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medisystems fistula needles
Medisystems
Summary: Medisystems fistula needles are used in hemodialysis for vascular access. They are primarily used by nephrologists and dialysis nurses in dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K823068 ↗
Decision Date
January 26, 1983
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The Medisystems fistula needles were cleared via the FDA 510k pathway on January 26, 1983. Manufactured by Medisystems, this device is classified as Class 2 under product code KOC.
What It Is
Medisystems fistula needles are specialized needles designed for accessing arteriovenous fistulas in patients undergoing hemodialysis. These needles are typically large-gauge, hollow-bore devices that facilitate efficient blood flow during dialysis sessions. They are essential in creating a reliable vascular access point, which is crucial for the effective treatment of patients with end-stage renal disease.
Clinical Applications
These needles are commonly used in dialysis centers and hospitals by healthcare professionals specializing in nephrology. They are integral to the hemodialysis process, allowing for repeated access to the patient's bloodstream. The primary patient population includes those with chronic kidney disease requiring regular dialysis sessions, and the device is crucial for maintaining effective and safe vascular access.
Indications for Use
The FDA indications suggest that Medisystems fistula needles are intended for use in patients requiring vascular access for hemodialysis. This typically includes individuals with end-stage renal disease who need regular dialysis treatments.
Practical Considerations
Medisystems fistula needles come in various sizes to accommodate different patient needs and fistula types. It is important to select the appropriate gauge and length based on the patient's vascular anatomy and the dialysis prescription. Proper technique in needle insertion and removal is crucial to minimize complications such as infiltration or hematoma.
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 healthcare workers due to needlestick injuries. While the study suggested that guarded needles could reduce these injuries, it noted a lack of published data on the effectiveness of such devices. The study emphasized the importance of compliance with safety regulations to protect healthcare workers.
Frequently Asked Questions
What is Medisystems fistula needles used for?
They are used for vascular access in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses in dialysis centers and hospitals.
What are the FDA-cleared indications?
For use in patients requiring vascular access for hemodialysis, typically those with end-stage renal disease.
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.