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The Food and Drug Administration released a long-awaited
report on the safety of di-2-ethylhexyl phthalate on Sept. 5, but
the conclusion will not end the debate on the safety of PVC health
care products.
According to the report, some young children undergoing
medical procedures may be exposed to harmful levels of di-2-ethylhexyl
phthalate, one of the most-widely used softeners used in PVC health
care products. The report said infants exposed to repeated treatments
can receive between five and 20 times the safe levels.
The report also said that a small number of adults
undergoing some types of blood transfusion, and patients who receive
enteral nutrition treatments, could be at risk.
But the FDA said for many people there is little
or no risk from exposure to DEHP in
medical devices.
Both phthalate industry officials and a health-care
group that had been raising concerns said the FDA report validates
their positions.
Health Care Without Harm said the report found
problems with adults and infants
undergoing extracorporeal membrane oxygenation, infants receiving
exchange transfusions, adults undergoing cardiopulmonary bypass,
all patients receiving enteral nutrition, nursing infants of mothers
receiving hemodialysis and infants receiving total parenteral nutrition.
“The FDA has taken a first step toward protecting
sick infants and seriously ill adults,” said Charlotte Brody,
coordinator of HCWH in Washington. “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.”
But Marian Stanley, director of the Phthalate
Esters Panel of the American Chemistry Council in Arlington, Va.,
said the FDA report found “little or no concern about the safety
of using DEHP plasticized medical devices in most applications.”
The areas where concerns have been raised “involve
relatively small populations. The uses are with very critically
ill newborns … who may have some prolonged exposures while
they are undergoing cutting edge life-saving medical treatment,”
Stanley said.
Donald Marlowe, director of the FDA´s Office
of Science and Technology, said the concern primarily centers around
male infants. Relative to body weight, infants are exposed to much
more of the chemicals than adults, and DEHP concentrates in the
testes, he said.
FDA will not likely be making recommendations,
instead leaving that to the value judgements of hospitals, which
must weigh the risk to benefit ratios in different circumstances,
he said.
The agency is concerned that some of the alternative
plasticizers for PVC have been much less studied than DEHP, Marlowe
said.
DEHP has been linked to damage in reproductive
tract development.
FDA also rejected a 1999 petition from Health
Care Without Harm to label the devices contained DEHP. The agency
said it would communicate risks via its Web site, and may take action
to label selected PVC medical devices.
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