Usage of PFAS in the Medical Device Industry and Current Challenges

Per- and polyfluoroalkyl substances (PFAS)-containing materials are currently being used in design and manufacturing of medical device products. PFAS-containing materials are currently and/or at risk of being negatively impacted by increased PFAS regulations, supply constraints, and higher costs. The exit of major suppliers (e.g. 3M, Solvay, and PPG) from the fluoropolymer and medical coatings market are causing medical device companies to initiate significant efforts to qualify substitutions for the many impacted products. We will review how Boston Scientific uses PFAS for many medical device applications, critical material characteristics for each application, and potential impact of PFAS removal to the medical device industry and patient lives. We will also review examples of successful alternative implementations and some cases of substitution regret with highlights of current challenges of non-fluorinated alternatives.