đź“Š Evidence-Based Reference
A V Fistula Needle Set
Summary: The a v fistula needle set by Cordis is used for vascular access in hemodialysis. Key evidence highlights its role in reducing needle-related complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K782021 ↗
Decision Date ?
March 21, 1979
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The a v fistula needle set was cleared by the FDA via the 510(k) pathway on March 21, 1979. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The a v fistula needle set is a medical device used for creating vascular access in patients undergoing hemodialysis. It facilitates the connection between the patient's circulatory system and the dialysis machine.
FDA-Cleared Indications
- Vascular access to an arteriovenous fistula during hemodialysis.
- Connection of the patient’s fistula to the extracorporeal hemodialysis circuit.
Clinical Applications
- Needle cannulation of a mature arteriovenous fistula before hemodialysis.
- Establishing arterial and venous access points for a hemodialysis treatment.
- Connecting fistula access to dialysis blood tubing during routine outpatient or inpatient hemodialysis.
Evidence Summary
The literature includes 15 studies ranging from 2015 to 2024, encompassing various study types such as RCTs and prospective cohorts. These studies focus on the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the a v fistula needle set is effective in maintaining vascular access patency and reducing the incidence of needle-related complications. It is associated with improved outcomes in hemodialysis access management.
Safety Profile
Reported complications include needle-related injuries and venous needle dislodgement, which can lead to significant clinical issues. However, the device is generally considered safe when used according to guidelines.
Evidence Limitations
Current evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to standardize outcomes and improve safety protocols.
Practical Considerations
- The needle gauge, length, tip configuration, and tubing arrangement must match the fistula, prescribed blood-flow rate, and dialysis system.
- Use requires trained assessment of fistula maturation, direction of blood flow, thrill, bruit, and the planned arterial and venous needle sites.
- The set is generally intended for single use; follow the product labeling and facility infection-control policy.
- Potential complications include infiltration, bleeding, hematoma, infection, thrombosis, and accidental needle dislodgement.
- This is not an implantable device and does not have an MRI-related implant safety issue; any attached metal components or other equipment should still be assessed before MRI.
Frequently Asked Questions
What are the clinical indications for a v fistula needle set?
The device is indicated for vascular access in hemodialysis patients, particularly those with arteriovenous fistulas.
What outcomes have been reported in clinical studies?
Studies have reported effective maintenance of vascular access and reduced needle-related complications.
What complications have been reported?
Safety data indicate potential for needle-related injuries and venous needle dislodgement.
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.