PFAS ban: Medical care for patients in the EU is at stake
Fluoropolymers are unique high-performance materials. Now they are threatened by a ban, even though there is no alternative for its use in medical technology. Consequently, human lives are at stake. According to the draft for a broad restriction of per- and polyfluoroalkyl substances (PFAS), more than 10,000 different substances are to be banned in the European Union (EU), many of which, however, are indispensable and currently also without alternative in medical technology. It is expected that the ban will take effect as early as 2026 with an 18-month transition period. This regulation would cause massive damage to European medical technology and thereby to patient care with more than 100,000 medical devices – from enormous effects on patient safety and treatment capability to the industry's ability to innovate. In the EU healthcare industry, we only recently had painful experiences with the effects of the Medical Device Regulation (MDR). A PFAS ban as far-reaching as the current proposal would far surpass that.
Reasonable regulation instead of mass banning of entire PFAS substance groups
The more than two-thousand-page long draft was submitted to the European Chemicals Agency (ECHA) in January 2023 by environmental authorities from five EU member states, initiating the start of a restriction process within REACH. This is not a "regular" EU lawmaking process that allows political positioning by the Commission, Council and Parliament, but "secondary legislation" in the so-called committee procedure. The Council and Parliament are only involved at the end of the procedure and only formally. Their right to object is therefore very limited. Europe would be well advised to take a pioneering role in PFAS and work towards a replacement wherever possible. As part of sustainable chemicals regulation, substances that create unmanageable risks due to their properties and use profile should be restricted or regulated based on scientific assessments. However, we as a company and the medical technology industry associations firmly reject broad regulation of entire groups of substances regardless of a proven risk in the use phase.
PFAS ban in EU ignores medical supply security
The Organization for Economic Cooperation and Development (OECD) classifies a subgroup of fluoropolymers that is essential for us as "polymers of low concern". Medical devices must demonstrate a favorable benefit-risk ratio and in addition prove their biocompatibility according to ISO 10993 for those with body contact. The authors of the restriction proposal seem to replace a risk assessment with a risk-unrelated attribute labeling. This attribute is called "persistence”, meaning their durability, longevity, and permanence on and in the human body or environment. Vocal critics therefore dismiss PFAS as “forever chemicals”, but for medical technology, fluoropolymers and fluoroelastomers are high-performance materials that have enabled decisive advances in recent decades – without them, for example, there would be no minimally invasive surgeries today.
From endoscopes to MRIs: the path recommended by ECHA risks human lives
In medical technology, fluoropolymers have been used for decades with a high reliability; they even make modern medicine possible in the first place. Currently, there are generally no substitutes for high-performance applications, which is why quite a few products could no longer be manufactured and consequently used in medicine. These include the fields of: endoscopy, minimally invasive surgery or interventional radiology in general, medical devices such as anesthesia equipment, incubators for newborns, heart-lung or dialysis machines, implants such as pacemakers, stents or joints, but also products with blood contact or packaging for medical devices that are placed on the market in sterile condition. The list is much longer and ranges from surgical aids, sutures, catheters and contact lenses to imaging devices such as MRI, CT or ultrasound.
Use of PFAS exemplified by the minimally invasive resectoscope
291.096 procedures performed in Germany 2021
Fluoropolymer components
1. Movable carriage (white), PTFE bulk material for precise cutting with fine motor control
2. Sleeves, PTFE
3. Sleeves (yellow) for electrical insulation, PTFE, 20kV/mm dielectric strength
4. Sealing rings, FKM
5. The lens coating process requires vacuum machines that depend on PFAS
Medical indications
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Removal of bladder tumors
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Ablation of benign enlarged prostate gland
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Uterus: polyp, myoma, endometrial resection or ablation
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Uterine malformations: metroplasties or septal resections
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Cesarean section scar repair
Too short transition periods and complex exception requests
The way recommended by ECHA to obtain extended transition periods with elaborate supporting documents is uncertain and in no way solves the problems of complex supply chains, lack of alternatives, or the challenge of being able to create evidence on commonly known expertise within six months during the consultation process, given the range of products affected. The resectoscope shown above and many other products would be massively affected. In addition, there is a very short transition period of only 18 months before the ban is to take full effect. This would be completely insufficient with typical development and introduction times of five to ten years. And this only applies if substitute materials were already available. If these are not available as well as validated for medical applications, the period is extended many times over. Extended transition periods are currently provided e.g., for implants, catheters, and tubes.
Initiative against the general prohibition
It is our goal to avert serious harm to patients before it is too late and to achieve regulation that serves people and is not ideologically driven, tearing our society apart and putting the EU out of business in the tough international competition. Through the industry association SPECTARIS and as a company, we have therefore participated in the public consultation and holding numerous discussions at all levels.