BETHLEHEM, Pa. -- B. Braun Medical Inc. announces it has 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 percent) reductions in bacteria Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter aerogenes and 3-log (99.9 percent) 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.
“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,” said Tom Sutton, director of marketing of IV Systems for B. Braun Medical Inc. “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).”
