Bio-Safety

CLAVE® NEEDLE-FREE CONNECTOR & I.V. SYSTEM

  • Mechanically and Microbiologically Engineered Closed System
  • Exclusive Sterile Internal Flow Path
  • A Proven Track Record for Assisting in the Fight Against CRBSI
  • Saline Flush Option can Eliminate the use of Heparin
CLAVE® Needle-Free Connector & I.V. System

Industry leading needlefree technology designed to reduce the risk of bacterial contamination and needle sticks while improving both healthcare worker and patient safety.

 

The Clave®'s mechanically and microbiologically engineered closed system helps protect the patient's catheter from contamination that can otherwise lead to bloodstream infections. 

The Clave® features a unique passive technology that cannot accept a needle, ensuring compliance with needlefree policies. The Clave® can be used on all peripheral, arterial, and central venous catheters for the administration of IV fluids or medications, and can be used with blood products. No additional components or adapters are required to access the device, and no end caps are required for sterility. Featuring a dedicated internal fluid path, at no time does the internal fluid path come into contact with the exterior or outer housing of the Clave®.

 

HOW IT WORKS
Unique features of the Clave® that may help reduce the risk of bacterial contamination:
  • Split-septum is noted in the CDC guidelines as a preferred design feature for connectors.
  • Straight fluid path allows for clearing of blood and blood residual with low flush volumes.
  • Minimal dead space (also referred to as residual volume) of 0.06 mL allows for lower flush volumes.
  • Flat smooth swabbable surface for ease of disinfection.
  • 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.
  • Approved for use with power injectors.

 

Accessing the Fluid Path

  1. When the Clave® is not being accessed, the silicone seal forms a safe, swabbable barrier to bacterial ingress.
  2. Upon luer access, the silicone seal is depressed and the fluid path windows are exposed through the device's split septum.
  3. Fluid is either infused or aspirated through the connector and catheter via the dedicated straight internal fluid path.
 

 

PRESENTATION

Catalog Number Description
011-C1000 Non-DEHP CLAVE® Connector, swabable I.V. connector, flow rate 185 mL/min, deadspace 0.06 mL, back pressure +75 psig, functional activations 600 and latex free. 100/case
011-C2000 CLAVE® Connector extension set with female luer slip and removable slide clamp. Internal diameter 1.2 mm. Length 7" (17.7 cm). 50/case
011-C2002 CLAVE® Connector extension set with male luer lock and removable slide clamp. Priming volume 0.3 mL. Internal diameter 1.2 mm. Length 7" (17.7 cm). 50/case
011-C2005-2 Bifuse kink resistant extension set with two (2) fixed CLAVE® Connectors with luer lock, and slide clamp. Internal diameter 2.3 mm. Total length 8" (20.3 cm). 50/case
011-C2202 Bifuse extension set, 2 fixed CLAVE® Connectors with luer lock and 2 removable slide clamps. Internal diameter 1.2 mm. Priming volume 0.3 mL. Total length 5" (12.7 cm). 50/case
011-C4231 CLAVE® Connector extension set with spin male rotating luer and slide clamp. Option Lock-Spin Luer Lock. Internal diameter 1.2 mm. Length 7" (17.7 cm). 50/case
011-CT1103 CLAVE® T-Connector extension set with removable slide clamp and male luer lock. Priming volume 0.36 mL. Length 5" (12.7 cm). 50/case
011-CU-1296 Trifuse extension set, 3 fixed CLAVE® Connectors with a male luer lock connector and 4 slide clamps.  Length 7" (18 cm) Internal diameter 1.2 mm. Priming volume 0.7 mL. 50/case
011-CU-1362 Trifuse extension set with three (3) fixed CLAVE® Connectors with male luer lock and 4 Roberts’s clamps. Internal diameter 2.3 mm. Priming volume 1.2 mL. Total length 7" (17.7 cm). 50/case

Distributed by Victus, Inc.

All technical information obtained from the manufacturer’s website and technical sheets.

Residual Volume 0.06 mL
Flow Rate at Gravity 185 mL /minute
Functional Activations 600
Blood Compatibility Yes
MRI Compatibility Yes

DRUG COMPATIBILITY

Alcohol Yes
Lipids Yes
Chlorhexidine Yes
Chemotherapy Yes

DIRECTIONS OF USE:

Disinfect to Protect

  • When placing a new Clave® on a catheter, disinfect the catheter hub and prime the Clave®.
  • Before accessing a Clave®, always disinfect the injection site with the approved antiseptic per facility protocol.
  • Scrub the injection site in accordance with facility protocol for appropriate scrubbing and drying times.

