Newborns in hospital intensive care units are vulnerable in so many ways.
Their paper-thin skin can be torn by medical tape. Their lungs may not be developed enough to supply their tiny bodies with oxygen. Their immature immune systems leave them susceptible to a wide world of germs.
Now, a growing number of hospitals are trying to protect babies like these from a newly recognized threat — the medical equipment that provides them with lifesaving blood, medicine or nutrition.
The plastic used in intravenous tubing, blood bags and other products — DEHP, or di(2-ethylhexyl) phthalate — can leach a hormone-like chemical linked to reproductive problems, says Richard Grady, interim chief of pediatric urology at Seattle's Children's Hospital & Regional Medical Center. While doctors agree that the benefits of specialized care for newborns outweigh the potential risks from plastic devices, leading medical organizations now say that hospitals should find safer substitutes whenever possible.
Grady notes that even minute amounts of hormones could cause problems for infants whose organs are still developing, especially newborn boys who spends weeks in neonatal intensive care units, or NICUs.
Manufacturers say their products are safe and note that there are only a few human studies of DEHP. Many doctors and nurses say they're concerned, however, about animal studies that suggest the chemical can suppress testosterone, impair fertility and alter the development of reproductive organs.
The Seattle hospital and more than 100 others across the USA have pledged to begin phasing out DEHP. Influential groups such as the American Medical Association and American Nurses Association in recent months also have urged hospitals to find safer substitutes.
Officials at hospitals such as Lucile Packard Children's Hospital at Stanford and John Muir Medical Center in Walnut Creek, Calif., say they've saved money since making the switch. While some DEHP-free products are cheaper, others are lighter, which saves money on waste disposal.
Jolene Farris of San Jose, Calif. had never heard of DEHP before giving birth last week. But she says she's glad that he's in a hospital using safer plastics to treat her son, Jameson, who was born about 8 weeks early. "They're already so small, why take the chance?" Farris asks. "It absolutely makes me feel safer."
But Grady says avoiding DEHP — which he calls "the everywhere chemical" — is no easy task. Beyond IV tubes, DEHP — which adds flexibility to polyvinyl chloride plastic, or PVC — is also found in a variety of consumer products, including flooring, wallpaper, auto upholstery, food packaging and toys.
Plastics often have no labels listing their ingredients, says Kathy Gerwig, vice president of workplace safety at Kaiser Permanente, the country's largest non-profit health system. "There's no way to know just by looking," says Gerwig, who says Kaiser now has phased out all DEHP in its neonatal intensive care units, except where substitutes are unavailable. "It was a hunt and guess process."
Manufacturers often refused to reveal the ingredients in their products, noting that ingredients are trade secrets, Gerwig says. "Even given our enormous size and buying power, we have had relatively little power getting this information," she says. "It really puts the burden on the user."
That's why Kaiser, the AMA and others support a petition, filed by a coalition of medical groups called Health Care Without Harm, asking the Food and Drug Administration to require manufacturers to label plastics that could expose patients to DEHP. Although the FDA rejected the group's petitions in 1999 and 2001, the agency did advise hospitals in 2002 to find alternatives to DEHP, especially for the most vulnerable patients: male newborns, pregnant women carrying boys and boys near puberty.
Concern about DEHP — which belongs to a class of chemicals called phthalates — has grown steadily since. Government studies have found the chemical in about 80% of Americans tested.
In December, the government's highly respected National Toxicology Program concluded there is "serious" concern — its highest level — that DEHP could harm critically ill baby boys. The program also found reason for "concern" — its second-highest level — in boys younger than 12 months and those born to pregnant women undergoing certain medical treatments.
Marian Stanley of the American Chemistry Council describes those risks as "theoretical," because of the scarcity of human studies. She said the federal report was "erring on the precautionary side, because you can't really get exposure information from these tiny infants."
Researchers say that the few available human studies add to worries about DEHP.
A 2005 study in Environmental Health Perspectives found that more intensive medical care increased the amount of DEHP in the bodies of newborn boys.
In another study that year, Shanna Swan of the University of Rochester School of Medicine found differences in the reproductive organs of boys whose mothers were exposed to higher levels of several phthalates. More highly exposed boys had a shorter distance between their anus and the base of their penis, a measurement that is usually longer in boys than in girls. Boys in whom this distance was shorter were also more likely to have incompletely descended testes.
The FDA hasn't yet answered the petition on DEHP, filed in late July. But the agency is working with international agencies to assess DEHP's risks and find a safe exposure level for hospitalized patients, says spokeswoman Karen Riley. That will help the FDA decide on labeling or further recommendations.
Some manufacturers say they're already seeing a boom in DEHP-free goods. B. Braun Medical Inc., a Pennsylvania-based manufacturer, is even building a new facility to help keep up with demand. With a burgeoning range of consumers choices, Allen Blakey, a spokesman for a trade group called the Vinyl Institute, says there's no need for FDA labeling.
But others are forging ahead. Catholic Healthcare West, a network of 40 hospitals in California, Arizona and Nevada, is making many environmental improvements, says Sister Mary Ellen Leciejewski, ecology program coordinator. Beyond using only DEHP-free IV bags and tubing, the network has eliminated most mercury and hopes to replace vinyl-backed carpeting.
Robert Felicelli of Hospira, Inc., an Illinois-based manufacturer, notes that hospitals are attracted to DEHP substitutes for many reasons. For example, they create 40% to 70% less waste, he says.
Avoiding PVC plastics helps the environment in many ways, Leciejewski says. Producing and incinerating PVC plastic releases dioxins, a class of potent carcinogen.
Blakey notes that PVC plastics product a very small amount of all the dioxins released. "They're not going to get rid of dioxin by getting rid of PVC devices," Blakey says.
"The Hippocratic Oath says to do no harm," Leciejewski says. "We should be going to these alternatives if at all possible."
More information about DEHP — and a list of hospitals phasing out the chemical — can be found at Health Care Without Harm, which advocates "environmentally responsible healthcare," at www.noharm.org/us.
Information also is available at the American Chemistry Council's Phthalate Information Center, which provides the plastics industry's perspective, at www.phthalates.org.