Medical IV bag suppliers with markets in the state of California have until 2030 to phase out di(2-ethylhexyl) phthalate, or DEHP, from the product category and replace them with new, FDA-approved products.
In August, the California State Senate unanimously passed AB2300, the Toxic Free Medical Devices Act, which requires phasing out DEHP in PVC IV bags and tubing sold, used or manufactured in the state. The ban on the chemical in tubing will begin in 2035.
The plasticizer, a common phthalate used to soften PVC in medical applications, can leach into intravenous solutions, entering patients' bodies or rending medications ineffective, Stephanie Pitts, RN and senior director of health care strategy and innovation at B. Braun Medical Inc., told Plastics News in an interview.
The chemical was banned from children's toys in California in 2007, which became a national standard in 2008, Pitts said. Since then, it has also been removed from water bottles, meat packaging and water pipes.
The Breast Cancer Prevention Partners (BCPP), an advocacy organization that co-sponsored the California bill with the California Black Health Network and the American College of Obstetricians and Gynecologists, also advocated for the federal ban of DEHP in children's toys in 2008.
BCPP provided expert testimony during deliberations and provided a report on phthalates in IV bags and tubing that outlines the risks of DEHP, and it advocates for safer alternatives for vulnerable populations like cancer patients and infants.
Research over the past 40 years has linked DEHP to a range of severe health problems, Laura Gillan, senior program and policy manager of BCPP, told PN. Health complications include endocrine disruption, reproductive harm, breast and other cancers, developmental issues and metabolic disorders like obesity and Type 2 diabetes.
Studies have also linked the chemical to drug resistance and showed that DEHP interfered with the effectiveness of breast cancer treatments like chemotherapies and tamoxifen, a selective estrogen receptor modulator used to treat breast cancer in men and women, Gillan said. "It's particularly troubling because … it's also associated with higher relapse rates and breast cancer mortality among patients with elevated DEHP levels."
Another study found premature infants in NICUs are exposed to levels of DEHP that are "thousands of times higher than what is considered safe, putting them at risk for reproductive disorders and liver toxicity," Gillan said.
"The human impact of this is not small," Pitts said, adding that about 70 percent of IV bags in the U.S. contain some form of DEHP. In some IV bags, the DEHP is 40 percent of the overall weight of the bag.