The general public, legislators, and media usually group per- and polyfluoroalkyl substances, referred to as PFAS or “without end chemical substances,” 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, aren’t thought of environmental contaminants and are indispensable to be used in medical gadgets. Specialists name for a balanced method to guard each the atmosphere 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, power, and well being care.
Of their article “The position of per- and polyfluoroalkyl substances in medical gadgets and supply techniques: Why the electrophysiologist ought to 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, “As a consequence of their excessive chemical stability, PFAS are persistent within the atmosphere 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 thought of environmental contaminants by the US Environmental Safety Company (EPA).”
PFAS embody greater than 12,000 compounds apart from PFOA and PFOS and fall into distinct lessons which have vastly completely different chemical, organic, and toxicological properties. One particular class of PFAS—fluoropolymers—are important to human and public well being, particularly to cardiac electrophysiology. In accordance with the US Meals and Drug Administration, roughly 250,000 accepted medical gadgets 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 aren’t thought of environmental contaminants by the EPA.
Fluoropolymers are essential in all phases of medical system use (e.g., cardiac implantable digital gadgets, ablation catheters and sheaths), together with their manufacturing course of, efficiency, and supply throughout the human physique.
Famous professional Roger Carrillo, MD, MBA, FHRS, Chief of Surgical Electrophysiology at Palmetto Normal Hospital, Miami, emphasizes: “Fluoropolymers play an important position in 1000’s of recent medical gadgets. Their distinctive properties have enabled the miniaturization of valves, created slippery surfaces for catheters, and offered the pliability and electrical insulation important for elements of leads and cardiac pacemakers.
“In contrast to smaller PFAS molecules linked to well being considerations and water contamination, these massive polymers haven’t been related to such points. It’s crucial that clinicians perceive the vital variations inside this various class of compounds. Dr. Vatterott et al’s contribution in Coronary heart Rhythm offers a concise, detailed, and informative perception into this subject.”
The authors level out, “At current, no different class of supplies exists with fluoropolymers’ distinctive mixed properties, together with lubricity, biostability, temperature tolerance, energy, flexibility, and electrical insulation. For over 50 years, they’ve been safely utilized in medical gadgets akin to mind shunts, cardiac valves, catheters, vascular grafts, pacemakers, and defibrillator techniques. Fluoropolymers allow minimally invasive procedures, enhance long-term system operate, reliability, and permit vital developments together with system miniaturization.”
Within the accompanying article “PFAS laws and the potential impacts on affected person 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 search to manage these greater than 12,000 distinct chemical substances as a single class, motivated by the identified dangers of particular water-soluble, small-molecule compounds, i.e., they don’t distinguish between poisonous water-soluble small-molecule PFAS and medical fluoropolymers. These efforts are threatening the provision of fluoropolymers even in circumstances the place medical system 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 each electrophysiologist ought to know and fear about,” Kenneth A. Ellenbogen, MD, FHRS, Medical School of Virginia / VCU Faculty of Medication, Richmond, and Charles D. Swerdlow MD, FHRS, Smidth Coronary heart Institute at Cedars Sinai Medical Heart, 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 producers aren’t ready for these laws to take impact. They’re exiting the medical fluoropolymer market, threatening the provision chain for all medical merchandise that use fluoropolymers. Thus, these proposed and enacted laws have vital implications for scientific electrophysiologists worldwide. The articles in Coronary heart Rhythm assist us higher perceive the advanced points surrounding PFAS and medical fluoropolymers.”
Dr. Vatterott concludes, “Lack of entry to fluoropolymers may have profound damaging results for our sufferers and on the apply of medication, particularly cardiac electrophysiology. It’s essential to discover a path that protects our surroundings however ensures the provision of fluoropolymers which can be important in medical gadgets, minimally invasive procedures, and drives ongoing innovation in medical expertise.”
Extra info:
The position of per- and polyfluoroalkyl substances in medical gadgets and supply techniques: Why the electrophysiologist ought to care, Coronary heart Rhythm (2025). DOI: 10.1016/j.hrthm.2025.05.057
Quotation:
Not all ‘without end chemical substances’ are equal: Specialists name for nuanced PFAS coverage to guard public well being and the atmosphere (2025, July 14)
retrieved 14 July 2025
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