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Reopening Dialysis ClinicsFDA Advice to Follow when Reopening Hemodialysis Clinics after Restoration of Power and Water |
This document gives recommendations to follow before reopening dialysis clinics after a period of time without power or water.
NOTE: If you perform dialysis at home, and you have lost power or water, see V. Home Hemodialysis Systems.
Before you reopen your dialysis clinic, check each component using the guidelines in each section below.
I. Water Treatment Systems
II. Dialysis Machines
III. Filters (Dialyzers) and Tubing
IV. Dialysate and Dialysate Mixing Systems
V. Home Hemodialysis Systems
VI. Additional Information
All dialysis units require purified, dialysis-quality water. Most dialysis units use on-site water treatment systems to purify the municipal water supply. Note that the loss of power to a water treatment system is just as serious as the lost of a potable water supply. Both can result in the potential contamination of water.
WARNING! Upon resumption of power and a potable water supply, DO NOT attempt to use water from your water treatment system for treating dialysis patients until you have fully assessed your water treatment system, replaced any contaminated system components, and disinfected and thoroughly rinsed the entire system.
Flooded Facilities:
If your facility flooded, even for a short time, the water treatment system
and distribution loops may be contaminated. Flooding can also lead to electrical
shorting of your power supply and loss of power, which compounds the problem.
Contaminated Water Supply:
If either your municipal water supply or your water treatment system is or was
contaminated, it may be difficult to produce dialysis-quality water. Follow
the steps below to determine whether or not you may resume producing water for
dialysis.
Why? If the municipal water supply does not meet EPA standards, you may not be able to purify it for dialysis and should consider it unsafe. In addition, pollutants or other toxins in the municipal water supply could damage or destroy components of the water treatment system.
Under a “boil water” alert, attempt to purify water for dialysis ONLY if you HAVE a working reverse osmosis (RO) system. For more information about treating water when you are under a “boil water” alert, see http://www.cdc.gov/ncidod/hip/dialysis/boilwater_advisory.htm.
Contact the company that services your water treatment system for information on how to flush and test system components. Do not use the water treatment system until it has been fully assessed, adjustments have been made, and all contaminated components have been replaced. For more information, see http://www.bt.cdc.gov/disasters/watersystemrepair.asp.
Why? Bacteria may grow on any component of a water treatment system that has been wet for an extended period of time, particularly if water has not been flowing through the system. Water passing through that component would be contaminated by the bacteria rather than being properly purified.
Disinfect the system and rinse system thoroughly. Make sure to test disinfectant residuals to ensure proper rinsing.
Upon resumption of normal operation of the water treatment system,
test the water output to make sure it meets AAMI standard RD62:2001 –
Water Treatment Equipment for Hemodialysis Applications.
Send a sample of water for a AAMI analysis (chemical analysis, chlorine
and chloramines, total microbial count, and endotoxin) as soon as is practical.
Store your water samples at 4-6°C and have them analyzed within 24 hours.
Why? AAMI RD62:2001 gives FDA-recognized maximal
allowable chemical and microbial levels in water used to prepare dialysate
and reprocess dialyzers.
If possible, test for endotoxin on site before you run patients. While waiting for test results, confirm water quality by monitoring water conductivity frequently.
Dialysis machines must be clean, dry, and disinfected prior to use.
WARNING! Do NOT use your dialysis machine if the outside or any internal components are wet, if your facility flooded, or if your facility was exposed to corrosive chemicals or excessive heat (above the limits listed in the manufacturer’s specifications).
Flooded Facilities:
If your facility flooded, even for a short time, the dialysis machines may be
contaminated.
Power Loss:
If your clinic lost power, your dialysis machines could be contaminated. Follow
the steps below before using your dialysis machines.
Hemodialysis systems use disposable dialyzers and tubing. Some dialyzers can
be reused for the same patient.
WARNING!
Do NOT reuse a dialyzer that is intended for single use. Follow instructions
on dialyzer label to determine if it can be reprocessed for reuse.
Flooded Facilities:
If your facility flooded, even for a short time, the seals and packaging on
disposable components may be compromised.
Power Loss:
If your clinic lost power, your supplies may be compromised. Follow the steps
below to make sure your dialyzers and tubing are safe to use.
Dialysate powder must be kept dry before mixing with purified water.
WARNING! Do NOT use dialysate concentrate that is standing in water, even if the container appears to be sealed, because it is difficult to determine if there has been seepage into the container.
Flooded Facilities:
If your facility flooded, even for a short time, the dialysate may have become
wet.
Power Loss:
If your clinic lost power, your dialysate or dialysate mixing system may have
been compromised. Follow the steps below before using your dialysate.
If you use a home hemodialysis system, and you lost power or water, your dialysis machine may not work properly. Check with your clinic or kidney doctor (nephrologist) if you are unsure about resuming treatment.
WARNING! Do NOT do home dialysis if you are unsure whether or not your water supply is clean or if your dialysis machine was in a room that flooded.
Q. Can you use your water treatment system on water that has been trucked
in from another location instead of using the municipal water supply?
A. Yes, if the water complies with EPA standards for potable water. For more
information on trucked water considerations, see: http://www.cdc.gov/ncidod/hip/Dialysis/dialysis.htm.
Q. Can you do dialysis with sterile, bagged dialysate?
A. Yes, if you have a dialysis system that uses sterile bagged dialysate that
does not require dilution, and you have all necessary components.
Q. Does FDA need to inspect my dialysis machines before I am ready
to restart them?
A. No.
Q. Can you use a reverse osmosis water treatment system that FDA has
not cleared for dialysis if that is your only way to get purified water?
A. Yes, if an unapproved reverse osmosis water treatment system is the only
device you have available, you may use it to prepare dialysis-quality water.
Under Section 561(a) of the Food, Drug, and Cosmetic Act, (21 U.S.C. 360bbb),
and FDA’s Guidance on Investigational Device Exemption (IDE) Policies
and Procedures, devices not yet approved or cleared for marketing may be used
in an emergency situation. As with any water treatment system, you must first
test the water output to make sure it complies with AAMI RD62:2001.
Within 5 days of using the system or learning of its use, you should send the following information to the FDA address below
The Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
IDE Program
9200 Corporate Blvd. (HFZ-403)
Rockville, MD 20850
Updated September 15, 2005
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