antimicrobial clave

2
Antimicrobial technology that provides a built in barrier to bacterial ingress. Clinically-proven needlefree technology with the integration of an antimicrobial ionic silver additive to improve the barrier against microbial ingress, providing increased protection to immunocompromised patients. Antimicrobial Clave ® Needlefree Connector

Upload: others

Post on 03-Feb-2022

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Antimicrobial Clave

Antimicrobial technology that provides a built in barrier to bacterial ingress.

Clinically-proven needlefree technology with

the integration of an antimicrobial ionic

silver additive to improve the barrier against

microbial ingress, providing increased

protection to immunocompromised patients.

Antimicrobial Clave®

Needlefree Connector

Page 2: Antimicrobial Clave

Antimicrobial Clave® Needlefree Connector

800.824.7890 | www.icumed.com©2012 ICU Medical, Inc. | M1-1210 Rev. 02

Reversed split septum and dedicated internal fluid pathway technology with ionic silver additive for enhanced protection from bacterial ingress.

The Antimicrobial Clave features a unique passive technology that cannot accept a needle, ensuring compliance with needlefree policies. No additional components or adapters are required to access the device, and no end caps are required for sterility.

Clinical Evidence

> Offers significant protection from catheter-tip and hub colonization.3

> Supports a statistically significant lower BSI rate compared to another connector.4

> Demonstrates the best barrier to bacterial transfer compared to all connectors.5

> Substantially reduces costs associated with flushing central lines by 87%.6

> Shown to decrease CRBSI’s by 49%.7

Features:

> Ionic silver additive is integrated into both the split-septum and internal fluid path for a continuous 96-hour use life.

> Demonstrates microbial efficacy with a 99.99% reduction rate of four common bacteria strains.8

> Minimal blood reflux in the catheter tip upon connection or disconnection of a luer.

> Allows a saline flush option which can eliminate the risk of Heparin Induced Thrombocytopenia (HIT).

> Clamping sequence not required, reducing educational burden and risk of error.

The Antimicrobial Clave features our

pioneering and still industry-leading

needlefree technology that contains

an ionic silver antimicrobial additive

which enhances the dedicated

internal fluid path technology of the

Clave by further reducing bacterial

contamination. The Antimicrobial

Clave is an extremely versatile

needlefree connector that is approved

for use on all peripheral, arterial, and

central venous catheters for the

administration of IV fluids or

medication, and can be used with

blood products.

DRUG COMPATIBILIT YAlcohol Yes

Lipids Yes

Chlorhexidine Yes

Chemotherapy Yes

TECHNICAL SPECIFICATIONSResidual Volume 0.06 mL

Flow Rate at Gravity 185 mL / minute

Functional Activations 600

Blood Compatibility Yes

MRI Compatibility Yes

Flatsmooth, swabbable

surface.

Straight fluid pathfor clearing blood and

blood residual with low

flush volumes.2

Minimal deadspace (also referred to as residual

volume) of 0.06 mL allows

for lower flush volumes.

Split-septuma preferred design feature

for connectors.1

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

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

3. Bouza E, Munoz P, Lopez-Rodriquez J, Jesus Perez M, Rincon C, Martin Rabadan P, Sanchez C, Bastida E. A needleless closed system device (CLAVE) protects from intravascular catheter tip and hub colonization: a prospective randomized study. JIH (2003) 54: 279-287.

4. Moore, C. RN, MBA, CIC; Landreth, R. RN; Maschmeier, C. MT, (ASCP) SM; Snyder, K. RN, MS, CCRN, CCSN; Prietley, G. RN, MSN, CCRN; Elliott, S. MD, FAAP. Siginificantly Decreased Rate of Catheter-Related Bloodstream Infections (CR-BSIs) After Discontinuation of a Luer Access Device (LAD) at an Academic Medical Center. April 2009

5. Ryder, M. Bacterial Transfer Through Needlefree Connectors: Comparison of Nine Different Devices. April 2007

6. Fournie K, Clements C, McManus S. Clinical and Economic Impact of the CLAVE® Needlefree System. Healthcare Quarterly Case Study. May 2005.

7. Maragakis L. MD; Karen L. Bradley, RN, BSN; Xiaoyan Song, MD, MS; Claire Beers, RN, MSN; Marlene R. Miller, MD, MSc; Sara E. Cosgrove, MD, MS; Trish M. Perl, MD, MSc. Increased Catheter-Related Bloodstream Infection Rates After the Introduction of a New Mechanical Valve Intravenous Access Port. ICHE; Vol. 27, No.1, pgs. 67-70, January 2006.

8. Antimicrobial efficacy of the Clave Connector using silversaturated fluid path elements M1-1211 Rev. 1. Data on file at ICU Medical.