SOURCE: Johns Hopkins University, news release, Nov. 13, 2014; website, U.S. Food and Drug Administration
THURSDAY, Nov. 13, 2014 (HealthDay News) -- Plastic medical products used to care for premature babies in hospitals may expose the infants to high levels of a chemical that could harm their health, a new study indicates.
Researchers found that premature babies in the neonatal intensive care unit (NICU) may be exposed to levels of di(2-ethylhexyl)phthalate (DEHP) that are 4,000 to 160,000 times higher than what is considered safe.
The chemical is used to increase the flexibility of many medical products made from polyvinyl chloride (PVC) plastic, including intravenous tubing, catheters, endotracheal bags and fluid and blood product bags.
DEHP doesn't bind with PVC and can leak into fluids and body tissues that come in contact with it, explained the authors of the study published online Nov. 13 in the Journal of Perinatology.
"It's remarkable that the care of sick and developmentally vulnerable preterm infants depends on an environment composed almost entirely of plastic," study leader Dr. Eric Mallow, a neonatologist and senior research program coordinator at Johns Hopkins Bloomberg School of Public Health in Baltimore, said in a Hopkins news release.
"The role of these synthetic materials in the clinical course of our patients remains almost completely unexplored. PVC is the predominant flexible plastic in most NICUs, and this can result in considerable DEHP exposures during intensive care," he noted.
However, a group representing the chemical industry took issue with that stand. The American Chemistry Council pointed to statements on the U.S. Food and Drug Administration's Web page regarding DEHP.
"It is possible that the effects observed in animal studies could occur in humans," the FDA states, "However, there are no human studies to date that show such effects. DEHP-containing devices have been used on newborn babies for many years without apparent ill effects, although studies have not been conducted which would rule out effects on humans."
The agency goes on to say that, "The risk of not doing a needed procedure is far greater than the risk associated with exposure to DEHP [in equipment]."
However, the FDA also noted that although more study is needed to confirm any risks, the agency "believes the greatest concern would be for very young male infants who are critically ill and have prolonged exposure to multiple devices containing DEHP."
According to Mallow's team, DEHP is thought to interfere with normal hormone function. Animal studies have also shown that DEHP increases inflammation, causes liver damage and interferes with the development of the lungs, eyes and brain, according to the researchers.
"We were floored by how high the exposures are when you look at all of the devices together," study co-author Mary Fox, an assistant professor in the department of health policy and management at Bloomberg, said in the news release.
"It's a population that we know is vulnerable to begin with. They're struggling to survive. And the concern now is whether this [DEHP] exposure is actually contributing to their problems when these medical products are supposed to be helping them get better," she explained.
The most effective initial step to protect premature infants would be to replace DEHP-containing medical products in the NICU with available alternatives that don't contain the chemical, the researchers said.
The U.S. Environmental Protection Agency has more about di(2-ethylhexyl)phthalate.