CMS SOM App. H, Tag V322

494.50(b)(1)

9 Reprocessing supplies

9.1 Specifications and testing

Each reprocessing material should meet a written specification. The fulfillment of that

requirement may be determined by certification by the product’s supplier that the product

meets necessary specifications, labeling for its intended purpose, or by testing procedures

by trained personnel, as appropriate. The requirement may also be complied with by

purchasing a specific grade as specified by the process, such as USP citric acid. When the

user performs testing, he or she should maintain a log of the date of test, the identifying

number (lot number) of the batch, the person performing any testing, and the test results.

When bleach is purchased from a commercial outlet, the labeled concentration should be

between 5.25% and 6.15%, and the formula should not contain fragrances or scents.

Interpretive Guidance § 494.50(b)(1)

ANSI/AAMI RD47:2002/A1:2003

9 Reprocessing supplies

9.1 Specifications and testing

Over the past few years, bleach (sodium hypochlorite) manufacturers have begun selling

household bleach in many new formulas. The concentration of sodium hypochlorite has gone

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from 5.25% to 6.15% in many cases. The CDC has not changed its recommendations for diluting

the bleach to take into account these percentage changes.

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.9 Reprocessing supplies

A.9.1 Specifications and testing

Testing of all incoming materials had been proposed. In recognition of the fact that most medical

supplies are certified by the vendor and not tested by the user, the AAMI RDD Committee

decided to recommend that supplies need not be tested by the facility doing hemodialyzer

reprocessing if they are marketed for hemodialyzer reprocessing.

Additional Guidance:

Most materials used in reprocessing will not require testing by the user since they are validated

and certified by a vendor. If the facility is using a material not commonly used in reprocessing, it

may not be certified by a supplier as meeting necessary specifications . For these materials,

there must be documentation of testing done by trained staff members to verify that the product

meets the necessary specifications.