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PFAS in the Medical Technologies Sector 1
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MedTech Europe
12December 2022
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Contents
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+ Uses and role of PFAS in
medical technologies
+ Substitution --availability and
assessment of alternatives
+ Conclusions
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About the medical technology sector
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About MedTech Europe
The European trade association for the medical technology industry including diagnostics, medical
devices and digital health.
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from diagnosis to cure
OUR MEMBERS
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About medical technology
Medical technology is any technology used to save and improve lives of individuals suffering from a
wide range of conditions.
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In Vitro Diagnostics (vps)
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Medical Devices (Ms)
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Examples of medical devices
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Complexity of the medical technologies' supply chain
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Uses of PFAS in medical technologies
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Where can PFAS be found in Medical Devices and IVDs?
Representative examples
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What are the types of PFAS/groups thereof used (non-exhaustive list)
IVD instruments & reagents
PTFE FEP PCTFE ETFE PVDF FKM/FPM fluoroelastomers FFKM/FFPM perfluoroelastomers Hexafluor propanol Triflouracetic acid Triflouracetic acid anhydride Triflourmethane-sulfonic acid anhydride Triflourtoluene Methyl trifluoromethanesulfonate
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MDs
PTFE FEP Perfluoropolyether PVDF PVDF-HFP 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)
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Why PFAS -- properties & functions fulfilled by PFAS
Properties such as chemical and heat resistance, lubrication and fe
PFAS is either a component of the final medical device or IVD, ora processing aid used during upstream manufacturing ( PFAS substances are often key to achieving the required high -- \ performance and durabilityofthe products in the various use areas
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What typical essential functions do PFAS fulfill in medical
technologies? 1/2
Medical Devices
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What typical essential functions do PFAS fulfill in medical technologies? 2/2
In Vitro Diagnostic Reagents& Instruments
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Heat-transfer agent in IVD PTS EE Aree
testing instruments, which
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in serum, plasma and urine
Fluoropolymers like PTFE
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analytical instruments
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Substitution - availability and assessment of alternatives
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Challenges with alternatives to PFAS
Without PFAS, these medical technologies would not be able to perform their intended purpose
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them preferred over alternatives
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Examples of applications of PFAS where alternatives are not
feasible
ep capoifpleraiphreryal venous catheter + Technically can be replacedwith PUR, but this may affect diagnostic performance and patient well-being.
+ No alternative since the main function of the device s based on this material,
PGTuFiEdecworateionfgtohnetdheevigceuitdoewithreetrorePaTFtEmceomnipttoe.nent nthe catheter i esentil or the delivery of the
+ there is no other cass of surfactants that represent a direct replacement
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Alternatives assessment under sectoral legislation
Medical technologies are invasive and/or cormeeguilnatocontact with the human body and are strictly
* Medical Devices Regulation and In Vitro Diagnostic Regulation have stringent:
++ driesskimgnanagement
+ 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.
FqouraliFfliucaotrioopnoalcycmoerrdsinign tcooem.gp.ocneerntatisn IoEfC asntaalnydtaircdasl. modules, all products would require new
* Materials with contact to blood or similarcits require a minimum approval time in case of is approximatively 3 years and can further exceed this range.
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Risk management under sectoral legislation
Where a CMR 1A/1B and/or endocrine-disrupting substances is used, it triggers a justification procedure, which includes a risk-benefit 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.
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Conclusions
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Concluding remarks
+ We have been doing a survey of our uses since the summer of 2022
+ tPeFcAhSnoalroeguiessed in a range of critical medical + Due to the expected broad impact of a
ftuetcuhrneologiPeAs S andrestsreicrtviiocne,s cnouumlderoubse affected in parallel
+ PFAS often have no alternative, and where
there is, it tends to be another PFAS
+ When considering a transition to a piomtpeonrttiaalnt tnoonc-oPnFsAiSder aplatteirneanttivwee,ll-ibteinigs asencdtotrhale lteigmiesllaitnieonand requirements under
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Thank you!
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www.medtecheurope.org
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