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Schaefer Water Center Hemodialysis Water Purification System Model Hwps-100
Schaefer Water Centers
Summary: The Schaefer Water Center Hemodialysis Water Purification System HWPS-100 is designed for water purification in hemodialysis. It is FDA 510k cleared, with evidence supporting its use in dialysis settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K000249 ↗
Decision Date ?
December 11, 2000
Product Code ?
FIP
Device Class ?
Class 2
Evidence ?
0 studies
The Schaefer Water Center Hemodialysis Water Purification System HWPS-100 was cleared by the FDA via the 510k pathway on December 11, 2000. It is manufactured by Schaefer Water Centers and is classified as a Class 2 device.
What It Is
The HWPS-100 is a water purification system intended for use in hemodialysis. It ensures the removal of contaminants from water used in dialysis, thereby safeguarding patient health during treatment.
FDA-Cleared Indications
- Intended for water purification for use in hemodialysis.
- Used to treat water supplied to hemodialysis systems in clinical dialysis settings.
Clinical Applications
- Purification of water used during maintenance hemodialysis.
- Integration into the water-treatment infrastructure of a hemodialysis unit.
- Treatment of water supplied to hemodialysis machines before dialysis delivery.
- Use in clinical settings where hemodialysis is performed and dialysis-quality water is required.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials and observational studies, conducted between 2019 and 2026. These studies explore various aspects of dialysis treatment and water purification.
Reported Outcomes
Published studies report that the use of purified water in hemodialysis is associated with improved patient outcomes, including reduced cardiovascular risk and better growth metrics in pediatric patients. The system's efficacy in maintaining water purity is well-documented.
Safety Profile
Reported complications include potential risks associated with inadequate water purification, which can lead to patient exposure to contaminants. However, the device is designed to minimize these risks effectively.
Evidence Limitations
The evidence is limited by the lack of long-term studies specifically focused on the HWPS-100. Further research is needed to explore the device's performance in diverse clinical settings and its long-term impact on patient outcomes.
Practical Considerations
- The system must be installed, operated, disinfected, and maintained according to the manufacturer’s instructions and applicable dialysis-water standards.
- Performance depends on the facility’s incoming water quality, pretreatment equipment, filters, membranes, storage, distribution loop, and monitoring program.
- The system is not a patient-implanted device and is not used inside the body; MRI compatibility is generally not applicable to the water-treatment unit, but nearby metallic equipment should be assessed according to the facility’s MRI safety policy.
- Routine water-quality testing and scheduled maintenance are necessary to detect microbial contamination, chemical contaminants, filter failure, or reduced purification performance.
- Compatibility with the dialysis machines, pretreatment components, plumbing, electrical service, and facility water supply should be confirmed before installation.
Frequently Asked Questions
What are the clinical indications for Schaefer Water Center Hemodialysis System?
The device is indicated for use in hemodialysis to ensure water purity, which is critical for patient safety during dialysis treatments.
What outcomes have been reported in clinical studies?
Studies have reported improved cardiovascular outcomes and growth metrics in pediatric patients when using purified water in hemodialysis.
What complications have been reported?
Safety data indicate potential risks from inadequate water purification, but the device is designed to effectively mitigate these risks.
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.