Document ZBYxZbDLe35o0v4LBOO4943aZ

Public comment for PFAS restriction about the medical wire 1. endoscopes 2. catheters 3. ultrasonic probes Comments Our company have been actively working to comply with chemical regulations in various countries. Furthermore, we support the ambitious efforts of the European Union (EU) to reduce risks posed by hazardous substances and have earnestly taken measures to meet the requirements of EU chemical regulations such as REACH. In addition we would like to emphasize that from an environmental and health perspective, we are fully committed to replacing PFAS in our products. However, there are no alternatives available for some applications that are essential to society. Therefore, we suggest an exemption for some essential uses. Medical cables are connected to medical equipment and sometimes used inside the human body. These cables require heat resistance, thin extrudability, low dielectric property and flexibility. There is no alternative material to meet these all characteristics. Medical devices can endanger human life if they do not function properly. To avoid these risks, we need to continue to use Fluorine insulation wire for medical application. Medical cable (Endoscope) Usage A medical device that allows examination and treatment while viewing images of the inside of the body. The cable consists of a multi-core cable and uses FEP/PFA for the insulation of each coaxial line/insulated line inside and the final jacket. Cable Diameter: 0.3~5.0mm AWG50 Coaxial wire Number of cores: 3C~200C 0.14mm Disposal method Hair 0.09mm Endoscopic cables are primarily heat sterilized after one use and reused many times. Estimated world PFAS use:about 1800kg/year Estimated EU PFAS use: about 450kg/year Medical cable (Endoscope) Required material properties Reason Low dielectric Low loss tangent Endoscope cables require high-resolution image transmission, and it is essential to use materials with low dielectric constant and low dielectric loss tangent. If the material properties deteriorate, the transmission performance may deteriorate and accurate image transmission may not be possible. High heat resistance ETnhderoesfcoorpee, ictaisblneescaersesahreyattostuesreilihziegdhlaythaehaitg-hretseismtapnetramtuatreeroiaflsa.bout 130C after use. Thin extrusion (small diameter) It is very important to reduce the diameter of endoscope cables that are inserted through the throat or nose to observe the inside of the body. In order to reduce the diameter, it is necessary to make each signal line thinner. Thicker cables are likely to increase patient burden. Flexibility Cables for endoscopes used to observe the inside of the body are bent and used, so the flexibility of the cables is important. Medical cable (Endoscope) Example of impact AWG40 50 Coaxial cable FEP (insulation) Jacket Shield Conductor PEEK (insulation) Cable diameter Attenuation (@400MHz) Material price FEP (PFAS) 0.33mm -3.2dB/m - PEEK (PFAS Alternatives) 0.42mm (+27%) -3.4dB/m (+6%) 4 times Thicker cables are likely to increase patient burden. The transmission performance may deteriorate and accurate image transmission may not be possible. Medical cable (Endoscope) Materials PFAS FEP PFA EPDM Dielectric constant () 2.1 2.1 >2.5 Loss tangent (tan) 0.0002 0.0002 - Continuous use temperature (Heat resistance)() 200 260 90 Thin extrusion Good Good Poor Flexural modulus (Flexibility)(Mpa) 610 590 10 PFAS Alternatives in the Proposed Restrictions Silicone PEEK Mica Polyvinyl Polyethyle chloride ne Ceramic Based >3.5 0.001~ 0.02 200 3.4 0.0035 260 >4.5 0.01~ 0.02 500 >2.8 2.3 0.010.1 0.0005 100 120 >4.0 0.0005~ 0.003 500 Poor Poor Poor Poor Poor Poor 100~ 16 3700 17000 2400 1500 2800~ Fluorine is the only material that satisfies all the required properties Medical cable (Catheter) Usage A medical device that can pass through blood vessels to perform examinations, treatments, and procedures. The cable has a structure that bundles multiple cores, and uses FEP/PFA for the insulation of each internal coaxial line/insulated line and the final jacket. Cable Diameter: 0.1~2.0mm Number of cores: 1C~20C Disposal method Basically disposable. it is a medical device, it will be properly disposed of in accordance with the Waste Disposal Law. Medical cable (Catheter) Required material properties Reason High heat resistance The coaxial wire used for the catheter cable is soldered at high temperature(>200) during processing. Thin extrusion (small diameter) It is very important to reduce the diameter of catheter cables that are inserted through blood vessels. In order to reduce the diameter, it is necessary to make each signal line thinner. Thicker cables are likely to increase patient burden. Flexibility Cables for catheter that pass through blood vessels are bent and used, so the flexibility of the cables is important. Medical cable (Catheter) - PFAS Materials FEP PFA Continuous use temperature 200 (Heat resistance)() Thin extrusion Flexural modulus (Flexibility)(Mpa) Good 610 260 Good 590 PFAS Alternatives in the Proposed Restrictions EPDM Silicone PEEK Mica Polyvinyl Polyethyle chloride ne Ceramic Based 90 200 260 500 100 120 500 Poor Poor Poor Poor Poor Poor Poor 10 16 3700 17000 2400 100~ 2800~ 1500 Fluorine is the only material that satisfies all the required properties Medical cable (Ultrasonic probe) Usage A medical device that can perform examinations by projecting ultrasonic waves that bounce back from the inside of the body. The cable consists of a multi-core cable, and uses FEP/PFA for the insulation of each coaxial line/insulated line inside. Cable Diameter: 3.0~10mm Number of cores: 10C~400C Disposal method Ultrasonic probe cables are mostly wiped with chemicals after one use and reused many times Estimated world PFAS use:about 3100kg/year Estimated EU PFAS use: about 780kg/year Medical cable (Ultrasonic probe) Required material properties Reason Low dielectric Low loss tangent Ultrasonic probe cables need to transmit and receive ultrasound signals, and it is essential to use materials with low dielectric constant and low dielectric loss tangent. If the material properties deteriorate, the transmission performance may deteriorate and accurate image transmission may not be possible. High heat resistance Ttehme pceoraaxtiualrew(>ir2e0u0sed) fdourrtinhge purltorcaessosninicgp. rove cable is soldered at high Thin extrusion (small diameter) Ultrasonic probe cables require ease of handling by the user and flexibility as a coaxial core, so it is very important to reduce the diameter. In order to reduce the diameter, it is necessary to make each signal line thinner. Thicker cables are likely to increase patient burden. Flexibility Ultrasonic probe cables are bent and used, so the flexibility of the cables is important. Medical cable (Ultrasonic probe) Materials Dielectric constant () Loss tangent (tan) Thin extrusion Flexural modulus (Flexibility)(Mpa) PFAS FEP PFA EPDM 2.1 2.1 >2.5 0.0002 0.0002 - Good Good Poor 610 590 10 PFAS Alternatives in the Proposed Restrictions Silicone PEEK Mica Polyvinyl Polyethyle chloride ne Ceramic Based >3.5 0.001~ 0.02 Poor 16 3.4 0.0035 Poor 3700 >4.5 0.01~ 0.02 Poor 17000 >2.8 2.3 0.010.1 0.0005 Poor 2400 Poor 100~ 1500 >4.0 0.0005~ 0.003 Poor 2800~ Fluorine is the only material that satisfies all the required properties