đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Accessing an established arteriovenous fistula for hemodialysis.
- Providing vascular access for blood withdrawal and return during dialysis treatment.
Clinical Applications
- Cannulation of an AV fistula before hemodialysis.
- Withdrawal of blood from the fistula for extracorporeal dialysis.
- Return of dialyzed blood to the patient through the fistula.
- Repeated vascular access during scheduled hemodialysis 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.
Practical Considerations
- Needle gauge, length, and configuration should be selected by trained dialysis staff based on the fistula, prescribed blood-flow rate, and patient anatomy.
- The needle must be handled using sterile technique and secured to reduce the risk of dislodgement, bleeding, infiltration, or loss of access.
- The needle is intended for vascular access through an AV fistula and should not be assumed to be appropriate for central venous, arterial, or graft access unless the labeling specifically permits it.
- This is a needle rather than an implanted device; MRI concerns generally relate to the needle's material and whether it remains in place. Follow the manufacturer's MRI labeling and institutional policy.
- Do not use through an infected, thrombosed, severely stenotic, or otherwise unsuitable fistula. Assessment by qualified dialysis clinicians is required before cannulation.
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.