In the global push to regulate per- and polyfluoroalkyl substances (PFAS), often referred to as ‘forever chemicals,’ a growing chorus of scientists and clinicians is warning against a one-size-fits-all approach.
While certain small-molecule PFAS, like perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), are rightly targeted for their toxicity and environmental persistence, experts stress that not all PFAS share these risks.
One class in particular, fluoropolymers, stands apart for its critical role in healthcare, especially in the manufacture and performance of advanced medical devices.
Understanding the PFAS spectrum
PFAS are a vast family of over 12,000 compounds used in everything from clothing and cookware to electronics and pharmaceuticals.
But within this chemical group, properties vary widely. While some PFAS are water-soluble and environmentally persistent – earning the forever chemicals label – others, like fluoropolymers, are large, inert, and stable materials that do not migrate or break down into harmful by-products.
Despite this, many governments and regulators are moving toward blanket bans that group all PFAS into a single regulatory category. This approach, experts warn, could jeopardise essential medical technologies.
Fluoropolymers in modern medicine
Fluoropolymers are indispensable in the field of cardiac electrophysiology and beyond.
According to the U.S. Food and Drug Administration (FDA), more than 250,000 approved medical devices incorporate fluoropolymers due to their unique characteristics: lubricity, strength, thermal stability, chemical resistance, electrical insulation, and long-term biocompatibility.
These properties are not just technical advantages; they enable life-saving treatments. Fluoropolymers are integral to devices such as:
- Pacemakers and implantable defibrillators
- Ablation catheters and vascular sheaths
- Brain shunts and cardiac valves
- Minimally invasive delivery systems for surgical procedures
Used safely for over 50 years, these polymers allow for device miniaturisation and long-term reliability, driving innovation in minimally invasive care and improving patient outcomes.
Misguided regulations could threaten medical supply chains
Recent publications in Heart Rhythm, the official journal of several leading electrophysiology societies, raise alarms about the unintended consequences of PFAS legislation.
New laws in the United States, EU, and Canada increasingly treat all PFAS as equal threats, ignoring the vast differences in chemical structure, behaviour, and toxicity.
Critically, many fluoropolymer manufacturers are already exiting the market in anticipation of sweeping PFAS regulations.
This exodus poses a real threat to the availability of medical-grade fluoropolymers, potentially disrupting the production and maintenance of essential healthcare devices.
The call for nuance and balance
Clinicians and materials scientists alike are calling for a more nuanced approach – one that distinguishes between harmful small-molecule PFAS and essential, non-toxic fluoropolymers.
Rather than an indiscriminate ban, experts advocate for targeted regulation based on scientific evidence and risk assessment.
Striking this balance is urgent. Without clear regulatory distinctions, the loss of fluoropolymers could stall innovation, limit access to critical medical technologies, and compromise patient care, particularly in high-stakes specialties like cardiac electrophysiology.
Protecting health and the environment
The global concern over PFAS pollution is justified and necessary. But failing to differentiate between types of PFAS puts the future of medical technologies at risk.
As the medical community and regulators move forward, preserving access to fluoropolymers must be part of any responsible strategy that protects both public health and the environment, experts say.
With lives on the line and technology advancing rapidly, a science-based, balanced approach is imperative.
