Transitioning to a DEHP-Free Future
View current non-DEHP Product InfoThis information is intended for U.S. audiences only. For globally-focused information, please visit our Medical Materials Use Position Statement.
Trusted Today, Ready for Tomorrow – a Confident Path to a Non-DEHP Future
Baxter is committed to delivering safe, reliable IV solutions. As the World's Largest Flexible IV Bag Supplier,19 it is our responsibility to support the healthcare industry through a changing materials and regulatory landscape. As we evolve to fully non-DEHP IV fluid bags and tubing product portfolios for the U.S. by 2030 and 2035 respectively*, we do so with careful consideration – and balancing innovation with a steadfast promise of never compromising the quality or availability of these essential products.
The Role of DEHP in Our Medical Products
DEHP is a material known as a plasticizer. Plasticizers are commonly added to plastics, such as PVC, to provide softness, flexibility and kink resistance, which are important to the performance of many medical products, including IV bags and tubing.1,2 DEHP is a widely used plasticizer for PVC in medical applications,3 including in Baxter’s Viaflex containers. Baxter products using the Viaflex container have an extensive history of safe and effective use in IV infusion products – supported by ongoing FDA approvals and clearances since 1970.4
An FDA risk assessment of DEHP exposure across a wide range of medical applications showed little to no risk to patients from the amounts of DEHP released from PVC IV bags during infusion of the most common type of IV fluids (crystalloid fluids).3 A 2022 toxicological report from the Agency for Toxic Substances and Disease Registry (ATSDR) reinforced this conclusion.5
For perspective, to reach the FDA Tolerable Daily Intake (TDI) for DEHP exposure:
- An adult would need to be infused with 240 L of saline (or 240 x 1 L bags) in a single day – a volume equivalent to approximately 3X the average adult weight in IV fluid.3
- A neonate would need to be infused with 2,800 mL saline (or 11.2 x 250 mL bags) in a single day – a volume equivalent to approximately three-quarters of their body weight in IV fluid.3
Confidence in Our Proven PVC-Based Products
Backed by more than 50 years of clinical use and FDA approvals and clearances, Baxter trusts our PVC-based products to perform in the moments that matter most.4 Globally, over 80% of single-use medical bags and over 50% of medical tubing are made with PVC, placing it among the most widely used plastics in medical products.9 Across decades of use, studies have not shown harmful effects from exposure to PVC plasticized with DEHP in IV fluid bags and tubing, even in high-risk patient groups identified by the FDA.10 Additionally, the National Cancer Institute specifically states that PVC is not a known or suspected carcinogen.11
Baxter is actively taking steps to protect our planet, and PVC-based products support these efforts throughout every stage of the product life cycle. PVC plastic is made up of less than 50% petroleum product, and abundant, easily accessed common salts make up the remainder of its content.12 A 2023 analysis by the European Chemicals Agency (ECHA) found that the risks to workers and the environment from PVC resin were adequately controlled and did not recommend regulation.13
Additionally, PVC-based medical products can be recycled – helping to reduce the amount of waste going to landfills and lower the carbon footprint. PVC medical IV fluid bags, oxygen tubing and face masks are commonly recycled in global markets, including Australia, Canada and Europe.14-16 In the U.S., Baxter has successfully piloted a PVC IV bag recycling program with a large Chicago-area hospital.17 For over 10 years, Baxter has successfully implemented IV bag recycling programs outside the U.S. that reduce the amount of PVC going to landfills.18 Learn more about one of Baxter’s PVC recycling initiatives here.
Confidence in Every Product – Today and Tomorrow
We stand behind the safety and reliability of our full product portfolio and are helping customers confidently transition to non-DEHP products – without compromising supply continuity, safety or patient care.
Transitions come with questions – but as the largest IV solutions provider in the world, you can count on Baxter to continue to deliver our standard for safety, reliability and performance that has been trusted for over 90 years.
*The timing of transition to DEHP-free IV fluid bags and tubing will be in full compliance with all existing legislation in the U.S., including California Assembly Bill (AB) 2300.