Information provided by:
Shayna Samuels
Partners for breast cancer prevention
Setting a high standard for patient safety for the first time, the California Senate unanimously passed the Toxic-Free Medical Devices Act (AB 2300) on Monday, August 26, in a bipartisan 40-0 vote, banning the use of the toxic chemical DEHP in IV bags and tubing manufactured, sold, or used in the state.
The bill was already approved by the Assembly in May, but as an internal procedure it will return to the Assembly for a concurrent vote. After that, it goes to the governor to sign the law.
The passage of this groundbreaking legislation is a significant step toward protecting patients across the country, as 90% of hospitalized patients in the United States receive intravenous or infusion therapy, and many are unknowingly exposed to this harmful chemical that is linked to cancer.
“As someone who has battled breast cancer firsthand, I understand the critical importance of ensuring our medical devices are safe and free of harmful chemicals like DEHP,” said California Assemblywoman Lori Wilson, who introduced the bill. “By passing AB 2300, we are taking an important step toward protecting the health and well-being of patients by ensuring our medical devices meet the highest safety standards.”
DEHP (Di-2-ethylhexyl phthalate) is a chemical that makes polyvinyl chloride (PVC) plastic more flexible. Approximately 60-70% of IV bags and tubes used in California and across the country are made from this chemical, despite the fact that it is known to be linked to breast, liver, lung, and testicular cancer. Because it is not a stable molecule, DEHP leaches from the plastic into medications and other fluids infused into patients’ bloodstreams, posing a serious health risk to already vulnerable populations.
The new law, which goes into effect in 2030 for IV bags and 2035 for IV tubing, requires the elimination of DEHP and related ortho-phthalates from these essential medical devices in California.
Although the new law applies only to California, its national implications are enormous. Most U.S. hospitals rely on a small group of manufacturers for their IV supplies. Although Baxter International, which supplies most of California’s and the nation’s IV bags made from DEHP and PVC, has lagged behind in offering nontoxic alternatives, other manufacturers such as B. Braun, Fresenius-Kabi and ICU Medical already sell FDA-approved DEHP-free IV bags.
“There’s nothing complicated about it; patients shouldn’t have to wonder and worry if their IV treatments are making them sicker,” said Janet Nudelman, senior director of programs and policy at Breast Cancer Prevention Partners (BCPP). “That’s just common sense. We hope this historic victory inspires healthcare institutions across the country to make this change immediately to eliminate DEHP exposures that are endangering the health of breast cancer patients and other vulnerable populations.”
The BCPP recently published a report, “Toxic-Free IV: Getting Harmful Chemicals Out of IV Bags and Tubing,” which details why DEHP has no place in medical devices, especially when safe alternatives exist.
“As an obstetrician and gynecologist, I work constantly to ensure that all necessary steps are taken to ensure the safety and well-being of my patients in the hospital,” said Dr. Kelly McCue, president of the American College of Obstetricians and Gynecologists, District IX, one of the bill’s co-sponsors. “By phasing out DEHP from medical devices, AB 2300 will significantly reduce these risks, providing safer healthcare for all Californians. No patient, in any setting, should be exposed to such dangerous chemicals, especially when safer alternatives exist.”
The American Academy of Pediatrics, the American Medical Association, the American Public Health Association and the U.S. Food and Drug Administration have urged hospitals and physicians to phase out PVC medical devices, especially those containing DEHP, which has been banned in toys nationwide since 2008 and in beauty and personal care products sold in California since 2020.
For cancer patients in particular, toxic IV bags and tubes pose a serious public health problem: DEHP fuels drug resistance and interferes with the ability of chemotherapy to fight breast cancer, rendering cancer cells “immortal.” Research also shows that patients with higher levels of DEHP in their system had higher rates of breast cancer relapse and mortality. This is especially alarming for the more than 300,000 women who battle breast cancer in the United States each year.
“The presence of DEHP in IV bags and tubing poses a serious public health concern and contributes to existing health disparities, particularly for Black women who already face increased exposure to toxic chemicals because of where we work, where we live, and the consumer products we use every day,” said Rhonda M. Smith, executive director of the California Black Health Network, one of the co-sponsors of AB 2300.
“DEHP in IVs makes this situation worse, especially for those with triple-negative breast cancer, a more aggressive cancer that disproportionately affects Black women. AB 2300 addresses the urgent need to eliminate DEHP from IV therapy to mitigate this disparity and improve health outcomes for all Californians.”
“This law is a victory not only for Californians, but for all Americans who deserve safe, toxic-free healthcare,” said Suzanne Price, CEO of BCPP. “Nontoxic alternatives are not only feasible, but readily available and cost-effective. There is no excuse not to make this transition.”
California health systems including Kaiser Permanente, Loma Linda University Health and City of Hope made the switch years ago. Kaiser Permanente successfully converted its entire hospital system to DEHP/PVC-free IV bags and tubing in 2012, demonstrating that switching to nontoxic materials is feasible and affordable.
“As hospitals across the U.S. brace for the impact of California’s new law, this victory represents a shift toward safer, more sustainable healthcare, free from the hidden dangers of toxic chemicals,” Price added.
“No one should be exposed to such dangerous chemicals, especially when safer alternatives exist.”
