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

Abstract

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.

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References

Center for Devices and Radiological Health . US Food and Drug Administration: safety assessment of di(2- ethylhexyl)phthalate released from PVC medical devices. http://www.fda.gov/cdrh/ost/dehp-pvc.pdf; 2001.

Schulte-Hermann R , Parzefall W , Huber W. A comprehensive literature review and toxicological risk assessment of possible effects on reproduction of di(2- ethylhexyl) phthalate (DEHP) and its metabolites from PVC-containing medical devices. Report to Austrian Ministry for Social Security and Generations (BMSG) , July 13th, 2001.

Department of Health and Human Services , US Food and Drug Administration: Public Health Notification . PVC devices containing the plasticizer DEHP. http://www.fda.gov/cdrh/safety/dehp.html; 2001.

Kahl R , Degen G , Foth H et al. Stellungnahme der Beratungskommission der Sektion Toxikologie der Deutschen Gesellschaft für experimentelle und klinische Pharmakologie und Toxikologie (DGPT) zu möglichen Gesundheitsgefahren durch Di(2-ethylhexyl)phthalat (DEHP) aus Medizinprodukten in neonatalogischen Intensivstationen . Umweltmed Forsch Prax 2003; 8: 25-30 .

Karle VA , Short BL , Martin GR et al. Extracorporeal membrane oxygenation exposes infants to the plasticizer, di(2-ethylhexyl)phthalate . Crit Care Med 1997; 25: 696-703 .

Wendel HP , Hildenbrand S , Wodarz R , Aebert H , Ziemer G. Heparin-coating decreases DEHP release from polyvinyl chloride . Eighteenth European Conference on Biomaterials including Third Young Scientists’ Forum, Stuttgart, 1-4 October, 2003, Poster 115.

Gourlay T , Samartzis I , Stefanou D , Taylor K. Inflammatory response of rat and human neutrophils exposed to di-(2-ethyl-hexyl)-phthalate-plasticized polyvinyl chloride . Artif Organs 2003; 27(3): 256-260 .

Ministry of Health, Labour and Welfare: Safety Division, Pharmaceutical and Food Safety Bureau, Notification Nr. 1017001 from 17 October, 2002.

Department of Health and Human Services , US Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation . Medical devices made with polyvinylchloride (PVC) using the plasticizer di-(2-ethylhexyl)phthalate (DEHP); draft guidance for industry and FDA. http://www.fda.gov/cdrh/ode/guidance/1407.pdf; 2001.

10.

Weber N , Wendel HP , Ziemer G. Hemocompatibility of heparin-coated surfaces and the role of selective plasma protein adsorption . Biomaterials 2002; 23: 429-439 .

11.

Weber N , Wendel HP , Ziemer G. Gene monitoring of surface-activated monocytes in circulating whole blood by using duplex RT-PCR . J Biomed Mater Res 2001; 56: 1-8 .