📊 Evidence-Based Reference
Haemodialysis Sets Dialiflex Fistula Needles
Infarkem
Summary: Haemodialysis sets dialiflex fistula needles are used for vascular access in dialysis. Key evidence highlights patient anxiety related to needling and infection risks with buttonhole technique.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K851236 ↗
Decision Date ?
July 26, 1985
Product Code ?
FJK
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on July 26, 1985. Manufactured by Infarkem, it is classified as a Class 2 medical device.
What It Is
Haemodialysis sets dialiflex fistula needles are designed for vascular access in haemodialysis, facilitating blood flow between the patient and the dialysis machine. They are intended for use in patients requiring regular dialysis treatment.
FDA-Cleared Indications
- Vascular access for haemodialysis treatment.
- Access to an arteriovenous fistula in patients requiring regular haemodialysis.
Clinical Applications
- Cannulation of an arteriovenous fistula for haemodialysis.
- Establishing blood access between a dialysis patient and the haemodialysis machine.
- Repeated vascular access during scheduled haemodialysis treatments.
Evidence Summary
The literature includes six studies ranging from 1999 to 2024, comprising qualitative, prospective, and other study types. These studies explore patient experiences, infection risks, and technical aspects of needling.
Reported Outcomes
Published studies report that patient anxiety and fear are significant factors during needling for haemodialysis. The buttonhole cannulation technique is associated with increased infection rates. Needle placement distance can affect dialysis efficiency.
Safety Profile
Reported complications include increased risk of vascular access-related infections with the buttonhole technique. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials. Further research is needed to explore patient experiences and optimize needle placement techniques to reduce complications.
Practical Considerations
- The needle size, length and configuration should be selected by qualified dialysis staff based on the fistula, prescribed blood-flow rate and access characteristics.
- Use requires aseptic technique and careful assessment of the fistula before and after cannulation to reduce bleeding, infiltration and infection risks.
- These needles are intended for vascular access during haemodialysis and should not be assumed to be compatible with every dialysis bloodline or access system without checking the device labeling.
- The device is a needle set, not a permanent vascular access. It is removed after the dialysis session unless the applicable labeling states otherwise.
- MRI compatibility should not be assumed from the 510(k) clearance. The needle set should generally be removed before MRI unless the exact product labeling confirms MR safety or conditional use.
Frequently Asked Questions
What are the clinical indications for haemodialysis sets dialiflex fistula needles?
The device is indicated for use in patients requiring vascular access for haemodialysis, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report patient anxiety during needling, infection risks with buttonhole technique, and effects of needle placement on dialysis efficiency.
What complications have been reported?
Safety data indicate an increased risk of infections associated with the buttonhole cannulation technique.
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.