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MEDICAL DEVICES
FDA has issued a draft guidance document on di-(2-ethylhexyl) phthalate, a compound used as a plasticizer in many polyvinyl chloride medical devices.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.
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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