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September 16, 2002
Volume 80, Number 37
CENEAR 80 37 p. 6
ISSN 0009-2347


MEDICAL DEVICES

FDA Suggests Replacing DEHP In Plastics

FDA has issued a draft guidance document on di-(2-ethylhexyl) phthalate, a compound used as a plasticizer in many polyvinyl chloride medical devices. FDA suggests that manufacturers either label certain devices with their DEHP content or "consider the feasibility of replacing PVC containing DEHP with either alternative materials or plasticizers, or using coatings that may minimize patient exposure to DEHP."

The long-term effects of exposure to DEHP on the human body are unknown, the agency explains. Although DEHP has shown some toxic and carcinogenic effects in lab animals, there are no studies that show such effects in humans, the document says.

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FDA also says that certain invasive medical procedures create exposures to DEHP that could exceed the levels determined to be safe for humans. Because of the aggregate exposures to DEHP, PVC devices used in neonatal intensive care units should be a primary focus of concern, the agency says. The guidance document lists nine devices that could expose sensitive patient populations to DEHP, including plastic tubes, catheters, and dialysis bags.

Health Care Without Harm, a group advocating less DEHP exposure, says FDA is moving in the right direction but should require, rather than merely recommend, labeling. In contrast, a statement from the Phthalate Esters Panel at the American Chemistry Council claims: "Alternative materials may not have the long track record and unique performance profile that makes PVC with DEHP a proven and lifesaving combination."



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Related Stories
Warning On DEHP
[C&EN, Feb. 4, 2002]

ALERT ON PHTHALATES
[C&EN, Aug. 7, 2000]

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