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Nipro Safetouch Safety Fistula Needle
Summary: The Nipro SafeTouch Safety Fistula Needle is a medical device used primarily in dialysis settings to access a patient's vascular system. It is designed for use by healthcare professionals specializing in nephrology and dialysis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K002813 ↗
Decision Date ?
November 21, 2000
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The Nipro SafeTouch Safety Fistula Needle was cleared through the FDA 510(k) pathway on November 21, 2000. It is manufactured by Nipro Medical and classified as a Class 2 device under product code FIE.
What It Is
The Nipro SafeTouch Safety Fistula Needle is a specialized needle designed for accessing arteriovenous fistulas in patients undergoing hemodialysis. It features a safety mechanism to prevent needlestick injuries, enhancing safety for healthcare providers. The needle is typically used in conjunction with dialysis machines to facilitate the removal and return of blood during treatment.
FDA-Cleared Indications
- Accessing an arteriovenous fistula for hemodialysis.
- Facilitating blood removal from and return to the vascular access during dialysis treatment.
Clinical Applications
- Cannulation of an arteriovenous fistula before hemodialysis.
- Connection of fistula blood access to standard hemodialysis tubing and equipment.
- Removal of blood for extracorporeal dialysis treatment.
- Return of filtered blood to the patient during hemodialysis.
Practical Considerations
- The device is available in different needle gauges and lengths; selection depends on fistula anatomy, access depth, prescribed blood-flow requirements and clinician preference.
- It should be used by trained dialysis or vascular-access personnel with appropriate skin preparation, cannulation technique and securement to reduce bleeding or accidental dislodgement.
- Compatibility with dialysis bloodlines and connectors should be confirmed before use; it is not a substitute for a dialysis catheter or graft unless specifically labeled for that use.
- The safety mechanism is intended to reduce occupational needlestick risk but does not eliminate the need for standard sharps-handling and blood-borne pathogen precautions.
- MRI safety should be verified from the current product labeling and facility policy. The needle should not be assumed to be MRI safe or MRI conditional based only on its use in dialysis.
Frequently Asked Questions
What is the Nipro SafeTouch Safety Fistula Needle used for?
It is used for vascular access in patients undergoing hemodialysis, specifically to access arteriovenous fistulas.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for hemodialysis, particularly those with arteriovenous fistulas.
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.