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jms av fistula needles
Jms
Summary: The JMS AV Fistula Needles are used for vascular access in hemodialysis patients. They are typically utilized by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis sessions.
FDA Clearance Information
Pathway
510K
Number
K911199 ↗
Decision Date
August 28, 1991
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The JMS AV Fistula Needles were cleared through the FDA 510(k) pathway on August 28, 1991. Manufactured by Jms, they are classified as Class 2 medical devices under product code FIE.
What It Is
JMS AV Fistula Needles are specialized needles designed for use in hemodialysis, providing access to arteriovenous fistulas. These needles are crucial for ensuring adequate blood flow rates during dialysis, typically exceeding 300 ml/min. They are designed to minimize trauma to the blood vessels and ensure patient comfort during repeated use.
Clinical Applications
These needles are commonly used in dialysis centers and hospitals by nephrologists and dialysis nurses. They are essential for patients with chronic kidney disease who require regular hemodialysis. The needles are used to access both native arteriovenous fistulas and synthetic grafts, facilitating the removal and return of blood during dialysis.
Indications for Use
The JMS AV Fistula Needles are indicated for patients requiring vascular access for hemodialysis. They are suitable for use with both native arteriovenous fistulas and synthetic grafts, providing a reliable means of accessing the bloodstream for dialysis treatment.
Practical Considerations
These needles are typically available in sizes such as 15G, which are compatible with standard dialysis equipment. Proper technique is essential to minimize complications such as infiltration or hematoma. Clinicians should be trained in the use of these needles to ensure patient safety and comfort.
Related Literature
The linked study evaluated hemolysis and blood trauma in different vascular access systems for hemodialysis. It highlighted issues such as insufficient blood flow and blood trauma associated with current technologies. The study introduced the LifeSite System as an alternative, noting its subcutaneous valve and 12F cannula accessed by a 14G needle. Limitations include its focus on in vitro conditions, which may not fully represent clinical scenarios.
Frequently Asked Questions
What is JMS AV Fistula Needles used for?
They are used for vascular access in hemodialysis, allowing for efficient blood flow during treatment.
What specialties typically use this device?
Nephrologists and dialysis nurses in dialysis centers and hospitals typically use these needles.
What are the FDA-cleared indications?
The needles are indicated for vascular access in patients requiring hemodialysis, suitable for use with both native fistulas and synthetic grafts.
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.