Since the publication of the PFAS restriction proposal by ECHA, there has been much commentary in all affected industries, including the medical device industry. In fact, you can read more about what is being proposed here.
Comments were welcomed from both the general public and private organizations on the content of the proposal, and an overwhelming amount of feedback was submitted to ECHA. Thousands of these comments are available on the ECHA website.
One common theme found in much of the feedback related to medical devices is on the topic of Fluoropolymers. Fluoropolymers are a subset of PFAS, made up of fluorine-carbon bonds.
Image 1: One of the thousands of comments on Fluoropolymers.
What are people saying about Fluoropolymers?
Many believe that the use of these substances in particular should be excluded from the restriction. Fluoropolymers are widely considered to be of low concern. Without conducting a benefit-risk analysis for each substance, or on each PFAS use it’s easy for the alleged low risk of Fluoropolymers to be overlooked. However, in spite of the mammoth task that an individualized approach would entail, the blanket approach being proposed isn’t necessarily the best course of action.
Image 2: As one commenter notes, fluoropolymers have unique properties that distinguish them from other PFAS.
The use of Fluoropolymers in manufacturing is expensive. They are costly substances and in many cases, it’s been attempted by manufacturers in the past to find viable alternatives to their use, in an effort to cut costs. PFAS concerns aside, it therefore seems that if it were possible to find suitable alternatives, this would already have been done.
Image 3: Does the ban on fluoropolymers contradict the principles of Hippocrates’ Oath?
Additionally, it’s argued by some that the disposal of products manufactured using Fluoropolymers is safe. Specific to medical devices, these products are generally incinerated after their use, limiting contact with soil and water and therefore environmental contamination. What’s more, the durability of Fluoropolymers could be seen as an environmental advantage. Their longevity means that frequent replacement and consequently further production of substances is reduced.
Our take?
The volume of feedback submitted to ECHA on this topic will be hard to ignore. The comments are currently under review, but it remains to be seen however whether a revision of the existing proposal will be published. Regardless of whether Fluoropolymers will benefit from the blanket exemption that is being called for by many, it does seem that the restriction on certain uses should be reconsidered to avoid resulting harsh and dangerous socio-economic consequences.
The next steps
Need help understanding what PFAS restrictions mean for your organisation? Our team provides seamless guidance on viable alternatives, sustainability strategy, supply chain impacts, stakeholder management and regulatory obligations, allowing for effective PFAS phase-outs that don’t compromise care standards or
market access. Book your free, no-obligation consultation by emailing the team directly at info@trinzo.com, calling us at +353 (0) 91 394 804, or visiting our Contact Us page.
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