B.Braun Medical Inc received 510(k) clearence from FDA for the industry’s first silver-impregnated

B. Braun Medical Inc.announced that it had received 510(k) clearance from the FDA for the industry’s first silver-impregnated antibacterial Luer Access Device (LAD) designed to reduce potential catheter-related bloodstream infections.

B. Braun’s ULTRASITE® Ag Luer Access Device uses a controlled release silver ion technology that effectively achieves 4-log (99.99%) reductions in bacteria Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter aerogenes and 3-log (99.9%) reductions in bacteria Staphylococcus aureus, MRSA and MRSE through a 96-hour product life cycle in clinical tests. Because all fluid path and external surfaces in the device are impregnated with silver, Ultrasite® Ag is designed to offer more protection against bacteria.

Tom Sutton, Director of Marketing of IV Systems for B. Braun Medical Inc said, The introduction of the Ultrasite® Ag LAD maintains our leadership position as a provider of advanced technology for medical device disposables that support patient and healthcare worker safety. This is a cutting edge product that combines the benefits of needle free access for reduced needlestick injuries, positive displacement to help minimize catheter occlusions, and impregnated silver to provide healthcare professionals a powerful new tool in their effort to reduce catheter related bloodstream infections (CRBSI)

Approximately 80,000 catheter-related bloodstream infections occur in U.S. intensive-care units each year, at a cost of $296 million to $2.3 billion in excess healthcare costs. (1-2). In an effort to address these excess costs, the Centers for Medicare and Medicaid services (CMS) as of October 1 will no longer provide payment for selected patient conditions that were not present at admission. One of these conditions is vascular catheter-associated infections. In support of the CMS ruling, use of the silver impregnated Ultrasite® Ag LAD combined with aseptic technique and best practices may help to prevent catheter-associated infections.

B. Braun’s ULTRASITE® Needle-Free IV System is also designed to reduce accidental needlesticks when injecting, aspirating or infusing fluids and medications into IV delivery systems. It can be used anywhere a standard injection cap is used and is compatible with leading pre-filled medication systems. It is one of many B. Braun products designed to increase safety for healthcare workers and patients.