title: Comparative study on the migration of di-2-ethylhexyl phthalate (DEHP) and tri-2-ethylhexyl trimellitate (TOTM) into blood from PVC tubing material of a heart-lung machine.
abstract: Medical devices like blood tubing often consist of PVC material that requires the addition of plasticizers. These plasticizers may migrate into the blood leading to an exposure of the patients. In this study the migration behavior of three different blood tubing sets (PVC material with two different plasticizers and silicone as control material) applied on a heart-lung machine standardly used for cardiopulmonary bypass (CPB) in children was studied. We analyzed the total plasticizer migration by analysis of both, the parent compounds as well as their primary degradation products in blood. Additionally, the total mass loss of the tubing over perfusion time was examined. The PVC tubing plasticized with DEHP (di-2-ethylhexyl phthalate) was found to have the highest mass loss over time and showed a high plasticizer migration rate. In comparison, the migration of TOTM (tri-2-ethylhexyl trimellitate) and its primary degradation products was found to be distinctly lower (by a factor of approx. 350). Moreover, it was observed that the storage time of the tubing affects the plasticizer migration rates. In conclusion, the DEHP substitute TOTM promises to be an effective alternative plasticizer for PVC medical devices particularly regarding the decreased migration rate during medical procedures.
authors.affiliation: Institute and Outpatient Clinic of Occupational, Social and Environmental Medicine, University of Erlangen-Nuremberg, Schillerstrasse 25/29, Erlangen, 91054 Germany. Electronic address: elisabeth.eckert@fau.de.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Eckert
authors.affiliation: Department of Pediatric Cardiac Surgery, University Hospital Erlangen, Loschgestr. 15, Erlangen 91054, Germany. Electronic address: Frank.Muench@uk-erlangen.de.
authors.forename: Frank
authors.initials: F
authors.lastname: Münch
authors.affiliation: Institute and Outpatient Clinic of Occupational, Social and Environmental Medicine, University of Erlangen-Nuremberg, Schillerstrasse 25/29, Erlangen, 91054 Germany. Electronic address: Thomas.Goeen@fau.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Göen
authors.affiliation: Department of Pediatric Cardiac Surgery, University Hospital Erlangen, Loschgestr. 15, Erlangen 91054, Germany. Electronic address: Ariawan.Purbojo@uk-erlangen.de.
authors.forename: Ariawan
authors.initials: A
authors.lastname: Purbojo
authors.affiliation: Institute and Outpatient Clinic of Occupational, Social and Environmental Medicine, University of Erlangen-Nuremberg, Schillerstrasse 25/29, Erlangen, 91054 Germany. Electronic address: Johannes.Mueller@ipasum.med.uni-erlangen.de.
authors.forename: Johannes
authors.initials: J
authors.lastname: Müller
authors.affiliation: Department of Pediatric Cardiac Surgery, University Hospital Erlangen, Loschgestr. 15, Erlangen 91054, Germany. Electronic address: Robert.Cesnjevar@uk-erlangen.de.
authors.forename: Robert
authors.initials: R
authors.lastname: Cesnjevar
mesh_terms: D000818:Animals; D001565:Benzoates / Q000097:blood / Q000737:chemistry; D004051:Diethylhexyl Phthalate / Q000097:blood / Q000737:chemistry; D004209:Disposable Equipment; D006355:Heart-Lung Machine; D010968:Plasticizers / Q000032:analysis / Q000737:chemistry; D011143:Polyvinyl Chloride / Q000737:chemistry*; D012756:Sheep
chemical_list: D001565:Benzoates; D010968:Plasticizers; C036101:tri-(2-ethylhexyl)trimellitate; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate
keywords: Blood tubing; Leaching; Medical devices; PVC; Plasticizers; Silicone