ICU Medical Receives FDA Clearance for its Neutral-Pressure Needleless Connector

August 4, 2010

ICU Medical, Inc., a manufacturer of disposable medical connection systems for use in vascular therapy applications, today confirmed that it has received FDA 510-k clearance for the Neutron Neutral-Pressure Needleless Connector.

ICU Medical, Inc., a manufacturer of disposable medical connection systems for use in vascular therapy applications, today confirmed that it has received FDA 510-k clearance for the Neutron Neutral-Pressure Needleless Connector. The new connector incorporates patented technology from ICU Medical that is designed to prevent all types of blood reflux in a catheter, including line or syringe disconnection, patient vascular pressure changes caused by coughing or sneezing, as well as an IV bag running dryall of which are associated with catheter patency.

As a neutral-pressure device, the use of the Neutron may help hospitals address Food and Drug Administration (FDA) concerns about the safety of positive-displacement needleless connectors and their possible connection to higher rates of device-associated bloodstream infections (BSI). Following three reports of deaths associated with BSI and positive displacement needleless connectorsand increased concerns raised by infection control authorities including the Society for Healthcare Epidemiologists of America and Infectious Disease Society of Americathe FDA last week ordered manufacturers of positive displacement connectors to conduct a post-market surveillance study on the safety of these devices.1

In addition to the device's neutral-pressure features, the Neutron also incorporates a pre-slit septum that was recently noted in the 2010 Draft CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections as being a preferred design feature to aid in the prevention of bloodstream Infections.2

ICU Medical, Inc. expects to conduct expanded clinical beta testing of the Neutron with select customers in the third quarter of 2010.

References:

1. FDA Medical Device Safety Alert, July 28, 2010: Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm220459.htm)

2. Guideline for the Prevention of Intravascular Catheter-Related Bloodstream Infections, Final Issue Review, May 17, 2010 (http://www.cdc.gov/hicpac/pdf/BSI_guideline_IssuesMay17final.pdf)