Health risks posed by use of di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: A critical review

Background Polyvinyl chloride plastics (PVC), made flexible through the add ition of di-2-ethylhexyl phthalate (DEHP), are used in the production of a wide array of medical devices. From the late 1960s, leaching of DEHP from P VC medical devices and ultimate tissue deposition have been documented. Methods A critical review of DEHP exposure, metabolism, and toxicity data f rom human and animals studies was undertaken. A brief analysis of alternati ves to DEHP-plasticized PVC for use in medical device manufacture was compl eted. Results DEHP leaches in varying concentrations into solutions stored in PVC medical devices. Certain populations, including dialysis patients and hemo philiacs may have long-term exposures to clinically important doses of DEHP while others, such as neonates and the developing fetus, may have exposure s at critical points in development. In vivo and in vitro research links DE HP or its metabolites to a range of adverse effects in the liver reproducti ve tract, kidneys, lungs, and heart. Developing animals are particularly su sceptible to effects on the reproductive system. Some adverse effects in an imal studies occur at levels of exposure experienced by patients in certain clinical settings. DEHP appears to pose a relatively low risk of hepatic c ancer in humans. However given lingering uncertainties about the relevance of the mechanism of action of carcinogenic effects in rodents for humans an d interindividual variability, the possibility of DEHP-related carcinogenic responses in humans cannot be ruled out. Conclusions The observed toxicity of DEHP and availability of alternatives to many DEHP-containing PVC medical devices presents a compelling argument for moving assertively, but carefully, to the substitution of other materia ls for PVC in medical devices. The substitution of other materials for PVC would have an added worker and community health benefit of reducing populat ion exposures to DEHP, reducing the creation of dioxin from PVC production and disposal, and reducing risks from vinyl chloride monomer exposure. Am. J. Ind. Med. 39:100-111, 2001. (C) 2001 Wiley-Liss, Inc.