Experts call for nuanced PFAS policy to protect public health and the environment

The public, legislators, and media often group per- and polyfluoroalkyl substances, known as PFAS or “forever chemicals,” which are found globally in countless products, into a single category. While certain PFAS are harmful for human and public health, new articles in Heart Rhythm emphasize that fluoropolymers, a specific class of PFAS, are not considered environmental contaminants and are indispensable for use in medical devices. Experts call for a balanced approach to protect both the environment and availability of essential medical technologies.

PFAS are found in a constellation of products across all sectors of commerce and all parts of the globe. These industries include textiles, aerospace, communications, electronics, pharmaceuticals, energy, and health care.

In their article “The role of per- and polyfluoroalkyl substances in medical devices and delivery systems: Why the electrophysiologist should care,” Heart Rhythm Society member and clinician from the Minneapolis Heart Institute Pierce J. Vatterott, MD, and biomaterial scientists Paul D. Drumheller, Ph.D., Nadine Ding, Ph.D., and Joyce Wong, Ph.D., explain, “Due to their high chemical stability, PFAS are persistent in the environment and certain PFAS have been linked to water contamination, environmental effects, and human disease.

“Two noteworthy substances are the water-soluble, small-molecule compounds perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). These two compounds are considered environmental contaminants by the US Environmental Protection Agency (EPA).”

PFAS encompass more than 12,000 compounds besides PFOA and PFOS and fall into distinct classes that have vastly different chemical, biological, and toxicological properties. One specific class of PFAS—fluoropolymers—are essential to human and public health, especially to cardiac electrophysiology. According to the US Food and Drug Administration, approximately 250,000 approved medical devices contain fluoropolymers.

These fluoropolymers undergo extensive biocompatibility and pre-clinical testing and have not been linked to health issues associated with their long-term use. Fluoropolymers are significantly larger than water-soluble PFAS and are not considered environmental contaminants by the EPA.

Fluoropolymers are critical in all phases of medical device use (e.g., cardiac implantable electronic devices, ablation catheters and sheaths), including their manufacturing process, performance, and delivery within the human body.

Noted expert Roger Carrillo, MD, MBA, FHRS, Chief of Surgical Electrophysiology at Palmetto General Hospital, Miami, emphasizes: “Fluoropolymers play a crucial role in thousands of modern medical devices. Their unique properties have enabled the miniaturization of valves, created slippery surfaces for catheters, and provided the flexibility and electrical insulation essential for components of leads and cardiac pacemakers.

“Unlike smaller PFAS molecules linked to health concerns and water contamination, these large polymers have not been associated with such issues. It is imperative that clinicians understand the important differences within this diverse class of compounds. Dr. Vatterott et al’s contribution in Heart Rhythm provides a concise, detailed, and informative insight into this topic.”

The authors point out, “At present, no other class of materials exists with fluoropolymers’ unique combined properties, including lubricity, biostability, temperature tolerance, strength, flexibility, and electrical insulation. For over 50 years, they have been safely used in medical devices such as brain shunts, cardiac valves, catheters, vascular grafts, pacemakers, and defibrillator systems. Fluoropolymers enable minimally invasive procedures, improve long-term device function, reliability, and allow significant advancements including device miniaturization.”

In the accompanying article “PFAS regulations and the potential impacts on patient care,” the authors highlight key proposed and enacted bans and restrictions, particularly in the US at the federal and state levels, Canada, and the European Union.

“Many legislations seek to regulate these more than 12,000 distinct chemicals as a single class, motivated by the known risks of specific water-soluble, small-molecule compounds, i.e., they do not distinguish between toxic water-soluble small-molecule PFAS and medical fluoropolymers. These efforts are threatening the availability of fluoropolymers even in cases where medical device exclusions are allowed,” notes lead author Paul D. Drumheller, Ph.D., American Institute for Medical and Biological Engineering, Washington, DC.

The authors of the accompanying editorial “What every electrophysiologist should know and worry about,” Kenneth A. Ellenbogen, MD, FHRS, Medical College of Virginia / VCU School of Medicine, Richmond, and Charles D. Swerdlow MD, FHRS, Smidth Heart Institute at Cedars Sinai Medical Center, Los Angeles, say, “Because small-molecule PFAS are toxic, PFAS are increasingly being regulated worldwide; and much legislation does not distinguish between small, toxic molecules and medical fluoropolymers.

“PFAS manufacturers are not waiting for these regulations to take effect. They are exiting the medical fluoropolymer market, threatening the supply chain for all medical products that use fluoropolymers. Thus, these proposed and enacted regulations have important implications for clinical electrophysiologists worldwide. The articles in Heart Rhythm help us better understand the complex issues surrounding PFAS and medical fluoropolymers.”

Dr. Vatterott concludes, “Loss of access to fluoropolymers will have profound negative effects for our patients and on the practice of medicine, especially cardiac electrophysiology. It is critical to find a path that protects our environment but ensures the availability of fluoropolymers that are essential in medical devices, minimally invasive procedures, and drives ongoing innovation in medical technology.”