Document Rwok7n3YmNegdqwaow54nZMk

Report summary medical devices 1 Contents Preface............................................................................................................... 3 1. Uses / Applications ...................................................................................... 4 2. Main PFAS substances ................................................................................. 4 3. Volume estimations ..................................................................................... 6 4. Manufacturing & Market ............................................................................. 9 5. Emissions ..................................................................................................... 9 6. Exposure .................................................................................................... 11 7. General discussion ..................................................................................... 11 8. Alternatives ............................................................................................... 12 9. Economic impacts in case of a full PFAS ban .............................................. 12 10. Methods used & uncertainties................................................................... 12 References ....................................................................................................... 13 Annex............................................................................................................... 14 2 Preface The scope of the report, is to present the results of a quick scan on PFAS use in the medical sector, in this report the medical devices are considered. This report does not contain the PFAS production nor the end of life phase / waste stage. Note: Medicinal products are described in a separate summary. Anesthetics and contrast media in the medicinal products report are reported individually. The lists presented in this document reflect non exhaustive lists. Alternatives are available. 3 1. Uses / Applications Medical Technology Medical devices In vitro diagnostic devices Medical devices and in vitro diagnostic devices are defined under EU Regulation 2017/745 and 2017/746. The EU Medical Device Regulation has classified devices into three classes with increasing risk: Class I, II and III, depending on their risk and critically. Each device class requires a different level of regulation and compliance. Examples of class I devices are tongue depressors, bandages, gloves, bedpans, and simple surgical devices. Examples of Class II devices are wheelchairs, X-ray machines, MRI machines, surgical needles, catheter and diagnostic equipment. Class III devices are used inside the body, for example heart valves, stents, implanted pacemakers, silicone implants and hip and bone transplants. EUDAMED (https://ec.europa.eu/tools/eudamed/#/screen/home EUDAMED database - EUDAMED (europa.eu) ) will be the central European database used in collecting information about medical devices, amongst others the risk class, clinical and safety studies and manufacturer's information. EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g. manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU. 2. Main PFAS substances In table 1 polymers in medical applications (as well as pharmaceutical production) are listed. Table 1: Polymers used in medical applications and pharmaceutical production. Polymer fluoroelastomers perfluoroelastomer polychlorotrifluoroethylene polyvinylidene fluoride fluorosilicones 4,4'-[2,2,2,-trifluoro-1-(trifluoromethyl)ethylidiene]diphenol 1,1,2,2,-tetrafluoro ethene perfluoroalkoxy poly(ethene-co-chlorotrifluoroethene) fluorinated ethylene propylene abbreviation FKM FFKM PCTFE PVDF FVQM Polymers BPAF base PTFE PFA ECTFE FEP poly(ethylene-co-tetrafluoroethylene 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene and tetrafluoroethene 1-propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene, 1,1,1,2,2,3,3-heptafluoro-3-[(trifluoroethenyl)oxy]propane and tetrafluoroethene ET THV THVP Cas number 64706-30-5 9002-83-9 9011-17-0 63148-56-1 1478-61-1 9002-84-0 26655-005 25101-45-5 25067-11-2 25038-71-5 25190-89-0 68182-34-3 4 Fluorotelomers: Fluorotelomers are being used for their contamination-resistant properties in medical textiles i.e. to protect doctors, nurses and researchers against contact with microbiological contaminants, such as viruses or bacteria, for example in surgical gowns and drapes. The below mentioned medical textiles were researched in this survey: woven and non-woven fabrics textiles for the treatment of patients (such as bandages, absorption mats, hernia mats) textiles in