NxStage PureFlow and System One Home Dialysis Products

TEXAS DEPARTMENT OF STATE HEALTH SERVICES
DAVID L. LAKEY, M.D.
COMMISSIONER
1100 West 49th Street * Austin, Texas 78756
P.O. Box 149347 * Austin, Texas 78714-9347
1-888-963-7111 * www.dshs.state.tx.us
TTY: 1-800-735-2989

March 26, 2008

Revised Position Statement for NxStage PureFlow and NxStage System One Home Dialysis Products
Please note that the January 25, 2008 Position Statement is revised in bold below to reflect the change from “…prior to mixing to prior to using…”. This is the only change and is in response to input from a stakeholder.
The Texas Department of State Health Services (DSHS) has recently completed an extensive review of the NxStage home dialysis products, manufacturing manuals and supporting documentation, and met with the manufacturer’s representative to determine whether said products can be safely used in Texas and be in compliance with the Texas licensing rules, 25 Texas Administrative Code Chapter 117. Also, neither the AAMI Standards nor the current licensing rules specifically address the delivery of dialysis treatment using these products.

Until the current licensing rules are amended, this document will provide guidance to DSHS survey staff and licensed ESRD facilities in Texas regarding the use of these products and is consistent with the recent CMS position statement. ESRD facilities that follow these guidelines when using the NxStage PureFlow product will be considered to be in compliance with the current licensing rules:

•   Chemical Quality of the Source and Treated Water: The chemical quality of the treated (product) water used for dialysis should be analyzed initially and at least every six months at the end of the Pack life or when any modifications are made to the Pack to ensure the source water meets the primary standards of Safe Drinking Water Act (SDWA).

•   Microbiological Quality of the Dialysate and Product Water: The microbiological quality of the water and dialysate should be analyzed monthly at the end of the Sack life using cultures and endotoxin measurements.

•   Chlorine and Chloramines Testing: A means shall be provided to sample the product water for chlorine / chloramines levels immediately prior to using each dialysate batch (SACK). Chloramines levels shall be <0.1mg/L. Results of testing shall be documented.
•   Verification of dialysate: Prior to the use of each dialysate batch (SACK), the user will verify the dialysate conductivity and pH of the batch with an independent device.

The NxStage System One, in its existing form, meets the current licensing rule requirements.
All other Texas ESRD licensing rules remain in effect and facilities must continue to be in compliance with those rules. Please contact your DSHS zone office should you have any questions.