CMS SOM App. H, Tag V339

494.50(b)(1)

11.4.1 Interior (blood/dialysate compartment)

11.4.1.1 Germicidal process

Chemical germicides or other procedures used for disinfecting of hemodialyzers have been

shown to accomplish at least high-level disinfection when tested in dialyzers artificially

contaminated with appropriate microorganisms.

If the germicide has an expiration date from the manufacturer, staff members should be

sure that the chemical is not outdated. Some germicides have recommendations for

maximum storage time after dilution or activation and before usage. If this is the case, the

expiration date of the prepared germicide solution should be marked on the outside of the

germicide solution container, and that date should be checked at the beginning of each day,

before reprocessing begins.

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The disinfection process shall not adversely affect the integrity of the dialyzer. Germicides

shall be rinsed from the dialyzer to below known toxic levels within a rinse-out period

established for the particular germicide (see AAMI 12.4). To prevent injury, staff members

shall take care not to mix reactive materials such as sodium hypochlorite and

formaldehyde.

Interpretive Guidance § 494.50(b)(1)

ANSI/AAMI RD47:2002/A1:2003

11.4.1 Interior (blood/dialysate compartment)

11.4.1.1 Germicidal process

If formaldehyde is used as the sole germicidal agent, the CDC recommends that a concentration

of 4% (W/V) be used in both the blood and dialysate compartments with a minimum contact time

of 24 hours at a temperature of at least 20° C; lower concentrations or shorter contact times are

appropriate if equivalent results can be demonstrated under other conditions. Formaldehyde

used for reprocessing dialyzers shall not be cloudy. Concentrated formaldehyde stored under

adverse conditions can polymerize to form paraformaldehyde, a white precipitate. Formaldehyde

should be of United States Pharmacopoeia (USP) standards or better quality. When other

germicides are used, the manufacturer’s instructions should be followed. If maximum storage

temperature limitations exist, records should be maintained to document this criterion.

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.11.4.1.1 Germicidal process

Unfortunately, no realistic procedure exists whereby a dialysis center can monitor the

effectiveness of the disinfection procedure. Such sophisticated microbiological tests cannot be

performed in dialysis centers because they require the use of specialized equipment and highly

trained microbiologists. Due to these constraints, a center should adhere strictly to established

protocols for QC and QA. Tests for total bacteria and endotoxin in the water used to make up the

germicide should be conducted at least monthly. If there are problems in maintaining water

quality at the level established by ANSI/AAMI RD62:2001, Water treatment equipment for

hemodialysis applications (referenced in RD52:2004), the testing may need to be performed

more frequently.

Testing the germicide’s final-use concentration should be a part of the center’s QC program as

well as verifying that each dialyzer was filled with germicide.

Potency testing of each batch of germicide is specifically recommended for batches of manually-prepared germicides, regardless of whether they are used with a manual or an automated

system. Germicide solutions diluted online by automated machines should be checked for

concentration at least monthly.

CMS requires (at 42 CFR § 494.50) that dialyzers not be subjected to multiple germicide

solutions because of possible combined actions of the germicides on the hemodialyzer

membrane. This requirement does not apply to the original sterilization process or chemical

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cleaning agents to which the hemodialyzer may be exposed for short periods during the cleaning

process for reuse.

Additional Guidance:

The reuse staff must be knowledgeable about the germicide used and the risks this germicide

presents to him/her and to the patients, such as injuries that may be caused by mixing reactive

materials such as sodium hypochlorite and formaldehyde.

Containers of germicide should be dated to indicate dilution and discard dates.