This is an article off the newswires today:

Ruth Scuderi
Westfield, MA

FDA Finds Unsafe Levels of Phthalates Leaching From Some PVC Medical Devices


Health Care Without Harm Calls on Health Care Providers to Take Action To

Limit Patients' Exposure

MINNEAPOLIS, Sept. 5 /PRNewswire/ -- Today the U.S. Food and Drug
Administration (FDA) warned that some medical products made from polyvinyl
chloride (PVC) may expose patients to unsafe amounts of the toxic chemical
di-2-ethylhexyl-phthalate (DEHP).  The agency released the findings in its
long-awaited safety assessment on DEHP, which is used to soften PVC medical
devices such as bags and tubing used to administer fluids, medication, blood,
oxygen, and nutritional formulas to patients.

The FDA's scientific assessment found that DEHP may not be safe for infants,
children and adults receiving certain medical treatments that involve PVC
medical devices.  The FDA expressed concern for adults and infants undergoing
Extracorporeal Membrane Oxygenation (ECMO), infants undergoing exchange
transfusions, adults undergoing cardiopulmonary bypass, all patients
receiving enteral nutrition, nursing infants of mothers on hemodialysis, and
infants receiving Total Parenteral Nutrition (TPN).

"The FDA today confirmed that some PVC medical devices pose a safety hazard
to the most vulnerable medical patients.  This should be considered
unacceptable because it is avoidable," said Charlotte Brody, RN, Coordinator
of Health Care Without Harm (HCWH).  "The FDA has taken a first step toward
protecting sick infants and seriously ill adults.  Now health care providers
need to turn the FDA's assessment into a plan of action that eliminates the
unnecessary threat of DEHP leaching from PVC products."

"The FDA concluded that children undergoing certain medical procedures are at
increased risk of harmful effects from DEHP," explained Ted Schettler, MD,
Science Director of the Science and Environmental Health Network, a HCWH
member organization.  "The FDA's finding was based on evaluation of a number
of studies that show that infants in neonatal intensive care units are likely
to be exposed to unsafe amounts of DEHP from multiple PVC medical products.
But their concern doesn't end there.  The FDA also noted that the levels of
DEHP in the breast milk of healthy mothers approach the safety limit for
nursing newborns.  We need to reduce exposures to DEHP, particularly for
pregnant women and their developing children, wherever possible".

The FDA joins other governmental agencies in the United States and abroad in
expressing concern about the risks posed by PVC medical devices that leach
DEHP.  In October 2000, the National Toxicology Program Center for the
Evaluation of Risk to Human Reproduction's expert panel report expressed
"serious concern" that exposure to DEHP may adversely affect male
reproductive tract development in critically ill infants and "concern" over
the levels of DEHP exposure to pregnant women, breast-feeding mothers and
healthy infants and toddlers.

In July, the Swedish Chemical Inspectorate, acting on behalf of the European
Union, reported that people "are exposed to DEHP during their entire
lifetime, via the environment, consumer products and medical equipment" and
that there is a need to institute additional risk reduction measures now.

Health Care Without Harm is an international coalition of 333 organizations
in 33 countries working to transform the health care industry so it is no
longer a source of environmental harm.  For the full FDA report, go to
http://www.fda.gov , click on "More News" and then "Center for Devices and
Radiological Health."

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