Document ym7m3Mz5Jq17L90xbvEJybLRr

** * 41.1.1 CONFEDERATION OF `op EUROPEAN ORL-HNS President Prof Per Caye-Thomasen, professor, consultant Dpt. of ORL-HNS, Copenhagen University Hospital Rigshospitalet. Copenhagen, Denmark @regionh.dk President-Elect Prof Jan Plzak, MD., PhD Head of Dpt. of ORL-HNS, ist Faculty of Medicine, Charles University. Motol University Hospital Prague, Czech Republic fnmotol.cz Secretary General Dr Elisabeth V Sjegren, MD PhD Dpt. of Otolaryngology -- HNS, Leiden University Medical Centre Leiden, The Netherlands Iumc.nl Secretary General-Elect Assoc. Prof Miroslav Tedla MD, MPH, PhD Dpt. of ORL-HNS, Comenius University, University Hospital Bratislava, Slovakia gmail.com Treasurer Prof Tomislav Baudoin, MD, PhD, FEBEORL-HNS (Hon) Head - Referral Center of Pediatric ORL. Dpt. of ORL-HNS Sisters of Mercy University Medical Center Zagreb, Croatia gmail.com Treasurer-Elect Assoc. Prof Elisabetta Zanoletti MD, PhD Otolaryngology Section University Hospital of Padova Padua, Italy @unipd.it Congress President 2024 Prof John Russell MB,BSc,MCh, FRCSI,FRCS (ORL) Dpt. of Paediatric Otolaryngology, Childrens Health Ireland (Crumlin) Dublin, Ireland =drjrussellent.com Congress President 2026 Prof Ann Hermansson MD, PhD Dpt. of ENT, University Hospital of Lund Lund, Sweden med.lu.se Past President Prof Cem Meco, MD, FEBORL-HNS Dpt. of ORL-HNS, Ankara University Medical School, Ankara, Turkey Dpt. of ORL-HNS, Paracelsus Medical University, Salzburg, Austria @gmail.com; salk.at Senior Counsellor Prof Manuel Bernal-Sprekelsen Hospital Clinic. University of Barcelona Medical School, Barcelona Spain @clinic.cat Senior Counsellor Prof Marc Remacle Director Voice and Swallowing Center Dpt. of ORL-HNS, CHL-Eich. Luxembourg chl.lu UEMS ORL Representative Mr Adrian M. Agius President of UEMS-ORL. Senior Lecturer at the University of Malta stannesclinic.com EBEORL-HNS Representative Mr Ricard Simo FRCS (ORL-HNS) PhD Vice Chairman EBEORL-HNS Department of ORL-HNS, Head and Neck Cancer Unit. Guy's and St Thomas' Hospital NHS Foundation Trust, London United Kingdom cloud.com Confederation of European Otorhinolaryngology -- Head & Neck Surgery Vienna, September 21st 2023 To whom I may concern, As President and General Secretary of the Confederation of European Otohinolaryngology and Head and Neck Surgery (CEORL-HNS) we are writing to you on behalf of our Presidential Council to voice our concerns regarding the proposed wide ranging "restriction on the manufacturing, placing on the market and use of per- and polyfluoroalkyl substances (PFAS)" in Europe. The CEORL-HNS is the European umbrella organization for the medical field of otorhinolaryngology (i.e. ear-nose and throat (ENT)) -- and head and neck surgery. As such we represent all the national and subspecialty ENT societies in Europe, corresponding to more than 35.00o health professionals. While we realize the need for continuous monitoring and improvement of health and environmental rules and regulations in Europe, both inside and outside the medical field, we want to express our concern that the intended restriction in its current form will have far reaching and unintended harmful consequences for the availability of a range of crucial medical devices in the field of otorhinolaryngology and head and neck surgery as well as other medical specialties in the near future. We want to reiterate the standpoint already expressed by other parties in our field that a ban on all types of fluoropolymers without thoroughly considering their individual characteristics and toxicity profiles could lead to an acute shortage of critical medical devices such as ventilation tubes, tracheostomy tubes, terminal for monopolar and bipolar coagulation and rigid and flexible endoscopes -- all essential