CMS SOM App. H, Tag V207

5.2.9 Ultrafiltration (effective/opaque housing)

6.2.9 Ultrafiltration (monitoring)

Refer to RD62:2001, 4.3.12 Ultrafilters: When used in a water purification system for

hemodialysis applications, an ultrafilter [should] be shown to reduce the concentrations of

bacteria and endotoxin in the feed water to the ultrafilter by factors at least as great as

those specified in the manufacturer's labeling.

5.2.9 Ultrafiltration

Refer to RD62:2001, 4.3.12 Ultrafilters: Ultrafilters [should]have an opaque housing or

that other means be used to inhibit proliferation of algae.

Ultrafilters should be included in routine disinfection procedures to prevent uncontrolled

proliferation of bacteria in the feed water compartment of the filter.

6.2.9 Ultrafiltration

The pressure drop across the ultrafilter (∆P) should be measured using simple inlet and

outlet pressure gauges. Ultrafilters operated in the cross-flow mode should also be

monitored in terms of the flow rate of water being directed to drain (concentrate).

Results of pressure measurements and bacteria and endotoxin levels should be recorded in

a log.

Interpretive Guidance § 494.40(a)

ANSI/AAMI RD52:2004

5.2.9 Ultrafiltration

Ultrafilters are membrane-based separation devices that may be used to remove particles as

small as 1,000 daltons and are thus well suited to remove both bacteria and endotoxins.

If bacterial proliferation is not controlled, bacteria may “grow through” the membrane and

contaminate the product water compartment of the filter.

6.2.9 Ultrafiltration

Such monitoring will indicate when membrane fouling has progressed to the point that

membrane replacement or cleaning is needed.

Monitoring is also necessary to ensure that the device is being operated in accordance with the

manufacturer’s instructions.

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Monitoring guidelines from ANSI/AAMI RD52, Table 4 include: For ultrafilters, monitor

pressure drops across the filter daily for pressure drop less than a value set by the facility.

Additional Guidance:

Test results drawn pre and post ultrafilter should be used to determine if the concentrations of

bacteria and endotoxin are reduced as stated by the manufacturer’s label. These samples can be

drawn at usual testing points: e.g., the post RO sample would function as the pre-UF sample,

and the sample from the first water distribution outlet would serve as the post-UF sample. Such

testing should be performed whenever an UF is originally installed, and whenever the specific

type of UF is changed. Low levels of bacteria and endotoxin in the feed water to the ultrafilter

may prevent the user from being able to show the manufacturer’s specified level of reduction; an

acceptable test result should be defined by facility policy, and in all cases must be within the

AAMI standards for microbial contamination.

Disposable ultrafilters do not require disinfection when used within the manufacturer’s

parameters and pressure monitored to detect fouling.

Every filter has an initial pressure drop when installed new. Users should monitor the change in

pressure and validate the acceptable pressure change each time the filter is replaced.

Ultrafilters are not required in every facility; the source water should determine the water

treatment components needed. As referenced in V204, an ultrafilter is required if DI is the last

water treatment component in the system. If ultrafilters are in use, the facility must follow these

requirements. The typical range of micron filter size is .001 to .05 microns.