Physical–chemical assessment of di-(2-ethylhexyl)-phthalate leakage from poly(vinyl chloride) endotracheal tubes after application in high risk newborns

Abstract

Poly(vinyl chloride) (PVC) is extensively used in the production of medical devices including endotracheal tubes. In order to make PVC flexible extensive quantities of plasticizers are added to the virgin matrix and among these, di-(2-ethylhexyl)-phthalate (DEHP) is the most used in PVC medical devices. DEHP is not covalently bound to PVC and during the use of medical devices, it tends to migrate out and accumulate in tissue. To the best of our knowledge, limited literature data are available on the DEHP release from PVC medical devices as a consequence of applications in humans. Aim of the present study was to verify through a physical–chemical characterization the occurrence of DEHP leakage from endotracheal tubes and to determine the correlation between the leaching of the plasticizer and the time of intubation of the tubes in high risk newborns. Thermogravimetric Analysis (TGA), Differential Scanning Calorimetry (DSC) and High-Performance Liquid Chromatography (HPLC) analyses were performed and the results show the effective release of DEHP from tubes. Moreover the study reveals that the release of DEHP occurs within the first 24 h of employments of the tubes.