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medisystems fistula needle
Medisystems
Summary: The Medisystems 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
K811838 ↗
Decision Date
September 8, 1981
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Medisystems Fistula Needle was cleared through the FDA 510(k) pathway on September 8, 1981. It is manufactured by Medisystems and classified as a Class 2 device under product code FIE.
What It Is
The Medisystems Fistula Needle is a specialized needle designed for use in hemodialysis, providing vascular access through arteriovenous fistulas. It is typically a large-gauge, hollow-bore needle that allows for high blood flow rates necessary for effective dialysis. The design may include safety features to reduce needlestick injuries, which are a concern in dialysis settings.
Clinical Applications
This device is commonly used in hemodialysis centers, where patients with chronic kidney disease undergo regular dialysis treatments. It is essential for creating a reliable vascular access point, which is crucial for the efficient removal and return of blood during dialysis. Nephrologists and dialysis nurses are the primary users, working with patients who have established arteriovenous fistulas.
Indications for Use
The Medisystems Fistula Needle is indicated for use in patients requiring hemodialysis, specifically those with established arteriovenous fistulas. It is designed to facilitate the high blood flow rates needed for effective dialysis treatment.
Practical Considerations
Clinicians should select the appropriate needle gauge based on the patient's vascular access and dialysis requirements. Compatibility with dialysis machines and tubing should be verified. Proper technique in needle insertion and removal is critical to minimize complications and ensure patient safety.
Related Literature
The linked study investigated the impact of using guarded fistula needles on needlestick injuries in hemodialysis settings. It highlighted the increased risk of bloodborne pathogen exposure among dialysis healthcare workers. While the study suggested potential benefits of guarded needles in reducing needlestick injuries, it noted a lack of extensive published data supporting this claim.
Frequently Asked Questions
What is Medisystems 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 hemodialysis patients with arteriovenous fistulas.
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.