Document NEYZKaq9kmkEO12qn2R6mMJgR

PFAS in the Medical Technologies Sector Roumiana Santos, Chemicals Manager MedTech Europe 12 December 2022 Contents About the medical technologies industry Uses and role of PFAS in medical technologies Substitution - availability and assessment of alternatives Conclusions 2 About the medical technology sector 3 About MedTech Europe The European trade association for the medical technology industry including diagnostics, medical devices and digital health. OUR MEMBERS 140+ multinational corporations* *medical devices, diagnostics and digital health 50 medical technology associations 4 About medical technology Medical technology is any technology used to save and improve lives of individuals suffering from a wide range of conditions. There are more than 500,000 products, services and solutions currently available 5 In Vitro Diagnostics (IVDs) What are IVDs? IVDs are devices that provide diagnostic information by examination of a specimen derived from the human body. Specimens include blood, urine, tissue Why are they useful? Major source of information to determine the healthcare pathway They also monitor, screen, manage and assess predispositions to diseases Examples of IVDs Pregnancy tests Blood glucose monitoring HIV tests Cancer screenings Blood type identification TB testing DNA genotyping & analysis Companion diagnostics 6 Medical Devices (MDs) What are MDs? They are products, services or solutions that prevent, diagnose, monitor, treat and care for human beings. They are innovative engineered technologies available to hospitals, physicians and patients. Why are they useful? They save lives, replace & restore body functions, prevent diseases development, monitor patients conditions and equip health institutions and home. Examples of medical devices Hospital beds, mattresses, sheets Surgical tools, gloves, tables Bandages Wheelchairs Surgical robots Pacemakers, defibrillators, stents Artificial hip, knee, legs. Eye lenses Hearing aids 7 Complexity of the medical technologies' supply chain Technological diversity Complexity of individual devices Depth of the supply chain 8 Medical technology industry embraces materials science, biochemistry, metallurgy, robotics, advanced textiles, all forms of electronic and IT systems. Individual devices differ greatly in complexity; it is not uncommon for routinely used devices to have hundreds and thousands of components and parts E.g. laboratory/diagnostic machines for blood testing and analysis. Supply chains of up to 30 tiers from materials to the final device exist. The average depth is smaller (e.g., four to six tiers for a seemingly simple product like an elastic bandage). Relying on suppliers to provide upstream traceability information can be lengthy, intensive, and can put a strain on business relationships. Uses of PFAS in medical technologies 9 Where can PFAS be found in Medical Devices and IVDs? Representative examples 10 What are the types of PFAS/groups thereof used (nonexhaustive list) IVD instruments & reagents PTFE FEP PCTFE ETFE PVDF FKM/FPM fluoroelastomers FFKM/FFPM perfluoroelastomers Hexafluor propanol Triflouracetic acid Triflouracetic acid anhydride Triflourmethanesulfonic acid anhydride Triflourtoluene Methyl trifluoromethanesulfonate 11 MDs PTFE FEP Perfluoropolyether PVDF PVDFHFP Perfluorinated acrylates (C6 - C14) Hydrophobic surface treatments - surface bound or reacted fluoropolymers of undisclosed composition PTFE coatings Specialty fluorinated lubricants FKM/FPM fluoroelastomers FFKM/FFPM perfluoroelastomers PTFE and PVDF suture materials Semifluorinated alkanes (for example 1(Perfluorhexyl)octane and 1(Perfluorobutyl)pentane) Why PFAS - properties & functions fulfilled by PFAS Properties such as chemical and heat resistance, lubrication and biocompatibility PFAS is either a component of the final medical device or IVD, or a processing aid used during upstream manufacturing PFAS substances are often key to achieving the required high performance and durability of the products in the various use areas 12 What typical essential functions do PFAS fulfill in medical technologies? 1/2 Medical Devices Ophthalmic endotamponades in surgery to reposition a detached retina Blood contact invasive devices - e.g. grafts/covered stents, catheter tubings for infusion of medication and IV fluids and drug eluting stent (DES) - blood flow within/between arteries and veins and for DES to control drug release to inhibit the vessel renarrowing Medication contact components minimise drugdevice interactions Surgical sutures: pledgets made of PTFE serve as suture abutments when suturing soft tissue. They are essential in heart valve operations Fluoropolymers, like PTFE and PVDF, are used in several components for the treatment of serious acute and chronic diseases In hernia meshes for rapid healing of hernia Cleaning of medical devices as cleaning solvents in vapor degreasing applications 13 What typical essential functions do PFAS fulfill in medical technologies? 