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Doctors Seek Alternative to 'Risky' PVC in Devices

The American Medical Association has urged the Food and Drug Administration (FDA) to expedite its evaluation of ways to address the potential risks that may be associated with the use of DEHP-containing medical devices used in certain procedures.

The AMA resolution, passed by the House of Delegates on Dec. 5, is in response to a recent FDA safety assessment that found that some medical products made from polyvinyl chloride (PVC) might expose patients to unsafe amounts of the toxic chemical DEHP.

Health Care Without Harm, an international campaign for environmentally responsible health care, heralded the resolution.

"We're pleased that the AMA has noted the significance of the FDA assessment on DEHP," said Charlotte Brody, RN, director of Health Care Without Harm.

"Like the AMA, Health Care Without Harm wants to focus on how we turn the FDA's concerns into action that reduces vulnerable patients' exposure to DEHP," Brody said.

DEHP (di-2-ethylhexyl-phthalate) is a plasticizer 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 assessment found that DEHP, which leaches from the PVC devices, might not be safe for infants, children, and adults receiving certain medical treatments. The FDA assessment found that infants undergoing certain medical procedures are at increased risk of harmful effects from DEHP. 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.

AMA also urged FDA to address the availability of alternatives to DEHP-containing PVC plastics, particularly for procedures performed on neonatal patients. AMA further resolved to assist the FDA in communicating its safety assessment on the use of DEHP-containing devices to health care providers and hospitals.

Health Care Without Harm has petitioned FDA to require labeling on some PVC medical devices used on the most vulnerable patients.

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