Medical Materials Use Position Statement

Medical Materials Use Position Statement

Position Statement: Materials Use

Baxter is committed to providing life-sustaining medical products and services that safely and effectively meet the needs of our healthcare customers and the patients who rely on them. As part of that commitment, we provide our customers with products made from appropriate materials – selected based on the unique characteristics of each product, the required performance attributes and supporting scientific evidence. 

Our choices of materials used in our products are informed by decades of scientific evidence and clinical performance. Baxter continually evaluates a variety of materials and allocates significant funding for research and development. In evaluating the appropriate materials for use in our products, Baxter’s research and development teams ensure that they meet critical performance criteria – including clarity and transparency, strength, flexibility, sterilizability and barrier capability – as well as other considerations, such as usability and environmental impact.

Supported by more than 50 years of safe and effective clinical use and a substantial body of scientific data, Baxter believes that PVC is an appropriate material for many products. PVC has a long history of use in a variety of medical products, including intravenous bags, oxygen tents and catheters. These products have undergone strict regulatory reviews by many government and independent health agencies throughout the world, including the U.S. Food and Drug Administration. The safety of these materials in IV fluid bags has been confirmed by decades of use and approximately eight billion patient days of acute and chronic exposure without report of significant adverse effects. PVC is also recyclable in various markets (including the U.S.). Recycling clean PVC can positively impact the environment by reducing the amount of waste that is landfilled or incinerated. 

While PVC is a widely used material that can consistently meet the rigorous requirements for medical products, it may not be appropriate for all clinical applications. To meet the preferences of some customers and address drug compatibility issues in specific clinical applications, Baxter offers a range of products that use or are contained in non-PVC materials, including intravenous medications, parenteral nutrition solutions, injectable drugs, biopharmaceuticals, IV sets and access devices.

Plasticizers are commonly added to plastics, including PVC, to provide softness, flexibility and kink resistance. One such plasticizer is DEHP [di-(2-ethylhexyl)phthalate], which is widely used in medical applications. Although often referenced together, PVC and DEHP are distinct materials with separate properties. Based on evolving customer preferences and regulatory and government requirements, Baxter is expanding our existing DEHP-free product offerings and will align with relevant sunset dates in various global jurisdictions. This includes a comprehensive transition to an entire DEHP-free IV containers and tubing portfolio in the U.S. by 2035.

Baxter remains committed to delivering a range of essential products, including both PVC-based and PVC-free options, and we will continue our reasoned, science-based approach to the development and adoption of materials used in our products.

Related Information: 
Baxter’s California AB-2300 Position Statement
Transitioning to a DEHP-Free Future