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Dial Medical Supply Fistula Needle Set
Dial Medical Of Florida
Summary: The Dial Medical Supply Fistula Needle Set is used in dialysis for vascular access. It is FDA 510k cleared and supported by evidence from four studies. Key findings highlight its role in managing venous needle dislodgement and cannulation techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K940441 ↗
Decision Date ?
June 10, 1994
Product Code ?
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class ?
Class 2
Evidence ?
0 studies
The Dial Medical Supply Fistula Needle Set was cleared through the FDA 510k pathway on June 10, 1994. It is manufactured by Dial Medical Of Florida and classified as a Class 2 device.
What It Is
The Dial Medical Supply Fistula Needle Set is a medical device designed for vascular access in dialysis patients. It facilitates the connection between the patient’s circulatory system and the dialysis machine, essential for effective hemodialysis treatment.
FDA-Cleared Indications
- Vascular access for hemodialysis through an arteriovenous fistula.
- Short-term intravascular therapeutic catheter use, consistent with FDA product code FOZ.
Clinical Applications
- Cannulation of an arteriovenous fistula before hemodialysis.
- Establishing arterial and venous access for connection to a dialysis machine.
- Repeated vascular access during maintenance hemodialysis treatments.
Evidence Summary
The available literature includes four studies, comprising randomized controlled trials, prospective, and retrospective analyses, conducted between 2004 and 2015. These studies focus on vascular access complications and techniques in dialysis patients.
Reported Outcomes
Published studies report that the device is effective in managing venous needle dislodgement and improving cannulation techniques. One study highlights the prevalence of venous pressure drops as a critical factor in detecting needle dislodgement. Another study discusses the importance of proper cannulation to prevent adverse outcomes.
Safety Profile
Reported complications include venous needle dislodgement, which can lead to significant clinical issues if not promptly detected. Other studies note the occurrence of thrombosis, catheter ruptures, and infections associated with vascular access devices.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design, which may affect the generalizability of findings. Further research is needed to explore long-term outcomes and optimize safety protocols for vascular access devices.
Practical Considerations
- The needle gauge, length, bevel direction, tubing, and connector configuration should be selected for the patient’s fistula anatomy and the dialysis circuit.
- Use aseptic technique and follow the dialysis unit’s protocol for skin preparation, cannulation, securement, and removal.
- Inspect the set before use and confirm compatibility with the dialysis bloodline and other connection components.
- Do not use through an infected, thrombosed, or otherwise unsuitable access site unless specifically directed by the treating team.
- MRI compatibility is not established by the information provided; verify the complete device labeling before MRI, and treat the set as potentially unsafe in the MR environment until confirmed.
Frequently Asked Questions
What are the clinical indications for Dial Medical Supply Fistula Needle Set?
The device is indicated for use in establishing vascular access in patients undergoing hemodialysis.
What outcomes have been reported in clinical studies?
Studies report effective management of venous needle dislodgement and improved cannulation techniques.
What complications have been reported?
Safety data indicate complications such as venous needle dislodgement, thrombosis, and infections.
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.