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Erika Wilhelm, Breast Cancer Prevention Partners, 415-321-2920
Upcoming California Vote Would Ban Unnecessary Toxic Chemical that Leaches from Medical Devices Into Patients and Pave the Way for Hospitals Nationwide
Next week the California legislature is expected to vote on the Toxic-Free Medical Devices Act (AB 2300-Wilson), which would ban the toxic chemical DEHP from IV bags and tubing manufactured, sold, or used in the state. Although the legislation would only apply to California, this is a national public health issue, as 90% of U.S. hospital patients receive IV therapy or infusion.
In anticipation of this vote, Breast Cancer Prevention Partners (BCPP) today released a new report – Toxic-Free IV: Getting Harmful Chemicals Out of IV Bags and Tubing describing in detail why DEHP has no place in medical devices, especially when safe alternatives exist.
DEHP (Di-2-ethylhexyl phthalate) is a colorless, odorless chemical that makes Polyvinyl chloride (PVC) plastic more flexible. Approximately 60-70% of IV bags and tubes used in California and nationwide are made with this chemical despite known links to breast, liver, lung, and testicular cancers. Because it’s not a stable molecule, DEHP leaches out of the plastic into medication and other fluids being infused into the bloodstream of patients, posing a major health risk to already vulnerable populations.
“Hospitals should not be a place where sick people have to worry that their IVs will make them worse instead of better,” said Suzanne Price, CEO of BCPP. “The fact that DEHP and other phthalates are not allowed in toys because they’re too toxic for children to suck on, but we allow them to be pumped into the veins of patients from newborns to people receiving cancer treatment is insanity. We call on the California legislature to vote yes on this important bill, and for this to be a wake-up call for hospitals nationwide.”
The American Academy of Pediatrics, the American Medical Association, the American Public Health Association, and the U.S. Food and Drug Administration have all urged hospitals and physicians to phase out PVC medical devices, especially those containing DEHP, which has been banned from toys on a national level since 2008 and from beauty and personal care products sold in California since 2020.
For cancer patients in particular, toxic IV bags and tubing represent another serious public health concern: DEHP promotes drug resistance, and interferes with chemotherapy’s ability to fight breast cancer, making cancer cells ‘immortal.’ Research also shows that patients with higher levels of DEHP in their system had higher rates of relapse and breast cancer mortality. This is especially frightening for the over 300,000 women each year who are battling breast cancer in the United States.
“It’s disheartening to learn that many IV bags and tubing contain a chemical which can undermine the effectiveness of chemotherapy,” said Susan Whitehead, a breast cancer survivor and Board Vice President of Bay Area Young Survivors. “This unnecessary risk weighs heavily on my heart, as even a slight decrease in treatment efficacy could lead to the devastating possibility of recurrence for patients like me.”
The California Toxic-Free Medical Devices Act, likely to be voted on next week by the state legislature, would ban DEHP—and its replacement with other chemicals in the same class of ortho-phthalates—from IV bags and tubing manufactured, sold, or used in California, effective 2030 for IV bags and 2035 for IV tubing. The bill has overwhelming bipartisan support, demonstrating lawmakers on both sides of the aisle recognize the public health concerns presented by these toxic medical devices.
“As someone who has battled breast cancer firsthand, I understand the critical importance of ensuring that our medical devices are safe and free from harmful chemicals like DEHP,” said California Assemblywoman Lori Wilson, who introduced the bill. “By passing AB 2300, we can take a significant step toward protecting the health and well-being of Californians, ensuring that our medical devices meet the highest safety standards.”
While one global corporation, Baxter, supplies more than 60% of the IV bags in California and the US, the vast majority of which are made with DEHP and PVC, there are comparably priced, non-toxic IV bags and tubing available today. Three of the four major IV bag manufacturers already have a large portfolio of FDA-approved DEHP-free IV bags, including B. Braun, Fresenius-Kabi, and ICU Medical.
Leading California health systems, including Kaiser Permanente, Loma Linda University Health, and City of Hope, made the change years ago. In fact, Kaiser Permanente converted its entire hospital system to DEHP/PVC-free IV bags and tubing in 2012.
“While the California ban wouldn’t go into effect for several years, there’s no reason for hospitals to delay taking action sooner,” said Janet Nudelman, Senior Director of Program & Policy at BCPP. “Switching to DEHP-free IV bags and tubing is not an expensive, multi-year process. It’s a no-brainer way to prevent unnecessary harm to patients. We urge hospitals throughout California and across the country to make this shift ASAP, whether it’s the law or not.”
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Other quotes from key stakeholders:
Janet Nudelman, Senior Director of Program & Policy, Breast Cancer Prevention Partners (BCPP): “It doesn’t matter if you’re a Democrat or a Republican, everyone knows IV treatments are supposed to help patients get better, not make them sicker,” said Janet Nudelman, Sr. Director of Program and Policy at Breast Cancer Prevention Partners. “That’s why AB 2300 has received the support of legislators from both sides of the aisle and is poised to become the nation’s first-ever ban of DEHP from IV bags and tubing. Thank you, Asm. Wilson for ensuring IVs will be safer for everyone.”
Dr. Lisa Bailey MD, Breast Cancer Surgeon and BCPP Board Chair: “Health care providers should not have to be concerned that the medical device being used to treat their patient’s illness might be making them sicker or contributing to an even worse health condition,” said Lisa Bailey, 40-year veteran breast cancer surgeon and chair of Breast Cancer Prevention Partners’ Board of Directors. “To protect the health of the millions of Californians who receive medical infusions every year, the California Senate should support this urgently needed, common-sense legislation.”