medical applications and medical laboratories (such as filter membranes) Medical implants An overview of fluoropolymers and alternative materials in medical implants is given in Table 2. Table 2 List of common medical implants and materials used (Teo, Mishra et al. 2016) PTFE P E P A PDMS PHA PE T P P Silicone LCP Parylene PMMA PE K P I SU 8 Anestesiology Epidural catheters Pacemaker, implantable defibrillator/cardioverter, left Cardiovascular ventricular assist device, heart valves, artificial blood vessels, catheters Dentures, dental implants, Dental orthodontic wires, dental instrumentation Cochlear implants, stapes implants, Ear, nose, throat nasal implants for nose reconstruction Penile implants, neurostimulator in Gastroenterology sacral nerve stimulation, foley and urology catheter, artificial urinary sphincter implant, hernia or vaginal mesh Synthetic blood vessels, breast General and implants, cheek, jaw and chin plastic surgery implants, lip implant, titanium surgical implants, hip implant, clamps for high frequency surgery Hematology and pathology Central venous access device, peripherally inserted central catheter Implantable pulse generator for Neurology deep brain stimulation, neuroprosthetiocs, cognitive protheses, catheters dexamethasone intravitreal implant, retinal prothesis, artificial Opthalmic inocular lens, glaucoma valve, fluocinolone ophthalmic implant, orbital implant, catheters Orthopedic Orthopedic implants, medical splints Fluoropolymer tubes Fluoropolymer tubes play an important role in many medical operations. There is a growing demand for minimal invasive procedures. The tubes are mostly made of ePTFE. 5 Fluorinated meshes and textiles The most frequently used textile implants worldwide are hernia meshes; more than a million are implanted every year. The first meshes were implanted in the 1950s. These meshes were made of polyethyleneterephthalate (PET) multifilament, but in the 1960s polypropylene (PP) monofilaments became available as mesh material. Expanded polytetrafluoroethylene (ePTFE) as porous membrane or polyvinylidene fluoride (PVDF) are also used as mesh material/patch. Coatings A way of coating of aluminum metered dose inhalers is done with a polymer layer of PFA or FEP. Table 3 The main coatings reported in the Response to the CfE (summer 2020) were: product name SF-coat AS-20280 SF-Coat SFE-X008 AsahiGuard AG-E082 CAS number 2414559-48-9 441049-46-2 746622-86-6 3. Volume estimations The total volume of polymers reported in the response on the CfE ranges from 1,700-14,000 ton/year. Table 4 lists the volume of individual substances. In some case the volumes are not reported or reported as lumped sum of a variety of polymers. For instance, the amount of PTFE tubes is not included in the list. Note that in the report summary on medicinal products an overview is given of tonnage ranges of different non-polymer PFAS. Table 4 Overview of usage and/or production volumes of fluorinated polymers polymer name PTFE C6-side chain fluorinated surfactants and coatings FEP PVDF PFA others incl. lumped Total CAS number 9002-84-0 1648842-31-2 2047310-70-1 24937-79-9 441049-46-2 746622-86-6 25067-11-2 2414559-48-9 26655-00-5 usage 1,300-10,000 >800 >200 10-100 23-32 1700 1,700-14,000 In 2018, a report, commissioned by the Fluoropolymers Group (FPG) of Plastics Europe estimated 1500 tons of fluoropolymers in the medical sector, representing a value of approximately 20 million euro. 1 Based on the response of the sector to the Call for evidence a higher volume of up to 14,000 ton/year (midpoint 8,900 ton/y) was computed. A total of almost 33,000 ton F-gases is retrieved from the ECHA database to be used in industrial processes related to medical applications. This is equivalent to 47 Mton CO2 equivalents (see Table 5). This seems to be an underestimation, because the atmospheric release of health care related Fgases is estimated to be 249 Mton per year (HCWH 2019). Three F-gases are responsible for 99.9% of 1 Publications :: Fluoropolymers (plasticseurope.org) 6 the medical F-gases reported (based on data from ECHA search and response to the CfE). These are HFC-134a, HFC-227ea and HFE-152a. Table 5 Estimated F-gas emissions based on reported tonnages of medical F-gases in the EU (response to CfE and ECHA database) and assuming an emission factor of 0.1%. CAS NR Chemical name 811-97-2 431-89-0 75-37-6 163702-08-7 163702-07-6 163702-06-5 163702-05-4 116-14-3 375-03-1 138495-42-8 57041-67-5 26675-46-7 28523-86-6 13838-16-9 151-67-7 76-19-7 76-16-4 355-25-9 115-25-3 75-73-0 HFC-134a HFC-227ea HFC-152a HFE7100 HFE7200 tetrafluoroethylene HFE7000 HFC-43-10mee desflurane isoflurane sevoflurane