đź“Š Evidence-Based Reference
a v fistula cannulation sets
Travenol Laboratories
Summary: A V fistula cannulation sets are used for vascular access in hemodialysis. Key evidence highlights potential infection risks associated with the buttonhole technique.
FDA Clearance Information
Pathway
510K
Number
K830021 ↗
Decision Date
January 14, 1983
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The device was cleared via the FDA 510(k) pathway on January 14, 1983. Manufactured by Travenol Laboratories, it is classified as a Class 2 device.
What It Is
A V fistula cannulation sets are medical devices designed for creating vascular access in patients undergoing hemodialysis. They facilitate repeated access to the bloodstream, essential for effective dialysis treatment.
Clinical Applications
These sets are commonly used in patients with chronic kidney disease requiring hemodialysis. They are particularly utilized in settings where long-term vascular access is needed, such as in dialysis centers.
Evidence Summary
The literature includes 7 studies, comprising prospective cohort studies and randomized controlled trials, published between 2006 and 2019. These studies explore various aspects of fistula cannulation, including infection risks and efficacy.
Reported Outcomes
Published studies report that the buttonhole cannulation technique is associated with increased rates of vascular access-related infections. Other studies have examined the effects of needle placement distance on dialysis efficacy, suggesting that closer needle placement may impact treatment outcomes.
Safety Profile
Reported complications include an increased risk of bacterial colonization and infection with the buttonhole technique. The studies highlight the need for careful monitoring and management of infection risks in patients using these devices.
Evidence Limitations
The evidence is limited by small sample sizes and variability in study design. Further research is needed to establish standardized protocols and to explore long-term outcomes of different cannulation techniques.
Frequently Asked Questions
What are the clinical indications for a v fistula cannulation sets?
The device is indicated for creating vascular access in patients undergoing hemodialysis, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report increased infection risks with the buttonhole technique and variable effects of needle placement on dialysis efficacy.
What complications have been reported?
Safety data indicate increased bacterial colonization and infection risks associated with the buttonhole cannulation technique.
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.