in both acute, life-threatening situations and in daily care. This in turn may lead to unnecessary morbidity and/or mortality and even longer waiting lists in routine care. Additionally, it will almost certainly lead to a sharp rise in medical costs as new substances will have to be developed and go through years of testing procedures. Business Address Mondial Congress & Events * Ms. Gloria Casanova * Operngasse 20b * 1040 Vienna, Austria * ceorl-hns.org * www.ceorlhns.org * ZVR-Zahl 344666629 ** * OWE CONFEDERATION OF `op EUROPEAN ORL-HNS President Prof Per Caye-Thomasen, professor, consultant Dpt. of ORL-HNS, Copenhagen University Hospital Rigshospitalet. Copenhagen, Denmark @regionh.dk President-Elect Prof Jan Plzak, MD., PhD Head of Dpt. of ORL-HNS, ist Faculty of Medicine, Charles University. Motol University Hospital Prague, Czech Republic fnmotol.cz Secretary General Dr Elisabeth V Sjogren, MD PhD Dpt. of Otolaryngology -- HNS, Leiden University Medical Centre Leiden, The Netherlands Iumc.nl Secretary General-Elect Assoc. Prof Miroslav Tedla MD, MPH, PhD Dpt. of ORL-HNS, Comenius University, University Hospital Bratislava, Slovakia gmail.com Treasurer Prof Tomislav Baudoin, MD, PhD, FEBEORL-HNS (Hon) Head - Referral Center of Pediatric ORL. Dpt. of ORL-HNS Sisters of Mercy University Medical Center Zagreb, Croatia gmail.com Treasurer-Elect Assoc. Prof Elisabetta Zanoletti MD, PhD Otolaryngology Section University Hospital of Padova Padua, Italy @unipd.it Congress President 2024 Prof John Russell MB,BSc,MCh, FRCSI,FRCS (ORL) Dpt. of Paediatric Otolaryngology, Childrens Health Ireland (Crumlin) Dublin, Ireland =drjrussellent.com Congress President 2026 Prof Ann Hermansson MD, PhD Dpt. of ENT, University Hospital of Lund Lund, Sweden med.lu.se Past President Prof Cem Meco, MD, FEBORL-HNS Dpt. of ORL-HNS, Ankara University Medical School, Ankara, Turkey Dpt. of ORL-HNS, Paracelsus Medical University, Salzburg, Austria @gmail.com; salk.at Senior Counsellor Prof Manuel Bernal-Sprekelsen Hospital Clinic. University of Barcelona Medical School, Barcelona Spain @clinic.cat Senior Counsellor Prof Marc Remacle Director Voice and Swallowing Center Dpt. of ORL-HNS, CHL-Eich. Luxembourg chl.lu UEMS ORL Representative Mr Adrian M. Agius President of UEMS-ORL. Senior Lecturer at the University of Malta stannesclinic.com EBEORL-HNS Representative Mr Ricard Simo FRCS (ORL-HNS) PhD Vice Chairman EBEORL-HNS Department of ORL-HNS, Head and Neck Cancer Unit. Guy's and St Thomas' Hospital NHS Foundation Trust, London United Kingdom cloud.com Confederation of European Otorhinolaryngology -- Head & Neck Surgery We would therefore urge the committee to perform separate and detailed evaluations of all subtypes of PFAS used in medical devices to ensure that these subtypes, that have already gone through years of rigorous testing and approval procedures, are not being restricted needlessly or unintendedly. Again, we support the statement of others in our field that such a nuanced approach would allow for the identification of any genuinely hazardous PFAS while still allowing the use of those that have a proven safety record. This approach aligns with the principle of evidencebased decision- making, ensuring that regulations are founded on scientific research and in the best interests of patient care. We hope that you will grant due weight to our concerns, and we remain at your disposal for further detailing of the potential impact the intended restrictions on patients in our medical field. Yours faithfully, Per Caye-Thomasen CEORL-HNS President Elisabeth V. Sjogren CEORL-HNS Secretary General Business Address Mondial Congress & Events * Ms. Gloria Casanova * Operngasse 20b * 1040 Vienna, Austria * ceorl-hns.org * www.ceorlhns.org * ZVR-Zahl 344666629