CMS SOM App. H, Tag V353

494.50(b)(1)

12.4.1 Testing for residual germicide

Residual germicide shall be measured by a test of appropriate sensitivity according to a

written procedure to ensure that the germicide level is below the maximum recommended

residual concentration . . . Completion of this step shall be documented, along with the

signature or other unique means of identifying the person performing the test.

A written policy should establish the maximum allowable time between rinsing the

germicide from the dialyzer and beginning dialysis . . . The priming, removal, and residual

testing process should be reinstituted after [any] delay sufficient to bring concentrations of

germicide above the recommended level (rebound) [by elution from these compartments].

Additional rinsing should be performed to yield a germicide level below the maximum

recommended concentration before initiating of dialysis.

A rinse procedure should be defined and documented step by step, and all personnel should

be familiar with and follow it.

If heat disinfection is used, the dialyzer should be cool to the touch before it is primed with

saline.

Interpretive Guidance § 494.50(b)(1)

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.12.4.1 Testing for residual germicide

Because certain germicides have been demonstrated to disperse into the solid components or

less rapidly exchangeable compartments of the of the hemodialyzer, the priming, removal, and

residual testing process should be reinstituted after any delay that provides sufficient time for

concentrations of germicide to rebound above the recommended level by elution from these

compartments.

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A number of procedural steps have been identified that, if not followed, may cause residual

germicide to remain in the hemodialyzer following rinsing. The following list of instructions,

though not all inclusive, should be carefully considered when developing a facility’s rinsing

procedure:

• Air bubbles in the fibers can cause individual fibers to become blocked. Be sure that

the arterial line is fully primed before [it is connected] to the hemodialyzer. If using

peracetic acid-type germicide, [the blood side should be flushed] before beginning

dialysate flow.

• Air trapped in the dialysate side of the hemodialyzer may cause germicide to also

remain trapped in portions of the hemodialyzer. [The dialyzer should be rotated]

during the rinsing process. This action normally releases the trapped air and allows

the germicide to be fully rinsed.

• Germicide may back up into the heparin or monitor lines. [The heparin line must be]

clamped [so] that fluid is not forced into the monitor lines.

• Germicide may back up into the saline bag during the rinsing procedure.

[Procedures for initiation of treatment must account] for all situations that may force

fluid from the dialysis circuit back into the saline bag.

• Take care to avoid a false-negative residual disinfection test, which can happen if you

sample too quickly after a quantity of saline has been infused.

• Discard the prime solution when beginning blood flow to the hemodialyzer.

Additional Guidance:

If the extracorporeal circuit is prepared ahead of time, staff should repeat the residual germicide

test just prior to treatment initiation to allow detection of any “rebound” of germicide. This is

particularly a concern if fluid circulation through the circuit and dialyzer is stopped, as may

happen when a patient is late coming to treatment.

If facility practice is to discard the priming solution by “bleeding patients on,” policy and

practice should reflect a requirement that a staff member constantly attend that patient while the

venous line is open as blood fills the extracorporeal circuit, to prevent accidental blood loss.

Generally, manufacturers of dialyzers labeled for reuse address the need to discard the prime

solution by advising users to replace the saline bag used for priming and refresh all fluid in the

extracorporeal circuit with saline from the new bag prior to beginning patient treatment.