This picture demonstrates using fluoropolymers poly(ethylene-tetrafluoroethylene) (ETFE) and polytetrafluoroethylene (PTFE) in frequent cardiac implantable digital gadget (CIED) lead constructions. A. Coaxial pacing lead; B. Coradial pacing lead; C. Lumenless pacing lead; D. Implantable cardioverter-defibrillator (ICD) lead. Credit score: Coronary heart Rhythm / Vatterott et al.
The general public, legislators, and media typically group per- and polyfluoroalkyl substances, referred to as PFAS or “forever chemicals,” that are discovered globally in numerous merchandise, right into a single class. Whereas sure PFAS are dangerous for human and public well being, new articles in Coronary heart Rhythm emphasize that fluoropolymers, a selected class of PFAS, usually are not thought-about environmental contaminants and are indispensable to be used in medical units. Consultants name for a balanced method to guard each the surroundings and availability of important medical applied sciences.
PFAS are present in a constellation of merchandise throughout all sectors of commerce and all elements of the globe. These industries embrace textiles, aerospace, communications, electronics, prescribed drugs, vitality, and well being care.
Of their article “The role of per- and polyfluoroalkyl substances in medical devices and delivery systems: Why the electrophysiologist should care,” Coronary heart Rhythm Society member and clinician from the Minneapolis Coronary heart Institute Pierce J. Vatterott, MD, and biomaterial scientists Paul D. Drumheller, Ph.D., Nadine Ding, Ph.D., and Joyce Wong, Ph.D., clarify, “Because of their excessive chemical stability, PFAS are persistent within the surroundings and sure PFAS have been linked to water contamination, environmental results, and human illness.
“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 embody greater than 12,000 compounds in addition to PFOA and PFOS and fall into distinct courses which have vastly totally different chemical, organic, and toxicological properties. One particular class of PFAS—fluoropolymers—are important to human and public well being, particularly to cardiac electrophysiology. Based on the US Meals and Drug Administration, roughly 250,000 authorised medical units include fluoropolymers.
These fluoropolymers bear intensive biocompatibility and pre-clinical testing and haven’t been linked to well being points related to their long-term use. Fluoropolymers are considerably bigger than water-soluble PFAS and usually are not thought-about environmental contaminants by the EPA.
Fluoropolymers are crucial in all phases of medical gadget use (e.g., cardiac implantable digital units, ablation catheters and sheaths), together with their manufacturing course of, efficiency, and supply throughout the human physique.
Famous knowledgeable Roger Carrillo, MD, MBA, FHRS, Chief of Surgical Electrophysiology at Palmetto Common Hospital, Miami, emphasizes: “Fluoropolymers play an important position in 1000’s of contemporary medical units. Their distinctive properties have enabled the miniaturization of valves, created slippery surfaces for catheters, and supplied the pliability and electrical insulation important for parts 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 level 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.”
Within the accompanying article “PFAS regulations and the potential impacts on patient care,” the authors spotlight key proposed and enacted bans and restrictions, significantly within the US on the federal and state ranges, 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 writer Paul D. Drumheller, Ph.D., American Institute for Medical and Organic Engineering, Washington, DC.
The authors of the accompanying editorial “What every electrophysiologist should know and worry about,” Kenneth A. Ellenbogen, MD, FHRS, Medical School of Virginia / VCU Faculty of Drugs, Richmond, and Charles D. Swerdlow MD, FHRS, Smidth Coronary heart Institute at Cedars Sinai Medical Middle, Los Angeles, say, “As a result of small-molecule PFAS are poisonous, PFAS are more and more being regulated worldwide; and far laws doesn’t distinguish between small, poisonous 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.”
Extra info:
The position of per- and polyfluoroalkyl substances in medical units and supply programs: Why the electrophysiologist ought to care, Coronary heart Rhythm (2025). DOI: 10.1016/j.hrthm.2025.05.057
Quotation:
Not all ‘ceaselessly chemical compounds’ are equal: Consultants name for nuanced PFAS coverage to guard public well being and the surroundings (2025, July 14)
retrieved 14 July 2025
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