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AV Fistula Needle Set
Summary: The AV fistula needle set by Terumo America is primarily used for vascular access in hemodialysis. Key evidence highlights the importance of early detection of access dysfunction and needle-related complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K771206 ↗
Decision Date ?
July 15, 1977
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The AV fistula needle set was cleared by the FDA through the 510(k) pathway on July 15, 1977. It is manufactured by Terumo America and classified as a Class 2 device.
What It Is
The AV fistula needle set is designed for vascular access in hemodialysis patients. It facilitates the connection between the patient's circulatory system and the dialysis machine, ensuring efficient blood flow during treatment.
FDA-Cleared Indications
- Accessing an established arteriovenous fistula for hemodialysis.
- Withdrawing blood from the patient and returning it through the hemodialysis circuit.
- Providing vascular access for blood flow during dialysis treatment.
Clinical Applications
- Cannulation of an AV fistula before a hemodialysis session.
- Connection of the arterial and venous sides of the fistula to a hemodialysis machine.
- Blood withdrawal and return during extracorporeal hemodialysis.
- Repeated vascular access in patients receiving maintenance hemodialysis through an AV fistula.
Evidence Summary
The literature includes 14 studies ranging from 2012 to 2024, encompassing various study types such as prospective cohorts and retrospective analyses. These studies focus on access dysfunction prediction and needle-related complications.
Reported Outcomes
Published studies report that early detection of arteriovenous access dysfunction can significantly improve patient outcomes. Needle-related complications, such as inadvertent cannulation injuries, are common and can impact the longevity of the vascular access.
Safety Profile
Reported complications include venous needle dislodgement, which can lead to significant adverse events if not promptly detected. The incidence of needle-related injuries highlights the need for improved cannulation techniques.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to standardize cannulation practices and improve safety measures.
Practical Considerations
- Needle gauge, length, bevel orientation, and tubing configuration should match the fistula, prescribed blood-flow rate, and dialysis equipment.
- The set is intended for trained clinical personnel and requires sterile handling and careful assessment of fistula thrill, bruit, skin condition, and hemostasis.
- Do not use a damaged, opened, expired, or visibly contaminated set; these are generally single-use devices unless the product labeling states otherwise.
- This device is not an implanted device. MRI considerations depend on the specific needle and tubing materials; remove the set before MRI unless its labeling confirms MRI safety or conditional use.
- Potential complications include infiltration, bleeding, hematoma, infection, pain, loss of access flow, and needle dislodgement.
Frequently Asked Questions
What are the clinical indications for AV fistula needle set?
The AV fistula needle set is indicated for vascular access in hemodialysis patients, specifically for accessing arteriovenous fistulas.
What outcomes have been reported in clinical studies?
Studies have reported improved detection of access dysfunction and highlighted the prevalence of needle-related complications in hemodialysis.
What complications have been reported?
Safety data indicate complications such as venous needle dislodgement and needle-related injuries during cannulation.
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.