Restriction of PFAS use in medical devices - what next for medical device manufacturers?
Martha Folan1, Matthew Fitzpatrick1, Olivia McDermott1
1College of Science & Engineering, University of Galway, Galway, Ireland.
Introduction:
The 2023 European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations have proposed imposing bans on the family of per- and polyfluoroalkyl substances (PFAS) in use across a multitude of sectors, including medical devices. This study will investigate the proposed PFAS regulations, their impact on the risks associated with PFAS use in general and in devices as well as the challenges that medical device manufacturers face due to the proposed PFAS regulations and the steps they are taking to address PFAS removal.
Areas Covered:
A literature review was conducted to assess the impact of PFAS on the Medtech industry and its customers over the period 2005-2025, utilizing academic databases such as SCOPUS, Web of Science and non-academic databases such as Google.
Expert Opinion:
The impact of global trends, particularly European (EU) REACH legislation, which proposes restrictions and removes PFAS use in medical devices, is both positive for public and environmental health and safety but will cause some uncertainty in terms of compliance and potential unforeseen implications.
Related Concept Videos
Good Manufacturing Practices
Bacterial Signaling
FDA Approved Drugs: Changes to Approved Drugs
Physical Methods for Controlling Microbial Growth: Radiation and Filtration
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Clinical Significance of Antibiotic Resistance


