FDA clearance comes as hospitals prepare for new CMS non-payment policy related to HAIs

DEERFIELD, Ill., Sept. 29 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation today announced that it received 510(k) clearance for expanded labeling for the first antimicrobial needleless intravenous (IV) connector, V-Link Luer-activated device (LAD) with VitalShield protective coating. With a new federal policy restricting reimbursement for healthcare-associated infections (HAIs) taking effect on October 1, healthcare professionals are seeking effective techniques and technologies to reduce the risk of contamination from a broad array of pathogens (infection-causing agents) within their hospitals.

Launched earlier this year, V-Link with VitalShield has now been shown to kill at least 99.99 percent of six common pathogens known to cause catheter-related bloodstream infections. The U.S. Food and Drug Administration (FDA) cleared expanded labeling for V-Link with VitalShield based on V-Link's ability to combat three additional pathogens: vancomycin-resistant Enterococcus faecalis (VRE), Escherichia coli (E. coli) and Staphylococcus epidermidis (coagulase negative). These three pathogens improve upon the previously cleared labeling, which included methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and Enterobacter cloacae.

Testing has demonstrated V-Link with VitalShield is effective against this broad spectrum of microorganisms and retains antimicrobial efficacy for up to a 96-hour period. In vitro testing for V-Link with VitalShield was conducted using six strains of six common pathogens known to cause bloodstream infections. V-Link with VitalShield is already available in the United States, Canada, Puerto Rico, Australia and New Zealand, and Baxter plans to launch the product in Europe later this year.

V-Link with VitalShield's expanded indications for use include VRE, a multi-drug resistant organism, which over the past 20 years has been increasingly reported as a source of healthcare-associated infections.(1,2) Pathogens such as VRE and MRSA can contaminate medical devices used to deliver IV fluids and medication to patients. The V-Link device is uniquely coated on both inner and outer surfaces with a proprietary silver-based antimicrobial technology, VitalShield, which helps to prevent contamination and growth of these pathogens within the device.

'The revised labeling and expanded indications for use further validate the broad spectrum antimicrobial coverage and effectiveness of V-Link with VitalShield in lowering the risk of pathogen contamination,' said Francois Lebel, MD, vice president of Clinical and Medical Affairs for Baxter's Medication Delivery business. 'This additional microbial coverage and long-lasting effect give healthcare professionals added confidence that they are taking extra precaution to address patient safety.'

'Bacteria can contaminate needleless IV connectors, particularly if healthcare workers do not adhere to proper infection prevention measures. In my practice, we have begun to evaluate this device and hope to see if its use leads to lower bloodstream infection rates,' said James Steinberg, MD, associate professor of medicine in the Division of Infectious Diseases at Emory University School of Medicine.

Starting this October, the Centers for Medicare and Medicaid Services (CMS) will no longer reimburse U.S.