đź“‹ 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 510K
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.
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 JMS AV Fistula Needle to access the patient's vascular system, ensuring efficient blood filtration. It is particularly important for patients with established AV fistulas or grafts, facilitating high blood flow rates necessary for effective dialysis.
Indications for Use
The JMS AV Fistula Needle is indicated for use in patients requiring hemodialysis, specifically those with an arteriovenous fistula or graft. It is designed to provide reliable vascular access, essential for patients undergoing regular dialysis treatments.
Practical Considerations
The JMS AV Fistula Needle typically comes in various sizes, often around 15G, to accommodate different patient needs and vascular access sites. Clinicians should ensure compatibility with the patient's vascular access type and be trained in proper insertion techniques to minimize complications such as infiltration or hematoma.
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.