Administer or Aspirate

  • Attach IV tubing, syringe or blood tube holder to Clave® by inserting the luer and twisting ¼ turn, or until a friction fit is achieved.
  • Do not over-tighten a luer beyond the friction fit as this may damage both the luer and the Clave®.
  • To disconnect, grasp Clave® and then twist the mating luer counterclockwise away from Clave® until loose. Do not hold catheter hub during disconnect as this may cause accidental removal of Clave® from hub.

Flush After Each Use

  • Flush the Clave® with normal saline or in accordance with facility protocol. After blood use, the Clave® can be flushed clean and does not require change-out.
  • Use routine flushing in accordance with facility protocol in order to maintain catheter patency.
  • Change Clave® in accordance with facility protocol and CDC guidelines.

 

FREQUENTLY ASKED QUESTIONS

 

Can needles be used with CLAVE®?

CLAVE® is the only system that is totally incompatible with the use of needles and caps. It’s a better system since it succeeds in reducing the risk of accidental inoculation by preventing the use of needles. The CLAVE® can only be activated with a male luer, NEVER with a needle.

 

What happens if I use a needle with CLAVE®?
The needle will pierce the silicone seal and a leak will occur.

 

What if this situation occurs?
The only solution is to change the CLAVE®.

 

Can we use the CLAVE®with all Luer connectors?
Yes, provided that the connectors are ISO luer Lock or ISO luer Slip (99% of the connectors on the market are of this type). It connects to all female luer connectors (lines, catheters, valves, extensions, etc.).

 

There is a space between the VALOX body and the Silicone seal. Isn't this a source of contamination?
This space provides for compression of the silicone seal. This space NEVER comes into contact with the flow or the patient's vascular system. Only the inside of the male luer touches the outside of the spike.

 

When should I change the CLAVE®?
The CLAVE® should be changed according to each institution's protocols. In bacteriological studies, the CLAVE® has been shown to stay sealed for up to 7 days in arterial as well as venous lines. The CLAVE® has shown to maintain its seal for 144 activations in 144 hours.

 

Can I use a cap with the CLAVE®?
The CLAVE® does not require caps. In addition, a cap can rupture the polycarbonate spike. The silicone seal withstands more than 3000 mmHg of pressure and acts as a bacterial barrier (after being disinfected). The CLAVE® is impermeable to air and water and a cap can keep it open.

 

What can I use to clean the CLAVE®?
The CLAVE® has been proven to be totally compatible with povidone-iodine, isopropyl alcohol, Betadine, and chlorhexidine.

 

Do we need to flush the CLAVE® after an extraction or an infusion?
Always follow the hospital's protocol. It is highly recommended that the CLAVE® be flushed after an infusion or an extraction.

 

Is the CLAVE® effectively flushed after a blood infusion?
Flushing with saline solution after the extraction or infusion of blood is highly effective in the CLAVE®.

  • 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
  • Guideline for the Prevention of Intravascular Catheter-Related Bloodstream Infections, Final Issue Review, May 17, 2010
  • Data on file at ICU Medical. Low Volume Flush Characteristics of Unique Needlefree Connectors M1-1223 Rev. 1.

Publications

  • A Needleless Closed System Device (Clave®) Protects From Intravascular Catheter Tip and Hub Colonization: A Prospective Randomized Study Bouza E., et al. Journal of Hospital Infection 2003; 54: 279–287
  • The Potential for Catheter Microbial Contamination from a Needleless Connector Brown J.D., et al. Journal of Hospital Infection 1997; 36:181-189
  • Increased Catheter-Related Bloodstream Infection Rates After the Introduction of a New Mechanical Valve Intravenous Access Port Maragakis L., Bradley K., et al. Infection Control and Hospital Epidemiology 2006, vol. 27, no. 1; 67-70

Clinical Reports

  • Bacterial Transfer Through NeedleFree Connectors: Comparison of Nine Different Connectors
  • Ryder M., et al. Presented at the Society for Healthcare Epidemiology of America Annual Scientific Meeting, April, 2007
  • Significantly Decreased Rate of Catheter-Related Bloodstream Infections After Discontinuation of a Luer Access Device At an Academic Medical Center Moore C., et al. From posters presented at the 2009 SHEA and 2010 APIC Annual Meetings and Facing the Challenge of CR-BSIs. Managing Infection Control; November, 2009
  • Evaluation of the Clave Technology and Resistance to Microbial Ingress 2008
  • The Clave® connector: meeting functional specifications when exposed to high-risk infusates over a 72-hour period

CLAVE® Needle-Free Connector & I.V. System