Critically Ill Infants Most at Risk From 
Plastic Softener DEHP a phthalate plasticizer used in PVC 

ENS 23oct00

BRUSSELS, Belgium - An international health care coalition claims that premature infants and newborns treated in neonatal intensive care units are likely to be exposed to significant amounts of a chemical suspected to cause reproductive and developmental problems in humans.

Health Care Without Harm, which represents more than 290 organizations in 27 countries, released its report in Brussels, Monday, to coincide with the European Commission's public hearing on environmental issues of polyvinyl chloride (PVC).

A review of DEHP exposure from vinyl medical products conducted by the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction noted "serious concern" about DEHP exposure in critically ill infants, but added "that the benefits of [these] medical procedures can outweigh the risks."

The report focuses on the chemical di-ethylhexyl phthalate (DEHP) and its effect on critically ill infants. DEHP is used in PVC medical products to make them soft and flexible. It is also used in other products, such as floorings, wall coverings, furniture, luggage and children's toys.

In the United States, DEHP is the preferred phthalate plasticizer in medical applications because other phthalates have not been certified by the U.S. Food and Drug Administration for use in products such as intravenous bags.

Flexible vinyl medical products typically contain 30 to 40 percent DEHP by weight, but that figure can reach 80 percent in applications where flexibility is critical, such as in tubing.

Today's report, entitled "Neonatal Exposure to DEHP and Opportunities for Prevention in Europe," claims that DEHP leaches from polyvinyl chloride medical products because it is not chemically bonded to the plastic.

Human exposure to DEHP occurs throughout life, beginning in the womb, but it rises dramatically for premature infants and newborns requiring intensive care in a neonatal unit, said the report.

"For infants requiring intensive care, DEHP exposures can occur at three orders of magnitude greater than average adult exposures and at or above levels causing reproductive effects in animals," said the report.

Blood bags are among the many medical items found neonatal intensive care units that contain DEHP.

This is because pre-term babies, especially low weight babies, may require many of the medical treatments that use DEHP plasticized vinyl products, including blood infusions, respiratory therapy, infusions of electrolytes, sugars, and medications, and intravenous nutrition.

The report cites animal studies which show DEHP harms the developing fetus. Adverse effects in the reproductive system include changes in the testes, reduced fertility, changes in sperm production in males and ovarian dysfunction and decreased hormone production in females.

Respiratory distress and changes in kidney and liver function have also been linked to DEHP exposure, said the report.

Although some of the effects occur only after relatively large exposures to DEHP, Health Care Without Harm is concerned that the developing male reproductive system is particularly susceptible to low level exposures, similar to those that can occur during medical care with equipment containing DEHP.

"Thus, it is of particular concern that human exposures are the highest for very small and underdeveloped babies when reproductive and other organs are developing," said the report.

"Given the availability of alternatives, the evidence of harm and the examples of multiple exposures during a critical period in human development, health care professionals should act upon the credo, 'First Do No Harm,'" said registered nurse Charlotte Brody, national coordinator for Health Care Without Harm.

Pre-term babies, especially low weight babies, may require many of the medical treatments that use DEHP plasticized vinyl products.

The report concludes that since DEHP releases from vinyl products are not easily controlled, prevention should be the primary management option. "For nearly all of the medical applications of concern, PVC free and DEHP free products are commercially or technically available," said the report.

"For relatively minor, short term cost increases, neonatal intensive care units could replace nearly all DEHP plasticized vinyl products with PVC free or DEHP free products. Market forces will likely drive the costs of alternative products down rather quickly," it continued.

In the United States, the Vinyl Industry trade association disputes the claim that alternatives could perform as well as vinyl.

"The truth is that substitutes for vinyl medical products - when available - may not perform as well as vinyl, or match the level of testing applied to vinyl over the past 40 years," it said. "Quite frankly, if the selection of health care materials was based on Health Care Without Harm's criteria, the quality and effectiveness of our health care would be set back by nearly a half century."

In July, a review of DEHP exposure from vinyl medical products conducted by the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction (CERHR) was greeted warmly by both sides of the debate for different reasons.

Health Care Without Harm was quick to jump on the expert panel's "serious concern" about the risks of DEHP in medical products to critically ill children.

But the Vinyl Institute, a U.S. trade association representing the leading manufacturers of vinyl, claimed vindication for its product, pointing to the panel's "minimal level of concern" about adult exposure.

Vinyl Institute president Timothy Burns pointed out that while the panel expressed "serious concern" about DEHP exposure in critically ill infants, it recognized "that the benefits of [these] medical procedures can outweigh the risks."

Last year, the European Union (EU) enacted an emergency ban on the use of phthalates in PVC children's toys in 15 countries, due to concerns about the health risks of phthalate exposure.

The European Union banned phthalates in PVC children's toys last year.

The PVC industry in Europe pointed out that in more than 40 years of use, there is not one known case of a child's health suffering as a result of using soft PVC toys. Industry groups such as the European Council for Plasticisers and Intermediates, and the European Council of Vinyl Manufacturers were angered by the ban.

Both groups argued that the ban was enacted contrary to European Union rules, which stipulate that the EU's Scientific Committee for Toxicity, Ecotoxicity and the Environment (CSTEE) must warn of "immediate and serious risk."

CSTEE did not call for a ban or say there was "an immediate and serious risk," claimed the groups.

• Health Care Without Harm