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Water Purification System for Hemodialysis
Usfilter/Ionpure
Summary: The water purification system for hemodialysis by Usfilter/Ionpure is designed to ensure the purity of water used in dialysis, crucial for patient safety. Key evidence highlights the importance of compliance with international standards to reduce chemical hazards.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K980182 ↗
Decision Date ?
November 16, 1998
Product Code ?
FIP
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared by the FDA through the 510(k) pathway on November 16, 1998. It is manufactured by Usfilter/Ionpure and classified as a Class 2 medical device.
What It Is
This device is a water purification system used in hemodialysis to remove contaminants from water, ensuring it meets the required purity standards for safe dialysis treatment. It is intended for use in clinical settings where hemodialysis is performed.
FDA-Cleared Indications
- Purification of water used in hemodialysis.
- Use in clinical hemodialysis settings where treated water is required for dialysis fluid preparation.
Clinical Applications
- Producing purified water for hemodialysis treatment.
- Treating water used to prepare dialysis fluid in dialysis centers.
- Treating water used for hemodialysis in hospitals and outpatient clinics.
Evidence Summary
The literature includes 14 studies, encompassing various types such as RCTs and retrospective analyses, published between 2019 and 2025. These studies focus on the importance of water purity in dialysis and its impact on patient safety.
Reported Outcomes
Published studies report that maintaining high water purity standards in hemodialysis is crucial for reducing chemical hazards and improving patient outcomes. The evidence underscores the role of water treatment systems in minimizing bioincompatibility and enhancing the safety of dialysis procedures.
Safety Profile
Reported complications include potential chemical hazards and bioincompatibility issues arising from inadequate water purification. Ensuring compliance with international standards is emphasized to mitigate these risks.
Evidence Limitations
While the studies highlight the importance of water purity, there is a need for more comprehensive data on long-term patient outcomes and the effectiveness of different purification technologies. Further research is needed to explore the impact of water quality on various patient populations.
Practical Considerations
- This is facility water-treatment equipment, not an implantable or patient-contact device; it is generally installed as part of a dialysis water system.
- The system must be compatible with the facility's incoming water supply, pretreatment equipment, distribution loop, dialysis machines, and required water-quality monitoring program.
- Routine maintenance, disinfection, filter or membrane replacement, and microbiologic and chemical testing are necessary to verify ongoing performance.
- MRI safety is generally not applicable because the equipment is not used near or inside the scanner; facilities should confirm the location and materials of any installed components.
- The system should not be used when water quality, maintenance status, alarms, or monitoring results do not meet the dialysis facility's applicable requirements.
Frequently Asked Questions
What are the clinical indications for water purification system for hemodialysis?
The system is indicated for use in hemodialysis to ensure water purity, reducing chemical hazards and improving patient safety.
What outcomes have been reported in clinical studies?
Studies report that high water purity standards are crucial for reducing chemical hazards and improving patient outcomes in hemodialysis.
What complications have been reported?
Reported complications include chemical hazards and bioincompatibility issues due to inadequate water purification.
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.