In the global push for regulating passfluoroalkyl substances (PFAs), often referred to as “Forever Chemicals,” the growing chorus of scientists and clinicians warn against approaches of all sizes.
Certain small molecule PFAs, such as Perfluorooctanin acid (PFOA) and Perfluorooctanesulfonic acid (PFO), correctly target toxicity and environmental sustainability, but experts emphasize that not all PFAs share these risks.
In particular, one class of fluoropolymers is separated, especially due to their important role in healthcare in the manufacture and performance of advanced medical devices.
Understanding the PFAS spectrum
PFA is a huge family of over 12,000 compounds used in everything from clothing and cooking utensils to electronics and medicines.
However, within this chemical group, the properties differ greatly. While some PFAs are water soluble and environmentally sustainable, they have acquired the Forever Chemicals label, others, such as fluoropolymers, are large, inert and stable materials that do not migrate or classify as harmful by-products.
Nevertheless, many governments and regulators are heading towards a blanket ban, which groups all PFAs into a single regulatory category. This approach to alerting experts warns that critical medical technology can be at risk.
Fluoropolymers in modern medicine
Fluoropolymers are essential in the field of cardiac electrophysiology and beyond.
According to the US Food and Drug Administration (FDA), more than 250,000 approved medical devices incorporate fluoropolymers due to their unique properties, including lubricity, strength, thermal stability, chemical resistance, electrical insulation and long-term biocompatibility.
These properties are not just technical advantages. They allow for life-saving treatment. Fluoropolymers are essential for devices such as:
Pacemaker and implantable defibrillator ablation catheter and vascular sheath brain shunts and heart valves are minimally invasive delivery systems for surgical procedures
These polymers have been safely used for over 50 years, allowing for device miniaturization and long-term reliability, promoting minimally invasive care innovation and improving patient outcomes.
False regulations can threaten the medical supply chain
Recent publications of Heart Rhythm are the official journals of several major electrophysiological associations, and have issued warnings about the unintended consequences of the PFAS Act.
New US, EU and Canada laws are increasingly treating all PFAs as equal threats, ignoring significant differences in chemical structure, behavior and toxicity.
Critically, many fluoropolymer manufacturers have already withdrawn from the market in anticipation of clearing PFA regulations.
This escape poses a real threat to the availability of medical-grade fluoropolymers, potentially disrupting the production and maintenance of essential healthcare devices.
A call for nuance and balance
Clinicians and materials scientists are looking for a more nuanced approach. This is an approach that distinguishes between harmful small molecule PFAs and essential non-toxic fluoropolymers.
Rather than a prohibitive prohibition, experts advocate for target regulation based on scientific evidence and risk assessment.
It’s urgent to strike this balance. Without a clear regulatory distinction, the loss of fluoropolymers can halt innovation, limit access to critical medical technologies, and compromise patient care, particularly in high-accumulation specialties such as cardiac electrophysiology.
Protect your health and the environment
Global concerns about PFA pollution are justified and necessary. However, inability to distinguish between types of PFA puts the future of medical technology at risk.
As medical and regulators move forward, maintaining access to fluoropolymers must be part of a responsible strategy to protect both public health and the environment, experts say.
As life and technology on line progresses rapidly, a balanced science-based approach is essential.
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