CMS SOM App. H, Tag V330

494.50(b)(1)

10.3 Information recorded on label/similar name warning

The dialyzer shall be labeled with the patient’s name, the number of previous uses, and the

date of the last reprocessing. Dialyzers of patients with similar last names should have a

warning to the user to take extra care in ensuring that the name or other identifying

information on the label corresponds to that of the patient. If there is sufficient room, the

dialyzer may also be labeled with the results of tests, the signature or other unique means

of identifying the person performing the various steps in the reprocessing procedure, and

the reference values for performance parameters. If this information appears on the label,

a permanent record should also be kept (see [AAMI] 4.2) Electronic records are

acceptable. If records are electronic, the test results should be available to the user.

Home dialysis patients are exempted from the recommendation that the patient’s name

appear on the label, unless the dialyzers are taken to a dialysis facility for reprocessing.

Interpretive Guidance § 494.50(b)(1)

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.10.3 Information recorded

A proposal to include all the recommended information on the label was rejected because space

is limited on the label, and such extensive labeling is deemed unnecessary. Displaying the

number of previous uses on the label is recommended so that this information is readily

available. Displaying the date of the last reprocessing facilitates verification that sufficient time

has elapsed since the introduction of the germicide to achieve sterilization or disinfection.

Additional Guidance:

At a minimum, except for home dialysis patients, each dialyzer must be labeled with the patient’s

name, the number of previous uses, and the date and time of the last reprocessing.

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For patients with similar names, a warning is necessary to alert staff and prevent dialyzer mix-ups. Direct care staff must be knowledgeable of the method used to alert them about dialyzers of

patients with the same/similar names. Dialyzers in use must demonstrate the use of warning

labels if there are two or more patients with similar names on the census.

Since the labels are discarded with the dialyzer, the information on the label must also be kept in

a permanent record, which may be electronic. The record of dialyzer reprocessing is considered

part of the patient’s medical record.