PFAS In Medical Devices: Expert Insights On Frequently Asked Questions

Shalene Thomas, R.E.P, SR. Emerging Contaminants Program Manager

Shalene Thomas, Senior Emerging Contaminants Program Manager at Battelle, recently hosted a webinar, PFAS in Medical Devices: Ask an Expert, to address key questions about PFAS (Per- and Polyfluoroalkyl Substances) in medical devices. With over 25 years of experience in consulting, including 16 years specializing in PFAS management, she guides companies in meeting evolving legislation.

PFAS, a family of chemicals divided into non-polymers and polymers, are used in various medical devices, including packaging, tubing, and coatings. Non-polymers, like PFOA and PFOS, are persistent, bioaccumulative, and toxic, raising environmental and health concerns. Polymers, such as PTFE, are more stable but increasingly regulated. PFAS are also used in sterilization processes and imaging agents. Environmental risks stem from PFAS emissions during manufacturing, usage, and disposal. Testing methods vary, from basic fluorine detection to advanced screening techniques.

Phasing out PFAS depends on device risk classifications. While lower-risk devices may transition to PFAS-free alternatives, essential, higher-risk devices face challenges in finding substitutes. Research on PFAS health risks and regulatory actions has intensified, influencing future safety standards.

Resources like the Interstate Technology Regulatory Council (ITRC) and PFAS Project Lab provide updates on legislation and management strategies. Organizations are advised to start with vulnerability assessments, prioritizing non-polymers due to their higher risk. A risk-based framework helps manage emerging chemicals effectively. Battelle offers guidance on PFAS product stewardship and compliance for medical device companies.