A Closer Look: The Impact Of PFAS Regulations On The Medical Device Industry
By Shalene Thomas, R.E.P, Sr. Emerging Contaminants Program Manager, Battelle

The medical device industry is currently facing a significant challenge as regulations and scrutiny surrounding the use of Per- and Polyfluoroalkyl Substances (PFAS) increase. PFAS have long been utilized in medical device manufacturing due to their desirable properties. However, concerns about their persistence in the environment and potential health risks have prompted global regulatory actions.
Both the United States and the European Union have implemented regulations to restrict the use of PFAS, and as a result, the medical device industry is feeling the impact. Companies are now faced with the need to reformulate their products to reduce or eliminate PFAS content. This process could potentially increase costs and pose reputational risks.
To successfully navigate these regulations, medical device companies must take a proactive approach. This includes conducting thorough product assessments to identify PFAS content, investing in research and development for PFAS-free alternatives, ensuring transparency within their supply chains, engaging with regulators, and educating stakeholders.
By adopting a strategic approach and embracing these necessary measures, the medical device industry can transform these regulatory challenges into opportunities for innovation and growth. Though the road ahead may be challenging, it is crucial for companies to adapt and evolve in order to thrive in this changing landscape.
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