New risk for newborns. (Children's Health).

In the September 2001 report Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices, the U.S. Food and Drug Administration (FDA) states that certain populations, particularly newborn males, may be at risk for adverse health effects due to DEHP exposure. DEHP is widely used to soften polyvinyl chloride (PVC) plastics, which are used in medical settings for IV bags and tubing, blood bags, feeding tubes, and tubing for dialysis and heart bypass procedures. Because DEHP does not bond to PVC molecules, it can leach from plastics containing it.

Numerous animal studies show that DEHP exposure produces toxic effects, especially impaired testicular development. But extending these results to humans is complicated by differences in routes of exposure, metabolism, and possible mechanisms of toxicity. Further, few human studies have been conducted, and exposures are often based on theoretical estimates. However, the FDA concludes there is sufficient evidence that DEHP in medical devices may pose a risk to certain patient populations undergoing procedures that involve PVC materials. Newborns undergoing intensive medical treatment may receive proportionally larger doses of DEHP and may be more sensitive to potential effects, so they draw special concern. Male newborns, whose testicles are still developing, are thought to be at the greatest potential risk.

"We did a risk assessment to see whether there was a level of concern following exposure to DEHP released from medical devices, and we identified some exposure scenarios that might possibly represent harm," says Mel Stratmeyer, health sciences branch chief at the FDA's Center for Devices and Radiological Health, which conducted the assessment. Stratmeyer emphasizes possibly. "We didn't feel there was a lot of concern with the possible exception of young male infants who might be critically ill and have prolonged exposure to numerous devices that contain DEHP," he says.

However, Health Care Without Harm (HCWH), an international coalition of 339 health, environmental, and other groups, believes greater concern is warranted. The group petitioned the FDA in June 1999 to require labeling of medical devices containing DEHP and to establish a program promoting PVC alternatives. The FDA rejected HCWH's request, although it is considering labeling certain medical devices, such as those used on critically ill newborns.

In October 2000 the National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction released evaluations of the effects of phthalates on reproduction and development. The report on DEHP concludes in part that there is "serious concern" that DEHP exposure in critically ill infants "may adversely affect male reproductive tract development." Additionally, DEHP risk assessments published by Health Canada in 2001 and the European Union in 2000 draw similar conclusions.

HCWH, which is resubmitting its petition for labeling of some PVC medical devices, generally commends the FDA assessment. "Overall, we're pleased with it," says Charlotte Brody, coordinator of HCWH. However, she says there are significant data gaps, especially in identifying and assessing fetal exposures during pregnancy, infant exposures during lactation, and aggregate exposure from multiple procedures. "The challenge is for the FDA and health care providers to protect vulnerable populations by minimizing exposures to PVC products that can leach DEHP," she says. "The FDA assessment is the first step in protecting vulnerable populations, but a plan of action is needed."