Document dYa5vo06KJmEe4XY9r40n0OOq

Sociedad Espaola de Otorrinolaringologa y Ciruga de Cabeza y Cuello SEORL CCC Presidente Prof.Manuel Bernal Sprekelsen ec l.net Secretaria General Dra.lsabel Garca Lpez ~~se, N I.net Vicesecretaria General Dra.Maria del Mar Medina Gonzlez sec l.net Tesorero Prof.Asoc.Jacinto Garca Lorenzo Presidente de la Comisin de Formacin Prof.Asoc.Jose Antonio Lpez Escmez Presidente de la Comisin de Relaciones Internacionales Dr.Pablo Parente Arias Presidenta de la Comisin de Congresos Dra.Ftima Snchez Fernndez @sec l.net Presidente de la Comisin de Audiologa Prof.Asoc. Faustino Jos Nez Batalla ff @secl l.net Presidente de la Comisin de Oncologa y Ciruga Cabeza y Cuello Dr.Jon Alexander Sistiaga Surez ~.@sec,tinet Presidente de la Comisin de Ciruga Plstica Facial Dr.Eduardo Morera Serna -na sec l.net Presidente de la Comisin de Investigacin Dr.Andrs Soto Varela -na seorl.net Presidente de la Comisin de Laringologa, Voz, Foniatra y Deglucin Dr.Juan Carlos Casado Morente -1 seorl. net Presidenta de la Comisin de ORL General Dra.Julia Sanjos Torices Presidente de la Comisin de ORL Peditrica Prof.Asoc.Ignacio Jimnez Huerta sec l.net Presidente de la Comisin de Otologa Prof.Asoc.Luis Lassaletta Atienza Presidente de la Comisin de Otoneurologa Dr.Marcos Rossi Izquierdo -( seorl.net Presidente de la Comisin de Rinologa, Alergia y Base de Crneo Anterior Prof.Asoc.Isam Alobid Alobid -1 seorl. net Presidente de la Comisin de Roncopata y Trastornos del Sueo Dr.Peter Baptista Jardn Presidente de la Comisin de Garantas, Deontologa, Control y Conflictos Prof.Miquel Quer I Agust eorl. net Presidenta de la Comisin de Protocolos, Guas Clnicas, Estndar y Nomencltor Dra.lrene Lpez Delgado seorl. net Presidenta de la Comisin de Residentes Dra.Carmen Ruiz Garca ~sec l.net Presidenta de la Comisin de Asociaciones Autonmicas Dra.Ana Isabel Navazo Egua To whom I may concern, I am writing to express my concerns regarding the initiative to ban all types of PFAS: PER-AND POLYFLUOROALKYL SUBSTANCES from medical devices, despite the fact that most fluoropolymers have shown no toxicity in humans. While we understand the importance of ensuring the safety of medical devices, it is crucial to consider the potential negative consequences of a blanket ban on fluoropolymers. Fluoropolymers have played a critical role in medicine, ranging from prosthetics and implants to catheters and tubing. These devices have demonstrated their efficacy, biocompatibility, and reliability over years of use. it is essential to recognize the extensive research and development that has gone into formulating these materiais to meet the specific requirements of medical appiications. Advocating for a ban on ali types of fluoropolymers without thoroughly considering their individual characteristics and toxicity profiles would be an oversimplification of the matter. Many fluoropolymers have shown no direct evidence of harm to humans since decades when used in medical devices. Moreover, these materiais undergo stringent testing and regulatory scrutiny before they are approved for clinical use. imposing a complete ban without concrete evidence of harm could have unintended consequences, limiting the availability of critical medical devices and impeding advancements in patient care. In our field of interest, we would run out of ventilation tubes, tracheostomy tubes, terminal for monoploar and bipolar coagulation, rigid and flexible endoscopes, just to list a some examples. Without any substitutive material, the whole (European) ENT-surgery would collapse and long waiting lists would be created. instead, we propose a comprehensive evaluation of specific fiuoropoiymers used in medical devices, considering their intended applications, potential risks, and existing scientific evidence. A nuanced approach would allow us to identify any genuineiy hazardous fiuoropoiymers whiie still allowing the use of those that have a proven safety record. This approach aligns with the principie of evidence-based decisionmaking, ensuring that reguiations are founded on scientific research and the best interests of patient care. I urge you to consider the significant implications of a ban on ali types of fluoropolymers in medical devices and to prioritize a thorough evaluation of the risks associated with individual materiais. As we strive for continuous improvement in healthcare, it is vital to make informed decisions that prioritize patient safety without unnecessarily impeding medical advancements. Thank you for your attention to this matter. Madrid, Sept.l2th., 2023 Dr.Manuel Bernal Sprekelsen President of the SEORL-CCC 1