Quantification of bis(2-ethylhexyl) phthalate released by medical devices during respiratory assistance and estimation of patient exposure

Abstract

Bis(2-ethylhexyl) phthalate (DEHP) migration from polyvinyl chloride (PVC) has been studied with infusion, transfusion and extracorporeal oxygenation devices, but no study has been conducted to estimate its migration via respiratory medical devices (MDs). This work aims to develop an ex vivo model to quantify DEHP released doses by these MDs, which will then be used to estimate newborns DEHP exposure from respiratory assistance MDs. We followed the Frensh National Research and Safety Institute (INRS) recommendations for the validation of a collecting and analysing method of DEHP in air, which will be used to quantify DEHP in air passing through PVC respiratory assistance MDs. The developed method met all the validation criteria for DEHP determination in air. DEHP in air passing through MDs on the sixth day reached a cumulative quantity of 122.86 μg when using a flow rate of 4 L min^-1 of non-humidified air while it was of 49.22 μg; 58.12 μg and 29.61 μg with flow rates of 2 L min^-1 of humidified air, 2 L min^-1 of dry air and 4 L min^-1 of humidified air, respectively. Model application to two patients undergoing two different respiratory procedure demonstrated that noninvasive ventilation patient received higher dose of inhaled DEHP, confirmed by DEHP metabolites quantification in urine. Although the protective effect of air humidifiers on DEHP exposure was demonstrated, the effect of flow rate is difficult to be established. This developed method should be tested to verify its capacity to collect and quantify other plasticizers used in PVC MDs.

Keywords: Medical devices; Neonates; Polyvinyl chloride; Respiratory; Respiratory assistance; bis(2-ethylhexyl) phthalate; ex vivo model.