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).”
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.
The product, available later this year, is the latest step in B. Braun’s commitment to support prevention of CRBSI. It follows B. Braun’s “Vein Starts Here” campaign stressing the importance of proper catheter hub care and best clinical practice techniques relating to catheters.
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.
1. Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med 2000;132:391-402.
2. Mermel LA. Preventing intravascular catheter-related infections [letter]. Ann Intern Med 2000;133:395.
Source: B. Braun