Migration of plasticizers from PVC medical devices: Development of an infusion model.
Alternatives to DEHP plasticizers are used in various PVC medical devices (MD) for infusion. As they are able to migrate from these MDs into infused solutions, they may come into contact with patient. Different and specific clinical parameters influence their migration in at-risk situations such as infusion. In contrast to the regulations for Food Contact Materials (MCDA), there is currently no acceptable migration limits for the use of these plasticizers in clinical situations. In order to assess their migration, and thus control the risks linked to these MDs, we developed a migration model for the plasticizers in MDs. To this end, we applied a cross-disciplinary methodological process similar to that used in the food-processing industry, taking into account the MDs' conditions of use in clinical practice. The simulation model is simple and includes the following conditions: MD should be tested with a dynamic method that respects our established clinical assumption (2 L of infused solutions via 13 dm(2) of plasticized PVC), at a temperature of 25 °C and during 24 h of contact, using a 50/50 (v/v) ethanol/water simulant. This model could be proposed as a tool for the safety evaluation of the patients' exposure risk to plasticizers from PVC medical devices for infusions.
CHU Clermont-Ferrand, Pôle Pharmacie, rue Montalembert, 63003 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 4676C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France. Electronic address: l_bernard@chu-clermontferrand.fr.
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Bernard
Clermont Université, Université d'Auvergne, EA 4676C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France.
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Cueff
Nutox Laboratory, Derttech "Packtox", INSERM UMR 866, AgroSup Dijon, 1 esplanade Erasme, 21000 Dijon, France.
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Chagnon
CHU Clermont-Ferrand, Pôle Pharmacie, rue Montalembert, 63003 Clermont-Ferrand, France.
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Abdoulouhab
CHRU Lille, Pharmacie, Avenue Oscar Lambret, 59037 Lille, France; Université Lille Nord de France, EA, GRITA, BP83, 59006 Lille, France.
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Décaudin
Centre de Ressources Technologiques 3s'Inpack, 63173 Aubière cedex, France.
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Breysse
CHU Clermont-Ferrand, Département d'anesthésie-réanimation, rue Montalembert, 63000 Clermont-Ferrand, France.
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Kauffmann
CHU Clermont-Ferrand, Service de Réanimation Chirurgie Cardiovasculaire, rue Montalembert, 63000 Clermont-Ferrand, France.
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Cosserant
CHU Clermont-Ferrand, Service de Réanimation médicale polyvalente, rue Montalembert, 63000 Clermont-Ferrand, France.
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Souweine
CHU Clermont-Ferrand, Pôle Pharmacie, rue Montalembert, 63003 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 4676C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France.
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Sautou
D004051:Diethylhexyl Phthalate / Q000737:chemistry; D006801:Humans; D007260:Infusion Pumps; D008962:Models, Theoretical; D010968:Plasticizers / Q000737:chemistry*; D011143:Polyvinyl Chloride / Q000737:chemistry*; D013696:Temperature; D014867:Water / Q000737:chemistry
D010968:Plasticizers; D014867:Water; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate
Clinical conditions; Infusion; Migration; Model; PVC; Plasticizers