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 our products. As part of that commitment, we provide our customers with products made from appropriate materials, taking into careful consideration the unique characteristics of the solutions going into the containers, the performance characteristics required, and scientific data.

Baxter continually evaluates a variety of materials and allocates significant funding for the research and development of biomaterials. In evaluating the appropriate material to use for a product, Baxter’s research and development teams ensure that the material and container 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.

Based on more than 40 years of safe and effective clinical use, and the large body of scientific data that supports its use, Baxter believes that PVC is an appropriate material for many products. PVC has a long history of use in a variety of medical products, such as contact lenses, intravenous bags, oxygen tents, and catheters. These products have undergone strict regulatory review by many government and independent health agencies throughout the world, including the U.S. Food and Drug Administration.  The safety of these materials has been confirmed by more than 40 years of use, with approximately eight billion patient days of acute and chronic exposure without report of significant adverse effects. Environmental questions relating to the incineration of PVC are being addressed with modern pollution control technologies that can reduce, for instance, dioxin emissions up to 99.9 percent.

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 portfolio of intravenous medications, parenteral nutrition solutions, injectable drugs, biopharmaceuticals, IV sets and access devices, and other products that use or are contained in non-PVC materials or non-DEHP [di-(2-ethylhexyl)phthalate], a common component of PVC materials.

Baxter will continue its reasoned, science-based approach toward the development and adoption of materials used in its products.