CMS SOM App. H, Tag V182

5 Equipment

5.1 General:

A dialysis facility should develop contingency plans to cover the failure of its water

purification and distribution system or a critical component of that system. Such

contingency plans should describe how to deal with events that completely prevent dialysis

from being performed, such as failure of the facility’s municipal water supply or electrical

service following a natural disaster or water main break. Other plans should address how

to deal with sudden changes in municipal water quality, as well as with the failure of a

critical component of the water purification and distribution system.

Interpretive Guidance § 494.40(a)

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ANSI/AAMI RD52:2004

5 Equipment

5.1 General

This section on equipment provides a brief description of the different components that may be

included in a water purification and distribution system used for hemodialysis applications.

Since feed water quality and product water requirements may vary from facility to facility, not

all of the components described will be necessary in every purification and distribution system.

Routine dialysis requires a well-functioning water purification and distribution system, since

dialysis cannot be performed without an adequate supply of water. In addition, specific

components of the water purification and distribution system are critical to its operation. An

example of such a critical component is the circulating pump in an indirect feed system.

Additional Guidance:

An emergency or contingency “plan” that specifies the facility will use tap water or dechlorinated tap water may include evidence that the water intended for use has been found safe

for such use (i.e., has levels below AAMI accepted limits of aluminum, copper, chloramines,

fluoride, nitrate, sulfate, zinc and other contaminates known to be toxic to dialysis patients).

Refer also to the requirements for emergency policies and procedures found under the Condition

for Physical Environment at V408.

No Tag

(Rev. )

ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)

5.2 Water purification systems

5.2.1 General

Water purification systems consist of three basic sections: a pretreatment section that

conditions the water supplied to the primary purification device, which may be followed by

other devices that polish the final water quality. The pre-treatment section commonly

includes a sediment filter, cartridge filters capable of retaining particles of various sizes, a

softener, and carbon adsorption beds. The primary purification process most commonly

used is reverse osmosis, which may be followed by deionization and ultrafiltration for

polishing the product water from the reverse osmosis system.

Whether a particular device is included in an individual water purification system will be

dictated by local conditions.

Interpretive Guidance § 494.40(a)

AAMI Rationale for the Development and Provision of This Recommended Practice

A.5 Equipment

A.5.2 Water purification systems

Devices marketed to purify water for hemodialysis are also subject to the U.S. Food and Drug

Administration’s (FDA) 510(k) approval process. The FDA has published guidelines for water

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purification devices used in hemodialysis (Guidance for the Content of Premarket Notifications

for Water Purification Components and Systems for Hemodialysis). Water purification devices

marketed for use in hemodialysis applications must be approved by the FDA, and users should

ensure that devices obtained from vendors have been approved by the FDA.

Design and instrumentation of individual purification devices may vary from these general

descriptions. For example, softeners may be configured as a single resin bed that is regenerated

outside the regular operating hours of the dialysis unit, or they may have a dual-bed

configuration that allows one bed to be regenerated. At the same time, the other is used to

provide water for normal dialysis operations.

Depending on the feed water quality and product water requirements, not every component may

be required in a given facility. Likewise, additional components may be required in certain

circumstances. For example, carbon adsorption may not provide adequate chloramine removal

if the water contains substances, such as polyphosphates, that mask the reactive sites on the

carbon particles. In those circumstances, other processes, such as infusion of sodium

metabisulfite, may be required to achieve product water that meets these requirements.

Users are encouraged to obtain detailed descriptions of all purification processes, together with

operating manuals and maintenance procedures, from the manufacturer or the vendor providing

the water purification and distribution system.

Additional Guidance:

This is an informational tag; specific requirements for various water treatment components and

deficient practices should be cited under the applicable component tags.

Under FDA regulations at the time these regulations were published (April 15, 73FR20369), all

water treatment devices and systems installed after May 30, 1997 must meet review requirements

under section 510(k) of the Food, Drug, and Cosmetic Act (21 U.S.C. sec. 360(k)) as described

in Guidance for the Content of Premarket Notifications for Water Purification Components and

Systems for Hemodialysis. If a facility is found to be using water treatment devices installed after

1997 that have not been approved by the FDA, they may be found out of compliance with 42

C.F.R. §494.20. Equipment installed prior to 1997 is not required to have evidence of FDA

510(k) approval. Regardless of when a water purification system was installed, the system must

yield water and dialysate that meets these AAMI standards and must be monitored and

maintained in accordance with the ANSI/AAMI RD52 guidelines, as incorporated by reference in

these regulations.

Each piece of water treatment equipment described below is not required for every system, and

determinations of necessary equipment will be made by the facility based on a number of factors

such as feed water analysis and geographical considerations. The water treatment system must

be designed to process the local source water into AAMI quality water. All facilities should have

primary and secondary carbon tanks to remove chlorine/chloramines, and reverse osmosis (RO)

or deionization (DI) treatment systems. Any component in use should meet the requirements

specified in these rules for that component.

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