Fistula Needle
Product Introduction – Safety Fistula Needle
The Safety Fistula Needle is a high-performance, single-use medical device specifically designed for reliable vascular access in hemodialysis patients. It is intended to puncture mature arteriovenous fistulas (AVF) or grafts, enabling safe and efficient connection to extracorporeal blood lines, thereby establishing a high-flow blood circulation pathway during hemodialysis treatment.
Engineered with patient comfort, clinician safety, and dialysis efficiency in mind, this safety fistula needle combines sharp, atraumatic puncture performance with advanced safety features to minimize complications and enhance procedural outcomes.
Intended Use
The Safety Fistula Needle is indicated for puncturing mature arteriovenous fistulas or grafts and connecting with blood lines to establish an extracorporeal blood circulating path during hemodialysis procedures. It is suitable for both arterial and venous access in chronic hemodialysis patients.
Key Features & Benefits
- Ultra-Sharp & Smooth PunctureThe needle features a finely polished triple-bevel blade with an optimized lancet point, allowing effortless, smooth, and atraumatic insertion into mature fistulas. This reduces patient pain, tissue trauma, and the risk of infiltration or hematoma formation.
- High Blood Flow Performance
- Back Eye Design: Provides an additional blood inlet, ensuring consistent and high blood flow rates even at lower negative pressures.
- Ultra-Thin Wall Technology: Maximizes the internal lumen diameter without increasing the outer gauge, delivering superior flow rates essential for efficient dialysis sessions.
- Integrated Safety Mechanism
- Safety Fistula Needle Design: Incorporates a simple yet highly effective safety activation system that shields the needle tip immediately after use.
- Protects healthcare workers from needlestick injuries by allowing one-handed activation.
- Eliminates the need for separate sharps containers during disposal in many clinical settings, improving workflow efficiency and safety compliance.
- User-Friendly Operation
- Simple, intuitive structure ensures easy handling and quick learning curve for dialysis nurses and clinicians.
- Excellent market acceptance due to its reliable performance and ergonomic design.
- Color-coded wings and clear tubing for easy identification of arterial and venous lines.
- Patient Comfort & Safety
- Siliconized needle surface reduces friction during insertion and removal.
- Flexible, kink-resistant tubing with rotating wings provides better fixation and patient mobility during long dialysis sessions.
- Latex-free and DEHP-free materials to minimize allergic reactions and ensure biocompatibility.
Quality & Regulatory Compliance
- Manufactured under ISO 13485 certified quality management system.
- CE Certified (EU Class IIa medical device).
- Complies with international standards for hemodialysis access devices, including ISO 8638 and relevant biocompatibility requirements (ISO 10993).
Available Sizes
Commonly available in:
- 15G, 16G, 17G
- Fixed or rotating wings
- Standard or safety versions
- Tubing lengths: 15 cm, 20 cm, 30 cm (custom lengths available upon request)
The Safety Fistula Needle offers an optimal balance of sharp puncture performance, high-flow efficiency, and robust needlestick protection, making it a trusted choice for hemodialysis centers seeking to improve both patient comfort and staff safety.
FAQs – Fistula Needle / Safety Fistula Needle
1. How does the safety fistula needle protect healthcare workers?
It features a built-in safety mechanism that covers or retracts the needle after use to prevent accidental sticks.
2. Can the safety fistula needle replace traditional sharps containers?
Its protective structure reduces the immediate danger of exposed needles, effectively replacing the need for certain disposal tools.
3. Is the operation of the safety needle complicated?
No, it is designed with a simple structure and easy operation for a seamless transition from standard needles.
4. Does the safety feature affect the puncture performance?
Not at all; the blade still undergoes a fine polishing process for easy and smooth vessel entry.
5. Why is market acceptance high for this safety design?
It balances clinical efficiency with enhanced occupational safety, making it a preferred choice for modern dialysis centers.
6. When should the safety mechanism be activated?
The safety shield should be activated immediately after the needle is withdrawn from the patient's fistula.
7. Does the safety needle also have an ultra thin-walled design?
Yes, the safety version maintains high-performance features like thin walls for high blood flow rates.
8. Are safety fistula needles color-coded?
Yes, the wings or hubs are typically color-coded by gauge size (e.g., green, yellow, or blue) for quick identification.
9. Is there an audible click when the safety lock engages?
Most safety designs provide a tactile or audible confirmation that the needle is securely locked.
10. How does this needle reduce biohazard waste risks?
By securing the needle tip, it minimizes the risk of infection during the waste disposal process.
11. Is it compatible with all standard hemodialysis machines?
Yes, it uses universal luer connectors to fit any standard blood line set.
12. What is the advantage of the back-eye in a safety needle?
It provides an extra path for blood, helping to maintain high flow and preventing suction against the vessel wall.
13. Can these needles be used for home hemodialysis?
Yes, the safety features make them particularly suitable for home settings where sharps disposal may be a concern.
14. Are the materials used in the safety needle DEHP-free?
Most modern safety needles use medical-grade, biocompatible, and often DEHP-free materials.
15. Does using safety needles comply with international safety regulations?
Yes, they help hospitals comply with "Sharps Injury Prevention" mandates and occupational health standards.
