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HomeRegulatory & QualityGroups Petition FDA to Label Devices Containing DEHP

Groups Petition FDA to Label Devices Containing DEHP

A group of healthcare organizations are demanding that FDA require the labeling of PVC devices that contain DEHP. A petition sent by Health Care Without Harm (HCWH) states that exposure to the toxic chemical can cause a disruption in the development of the male reproductive tract, along with harmingÂ vulnerable patients such as those on dialysis. For years there has been a debate about whether or not DEHP is harmful.

Jul 25, 2007

The European Union has already announced mandatory labeling of medical devices that have DEHP, and it currentlyÂ bans DEHP and other phthalates from toys and cosmetic products. HCWH says that the proper labeling of devices will allow hospitals to switch to safer alternatives. In 2002, FDA issued a warning about the use of DEHP in medical devices, but took no action to enact mandatory labeling.

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