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jms av fistula needle
Jms
Summary: The JMS AV Fistula Needle is a medical device used in hemodialysis for vascular access. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis sessions.
FDA Clearance Information
Pathway
510K
Number
K970962 ↗
Decision Date
August 7, 1997
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The JMS AV Fistula Needle was cleared through the FDA 510(k) pathway on August 7, 1997. 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 designed for use in hemodialysis, providing access to the bloodstream via an arteriovenous fistula. It is typically a 15G needle, which is standard for this type of procedure, ensuring adequate blood flow rates necessary for effective dialysis. The needle's design minimizes trauma and maximizes efficiency during repeated vascular access.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients with chronic kidney disease undergo regular hemodialysis. Nephrologists and dialysis nurses use the needle to access the patient's AV fistula, a surgically created connection between an artery and a vein, to facilitate the removal and return of blood during dialysis. It is essential for maintaining the high blood flow rates required for effective treatment.
Indications for Use
The JMS AV Fistula Needle is indicated for use in patients requiring hemodialysis, specifically those with an arteriovenous fistula. It is suitable for patients with chronic kidney disease who need regular dialysis sessions.
Practical Considerations
The needle is typically available in a standard 15G size, which is compatible with most AV fistulas. Clinicians should be trained in proper cannulation techniques to minimize complications such as infiltration or hematoma. The needle should be used with care to prevent damage to the fistula.
Related Literature
The linked study evaluated hemolysis and blood trauma in a novel subcutaneous vascular access system for hemodialysis. It compared the LifeSite System, which uses a 14G needle, to traditional AV access methods. The study highlighted issues such as blood flow and trauma, but was limited by its in vitro nature, which may not fully replicate clinical conditions.
Frequently Asked Questions
What is the JMS AV Fistula Needle used for?
It is used for vascular access in hemodialysis, allowing efficient blood flow during treatment.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis with an arteriovenous fistula.
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.