Infant Exposure to Controversial Compound Continues in Hospitals

However, whether high levels hurt sperm production not certain

THURSDAY, June 9, 2005 (HealthDay News) -- Despite FDA warnings to hospitals to reduce the use of plastics that contain a compound that might affect male fertility in infants, a new study found high levels of the compound among newborns in neonatal intensive care units.

The compound, known as di(2-ethylhexyl) phthalate (DEHP), is a softening agent that makes plastic flexible. Medical devices that may contain DEHP include intravenous bags and tubing, umbilical artery catheters, blood bags and infusion tubing, nutrition feeding bags and nasogastric tubes. The problem is it can leach into solutions that come in contact with the plastic.

"It has been known for some time that DEHP leaches out of some medical devices, causing direct patient exposures," said study author Dr. Ted Schettler, science director at the Science and Environmental Health Network.

DEHP has been shown in animal experiments to be toxic to reproduction and development. "The developing male reproductive tract is particularly vulnerable," Schettler added.

In 2000, the National Toxicology Program Center for the Evaluation of Risks to Human Reproduction concluded that exposure to DEHP from medical devices that might be used on infants in the hospital could adversely affect the male reproductive tract. In its 2002 warning, the FDA noted that male infants, in particular, might be susceptible to DEHP.

In the latest study, Harvard researchers looked at the levels of DEHP in 54 infants in neonatal intensive care units from two Boston hospitals. The research team measured the amount of mono(2-ethylhexyl) phthalate (MEHP), a breakdown product of DEHP, in the urine of the infants.

"We found that the intensity of product use that contains DEHP was highly correlated with the levels of MEHP," said study co-author Dr. Howard Hu, a professor of occupational and environmental medicine at the Harvard School of Public Health. "The contrast between the high product use and the low product use was fivefold."

The researchers discussed their findings at a press conference Wednesday in Boston, and the study appears in the June 8 online issue of Environmental Health Perspectives.

According to Hu, these results provide good evidence that infants are absorbing DEHP from the medical products used in neonatal units.

Study co-author Dr. Russ Hauser, an associate professor of environmental and occupational health at Harvard's School of Public Health, noted the study was not designed to determine whether the infants developed health problems after exposure to DEHP.

The only way to determine whether exposure to DEHP is harmful is with further investigation. "We need more studies," said study co-author Antonia M. Calafat, from the Organic Analytical Toxicology Branch of the CDC's National Center for Environmental Health. "The studies need to be in diverse populations with larger sample size and follow-up in the children," she added.

There are alternative products to those that contain DEHP, Schettler said. "However, the awareness of this issue is very spotty," he said. "There are enormous numbers of hospitals that probably aren't aware of this at all."

Hu thinks that one way to tackle the problem is by having parents take an active role in reminding their hospital of the potential danger of DEHP exposure. "Parents should take this as an opportunity to raise the awareness of their hospital, particularly if they happen to be a parent of a child who needs neonatal intensive care facilities," he said.

One expert agrees that DEHP poses a potential danger and alternative products should be used.

"This paper confirms what many of us believe to be true," said Dr. Ian R. Holzman, chief of the Division of Newborn Medicine at Mount Sinai School of Medicine in New York City.

"There is some leaching of DEHP from medical devices used in the neonatal units and the rest of the hospital," Holzman said. "What is less clear is what the health implications of this are. I do not think we know with any certainty that there is an identifiable problem to our neonates. Nevertheless, this speaks to the need to move towards using DEHP-free materials."

More information

The FDA can tell you more about DEHP.

SOURCES: Ted Schettler, M.D., M.P.H., science director, Science and Environmental Health Network, Ames, Iowa; Howard Hu, M.D., M.P.H., Sc.D., professor, occupational and environmental medicine, Harvard School of Public Health, Boston; Russ Hauser, M.D, M.P.H., Sc.D., associate professor, Occupational Health Program, Harvard School of Public Health, Boston; Antonia M. Calafat, Ph.D., Organic Analytical Toxicology Branch, National Center for Environmental Health, CDC, Atlanta; Ian R. Holzman, M.D., chief, Division of Newborn Medicine, vice chairman, clinical cffairs, and professor, Pediatrics, Mount Sinai School of Medicine, New York City; June 8, 2005, Environmental Health Perspectives online
Consumer News