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central venous multi-lumen catheters and kits
Spectramed
Summary: Central venous multi-lumen catheters by Spectramed are used for venous access in critical care settings. Key evidence highlights their role in reducing bloodstream infections and complications associated with catheter use.
FDA Clearance Information
Pathway
510K
Number
K871573 ↗
Decision Date
September 16, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Spectramed central venous multi-lumen catheters were cleared through the FDA 510(k) pathway on September 16, 1987. They are classified as Class 2 medical devices.
What It Is
Central venous multi-lumen catheters are medical devices designed for venous access, allowing simultaneous administration of multiple infusions. They are primarily used in intensive care settings for critically ill patients.
Clinical Applications
These catheters are commonly used in intensive care units for patients requiring multiple intravenous therapies, hemodynamic monitoring, or parenteral nutrition. They provide a practical solution for managing complex infusion regimens.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, spanning from 2004 to 2024. These studies explore various aspects of catheter use, including infection rates and infusion compatibility.
Reported Outcomes
Published studies report that multi-lumen catheters can reduce the incidence of central-line-associated bloodstream infections (CLABSIs) and improve infusion compatibility in neonatal and adult intensive care settings. Some studies also highlight the cost-effectiveness of these devices in reducing infection-related complications.
Safety Profile
Reported complications include insertion-related issues, infections at the insertion site, and catheter-related bloodstream infections (CRBSIs). Some studies also note the potential for sepsis and other metastatic infections associated with catheter use.
Evidence Limitations
Evidence gaps include a lack of consensus on the optimal lumen for sampling in infection detection and limited data on long-term outcomes. Further research is needed to explore the comparative effectiveness of different catheter materials and designs.
Frequently Asked Questions
What are the clinical indications for central venous multi-lumen catheters?
These catheters are indicated for use in patients requiring multiple simultaneous infusions, particularly in intensive care settings.
What outcomes have been reported in clinical studies?
Studies report reduced rates of bloodstream infections and improved infusion compatibility with the use of multi-lumen catheters.
What complications have been reported?
Complications include insertion-related issues, site infections, and catheter-related bloodstream infections.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.