Description
m|devices NeutralSite™ provides neutral pressure displacement and is specially designed not only to reduce blood reflux to avoid catheter occlusion, but also to decrease the risk of catheter related bloodstream infections (CRBSI) due to its swabable flat surface with pre-slit septum. In addition, the internal straight fluid pathway helps to minimise the priming volume and address dead space concerns. The NeutralSite™ is recommended for use of up to 7 days as per independent laboratory test study following Guidance for Industry and FDA staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)] and Standard: YY/T 0923-2014 Needleless access port for fluid lines and blood lines - Test method for microbial ingress. The NeutralSite™ was challenged with four ATCC test microorganisms, selected in accordance with the FDA guideline. The NeutralSite™ was challenged with a high concentration of inoculum which was assessed to higher than that normally seen in a clinical setting. The mean results produced show that the valve does have an effective barrier with vigorous disinfection, achieving a bacterial log reduction of 7. The study was conducted over a 7-day period with 140 activations.
