📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients with an arteriovenous fistula.
- Repeated needle access to an established hemodialysis vascular access site.
Clinical Applications
- Cannulation of an arteriovenous fistula before a hemodialysis session.
- Withdrawal of blood from the fistula for processing by a hemodialysis machine.
- Return of dialyzed blood to the fistula during hemodialysis.
- Repeated access to a mature fistula for ongoing dialysis treatments.
Practical Considerations
- Needle gauge and length should be selected according to the fistula, vessel depth, blood-flow prescription and dialysis protocol.
- These needles are intended for trained healthcare professionals using sterile technique; incorrect placement can cause infiltration, bleeding, hematoma or loss of access function.
- The needle and tubing must be compatible with the dialysis bloodline and connection system used by the dialysis facility.
- They are single-use access devices and should not be reused or resterilized unless the specific labeling permits it.
- MRI safety depends on the exact needle model and whether it is in use with connected tubing or other components; check the current manufacturer labeling before an MRI examination.
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.