Expert review of medical devices · 2018
Patients' exposure to PVC plasticizers from ECMO circuits.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Fernandez-Canal Charlotte, Pinta Pierre-Gabriel, Eljezi Teuta, Larbre Virginie, Kauffmann Sophie, Camilleri Lionel, Cosserant Bernard, Bernard Lise, Pereira Bruno, Constantin Jean-Michel, Grimandi Gael, Sautou Valérie, for Armed Study Group
Аннотация
BACKGROUND: ECMO is a therapeutic act with a high risk of exposure to diethylhexylphthalate (DEHP), plasticizer from PVC tubings. The replacement of this plasticizer with alternative compounds is recommended but the risks associated with the use of new plasticizers have not been evaluated in ECMO situations.
METHODS: Ex vivo ECMO models were performed with different flow rates over 6 days to evaluate the migration of plasticizers and their potential toxic risk for patient. The release of plasticizers during ECMO was measured and compared to reference value (derived no effect level, DNEL) and to cytotoxic concentration carried out with MTT test.
RESULTS: Trioctyltrimellitate (TOTM), main plasticizer present in circuit (44% w/w), is weakly released during ECMO. Concentrations are not cytotoxic and exposure doses are lower than DNEL. In contrast, DEHP doses are higher than the DNEL despite a lower presence of DEHP in the circuit (0.2%). We have shown that DEHP is not coming from the circuit but from the priming bag. Replacing this bag with a multilayer one avoids the exposure to DEHP.
CONCLUSION: Our study shows that circuits made of PVC plasticized with TOTM against DEHP improves the safety of ECMO.
METHODS: Ex vivo ECMO models were performed with different flow rates over 6 days to evaluate the migration of plasticizers and their potential toxic risk for patient. The release of plasticizers during ECMO was measured and compared to reference value (derived no effect level, DNEL) and to cytotoxic concentration carried out with MTT test.
RESULTS: Trioctyltrimellitate (TOTM), main plasticizer present in circuit (44% w/w), is weakly released during ECMO. Concentrations are not cytotoxic and exposure doses are lower than DNEL. In contrast, DEHP doses are higher than the DNEL despite a lower presence of DEHP in the circuit (0.2%). We have shown that DEHP is not coming from the circuit but from the priming bag. Replacing this bag with a multilayer one avoids the exposure to DEHP.
CONCLUSION: Our study shows that circuits made of PVC plasticized with TOTM against DEHP improves the safety of ECMO.