Bio-Safety

MICROCLAVE® NEEDLEFREE NEUTRAL DISPLACEMENT CONNECTOR

  • Does not Require a Change in Clinical Practice or Techniques
  • Saline Flush Option can Eliminate the use of Heparin
  • Minimal Blood Reflux in the Distal Catheter Tip
  • No Clamping Sequence Required
  • Can be Used in Infusion Pump Sets
MicroClave® Needlefree Neutral Displacement Connector

MicroClave® is a needlefree device with neutral displacement straight fluid path design, split-septum and minimal dead space that will help protect your patients and clinical staff by providing a safe and effective microbial barrier.

 

The design of your needlefree intravenous (I.V.) connector plays a substantial role in your ability to limit hospital-acquired bloodstream infections (HA-BSI).  The neutral displacement straight fluid path design, split-septum and minimal dead space of the MicroClave® work together to help minimize blood reflux into the tip of the catheter upon connection or disconnection of the luer. Not only does MicroClave® provide enhanced patient safety through innovative technology, but it has also been proven to provide an effective microbial barrier against bacteria transfer and contamination.

The MicroClave® 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. Because it is a neutral displacement device, MicroClave® does not require a change in clinical practice or technique and may help you address recent concerns raised by the FDA regarding the safety of positive displacement connectors.

 

HOW IT WORKS
Unique features of the MicroClave® 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 0.04 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 MicroClave® 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-C3300 MicroClave® Neutral Displacement I.V. Connector, swabable seal surface, flow rate 165 mL/min, dead space 0.04 mL, backpressure +45 psig. DEHP and latex free. 100/case
011-C3300Ag MicroClave® Antimicrobial, Silver Ion impregnated Neutral Displacement I.V. Connector swabable seal surface, flow rate 165 mL/min, dead space 0.04 mL, backpressure +45 psig. DEHP and latex free.  100/case
011-C3301 7" (18 cm) Non-DEHP Smallbore Extension Set w/ MicroClave®, Clamp, and Luer Slip. 50/case
011-C3302 7" (18 cm) Non-DEHP Smallbore Extension Set w/MicroClave®, Clamp, Rotating Luer. 50/case
011-C3319 6" (15 cm) Smallbore Extension Set w/ MicroClave® Connector, Removable Slide Clamp, Rotating Luer. 50/case
011-C3333 9" (23 cm) Non-DEHP Smallbore Extension Set w/MicroClave®, Clamp, Rotating Luer. 50/case
011-C4203-1 6.25" (16 cm) Non-DEHP Standardbore Extension Set w/Y port MicroClave®, Clamp, and Rotating Luer. 50/case
011-C4203-2 8.5" (22 cm) Non-DEHP Standardbore Extension Set w/2 Y port MicroClave®, Clamp, Rotating Luer. 50/case
011-C3312 8" (20 cm) Non-DEHP Standardbore Extension Set, kink resistant, Bifurcated Extension Set w/ 2 MicroClave® connectors and rotating luer 50/case
011-C3316 5" (13 cm), Smallbore Bifurcated Extension Set w/ 2 MicroClave®, 3 clamps, and rotating luer. 50/case
011-C3322 5" (13 cm) Non-DEHP Smallbore Bifurcated Extension Set w/ 2 MicroClave®, 2 clamps and rotating luer. 50/case
011-C3323 7" (18 cm) Non-DEHP Smallbore Trifurcated Extension Set w/ 3 MicroClave®, 3 clamps and rotating luer. 50/case
011-C3324 6" (15 cm) Non-DEHP Standardbore, kink resistant, Trifurcated Extension Set w/ 3 MicroClave® color coded pinch clamps and rotating luer. 50/case

Distributed by Victus, Inc.

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

 

Residual Volume 0.04 mL
Flow Rate at Gravity 165 mL /minute
Functional Activations 600
Blood Compatibility Yes
MRI Compatibility Yes
High Pressure Compatibility 10 mL/second

DRUG COMPATIBILITY

Alcohol Yes
Lipids Yes
Chlorhexidine Yes
Chemotherapy Yes

DIRECTIONS OF USE:

Disinfect to Protect

  • When placing a new MicroClave® on a catheter, disinfect the catheter hub and prime the MicroClave®.
  • Before accessing a MicroClave®, 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 dry times.

