California Lists DEHP as a Reproductive Toxicant

SF Bay Area PSR has been very active in California hospitals’ efforts to reduce or eliminate the phthalate di-2-ethylhexyl phthalate (DEHP) – a chemical that leaches from medical devices made of polyvinyl chloride (PVC) plastic. We helped to spearhead the California Medical Association’s resolution in 2002 calling on hospitals to reduce or eliminate DEHP from their medical products. Since then, Kaiser Permanente, Miller Children’s Hospital in Long Beach, Lucile Packard Children’s Hospital at Stanford University, and John Muir Medical Center in Walnut Creek have all initiated efforts to phase-out PVC medical devices from Neonatal Intensive Care Units (NICUs). (For more information on these hospital efforts, see the case studies at http://www.noharm.org.)

We are happy to report a huge victory in our efforts. In October 2003, California regulators added DEHP to the Proposition 65 list of chemicals known to cause birth defects or reproductive harm. Manufacturers and others who make or use products containing DEHP have until October 2004 to either reformulate products or provide a warning to consumers that products contain DEHP, a known reproductive toxicant.

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, entering the bodies of patients. Animal studies considered relevant to humans link DEHP exposure to defects of male reproductive organs, such as the testicles. Ample scientific evidence shows that certain patients, particularly pregnant women and developing boys, should be protected from DEHP.

The Proposition 65 listing from the California Office of Environmental Health Hazards Assessment (OEHHA) follows on the heels of warnings from the Food and Drug Administration (FDA), National Toxicology Program (NTP), 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 that DEHP-free alternatives should be used for some medical treatments, particularly in NICUs.

SF Bay Area PSR member Brian Linde, MD, worked with staff at John Muir Medical Center to virtually eliminate DEHP from the NICU. “We’ve been following the science on DEHP exposures at John Muir Medical Center and have moved to eliminate DEHP products whenever possible in the Intensive Care Nursery,” said Dr. Linde. “OEHHA’s listing of DEHP as a reproductive toxicant will make our jobs easier. We won’t have to waste precious nursing hours making phone calls to determine whether an IV bag or nasogastric tube contains DEHP.”

Staff efforts at John Muir’s Intensive Care Nursery eliminated all the potential exposures to DEHP for babies receiving care in the ICN. “This is an accomplishment we are proud of,” said Dr. Linde. “The entire NICU staff is proud because we believe in providing the best care to patients and the best service to the community that we possibly can.”SF Bay Area PSR continues to provide technical support to hospitals wishing to eliminate or reduce DEHP. Please contact us at 510-845-8395 if you or your facility need assistance

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