enflurane halothane perfluoropropane (PFC-218) perfluoroethane (PFC-116) perfluorobutane (PFC-3-1-10) octafluorocyclebutane tetrafluoromethane HFE7000 GWP 1,430 3,320 124 2,597 59 4 575 1,640 989 350 216 583 41 8,830 12,200 8,860 10,300 7390 production volume (ton/y) midpoint 25,487 77.7% 3068 9.4% 3578 10.9 % 556 1.7% 55 55 8 5.5 1 0.25 0.25 0.25 0.25 0.25 0.15 0.1 0.05 0.03 32,806 0.2% 0.2% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% <0.1% 100% CO2 equivalents (ton/y) 36,446 10,186 444 165 77.1% 21.6% 0.9% 0.3% 3 3 3.2 1.6 0.2 0.1 0.1 0.1 0.0 1.3 1.2 0.4 0.3 0.1 47,252 <0.01% <0.01% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100% The dispersal estimation have been based on the midpoint of the usage volumes. An uncertainty factor of at least 2 is applicable (See Figure 1). Considering the dispersal potentials of different use categories, we estimated that 5,600 ton/y could end up in the environment. Almost 70% of this dispersal consists of F-gases. This concerns propellants, that have an exemption for medical use under the F-gas regulation and F-gases in the category "non-polymer PFAS in industrial processes" (83% of the tonnage in this category is F-gas). F-gases will be dispersed to air. 7 Figure 1 Use of PFAS for medical applications and production. Figure 2 Overview of estimated usage of PFAS used in medicinal products and medical applications and the manufacturing thereof and their potential environmental dispersal. Midpoint of the uncertainty range in ton/y. For overview also medicinal product / pharmaceuticals are plotted (orange). It should be noted that both medical applications and medicines are depicted in these graphs. For an overview of PFAS volumes in the medical sector and provisional estimation of their potential dispersal, check table 6 under emissions. 8 4. Manufacturing & Market 79 companies indicated that they produce, import or distribute PFAS substances, both for medicines and medical applications (Call for Evidence, summer 2020). Most likely this number of production sites may be much higher. No further information is available. 5. Emissions Fluoropolymers in medical applications generally have a low emission profile during use. In table 6 EUSES Environmental Release Categories (ERC's) are listed. Table 6 List of Environmental Release Categories and default worst-case release factors of EUSES. In table 7 an overview of PFAS volumes and estimated emissions is given for the medical sector (both medical devices and medicinal products) 9 Table 7: Overview of PFAS volumes in the medical sector and provisional estimation of their potential dispersal. H(igh)= dispersal to water, air or soil through PFAS excretion by humans or animals; M(edium) = PFAS may be disposed of as waste, recovered after the production processes or treated in industrial waste treatment plants; L(ow)= PFAS in products that are collected as waste. non-polymers Use ton/year 27,000-58,000 source approx. 160 volume distribution over molecular size (based on midpoint of uncertainty range) C1-C6 C7-C25 >C25 total dispersal potential Medicinal products (use) human >500 68 >500 veterinary unknown 3 M anesthetics (use) 2-1000* 5 500 contrast media (use) 2-100 1 50 propellants (use) 160-400** 3 280 High (90-100%) >1,300 ton/y intermediates 2,200-14,000 27 Industrial processes 24,000-43,000 54 including F-gases production polymers 3,700-14,000 4,000 32,000 4,200 1,200 8,900 Medium (10%) 4,200 ton/y Low (1%) 90 t/y Total 31,000-71,000 37,000 >5,900 8,900 71% 12% 17% *: Might be an overestimation as HCWH 2019 is looking broader than needed here **: Might be an underestimation as Dutch (extrapolated) data will lead to roughly doubling of the range. 52,000 5,600 Vaporised halogenated anesthetics are predominantly greenhouse gases. For fluorinated gases used in anesthesia, the global emissions to atmosphere in 2014 was estimated to be 3.10.6MtCO2 equivalents (HCWH 2019). Due to increasing uptake of these gases, the footprint from anesthetic gases can be expected to increase. In table 8 an overview of fluorinated anesthetics is given. 