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Chemical
USA
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.

Breaking News | Multiple Companies Violate California Proposition 65 Due to Bisphenol S

Recently, the Center for Environmental Health (CEH) in the United States has charged over 50 companies for failing to warn about the exposure risks of Bisphenol S (BPS) in paper receipts as required by California Proposition 65. Notices of violation were issued, and there are plans to sue these companies under Proposition 65. According to this law, businesses that fail to comply with the warning requirements may face severe legal consequences, including but not limited to fines and injunctions. If sued and found in violation, companies could face fines in the hundreds of thousands, resulting in significant financial and reputational damage.