Document 8V9NkKgZv6gQx7O97KKYqDB0K

Athens, 22 September 2023 To whom it may concern Submission of Evidence of the Hellenic Urological Association regarding the proposed PFAS restriction. Ladies and gentlemen, the Hellenic Urological Association represents around 1.500 Greek Urologists. After consultation with representatives of the medical device industry, we express severest concerns about the proposed and far reaching European PFAS restriction proposal. Short term action has to be taken to stop foreseeable, irresponsible impact on clinical and medical care in general. Micromanagement with a multitude of fine-granulated additional derogations will end in "regrettable legislation" missing unexpected situations. This seems inevitable due to the highly complex supply chains from base material production via multiple intermediates (semifinished product producers, manufacturers, medical device industry, dealers) to us as the professional end-users. We as medical professionals need to be extremely precautious not to lose any diagnostics, treatment, or surgery without clinically and technically proven alternative. Patient safety and performance must not be compromised by introducing materials that are deemed to be adequate substitutes. Generally speaking, Europe would be well advised to take a pioneering role with respect to PFAS and to work on replacement with innovations wherever possible. In the context of sustainable chemicals regulation, substances that pose unmanageable risks due to their properties and use profile should be restricted or regulated based on scientific assessments. However, we as the Hellenic Urological Association strongly oppose the broad regulation of entire groups of substances even regardless of any proven risk during their use-phase. OECD1 defines criteria for polymers of low concern and concludes: "Polymers of low concern are those deemed to have insignificant environmental and human health impacts. Therefore, these polymers should have reduced regulatory requirements." Henry1 and others have further investigated many fluoropolymers and clearly regard them as "Polymers of low concern". Medical devices must prove a favorable risk-benefit ratio and those with body contact additionally have to prove their biocompatibility according to ISO 10993. The authors of the restriction proposal seem to replace a risk assessment by attribute-labeling. The labeled attribute is "persistence" which means their durability, their longevity and resistance on and in the human body or the environment. 1 OECD Environment, Health and Safety Publication (2008), Data analyses of the identification of the correlations between polymer characteristics and potential for health or ecotoxicological concern. 2 Barbara J Henry et al. (2018), A Critical Review of the Application of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers; Integrated Environmental Assessment and Management; Volume 14, Issue 3. The property "persistence" is inevitably required for our high-end medical applications. It is completely unsuitable as the foundation of a restriction1. Anderson, Brecher, Cousins, et.al1 conclude "...that `all PFAS' should not be grouped together, persistence alone is not sufficient for grouping PFAS for the purposes of assessing human health risk, and that the definition of appropriate subgroups can only be defined on a case-by-case manner." Persistence is even required for any future replacement material which is not even seen on the scientific horizon for our demanding and often life-saving applications. Why do we need persistent materials for medical devices? - Reusable surgical instruments need to be autoclave-stable and absolutely chemically inert w.r.t. cleaning and sterilization chemicals. - All medical devices in body contact need to be biocompatible which fluoropolymers prove to be. - Electrosurgical medical devices need high disruptive strength and high kreep resistance. - Fine motor articulation and movements need lowest possible friction coefficients. - Catheters and other implants may not stick with the body to allow gentle removal, for long-term-implants additionally decade-long biostability is key where there is plenty of experience with existing fluoropolymers. - Many medical devices are high value investment goods that have long lifetimes; investment goods need service which is not considered at all. - Many medical devices need a combination of the unique properties of certain PFAS. - Only persistent materials enable complex equipment with sealings, bearings, lubrication. According to our aggregated expert opinion as the Hellenic Urological Association we strongly endorse the following statements: 1. Fluoropolymers are used in medical care and surgery since more than six decades. 2. To our knowledge, fluoropolymers like Teflon and Fluoroelastomers like Viton are clinically used without any relevant negative health issue. 3. The following procedures will no longer be available (without claim to completeness): - Any surgery requiring anesthesia and / or ventilation. - Any minimally invasive procedure and endoscopy not limited to cystoscopy, resection, ureteroscopy, or laparoscopy (in- and out-patient settings, with and without anesthesia), including products like: o any type of endoscope (rigid, flexible, semirigid, optical or electronic imaging) 3 PFAS restriction proposal, p. 23: "... the role of persistence in decision making as the most important criterion or only property to justify regulation." 4 Regulatory Toxicology and Pharmacology 134 (2022) 105226 o trocars, obturators, sealings o instruments like resectoscopes, knot pushers, scissors, forceps, punches, cytology brushes, dilators, hooks, retractors. - Any type of electrosurgery (open or minimally invasive). - Any type of Laser-surgery (open or minimally invasive). - Any type of robotic surgery. - Any type of dialysis. - Any type of imaging technology like MRT, CT, ultrasound. - Oncological and other laboratory diagnostics involving e.g. microscopes (H&E sections) or chromatography (used e.g. for the determination of tumor markers) - Reproductive medicine with instruments or cryogenic equipment. - Any type of treatment or diagnostics involving electronics. - Many types of implants or catheters. - Special types of sutures, wound dressing, products with blood contact or packaging for medical devices placed on the market in sterile condition. European numbers for some of the main urological treatments in Europe total to 2,968,546 (2023) Interventional Stone Urinary Prostate Nephrostomy Erectile BPH Management Incontinence Cancer Procedures Dysfunction Procedures Procedures Procedures Treatment Management Procedures Procedures 375,765 1,543,374 50,385 902,424 92,156 4,443 Source: iData Research 2022 - Europe Market Report Suite for Urological Devices: with Impact of Covid-19; Geography: Germany, France, U.K., Italy, Spain, Benelux, Scandinavia, Austria, Switzerland and Portugal In addition, Cystoscopies, which are mainly diagnostic, sum up to 970,384 (2023) Source: iData Research 2022 - Global Market Report Suite for Single-Use Endoscopes; Geography: Germany, France, U.K., Italy, Spain, Scandinavia Even if for very selected products (e.g. implants, catheters) extended transitional periods of 5-12 years are foreseen in the proposal, we as clinicians have to obeying the precautionary principle and without any proven material-related risk, we cannot accept any phase-out of any instrument related to PFAS before a validated and clinically accepted replacement is available. We need to reverse the selected order: First proven, safe and durable (persistent) alternatives, then reasonable transition periods and phase out. By now we cannot foresee at all the cost of the intended change. Anyhow the burden for the healthcare system, the taxpayer and the population will be tremendous. The fact that legally binding secondary law can cause such severe distortions in the healthcare system, in our view, needs to be urgently addressed by top-level European policy makers. We need crystal-clear political signs that this scenario is not the position of the European Union, this proposal neither. Otherwise, industry will walk away from Europe, with every day no clear decision is taken. Specialized healthcare services in the EU might also be phased-out, with non-EUregions taking advantage of that. This is not just an early phase of the dossier, with subsequent adjustments to be expected. This type of legislative proposal is in its described parts lifethreatening to the population of the Union. Sincerely, Evangelos Liatsikos Chairman of HUA Georgios Zoupanos General Secretary