FDA clears "first silver impregnated needle-free access device"
This article was originally published in Clinica
Executive Summary
B Braun Medical's Ultrasite Ag Luer access device has received 510(k) clearance from the US FDA. The company claims it is the industry's first silver-impregnated antibacterial Luer access device designed to reduce potential catheter-related bloodstream infections, such as MRSA. The clearance comes at a time when there is increased focus on the prevention of these infections – it is expected to be a major topic at the upcoming US Association for Vascular Access (AVA) meeting, following major changes to the Medicare programme that will stop payments for certain conditions not present at hospital admission (see Clinica No 1322, p 9). The Bethlehem, Pennsylvania firm added that the needle-free system, which will be available later this year, also reduces accidental needlesticks.