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

Abstract

Background Polyvinyl chloride plastics (PVC), made¯exible through the addition 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 PVC medical devices and ultimate tissue deposition have been documented. Methods A critical review of DEHP exposure, metabolism, and toxicity data from human and animals studies was undertaken. A brief analysis of alternatives to DEHP-plasticized PVC for use in medical device manufacture was completed. Results DEHP leaches in varying concentrations into solutions stored in PVC medical devices. Certain populations, including dialysis patients and hemophiliacs may have long-term exposures to clinically important doses of DEHP, while others, such as neonates and the developing fetus, may have exposures at critical points in development. In vivo and in vitro research links DEHP or its metabolites to a range of adverse effects in the liver, reproductive tract, kidneys, lungs, and heart. Developing animals are particularly susceptible to effects on the reproductive system. Some adverse effects in animal studies occur at levels of exposure experienced by patients in certain clinical settings. DEHP appears to pose a relatively low risk of hepatic cancer in humans. However, given lingering uncertainties about the relevance of the mechanism of action of carcinogenic effects in rodents for humans and interindividual variability, the possibility of DEHPrelated 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 materials for PVC in medical devices. The substitution of other materials for PVC would have an added worker and community health bene®t of reducing population exposures to DEHP, reducing the creation of dioxin from PVC production and disposal, and reducing risks from vinyl chloride monomer exposure.

Short period exposure to di-(2-ethylhexyl) phthalate regulates testosterone metabolism in testis of prepubertal rats

“…On the exposure of humans to phthalates certain populations may be exposed to much higher levels. The range of DEHP concentrations in medical devises are 3.1-650 mg/l (Tickner et al 2001). Patients undergoing hemodialysis or blood transfusion received as much as 0.5-360 mg or 14-600 mg of DEHP via plastic medical devices, respectively (Gibson et al 1976;Kevy and Jacobson 1982).…”

Stoffmonographie Di(2-ethylhexyl)phthalat (DEHP)—Referenzwerte für 5oxo-MEHP und 5OH-MEHP im Urin

“…150 mg/kg KG/d be ob ach tet, und his to lo gi sche Ab nor ma litä ten in der Le ber so wie eine re du zier te Le ber funk ti on er ga ben sich bei Rhe susaf fen, de nen Blut aus PVC-Beu teln in trave nös ap pli ziert wor den war, das ca. 100-300 mg DEHP ent hielt [39]. Nie ren schä-den kön nen sich in Form his to lo gi scher Ver än de run gen der Nie re, Bil dung rena ler Zys ten und ei ner Atro phie der Tu bu li mani fes tie ren [39].…”

“…100-300 mg DEHP ent hielt [39]. Nie ren schä-den kön nen sich in Form his to lo gi scher Ver än de run gen der Nie re, Bil dung rena ler Zys ten und ei ner Atro phie der Tu bu li mani fes tie ren [39]. Die Er geb nis se zur Re pro duk ti ons to xizi tät von DEHP bei Na gern de monst rie ren Ef fek te auf die Re pro duk ti on und Fruchtbar keit in bei den Ge schlech tern und Entwick lungs schä den bei den Nach kom men.…”

Sensitive biomonitoring of phthalate metabolites in human urine using packed capillary column switching liquid chromatography coupled to electrospray ionization ion-trap mass spectrometry

“…Furthermore, various phthalates are used in many PVC building materials and are therefore present in airborne dust in both occupational settings and private households, potentially causing bronchial obstruction and asthma when inhaled [12,13]. Special attention has also been directed towards medical patients as potentially heavily exposed individuals, due to the fact that numerous bags and tubes used in hospitals are made of PVC and these leach phthalate plasticizers [14,15,16,17,18].…”