Dr. Shanna Swan, PhD, Senior Scientist, Environmental Health Sciences: “Decreased sperm count; hypospadias and undescended testicles; preterm birth, infertility and other adverse effects on reproductive health; altered neurodevelopment and increased obesity have all been associated with DEHP exposure,” said Shanna Swan, leading environmental and reproductive health epidemiologist. “As a scientist who has studied the multiple health concerns linked to exposure to this toxic, endocrine disrupting compound for over 20 years, I can say without a doubt that DEHP has no place in IV bags or tubing.”
Susan Whitehead, Vice President, Breast Cancer Survivor, Bay Area Young Survivors (BAYS): “As a breast cancer survivor and the Board Chair & Vice President of Bay Area Young Survivors (BAYS), my journey through treatment has been both challenging and enlightening. I deeply understand how crucial it is to ensure that every aspect of our care is as effective as possible. It’s disheartening to learn that many IV bags and tubing still contain a plastic softener called DEHP, which can undermine the effectiveness of chemotherapy. This unnecessary risk weighs heavily on my heart, as even a slight decrease in treatment efficacy could lead to the devastating possibility of recurrence for patients like me. Thankfully, DEHP-free bags are commercially available, which offers us a logical and ethical choice to protect our health. We owe it to ourselves and to those who will face cancer in the future to advocate for the use of these safer alternatives.”
Dr. Barb Sattler, RN, Professor Emeritus, School of Nursing and Health Professions, University of San Francisco: “In the early 2000s, I learned from fellow nurses employed in the UK’s National Health Service that they only used DEHP-free IV bags/tubing,” said Barbara Sattler, California Nurses for Environmental Health and Justice. “It is appalling to me that similar steps have not been taken in the U.S., to protect infants and others from the well-known toxic effects of DEHP exposure from IV bags and tubing. I implore the legislature to heed the scientific warnings and pass AB 2300 so that California patients won’t have to wonder and worry if their IV treatment is compromising their health.”
Rhonda M. Smith, Executive Director, California Black Health Network: “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 higher exposure to toxic chemicals due to where we work, where we live, and the consumer products we use every day. DEHP in IV bags and tubing worsens this situation, especially for those with triple-negative breast cancer, a more aggressive and challenging-to-treat subtype of cancer that disproportionately affects Black women at three times the rate of other racial or ethnic groups. AB 2300 addresses the urgent need to eliminate DEHP from IV therapy to mitigate this disparity and improve health outcomes for all Californians.”
Dr. Kelly McCue, MD and Chair of the American College of Obstetricians and Gynecologists, District IX, co-sponsors of the bill: “As an OB/GYN, I constantly work to ensure every step is taken to ensure the safety and well-being of my hospital patients. The harmful effects of DEHP, a toxic chemical found in IV bags and tubing, are well-documented, including its links to cancer, birth defects, and developmental issues in children. By phasing out DEHP in 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 are available.”
Judith Enck, President, Beyond Plastics: “No plastic creates more harmful exposures for consumers, workers, communities, or the planet, than polyvinyl chloride (PVC),” said Judith Enck, President of Beyond Plastics and former EPA Regional Administrator. “It’s a well-kept secret that the same PVC that’s used in vinyl flooring, shower curtains and building materials is also in the majority of IV bags and tubing found in California and across the nation. This is bad for the environment because PVC is toxic at every stage of its lifecycle, from the highly carcinogenic dioxins released into the air when you burn it, to the landfills that discharge vinyl chloride exposing already vulnerable communities to this dangerous breast carcinogen, to the water pollution created when PVC leaches into our waterways. I urge the California legislature to pass this much-needed legislation and pave the way for the rest of the nation’s hospitals to follow suit and get DEHP and PVC out of IV production and use.”
Patrick Witmer, Corporate Vice President, Corporate Affairs, B. Braun Medical Inc.: “More than 40 years ago, B. Braun recognized the patient and environmental risks posed by medical products containing PVC and DEHP. We’ve never manufactured our IV fluid containers with PVC or DEHP, and we continue to bring new infusion therapy products to the market using safe materials because it’s the right thing to do for patients, healthcare providers, and the environment. B. Braun is proud to support AB 2300 – the Toxic Free Medical Devices Act – which will help ensure that millions of patients across California are not exposed to harmful chemicals when receiving IV therapy.”
Rachelle R. Wenger, System Vice President, Public Policy & Advocacy Engagement for CommonSpirit Health: “AB 2300’s health protective standard for IV bags and tubing in California sends a signal across the country to prioritize safer, cost-effective alternatives without PVC/DEHP,” said Rachelle R. Wenger, System Vice President, Public Policy & Advocacy Engagement for CommonSpirit Health. “We applaud California for leading the way by addressing this urgent public health concern, putting first the needs of those most vulnerable.”
Peter Allen, Senior Vice President, IV Therapy, Fresenius-Kabi: “At Fresenius-Kabi, we manufacture and sell more than 1 billion IV solution containers per year globally, all made without PVC/DEHP. Because the world takes seriously the health and environmental risks associated with these chemicals of concern, we moved toward alternatives decades ago. Kudos to California for raising the bar for safety of medication delivery with AB 2300 and paving the way for other states to do the same.”
