A new California law, the Toxic-Free Medical Devices Act (AB 2300), will phase out the use of one specific toxic chemical (DEHP) in IV bags and tubing by 2030 and 2035.
DEHP (Di-2-ethylhexyl phthalate) is a plasticizer used in medical devices like IV bags and tubing, which has been linked to cancer and other health risks.
The law represents a shift in medical device regulations, particularly as hospitals have used IV bags with DEHP for decades, despite long-standing concerns about the chemical’s impact on human health.
More About DEHP
DEHP is a phthalate. It is used to make plastics like polyvinyl chloride (PVC) softer and more flexible.
As you might imagine, this flexibility is important for the functionality of IV bags and tubing, which must be pliable and durable at the same time.
However, studies have shown that DEHP can leach out of these plastics and enter the fluids that patients receive intravenously, potentially exposing them to significant health risks.
Some of the known health impacts of DEHP exposure include:
- Increased risk of cancers, including breast, liver, lung, and testicular cancers
- Endocrine disruption
- Interference with chemotherapy, making cancer cells more resistant to treatment
This is especially concerning when you consider the fact that a lot of the people exposed to these phthalates via IV equipment are already in compromised health. This includes babies in the Neonatal Intensive Care Unit.
California’s New Law
The new law bans the use of DEHP in IV bags starting in 2030 and in IV tubing by 2035.
While the legislation is specific to California, the implications are expected to ripple across the country due to California’s large healthcare market. Many medical device manufacturers supply both California and other states, making it unlikely that companies will produce DEHP-containing IV bags solely for states outside California.
Key provisions of the law include:
- January 1, 2030 deadline: IV bags with DEHP must be phased out.
- January 1, 2035 deadline: IV tubing containing DEHP must be phased out by this time.
- Restricts the replacement of DEHP with other ortho-phthalates in these medical devices. The bill specifically lists several ortho-phthalates, including DBP, DINP, and BBP, as chemicals that cannot be used as substitutes for DEHP. This broad approach is designed to prevent the substitution of one harmful chemical with another from the same class, ensuring that medical devices become safer for patients in the long term.
While the law provides a decade-long timeline for full compliance, organizations such as Breast Cancer Prevention Partners (BCPP) are urging hospitals to adopt DEHP-free products as soon as possible.
Switching to DEHP-Free Alternatives Is Feasible & Cost-Effective
California’s legislation has been met with support from many healthcare systems and manufacturers that have already moved away from DEHP. For example, Kaiser Permanente eliminated DEHP from its entire hospital system as early as 2012, demonstrating that a shift to safer alternatives is feasible and cost-effective.
Several other organizations have also signed a pledge to phase out DEHP and PVC in medical devices:
CommonSpirit Health, one of the largest healthcare systems in the U.S., operates over 700 care sites and has committed to removing DEHP from its supplies.
Sharp HealthCare, a San Diego-based system, has similarly pledged to prioritize patient safety by transitioning to safer materials.
“We are thankful to California for passing this important legislation, but we hope we don’t have to wait another decade to phase out these toxic medical devices,” said Suzanne Price, CEO of Breast Cancer Prevention Partners (BCPP). “There are cost-effective and safe alternatives to DEHP and PVC medical devices available right now that provide the same level of functionality without the associated health risks. Making the transition is both feasible and safer for patients, healthcare providers, and the environment.”
The Broader Push for DEHP-Free Medical Devices
Although this law focuses on IV bags and tubing, DEHP is found in many other medical devices, such as catheters and nasogastric tubes. Advocacy groups like BCPP are pushing for broader legislation to eliminate DEHP from all medical devices, not just IV supplies.
According to research, approximately 60–70% of IV bags and tubes used in the U.S. contain DEHP, putting millions of patients at risk, especially vulnerable populations such as cancer patients, pregnant women, and newborns.
Despite these risks, DEHP has been banned from toys and personal care products in California for years. In fact, it was banned from children’s toys nationwide as early as 2008. This has led to questions about why medical devices, which come into direct contact with the human body, have not faced the same level of scrutiny.
National and Global Implications
As I mentioned, California’s decision could set a precedent for other states. For example, Pennsylvania is considering a similar law that would phase out DEHP IV bags for pediatric and cancer patients by 2026, with a full ban by 2030.
Globally, the European Union has also passed legislation banning DEHP from medical devices, with a deadline for compliance set for 2030. This alignment between California and the EU could further pressure manufacturers to adopt safer materials worldwide.
What You Can Do
As a patient or healthcare provider, there are several practical steps you can take to minimize exposure to toxic chemicals like DEHP:
- Ask your healthcare provider: When receiving IV therapies, ask if the hospital uses DEHP-free IV bags and tubing. Many hospitals have already made the switch, and others may be able to provide alternatives if requested.
- Check hospital policies: If you’re involved in hospital administration or patient advocacy, encourage your facility to adopt DEHP-free medical devices ahead of the 2030 deadline.
- Support legislation: Advocate for similar legislation in other states to ensure that DEHP is phased out across the country, not just in California.
- Stay informed: Follow updates from healthcare advocacy organizations, such as Breast Cancer Prevention Partners, to stay informed about ongoing efforts to eliminate toxic chemicals from medical devices.