle offers comprehensive support for navigating PFAS challenges, from evaluating alternative chemistry formulations to chemical analysis and human health exposure studies. With nearly two decades of experience, Battelle provides scalable enterprise-wide vulnerability assessments, technical evaluations, and risk management strategies. Our services include regulatory reviews, litigation risk assessments, and environmental investigation, clean-up, and destruction technologies. 

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