Per- and Polyfluoroalkyl Substances (PFAS) are persistent, toxic chemicals used in industries like MedTech for their resistance and biocompatibility. Recent regulations in the EU and the US seek to restrict PFAS, creating compliance and supply chain challenges for medical device manufacturers. Agencies such as ECHA and EPA are introducing strict limits, though some medicinal and biocidal products are exempt. The release of PFAS during manufacturing and disposal raises significant health and environmental concerns, prompting increased regulatory and public scrutiny.

Restrictions significantly impact MedTech because PFAS are vital to device performance, yet alternatives remain limited and supply chains are disrupted. While fluoropolymers (a PFAS subgroup) are more stable, their breakdown can produce harmful byproducts. The industry is responding by assessing products, engaging supply chains and developing PFAS-free solutions, but this transition is complex and resource-intensive.

Lifecycle Assessment frameworks are being created to evaluate PFAS impacts and companies like HCLTech are helping MedTech clients identify PFAS and find safer alternatives using advanced technologies. The EU’s restrictions have global implications, underscoring the urgent need for effective substitutes in the medical sector.

Our latest whitepaper outlines the environmental and health concerns associated with PFAS, emphasizing their release during manufacturing, use and disposal. It also details the industry's response, including the assessment of product portfolios, engagement with supply chains and research into sustainable alternatives.

Download the whitepaper now!