CMS SOM App. H, Tag V306

494.50(b)(1)

4.1 Dialyzer reprocessing manual

Page 120 of 420

The dialyzer reprocessing manual should be a compilation of all specifications, policies,

training materials, manuals, methodologies, and procedures that may be integrated into the

dialysis facility’s policy and procedures manual. The dialyzer reprocessing manual should

also contain samples of forms and labels, if appropriate. The operational logs, manuals,

and files may be kept separate from the dialyzer reprocessing manual. The dialyzer

manufacturer’s labeling should be consulted to determine if a specific dialyzer requires

special considerations.

Interpretive Guidance § 494.50(b)(1)

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.4 Records

Documentation is essential to a safe, effective hemodialyzer reprocessing program. The overall

dialyzer reuse procedure documentation includes reference materials, procedures, and policies,

some of which may be distributed in the facility for operating purposes. The other records serve

to document aspects of the reuse procedure for each dialyzer, along with QC and QA measures,

so that a complete history of the reprocessing of each dialyzer and QC/QA procedures exists.

Allowance is made for keeping the reprocessing record data in the reprocessing log, the

patient’s chart, or a combination of the two, because both of them are traceable, permanent

records, and it may be inconvenient to record all of the information in one location.

Additional Guidance:

The reprocessing manual must be complete for the reprocessing method, germicide, and system

in use. The manual must address test procedures, maintenance and calibration of the

reprocessing equipment and training and competency testing of personnel. The manual may be

separate or combined with the general policy and procedure manual. The manufacturer’s

“labeling” of a dialyzer includes the package insert, usually found in the shipping container for

multiple dialyzers of the same type, and contains the dialyzer manufacturer’s directions for use.

If a specific dialyzer in use requires special consideration, the reprocessing manual should

reflect the manufacturer’s guidance.