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 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 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 materials for PVC in medical devices. The substitution of other materials for PVC would have an added worker and community health benefit of reducing population exposures to DEHP, reducing the creation of dioxin from PVC production and disposal, and reducing risks from vinyl chloride monomer exposure.

Democratic participation: a critical element of precautionary public health decision-making.

The precautionary principle is increasingly discussed in debates about threats to health and the environment, particularly when government actions might inhibit free trade. It is gaining recognition as an overarching principle of decision-making, one that underlies efforts for sustainable development. Pronouncements about the precautionary principle have focused generally on the responsibility of government to act in the face of uncertainty and the shifting of burdens onto proponents. This assumes that government will have the resources, knowledge, expertise, and will to act. The role of the public those who may be affected by environmental degradation or their representatives is mostly missing from the discussions. This article outlines a rationale for why participation is critical and explores the theory of citizen participation. The article also describes participatory models used around the world, primarily examples of citizen participation though various models also exist for workers.

Children's environmental health: a case study in implementing the precautionary principle.

The plausible threat to children from environmental exposures and uncertainty as to the magnitude and nature of potentially harmful effects provide a rationale for taking precautionary measures to prevent such exposures. The authors present principles for applying precaution to children's environmental health, and policy tools for implementing them. A stronger focus on primary prevention and a better understanding of the risks are needed.