An effective, reasonably priced plasticizer used in medical devices has been flagged as potentially harmful to children and fetuses by the U.S. Food and Drug Administration (FDA).

Di(2-ethylhexyl)phthalate (DEHP) been linked to abnormal testicular and sperm development in studies conducted in laboratory animals. When added to polyvinyl chloride (PVC), the DEHP changes normally rigid plastic into a flexible polymer that can be used to make devices such as IV bags and dialysis tubing.

The FDA issued a public health notification advising clinicians that its safety assessment of DEHP revealed that this chemical can leach out of PVC that is used in medical devices and may pose a health risk in certain high-risk groups, such as male fetuses and neonates, and prepubertal boys. (See www.fda.gov/cdrh/safety.html for contents of notification letter and www.fda.gov/cdrh/ost/dehp-pvc.pdf for the FDA’s study.)

“Even though the data come from young animals, expert panels worry that there may be...

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