2/2 In Vitro Diagnostic Reagents & Instruments IVD testing kits for hemostasis products which detect blood coagulation Heattransfer agent in IVD clinical chemistry diagnostic testing instruments, which is essential to the functioning of the instrument Surfactant properties in in vitro diagnostic assays, which allow measures of various parameters such as magnesium concentration in serum, plasma and urine Fluoropolymers like PTFE and PVDF are used in several components for analytical instruments Other: Coating on the dispense tip, tubing and tubing connectors, distributors, seals and gaskets, syringe pump valves, Orings and sealants 14 Substitution - availability and assessment of alternatives 15 Challenges with alternatives to PFAS Without PFAS, these medical technologies would not be able to perform their intended purpose Sometimes, the alternative is another type of PFAS Apart from PFAS, it is unlikely that any alternative would have similar or superior functions. The functionalities of PFAS make At the same time, some of the intrinsic properties which render these substances the preferred choice are the very same that create a burden on the environment. them preferred over alternatives A nonPFAS replacement would likely lead to: less lubricity increased incidence of puncture wounds, no deliverability of the guidewire or catheter to the target lesion or other adverse events. reduced chemical inertness and hydrophobicity increased incidence of device malfunction and inability of the surgeon to sufficiently visualize the surgical site. 16 Examples of applications of PFAS where alternatives are not feasible FEP capillary of peripheral venous catheters: Technically can be replaced with PUR, but this may affect diagnostic performance and patient wellbeing. Devices for ultrasound supported needle tip tracking: No alternative since the main function of the device is based on this material. PTFE - Guidewires or delivery device catheter: PTFE coating on the guidewire or PTFE component in the catheter is essential for the delivery of the guidewire or the device to the treatment site. For PFAS in in vitro diagnostic assays: there is no other class of surfactants that represent a direct replacement. In filters for critical care medications, such as antineoplastic drugs 17 Alternatives assessment under sectoral legislation Medical technologies are invasive and/or come into contact with the human body and are strictly regulated Medical Devices Regulation and In Vitro Diagnostic Regulation have stringent: risk management design safety quality performance and alternatives validation requirements. Manufacturers of IVD reagents and systems fluids must proceed to design change procedures under specific regulations that can take between 3 to 12 years to complete. For Fluoropolymers in components of analytical modules, all products would require new qualification according to e.g. certain IEC standards. Materials with contact to blood or similar criticality require a minimum approval time in case of is approximatively 3 years and can further exceed this range. 18 Risk management under sectoral legislation Where a CMR 1A/1B and/or endocrinedisrupting substances is used, it triggers a justification procedure, which includes a riskbenefit analysis (Section 10.4 of the MDR). Most applications are medical devices that end up as clinical waste which is collected separately treated in accordance with applicable legislation (e.g. WEEE Directive) by licensed waste operators Healthcare institutions as a major user of medical devices represent a strictly regulated, professional work environment. 19 Conclusions 20 Concluding remarks We have been doing a survey of our uses since the summer of 2022 PFAS are used in a range of critical medical technologies Due to the expected broad impact of a future PFAS restriction, numerous technologies and services could be affected in parallel PFAS often have no alternative, and where there is, it tends to be another PFAS When considering a transition to a potential nonPFAS alternative, it is important to consider patient wellbeing and the timeline and requirements under sectoral legislation 21 Thank you! Roumiana Santos @medtecheurope.org www.medtecheurope.org f1% MedTech Europe from diagnosis to cure