B. Braun Medical Providing Safer DEHP-free Device Options for Preemies, Neonates and Other At-risk Populations

BETHLEHEM, Pa. -- To help improve patient outcomes and enable healthcare providers to comply more rapidly with FDA recommendations concerning limiting exposure to DEHP, a plasticizer in some PVC-based devices, B. Braun Medical Inc. announced that more than 80 percent of its IV administration and medication pump sets are DEHP-free. In addition, 100 percent of its basic IV solution containers are DEHP-free.  These numbers reflect a company-wide philosophy that innovation should also reflect high safety and environmental standards.

DEHP, listed by the State of California as a reproductive toxicant, can harm the normal development of the male reproductive system in premature neonates, toddlers and adolescent boys.1,2  

Healthcare providers are encouraged by the FDA to avoid DEHP products where possible, especially in perinatal and neonatal care.3 B. Braun, a supplier of DEHP-free IV solution containers and infusion devices in the United States, provides clinicians and patients safer alternatives to DEHP-plasticized PVC intravenous medical products.

Di(2-ethylhexyl)phthalate (DEHP) is a chemical compound used to make polyvinyl chloride (PVC) products, such as intravenous bags and tubing, soft and pliable.

We have made tremendous progress over the last decade and will continue to dedicate ourselves to providing our clinicians with the ability to administer 100 percent of their infusion therapy needs with devices that are DEHP and PVC free alternatives, said Greg Jones, director of marketing, IV systems for B. Braun Medical. Our goal is to help clinicians safely meet the needs of our smallest and most vulnerable patients, the preemies.

B. Braun, a provider of PVC-free, DEHP-free alternatives for basic parenteral solutions, has always manufactured its IV and nutrition solutions in PVC-free, DEHP-free containers. The polypropylene-based materials used to manufacture B. Braun EXCEL and PAB  containers provide a safe and accurate means of administering IV medications without potential toxicity to the patient.  In addition, B. Braun offers DEHP-free IV tubing, irrigation solutions, and parenteral nutrition solutions specifically formulated for neonatal and pediatric patients.

References:
 1.   California Environmental Protection Agency Office of Environmental
 Health Hazard Assessment: Safe Drinking Water and Toxic Enforcement Act of 1986; Notice of Intent to List Chemicals, April 2003.
 2.   FDA: Safety Assessment of Di-(2-ethylhexyl) phthalate (DEHP) Released from Medical Devices, September 2001.
 3.   FDA Public Health Notification: PVC Devices Containing the
 Plasticizer DEHP, July 12, 2002

Source: B. Braun
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