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a-v fistula needle
Bd Becton Dickinson Vacutainer Systems Preanalytic
Summary: The a-v fistula needle is used for vascular access in hemodialysis. Key evidence highlights its role in effective cannulation and pain management. Studies explore needle direction and technique impacts on dialysis adequacy.
FDA Clearance Information
Pathway
510K
Number
K781331 ↗
Decision Date
August 17, 1978
Product Code
DJC
Device Class
Class 2
Evidence
0 studies
The a-v fistula needle by Bd Becton Dickinson Vacutainer Systems Preanalytic was cleared via the FDA 510k pathway on August 17, 1978. It is classified as a Class 2 device.
What It Is
The a-v fistula needle is a medical device designed for vascular access in patients undergoing hemodialysis. It facilitates the cannulation of arteriovenous fistulas, which are surgically created connections between an artery and a vein.
Clinical Applications
Commonly used in hemodialysis settings, the a-v fistula needle is essential for accessing the bloodstream through arteriovenous fistulas. It is crucial for patients requiring regular dialysis treatments.
Evidence Summary
The literature includes 14 studies, encompassing RCTs, systematic reviews, and narrative reviews, published between 2019 and 2025. These studies investigate various aspects of fistula cannulation, including pain management and technique efficacy.
Reported Outcomes
Published studies report that effective cannulation techniques can significantly impact hemodialysis adequacy, as measured by KT/V and access recirculation. Pain management during cannulation is also a critical outcome, with various interventions explored to enhance patient comfort.
Safety Profile
Reported complications include potential damage to the arteriovenous fistula, which can lead to access failure. The choice of cannulation technique and needle direction are factors that may influence these outcomes.
Evidence Limitations
Evidence gaps include a need for more high-quality, randomized controlled trials to establish standardized cannulation techniques. Further research is needed to explore long-term outcomes and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for a-v fistula needle?
The a-v fistula needle is indicated for vascular access in patients undergoing hemodialysis, specifically for cannulating arteriovenous fistulas.
What outcomes have been reported in clinical studies?
Studies report outcomes related to hemodialysis adequacy, such as KT/V and access recirculation, as well as pain management during cannulation.
What complications have been reported?
Safety data indicate complications such as potential damage to the arteriovenous fistula, which can lead to access failure.
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.