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a v fistula blunt needle set
Jms North America
Summary: The a v fistula blunt needle set is used for cannulation in hemodialysis patients. It is primarily used with the buttonhole technique. Key evidence highlights variations in cannulation techniques and associated complications.
FDA Clearance Information
Pathway
510K
Number
K082882 ↗
Decision Date
January 21, 2009
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA via the 510(k) pathway on January 21, 2009. It is manufactured by Jms North America and classified as a Class 2 device.
What It Is
The a v fistula blunt needle set is designed for the cannulation of arteriovenous fistulas in hemodialysis patients. It facilitates access to the vascular system using a blunt needle, intended to minimize trauma to the vessel.
Clinical Applications
This device is commonly used in hemodialysis settings for patients with mature arteriovenous fistulas. It is particularly utilized in the buttonhole cannulation technique, which is preferred by some patients for its potential to reduce discomfort.
Evidence Summary
The literature includes 13 studies, comprising randomized controlled trials, cohort studies, and mixed-methods research, published between 2017 and 2024. These studies explore various cannulation techniques and their implications.
Reported Outcomes
Published studies report that the buttonhole technique with blunt needles can reduce discomfort during cannulation. However, there is an increased risk of infection compared to other techniques. The studies also highlight the need for standardized cannulation practices to improve patient outcomes.
Safety Profile
Reported complications include an increased risk of infection with the buttonhole technique. Some studies suggest that blunt needles may reduce trauma to the vessel, but the risk of infection remains a concern.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of standardized protocols for cannulation techniques. Further research is needed to establish best practices and to address the infection risk associated with the buttonhole technique.
Frequently Asked Questions
What are the clinical indications for a v fistula blunt needle set?
The device is indicated for the cannulation of arteriovenous fistulas in hemodialysis patients, particularly using the buttonhole technique.
What outcomes have been reported in clinical studies?
Studies report reduced discomfort with blunt needles but highlight an increased infection risk with the buttonhole technique.
What complications have been reported?
Safety data indicate an increased risk of infection with the buttonhole technique, despite potential reductions in vessel trauma with blunt needles.
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.