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Two leading manufacturers of intravenous bags and tubes will offer new products that health and environmental activists say are safer-especially for neonatal, pediatric, and cancer patients. The new equipment will be made of propylene rather than polyvinyl chloride (PVC), also called vinyl, and will be free of diethylhexyl phthalate (DEHP), a plasticizer used to soften PVC. The two companies join a third, smaller manufacturer, which has sold such products for 30 years.
PVC is considered environmentally unsafe by many public health organizations because it contributes to dioxin formation during manufacture and incineration. Regarding DEHP, the Food & Drug Administration and the Department of Health & Human Services' National Toxicology Program Center for the Evaluation of Risks to Human Reproduction have said that the plasticizer demonstrates a potential for liver damage and testicular atrophy, especially in neonates and infants under one year of age. DEHP has also demonstrated an ability to bond with certain drugs, such as the cancer drug paclitaxel (Taxol) and therefore could leach into a patient's bloodstream. The FDA issued a DEHP warning in 2002, recommending that hospitals switch to alternatives.
Hospira Inc., in Lake Forest, Ill., and Baxter Inc., in Deerfield, Ill., will begin marketing their new PVC/DEHP-free products later this year. One source estimates that the two companies control about 90% of the nation's annual $1.2 billion IV bag and tube market. Hospira officials said they expect to replace all their current IV bags and tubes with the safer products, although they have not announced a time frame. They also said that the new equipment, to be marketed under the brand name VISIV, may cost more per unit than current products, but the overall cost to hospitals may be less. The new propylene bags do not require disposal of PVC-product special wrapping, and they weigh 40% to 60% less than other flexible IV containers, thus making them easier to manage.
Baxter is conducting pilot studies rather than a full rollout because the new products are less flexible and somewhat more difficult to manage in relation to tube insertion, said Diane Sekula, R.Ph., Baxter's senior clinical affairs manager. "We are offering these products now because of an increasing interest among our customers," she said. "We want to gather the information necessary to enhance training and services." The pilot studies will also help gauge consumer interest, she added.
In marketing the new products, the two companies join B. Braun Medical in Bethlehem, Pa., which controls most of the remaining 10% of the market and has been selling PVC-free and DEHP-free products for more than 30 years. "We have long believed that studies do show the potential dangers of PVC and DEHP. In fact, DEHP is banned in young children's toys as a possible carcinogen," said Jessica Pitt, Pharm.D., B. Braun's product manager for fluid therapy. "Pharmacists must be aware of what IV bags are made of for the safety of their patients, and be aware of potential container/drug interaction, especially for vulnerable patients. It's their responsibility to optimize patient safety."