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FOR IMMEDIATE RELEASE
Contact: Christine Crooks, Director of Marketing Carmel Pharma, Inc. 1-866-487-9250 ext 202 COURT RULING CONFIRMS THE TEVADAPTOR (ONGUARD SYSTEM) DOES NOT MEET THE REQUIREMENTS OF A TOTALLY CLOSED SYSTEM Gothenburg Administrative Court of Appeal reinforced the ruling of the Regional Administrative Court that the Tevadaptor (distributed by B.Braun as the OnGuard System in the United States), manufactured by Teva Medical in Israel, does not meet the definition of a totally closed system. In 2006, the Västra Götaland County Council, which is the society that is responsible for all hospitals in the western part of Sweden, conducted an open procurement review of injection/infusion products. The County Council asked for the following three mandatory requirements:
On October 2, 2006, Teva was awarded the procurement. Carmel Pharma refuted this ruling, citing, “A system must mechanically prevent substances from leaking out in order to be classified as totally closed. A product with a ventilated system can never accomplish that”. In the opinion of the Regional Administrative Court, the system must not leak anything into the environment (see NIOSH’s definition of a closed system drug-transfer device). Given that, in accordance with its intended function, Tevadaptor ventilates out, it also leaks something into the environment and thereby fails to meet the mandatory requirement that it be totally closed. The Regional Administrative Court concluded in the ruling that the Tevadaptor does not fulfill any of the three mandatory requirements, and therefore the County Council ordered that the procurement be redone. Teva Sweden AB appealed the case at Gothenburg Administrative Court of Appeal. On September 19, 2007, Gothenburg Administrative Court of Appeal reinforced the ruling from the Regional Administrative Court. This court also concluded that the Tevadaptor is not a totally closed system. The Teva appeal was rejected. |
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