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USA
PFAS
Chemical
PFAS Regulatory Wave: Compliance Challenges & Solutions for Medical Devices

Per- and Polyfluoroalkyl Substances (PFAS), commonly known as "forever chemicals", feature extremely stable carbon-fluorine bonds, high bioaccumulation potential and suspected endocrine disrupting properties, leading to stringent regulatory restrictions worldwide. According to OECD statistics, the PFAS family comprises over 10,000 substances. Fluoropolymers including Polytetrafluoroethylene (PTFE), FEP, PFA, PVDF and PCTFE are widely applied in cardiovascular catheters, implant coatings, pacemaker wire insulation, as well as sterile high-barrier packaging for medical devices.

US EPA New Rules: Strengthening Control of Persistent Chemicals PFAS

On September 28, 2023, U.S Environmental Protection Agency (EPA) announced an important new rule under the Toxic Substances Control Act (TSCA), requiring manufacturers of per- and polyfluoroalkyl substances (PFAS) to provide more data for better regulation. PFASs are a large class of chemically stable organic fluorides known for their water and stain resistance, as well as good insulation. They find extensive use in various industrial sectors, including food packaging, electronics, leather and apparel, construction and household applications, firefighting, and medical supplies. However, PFASs are persistent and migrate in the environment, making them difficult to degrade. They are also called persistent chemicals and have posed a significant threat to human health and the ecological environment.