[Pharmwaste] Hospitals move to phase out chemical [DEHP, or di(2-ethylhexyl) phthalate]

DeBiasi,Deborah dldebiasi at deq.virginia.gov
Wed Aug 15 09:39:23 EDT 2007


http://www.usatoday.com/news/health/2007-08-14-dehp_N.htm

Hospitals move to phase out chemical 

By Liz Szabo, USA TODAY
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.
Deborah L. DeBiasi
Email:   dldebiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov
Virginia Department of Environmental Quality
Office of Water Permit Programs
Industrial Pretreatment/Toxics Management Program
Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!)
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028
FAX:      804-698-4032



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