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Health Care Without Harm News Release

New Harvard Study: Sick Infants in Hospital Intensive Care Units Exposed to High Levels of Toxic Phthalate

13.06.2005 |Sonja Haider




Study is posted here.

FDA warning to health care providers.
Reducing PVC resources

Many hospitals still using DEHP-containing vinyl medical devices, despite FDA warnings 

Boston, Mass -- A first-of-its-kind study released today by Harvard University scientists found that babies in Neonatal Intensive Care Units (NICUs) receiving intensive therapy with polyvinyl chloride (PVC) medical devices were exposed to a toxic phthalate at very high levels – an average of 25 times higher than the general population and up to 50 times higher for the most exposed. As their medical treatments intensified, the sick infants were exposed to progressively higher exposures of di(2-ethylhexyl) phthalate, or DEHP.

DEHP is a reproductive toxicant that alters development of the male reproductive system in laboratory animal studies. The phthalate is used to soften PVC (vinyl) plastic medical devices such as IV bags and tubing, and it oozes out of the plastic and into patients’ bodies.  

The U.S. Food and Drug Administration (FDA) has warned health care providers to protect certain vulnerable patients – including male infants – from DEHP-containing PVC medical devices, but many hospitals are still using these devices despite the availability of cost-effective alternatives. 

“There is no longer any justification for hospitals to continue using PVC/DEHP devices where alternatives exist,” said Ted Schettler, MD, science director of the Science and Environmental Health Network. “This new exposure information confirms the concerns of both the National Toxicology Program and FDA that sick babies in neonatal units receiving multiple kinds of medical therapy are being exposed to excessive levels of DEHP.”

“We urge hospitals to switch to PVC-free, DEHP-free medical devices immediately,” said Anna Gilmore Hall, RN, executive director of Health Care Without Harm, a coalition of 435 health and environmental groups in 53 countries working to reduce pollution in the health care industry.

The peer-reviewed study, published today in Environmental Health Perspectives, also contained some good news. The study compared infants in two Boston-area NICUs and found significantly lower phthalate levels in the babies who received care at the hospital that had switched to DEHP-free medical devices for some applications. 

“When health care providers switch to safer non-vinyl medical devices, they are protecting their littlest patients from unnecessary toxic exposures,” Gilmore Hall said.

“We need more champions in the health care industry to help make the switch to safer, toxic-free products. We need more companies to make products free of phthalates and PVC plastic. And we need the FDA to take a stand and require labeling of PVC plastic so that it can be easily identified,” she said.