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FDA urged to reduce phthalates in medical equipment

by Britt E. Erickson
February 27, 2021 | A version of this story appeared in Volume 99, Issue 7


Medical worker handling a plastic IV bag.
Credit: Shutterstock
Lawmakers want the FDA to reduce harmful phthalates in IV bags and other medical devices.

The US health-care system has made minimal progress during the past 2 decades to rid medical devices of harmful phthalates and other chemicals that disrupt the endocrine system, according to six members of Congress. In a Feb. 18 letter to the US Food and Drug Administration, the lawmakers urge the agency to update its 2002 guidelines for use of such chemicals in medical devices, particularly IV bags. Phthalates like diethylhexyl phthalate (DEHP), which are used to increase the flexibility of plastic IV bags, can leach into patients during infusions. “The evidence of patient exposure to DEHP and other toxins during the course of clinical care is well established, and science continues to demonstrate the need to reduce patient risk from such exposure,” the representatives write. Exposure to phthalates can have adverse effects on male reproductive development (Environ. Int. 2018, DOI: 10.1016/j.envint.2018.07.029), and recent research suggests the chemicals can impair brain development (Am. J. Public Health 2021, DOI: 10.2105/AJPH.2020.306014). IV bags that don’t contain DEHP are available, but estimates suggest that over 60% of bags used in the US contain DEHP, the lawmakers say.


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