Migration of plasticizers from PVC medical ...
Document type :
Article dans une revue scientifique
PMID :
Permalink :
Title :
Migration of plasticizers from PVC medical devices: Development of an infusion model
Author(s) :
Bernard, L. [Auteur]
Cueff, R. [Auteur]
Chagnon, M. C. [Auteur]
Abdoulouhab, F. [Auteur]
Décaudin, Bertrand [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Breysse, C. [Auteur]
Kauffmann, S. [Auteur]
Cosserant, B. [Auteur]
Souweine, B. [Auteur]
Sautoua, V. [Auteur]
Cueff, R. [Auteur]
Chagnon, M. C. [Auteur]
Abdoulouhab, F. [Auteur]
Décaudin, Bertrand [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Breysse, C. [Auteur]
Kauffmann, S. [Auteur]
Cosserant, B. [Auteur]
Souweine, B. [Auteur]
Sautoua, V. [Auteur]
Journal title :
International journal of pharmaceutics
Abbreviated title :
Int. J. Pharm.
Volume number :
494
Pages :
136-145
Publication date :
2015
HAL domain(s) :
Sciences du Vivant [q-bio]
French abstract :
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 ...
Show more >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.Show less >
Show more >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.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Research team(s) :
Innovation/évaluation des dispositifs médicaux de perfusion
Submission date :
2019-02-26T17:15:45Z