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PVC-plasticizer DEHP in medical products: do thin coatings really reduce DEHP leaching into blood?

Department of Occupational and Social Medicine, University Hospital of Tuebingen, Tüebingen, Germany

Hans-Dieter Lehmann

Maquet Cardiopulmonary AG, Hirrlingen, Germany

Roman Wodarz

Department of Occupational and Social Medicine, University Hospital of Tuebingen, Tüebingen, Germany

Gerhard Ziemer

Department of Thoracic, Cardiac and Vascular Surgery, University Hospital Tuebingen, Tuebingen, Germany

Hans P Wendel

Department of Thoracic, Cardiac and Vascular Surgery, University Hospital Tuebingen, Tuebingen, Germany, hp.wendel{at}uni-tuebingen.de

The hemocompatibility of artificial surfaces in extracorporeal blood circulation systems can be improved by coatings. According to the literature, heparin coatings should avoid the leaching of the plasticizer di(2-ethylhexyl) phthalate (DEHP) into the blood from components made from plasticized polyvinyl chloride (PVC). DEHP and its metabolites are known to impair the fertility of male rodents; effects on human fertility are assumed.

Three different surface coatings with and without heparin were examined in a Chandler Loop model at 37°C using fresh human blood to evaluate their hemocompatibility and barrier property to plasticizer.

The levels of toxic oxidation products of DEHP generated in the blood, particularly, were found as high as in the uncoated tubing. The coatings improved the hemocompatibility, but are not safe protection against the hazardous metabolites of DEHP.

For pregnant women, neonates and children, we would recommend using the available surface-coated plasticized PVC tubing sets, but free of DEHP.

Perfusion, Vol. 20, No. 6, 351-357 (2005)
DOI: 10.1191/0267659105pf836oa


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