Chemical in PVC Medical Devices to be Listed As Reproductive Toxin in California

23-Oct-2003

On Friday, the state of California will add the phthalate DEHP -- a chemical that leaches from medical devices made of polyvinyl chloride (PVC) plastic -- to the Proposition 65 list of chemicals known to cause birth defects or reproductive harm.

"The Office of Environmental Health Hazard Assessment (OEHHA) has made the right decision to officially list DEHP as a reproductive toxicant," said Charlotte Brody, RN, executive director of Health Care Without Harm. "Now manufacturers have a choice, they can either make products without Prop 65 reproductive toxins or other dangerous chemicals, or they can notify health care providers that their products contain DEHP and may pose reproductive hazards."

DEHP, or di-2-ethylhexyl phthalate, is used to make vinyl plastic products soft and flexible. Because it is not chemically attached to the vinyl, it oozes out of the plastic. Studies have shown that DEHP can leach from plastic bags that contain intravenous fluids, blood, tube feedings, or other medical treatments, and thereby can get into the bodies of patients.

"Animal studies considered relevant to humans link DEHP exposure to defects of male reproductive organs, such as the testicles," said Ted Schettler, MD, a practicing physician in Boston and science director of the Science and Environmental Health Network. "Ample scientific evidence shows that certain patients, particularly pregnant women and developing boys, should be protected from DEHP."

The Proposition 65 listing follows on the heels of warnings from the Food and Drug Administration, National Toxicology Program, and Health Canada that DEHP may cause birth defects and other reproductive harm. FDA has warned health care providers that they should protect certain vulnerable patients from DEHP and has said DEHP-free alternatives should be used for some medical treatments, particularly in Neonatal Intensive Care Units (NICUs).

"Health care providers all over the country have begun to raise concerns about DEHP exposures and have initiated efforts to investigate and eliminate DEHP in their facilities," Brody said. California hospitals have been leaders in this effort.

https://www.chemeurope.com/en/news/30313/chemical-in-pvc-medical-devices-to-be-listed-as-reproductive-toxin-in-california.html