AIMBE’s Industry Council is leading the charge to highlight the importance of Per- and Polyfluorinated Substances (PFAS) to the medical device industry. These so-called “forever chemicals” are rightfully being scrutinized to protect our health and environment; however, a very small number of these chemicals play critical roles in making sure that our medical devices save tens of millions of patients’ lives. AIMBE hosted a roundtable meeting to gather stakeholders to discuss the use of PFAS in medical devices and how they may be impacted by supply and pending regulatory changes. Perspectives including suppliers/processors of PFAS, medical device companies (users of PFAS), federal agencies (e.g., FDA, NIH, NIST, EPA, etc.), academia, public health, policy, and more were represented. A congressional lunch briefing, hosted by AIMBE, was held on the same topic to educate lawmakers and staffers about the importance of fluorinated polymers to live-saving medical devices. The briefing featured AIMBE Fellows Dr. Kim Chaffin, Medtronic and Dr. William Wagner, University of Pittsburgh.
At the state level, AIMBE Fellows, Dr. Nadine Ding (Abbott) and Dr. Bill Wagner (University of Pittsburgh), presented to the Maine State Chamber of Commerce on the importance of PFAS in medical devices in the context of Maine’s PFAS in Products Law which mandated that manufacturers of products containing intentionally added PFAS disclose their presence to the Department of Environmental Protection (DEP) by January 1, 2023 (later extended to 2025). It also prohibited the sale of such products if they failed to report and set a ban on all products containing intentionally added PFAS starting in 2030, with few exceptions. Drs. Ding and Wagner discussed the impact this law would have on medical devices and patients. Following their impactful comments, on April 16, 2024, Maine Governor Janet Mills approved significant revisions to the PFAS in Products Law. The amendments eliminate the reporting obligation unless the DEP determines that the use of PFAS in the product is deemed “currently unavoidable.” They also remove the deadline for such notification and establish exemptions from the law for specific products containing intentionally added PFAS. Importantly, medical devices were included on the list of exemptions. Click here for more information.
On a national level, new articles published in the Heart Rhythm Journal called for clear distinctions between harmful PFAS compounds and essential fluoropolymers used in life-saving medical devices. AIMBE Fellows Nadine Ding, PhD, Paul Drumheller, PhD, Joyce Wong, PhD, and AIMBE Executive Director, Dawn Beraud, PhD, co-authored two of the featured articles, warning of the consequences to patient care if access to fluoropolymer-containing devices is compromised. Public and legislative efforts increasingly seek to regulate PFAS, often treating them as a single group. However, these articles emphasize that not all PFAS are the same. Fluoropolymers, a specific subclass of PFAS, are non-toxic, non-bioavailable, and critically important to modern medicine, particularly in cardiac electrophysiology. Through these publications, these experts reached a key clinical audience and reinforced the importance of education as a tool for effective advocacy.