ICU Medical Position Statement:  Medical Materials

ICU Medical is committed to providing life-sustaining medical products that safely, accurately and effectively meet the needs of our customers and patients.  We provide our customers with products manufactured from appropriate materials, meeting the performance characteristics required, and supported with scientific data.

ICU Medical continually evaluates various materials during the product development and lifecycle management processes. The ICU Medical research and development teams ensure that device and container materials meet critical performance criteria including clarity and transparency, biocompatibility, strength, flexibility, sterilizability, and barrier capability.

Based on the body of scientific data and more than 40 years of safe and effective clinical use, ICU Medical believes that polyvinyl chloride (PVC) is an appropriate material for many products. PVC has an established history of acute and long-term use in a variety of medical products, such as contact lenses, intravenous bags, oxygen tents, and intravenous catheters. Products containing PVC have undergone strict regulatory review by global governmental and independent health agencies, including the U.S. Food and Drug Administration, and have been found to be safe and effective. Environmental questions relating to the disposal of PVC are being addressed with modern pollution control technologies.

While PVC is widely used and consistently meets the rigorous requirements for medical products, it may not be the optimal material for all clinical applications. To meet the clinical need for a variety of material options, ICU Medical offers a portfolio of infusion therapy products assembled from non-PVC and/or non-DEHP [di-(2-ethylhexyl)phthalate] plastic formulations.

ICU Medical will continue to base our product material selections on scientific data to best meet the needs of our patients and clinicians.