10 Table 8 Overview of fluorinated anesthetics and their characteristics. (Vollmer, Rhee et al. 2015) Desflurane and isoflurane are racemic mixtures of (R) and (S) optical isomers (enantiomers), indicated by the asterix. Common name Synonyms Sevoflurane Sevorane, Sevofrane, Sojourn, Ultane, Desflurane Suprane, HFE 236, HFE 236eaEbg Structure Isoflurane Florane, , Forane, Forene, IsoFlo, Isoforine, Isoflurano, HCFE 235da2, Aerrane Halothane Fluothane, Narkotan,Narcotan, Halan, Ftorotan, Freon 123B1, Fluktan, Anestan, Alotano, Halsan, Rhodialothan Molecular formula Metabolites CAS number Year of introduction WHO EML Global atmospheric emission (tonnes/year) Atmospheric lifetime (years) Atmospheric concentration (ppt) Global warming potential (100 y) Reference: CO2=1 C4H3F7O C3H2F6O Hexafluoro-isopropanol and inorganic fluoride 28523-86-6 57041-67-5 1993-1995 1992 1200 1.1-4.0 0.13 130 960 8.9-21.0 0.3 2540 C3H2ClF5O 26675-46-7 1981 x 880 3.2-5.9 0.097 510 C2HBrClF3 151-67-7 1956 x 250 1.0-7.0 0.0092 50 It has been estimated that the health care sector globally emitted 2-4 gigaton CO2 equivalents in 2015 (Lenzen, Malik et al. 2020). In this figure, anesthetic gases and propellants of metered dose inhalers were excluded. They were estimated to add respectively 3.1 and 6.9 Mton CO2 equivalents (0.3% and 0.2%). 6. Exposure No further information was available. 7. General discussion A total PFAS use, for medical applications + medicines of 30,000-71,000 tonnes PFAS per year has been estimated. In the following paragraphs explanation is provided on medicinal products, small PFAS with 1-6 carbon atoms including F-gases, medium size PFAS (7-25 carbon atoms) and polymers. The dispersal estimation have been based on the midpoint of the usage volumes. An uncertainty factor of at least 2 is applicable. Considering the dispersal potentials of different use categories, it was estimated that for medical applications + medicines a total of 5,600 ton/y could end up in the environment. Almost 70% of this dispersal consists of F-gases. 11 Reported volumes are compared with estimations that were based on statistics from other sources and databases (for instance EMA, WHO, Eurostat and ECHA). It should be noted that in the ECHA database there is information about non-polymers only, so for polymer volumes information of the Response on the Call for Evidence (CfE), summer 2020, has been included. Fluoropolymers The fluoropolymers have a wide range of applications, ranging from products like implants, tubes and valves, medical textiles and meshes. 8. Alternatives For medical applications some non-PFAS alternatives seem to be available. It is outside the scope of this document to further go into detail about potential and actual alternatives. 9. Economic impacts in case of a full PFAS ban No data is available. 10. Methods used & uncertainties It has been difficult to provide a clear and concise overview of all the PFAS used in medical applications. One of the reasons is that the PFAS have multiple applications and that non-PFAS alternatives are also being used for the (some of the) same applications. PFAS can be applied as surfactant, cleaner, cooling liquid, solvent, pharmaceutical, intermediate, or as articles such as tubes, stents, catheters, medical packaging, membranes, contrast media, propellant, anesthetic. Due to overlapping functions, also with other fields of applications, such as electronics, textile, packaging, energy and construction the amounts used for medical purposes cannot always be isolated from other applications. Due to the uncertainties most volumes are presented as a volume range. 12 References HCWH (2019). Health care's climate footprint. How the health sector contributes to the global climate crisis and opporrtunities for action: 48 Lenzen, M., A. Malik, M. Li, J. Fry, H. Weisz, P. P. Pichler, L. S. M. Chaves, A. Capon and D. Pencheon (2020). "The environmnetal footprint of health care: a global assessment." Lancet Planet Health 4: e271-279. Teo, A. J. T., A. Mishra, I. Park, Y.-J. Kim, W.-T. Park and Y.-J. Yoon (2016). "Polymeric Biomaterials for Medical Implants and Devices." ACS Biomaterials Science & Engineering 2(4): 454-472. Vollmer, M. K., T. S. Rhee, M. Rigby, D. Hofstetter, M. Hill, F. Schoenenberger and S. Reimann (2015). "Modern inhalation anesthetics: Potent greenhouse gases in the global atmosphere." Geophysical Research Letters 42(5): 1606-1611. 13 Annex Overview of PFAS volumes in the medical sector and provisional estimation of their potential emission (based on dispersal potential). Sub-use* Tonnage PFAS/y in EEA# Expected tonnage trend (--/-/0/+/++)*** Emission/y EEA (tonnes PFAS) Anesthetics 2 - 1,000* + Contrast media 2 - 100 ? Propellants 160 - 400** ? MDI 24,000 - 43,000 ? incl. F-gases Medical applications incl. 3,700 - 14,000 ? packaging (mainly polymers) Contrast media, propellants and F-gases are mentioned here as medical applications #: Tonnage includes export *: Might be an overestimation as HCWH 2019 is looking broader than needed here **: Might be an underestimation as Dutch (extrapolated) data will lead to roughly doubling of the range. ***: --=strong decrease, -=decrease, +-=increase, ++=strong increase, 0=neutral 2 - 1,000 2 - 100 160 - 400 4,200 90 14