B. Braun Implements Labeling On Entire Line Of PVC-Free And DEHP-Free IV Containers As DEHP Becomes A Growing Concern; California Lists DEHP As A Reproductive Toxicant.

Business Editors

BETHLEHEM, Pa.--(BUSINESS WIRE)--Dec. 2, 2003

B. Braun Medical Inc., the only U.S. provider of a full line of basic IV solutions in PVC-free and DEHP-free IV solution containers, today announced that they have begun implementing labels on their entire line of EXCEL(R) and PAB(R) IV containers to more clearly identify their DEHP-free product offering. On the heels of the news that the State of California intends to list Di(2-ethylhexyl) phthalate, DEHP, as a reproductive toxicant, B. Braun has taken the lead as a safety company to educate clinicians and their patients on the available alternatives to DEHP-plasticized PVC intravenous medical products.

"Every day we see more research being conducted on DEHP and the results are always the same. DEHP has harmful effects on humans. B Braun feels very strongly about the need to alert people that PVC-free and DEHP-free products do exist and are available today," said Dr. Marcus Schabacker, Corporate Vice President, Research and Development and Medical and Clinical Affairs of B. Braun Medical Inc. "We're pleased to say that we have begun labeling our entire line of EXCEL(R) and PAB(R) IV containers to read 'PVC -free, DEHP-free.' Since DEHP has been declared a risk by the FDA, and our EXCEL(R) and PAB(R) bags have been PVC-free and DEHP-free since their inception, this new labeling makes it more clear to the clinicians that alternatives are available and it enables them to make a more educated decision on which products they choose to work with."

Di(2-ethylhexyl)phthalate (DEHP) is a chemical compound used to make polyvinyl chloride products, such as intravenous bags and tubing, soft and pliable. DEHP has been classified as a "probable human carcinogen" by the U.S. Environmental Protection Agency (EPA).(1) It is recognized as being harmful to normal development of the male reproductive system by the FDA and others.(2) The FDA encourages healthcare providers to avoid DEHP products where possible -- especially in perinatal and neonatal care. (3)

The California Office of Environmental Health Hazard Assessment (OEHHA), the lead agency for the implementation of Proposition 65, has listed DEHP as "known to the State to cause reproductive toxicity"(4). A recent study shows that a correlation exists between low birth weight and decreased fertility in adult males.(5) These low birth weight infants may have been given blood, blood products, Total Parenteral Nutrition (TPN) and IV solutions at birth, thus exposing them to DEHP.(3) Another study reported that the daily intake of DEHP in Germany is 8 times higher than the EPA reference dose (RfD).(6) The authors of the German study express concern for public health, given the strong evidence linking DEHP to infertility and hormonal imbalance. (6)

B. Braun has always manufactured its IV and nutrition solutions in PVC-free, DEHP-free containers. Over ten years ago, the Company invested more than $40 million into the development of a line of IV solutions in PVC-free and DEHP-free bags. Today, B. Braun's EXCEL(R) and PAB(R) containers are used by major healthcare providers across the United States. B. Braun's position is clear: If alternative products are offered, why subject your patients to risk?

B. Braun is currently the only company in the United States to provide PVC-free, DEHP-free alternatives for basic parenteral solutions. The polypropylene-based materials used to manufacture EXCEL and PAB containers provide a safe and accurate means of administering IV medication. In addition, B. Braun offers DEHP-free IV tubing, irrigation solutions, and parenteral nutrition solutions specifically formulated for neonatal and pediatric patients.

About B. Braun

Since its founding in 1839, B. Braun has built an unparalleled store of knowledge and expertise in delivering innovative healthcare products, devices, and services enhancing both patient and health-professional safety. Its 29,000 employees worldwide are proud of their commitment to translating customer needs into products with unmatched quality, superior technology, cost-effectiveness and environmental responsibility.

Through its "Sharing Expertise(TM)" initiative, B. Braun shares "lessons learned" with its customers and suppliers in order to improve the quality of healthcare delivery around the world. For more information about B. Braun or its safety healthcare products, call 800-854-6851, or visit B. Braun at www.bbraunusa.com.

References

1. U.S. Environmental Protection Agency: Di(2-ethylhexyl) phthalate (DEHP), 1993.

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, 2002.

4. 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.

5. Ciognani A, et al: Low birth weight for gestational age and subsequent male gonadal function. Journal of Pediatrics 2002; 141: 376-380.

6. Koch HM, et al: An estimation of the daily intake of di(2-ethylhexyl) phthalate (DEHP) and other phthalates in the general population. International Journal Hygiene Environmental Health 2003; 206:1-7.