CMS SOM App. H, Tag V325

494.50(b)(1)

7.2.2 Process control testing: concentration of germicide

7.2.2.2

The test for the concentration of germicide or chemical shall be established before clinical

use of the reprocessed dialyzers ([AAMI] 11.4.1.6 and 12.3.2). For systems using heat

disinfection, verifiable evidence shall be available before the next use that dialyzers have

been exposed to the appropriate temperature for the time required. If chemicals are used

to enhance heat disinfection, both a presence test and a verification of time and

temperature shall be performed.

Interpretive Guidance § 494.50(b)(1)

The reuse manual should document how the concentration of germicide will be tested.

If heat disinfection is the reprocessing method, records of each batch of dialyzers processed must

include an indicator, such as an automated time/temperature recording log, that the dialyzers

were exposed to the appropriate temperature for the time required. If a chemical, such as citric

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acid, is used to enhance heat disinfection, a presence test is also required before clinical use of

the dialyzers.

If an incubator or oven is used to raise the dialyzer storage temperatures, a recording

thermometer should be in use to ensure sufficient temperature is consistently maintained.

Records should document that these devices functioned as expected.