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.