Administer or Aspirate

  • Attach IV tubing, syringe or blood tube holder to MicroClave® 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 MicroClave®.
  • To disconnect, grasp MicroClave® and then twist the mating luer away from MicroClave® until loose. Do not hold catheter hub during disconnect as this may cause accidental removal of MicroClave® from hub.

Flush After Each Use

  • Flush the MicroClave® with normal saline or in accordance with facility protocol. After blood use, the MicroClave® 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 MicroClave® in accordance with facility protocol and CDC guidelines.

 

FREQUENTLY ASKED QUESTIONS

 

Can needles be used with MicroClave®?
MicroClave® 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 MicroClave® can only be activated with a male luer, NEVER with a needle.

 

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

 

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

 

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

 

Can I use a cap with the MicroClave®?
The MicroClave® 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 MicroClave® is impermeable to air and water and a cap can keep it open.

 

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

 

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

 

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

  • Jarvis W., MD. Choosing the Best Design for Intravenous Needleless Connectors to Prevent Bloodstream Infections. Infection Control Today, August 2010
  • Ryder M, RN, PhD. Bacterial transfer through needlefree connectors: Comparison of nin different devices. Poster presented at the Annual Society for Healthcare Epidemiology of America (SHEA) conference 2007, Abstract 412.
  • Moore C, RN, MBA, CIC. Maintained Low Rate of Catheter-Related Bloodstream Infections (CR-BSIs) After Discontinuation of a Luer Access Device (LAD) At an Academic Medical Center. Poster presented at the annual Association for Professionals in Infection Control and Epidemiology (APIC) Conference 2010, Abstract 4-028.
  • FDA Medical Device Safety Alert, July 28, 2010: Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors
  • 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

  • Developing a Closed, Intravenous Medication System for a Neonatal Intensive Care Unit, Tanner J, Neonatal Intensive Care Journal, July-August 2012
  • Efficacy of three different valve systems of needle-free closed connectors in avoiding access of microorganisms to endovascular catheters after incorrect handling, Yébenes J, Delgado M, Sauca G, Serra-Prat M, Solsona M, Almirall J, et al. Critical Care Medicine, 2008
  • A needleless closed system device (Clave®) protects from intravascular catheter tip and hub colonization: a prospective randomized study, Bouza E, Munoz P, Lopez-Rodriguez J, Jesus Perez M, Rincon C, et al. Journal of Hospital Infection, 2003

Clinical Reports

  • Comparison of Bacterial Transfer and Biofilm Formation on Intraluminal Catheter Surfaces Among Eight Connectors in a Clinically Simulated in vitro Model, Ryder M, Pulcini E, Parker A, James G. Presented at the American Society for Parenteral and Enteral Nutrition Clinical Nutrition Week, February 2013
  • Differences in bacterial transfer and fluid path colonization through needlefree connector-catheter systems in vitro, Ryder M, James GA, Pulcini E, deLancey, Bickle L, Parker AE. Presented at INS, May, 2011
  • Evaluation of the Clave Technology and Resistance to Microbial Ingress, 2008
  • Significantly decreased rate of catheter-related bloodstream infections (CRBSIs) after discontinuation of a luer access device (LAD) at an academic medical center, Moore C, Landreth R, Maschmeier C, Snyder K, Priestly G, Elliott S. Presented at SHEA 2009, APIC 2010, and Facing the Challenge of CRBSIs. Managing Infection Control, November, 2009
  • Maintained low rate of catheter related bloodstream infections (CRBSIs) after discontinuation of a luer access device (LAD) at an academic medical center, Moore C, Landreth R, Maschmeier C, Snyder K, Priestly G, et al. Presented at APIC, July, 2010
  • The in vivo evaluation of the flushing efficiency of different designs of clear needle-free connectors, Breznock EM, Sylvia CJ Jr. BioSurg, Inc., 2011
  • Bacterial transfer through needlefree connectors: comparison of nine different devices, Ryder M, Fisher S, Hamilton G, Hamilton M, James G. Presented at the Society for Healthcare Epidemiology of America Annual Scientific Meeting, April 2007

MicroClave® Needlefree Neutral Displacement Connector