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Patients' exposure to PVC plasticizers from ECMO circuits.
Charlotte Fernandez-Canal1, Pierre-Gabriel Pinta2, Teuta Eljezi3
1a Département de médecine périopératoire , CHU Clermont-Ferrand , Clermont-Ferrand , France.
Expert Review of Medical Devices
|April 17, 2018
Summary
Replacing diethylhexylphthalate (DEHP) in extracorporeal membrane oxygenation (ECMO) circuits with trioctyltrimellitate (TOTM) improves patient safety. TOTM showed lower migration and non-cytotoxic levels, unlike DEHP from priming bags.
Area of Science:
- Medical Devices
- Toxicology
- Biomaterials
Background:
- Extracorporeal membrane oxygenation (ECMO) involves high risk of exposure to diethylhexylphthalate (DEHP), a plasticizer in PVC tubing.
- Alternative plasticizers are recommended, but their safety in ECMO is unevaluated.
Purpose of the Study:
- To evaluate the migration and toxic risk of plasticizers used in ECMO circuits.
- To compare DEHP and trioctyltrimellitate (TOTM) safety profiles during ECMO.
Main Methods:
- Ex vivo ECMO models were used over 6 days with varying flow rates.
- Plasticizer release was measured and compared to derived no-effect levels (DNEL) and cytotoxic concentrations (MTT test).
Main Results:
- Trioctyltrimellitate (TOTM), comprising 44% of the circuit, showed weak release, with concentrations below DNEL and non-cytotoxic.
- Diethylhexylphthalate (DEHP) exposure exceeded DNEL, originating from the priming bag, not the circuit.
- Using a multilayer priming bag eliminated DEHP exposure.
Conclusions:
- PVC circuits plasticized with TOTM offer improved safety compared to DEHP in ECMO.
- Replacing DEHP-containing priming bags is crucial for enhancing ECMO patient safety.