A blanket ban is expected to happen as early as 2026 by the European Union. The target products are complex chemicals called per- and polyfluoroalkyl substances (PFAS). The proposal for this ban was first made in January 2022 at the gathering of EU member states.
Despite the proposal to the European Chemicals Agency (ECHA), reviews are still ongoing. In all likelihood, PFAS will be banned since the same is happening worldwide. It is also expected that this ban will be the most extensive chemical ban in human history.
Since PFAS are considered to be ubiquitous at this point, all industry verticals will be affected in one way or another. This applies even to the medical device manufacturing sector. In this article, we will discuss the incoming PFAS ban in detail, along with its implications for the medical device industry.
What Are PFAS?
We just mentioned the full form of PFAS, so let’s add more context. These include a group of at least 10,000 chemicals out of which only a few have been widely studied. The chemistry of PFAS was first known in the 1930s, but these chemicals have been used for industrialization since the 1940s.
PFAS share a common carbon-fluorine bond which is very tight. In other words, these chemicals are difficult to break down into simpler compounds. This is what makes them resistant to water, oil, and grease. PFAS were mainly used in consumer products like stain-resistant upholstery and non-stick cookware.
They were also widely used in producing Class B firefighting foam in the 1960s. Also known as Aqueous Film Forming Foam, PFAS-based AFFF could easily put out fires caused by liquid fuels like jet fuel.
Why Are PFAS Banned and From When?
The most widely studied chemicals under PFAS are toxic in nature. They are carcinogenic and can also contaminate the environment. What’s worse is that PFAS can indefinitely stay in the soil or the human body.
As a result, they threaten to sever lives and wreak havoc on the environment. This was further proven when hundreds of cases of cancer emerged among firefighters. In 2017, the affected firemen and other military personnel filed an AFFF firefighting foam lawsuit against PFAS manufacturers.
Even municipalities facing underground water contamination issues filed a lawsuit under a separate category for the same. According to TorHoerman Law, the main cancers associated with this litigation include bladder, testicles, and kidney cancer.
What’s interesting about the AFFF litigation is that the chemicals’ toxicity alone did not cause a ban proposal. There are plenty of harmful synthetic chemicals in the world today. What puts PFAS in a class of its own is the fact that it is ubiquitous and ‘forever’ in addition to being toxic.
Studies have found that these chemicals are present practically everywhere. Besides consumer products, even rainwater samples worldwide include PFAS traces. It can be safely assumed that every human being in this world today has some degree of PFAS in their bloodstream. This makes a PFAS ban crucial, which will most likely take place by the end of 2025 or early 2026.
How Does the Medical Device Industry Use PFAS?
In the medical device manufacturing industry, fluoropolymer coatings (having PFAS) are used across a wide range of products. These include contact lenses and catheters. Fluoropolymer coatings are essentially high-performance plastic-like materials that are repellent to heat and abrasions.
They can be similar to the Teflon-like coatings used for non-stick cookware. These coatings do offer some benefits to the medical device industry. They include bio-inertness, high flexibility, and resistance against aggressive sterilization processes.
Also, products like guidewires and catheters need to glide past the vasculature without adhering to the tissue. If not, it would cause much pain to the patient. The smooth gliding is made possible by the low coefficient of friction that fluoropolymer coatings are known for.
What Will Happen Next?
Despite the advantages, the fact remains that PFAS will be banned soon. This means the medical device manufacturing industry must come up with alternatives for fluoropolymer coatings. Some options available for the industry include –
- Silicone hybrid resin, which is also heat-resistant.
- Ultra-high molecular weight polyethylene is a melt-processable resin that is highly resistant to chemicals, abrasion, and friction.
Once the PFAS ban is officially effective, an 18-month transition period may be provided. Some fields may even receive a five-year derogation in case no viable alternatives are currently present. In any case, every industry must start preparing itself for this historic ban with PFAS alternatives.
