Baxter 6N8399 - DEVICE, V-LINK, LUER, W/VITAL SHLD, 200 EA/CS
V-LINK, Luer Activated Device with VITALSHIELD Protective Coating
The Baxter V-LINK Luer Activated Device with VitalShield Protective Coating was one of the products selected for an evaluation. Intravascular catheters are widely used in modern medical practice for the administration of drugs and fluids and for haemodynamic monitoring but they are also recognised as being one of the largest cause of hospital-acquired bacteraemia and are associated with significant increases in medical costs and length of hospital stay.
Baxter has developed a technology called VitalShield Protective Coating which is applied to the interior and exterior surfaces of the V-LINK connector. This coating results in the controlled release of silver ions, which are a well-known antimicrobial substance, effective against a wide spectrum of microorganisms.
Baxter's V-LINK device is a key addition to a broad line of needleless IV access products and is based on a well-known design:
- Needleless IV access device
- Flat, swabable surface
- Translucent housing
- Double-seal protection
- Promotes standardized technique
Technique and Technology are Needed to Fight Pathogens
- Every day, you do all you can to prevent microbial contamination - Proper aseptic technique at the IV insertion site can reduce extraluminal contamination (outside the catheter walls)
- Study results concluded that after specific preventive measures have been taken, 60% of catheter-related bloodstream infections (CR-BSIs) are likely to originate from the catheter fluid path - Technology to help protect the intraluminal pathway (the fluid path) is also needed to further reduce the risk of CR-BSIs
Now kills at least 99.99% of 6 common pathogens known to casue CR-BSIs2
These in vitro test results of typical devices have not been shown to correlate with a reduction in infections.
- Fights pathogen contamination and microbial growth in the fluid path
- Consistently high efficacy across multiple bacterial strains
- Demonstrated durability and efficacy over 96 hours
Proprietary VitalShield Silver Antimicrobial Coating
Empowering you to fight an ever-present danger
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Device Characteristics
| What MRI safety information does the labeling contain? | MR Conditional |
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): | No |
| Device labeled as "Not made with natural rubber latex": | Yes |
| For Single-Use: | Yes |
| Prescription Use (Rx): | Yes |
| Over the Counter (OTC): | No |
| Kit: | No |
| Combination Product: | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): | No |
Sterilization
| Device Packaged as Sterile: | Yes |
| Requires Sterilization Prior to Use: | No |
Contraindication
The V-LINK device is contraindicated for individuals with hypersensitivity to silver or silver components.
Instructions for Use
Rx only. For safe and proper use of this device, please refer to the complete instructions for use.
DEHP Free
Infusion Therapy Standards of Practice advise to usee administration sets free of di-ethylhexyl-phthalate (DEHP) to administer lipid-based infusates, such as IVFE or TNA. DEHP is lipophilic and is extracted into the lipid solution with commonly used polyvinyl chloride administration sets and containers. DEHP is considered a toxin, and studies have demonstrated increased DEHP levels in lipid solutions, which is especially a risk with neonatal, pediatric, and long-term home care patients (42).
