CMS SOM App. H, Tag V332

494.50(b)(1)

11.2 Rinsing/cleaning

11.2.1

When pre-cleaning is done, it is part of the reprocessing procedures.

All applicable requirements for design and maintenance of equipment included in this

document should be adhered to for pre-cleaning of equipment. The maximum pressures for

the dialyzer, or other limits set by the manufacturer, should be adhered to.

Interpretive Guidance § 494.50(b)(1)

ANSI/AAMI RD47:2002/A1:2003

11.2.1 Rinsing/cleaning

Many facilities pre-clean dialyzers. This process is typically accomplished with an apparatus

developed by users and is intended to remove gross deposits of blood and products before

rinsing and cleaning with a reprocessing machine or device.

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.11.2.1 Rinsing/cleaning

Aqueous liquids rather than gases such as air are preferred for rinsing and cleaning.

Additional Guidance:

Page 139 of 420

Maximum pressures allowed during reprocessing will be defined in the dialyzer manufacturer’s

directions for use (DFU). Use of higher pressures may cause breaks in the dialyzer fibers and

potential blood leaks. A pressure gauge must be in place to monitor the pressure of the treated

water source used for rinsing the used dialyzers, and the maximum limits of the pressure to be

used must be defined and known to the operator.

Use V315 if there is no pressure gauge in the water line at the rinse sink; use this tag (V332) if

the manufacturer’s specified pressures are exceeded.