📋 FDA Reference
Jms AV Fistula Needle
Jms
Summary: The JMS AV Fistula Needle is a medical device used for vascular access in hemodialysis. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis sessions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860241 ↗
Decision Date ?
February 5, 1986
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The JMS AV Fistula Needle was cleared through the FDA 510(k) pathway on February 5, 1986. It is manufactured by Jms and classified as a Class 2 device under product code FIE.
What It Is
The JMS AV Fistula Needle is a specialized needle designed for accessing arteriovenous fistulas, which are surgically created connections between an artery and a vein. This device is crucial in hemodialysis, allowing for repeated vascular access with minimal discomfort and reduced risk of complications. Its design typically includes features to minimize blood trauma and ensure stable blood flow rates during dialysis.
FDA-Cleared Indications
- Vascular access for hemodialysis through an arteriovenous fistula.
- Vascular access for hemodialysis through an arteriovenous graft.
Clinical Applications
- Accessing an established arteriovenous fistula for a hemodialysis treatment.
- Accessing an arteriovenous graft for a hemodialysis treatment.
- Providing blood inflow and outflow access for the extracorporeal hemodialysis circuit.
Practical Considerations
- Available needle sizes and configurations should be selected according to the access anatomy, prescribed dialysis blood-flow rate, and facility protocol; 15-gauge needles are commonly used in adult hemodialysis, but the exact size varies.
- The needle must be compatible with the patient's fistula or graft and the dialysis blood tubing or connector system.
- Insertion should be performed by trained dialysis personnel using appropriate aseptic technique to reduce infection, infiltration, hematoma, and access injury.
- The needle is intended for single-use access during a dialysis treatment and should not be reused.
- MRI safety depends on the specific needle materials and whether the needle remains in place; the product labeling and local MRI screening policy should be checked before scanning.
Related Literature
The linked study evaluated hemolysis and blood trauma associated with different vascular access systems for hemodialysis. It highlighted challenges like insufficient blood flow and thrombosis in existing systems. The study introduced the LifeSite System as an alternative, featuring a subcutaneous valve and a 12F cannula accessed by a 14G needle. While promising, the study's findings were limited to in vitro conditions, necessitating further clinical evaluation.
Frequently Asked Questions
What is JMS AV Fistula Needle used for?
It is used for vascular access in hemodialysis, particularly for patients with arteriovenous fistulas or grafts.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in hemodialysis patients requiring reliable vascular access through an arteriovenous fistula or graft.
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.