CMS SOM App. H, Tag V315

494.50(b)(1)

7.2 Reprocessing systems

7.2.1 Utility requirements

The quality, pressure, flow rate, and temperature of the water used for reprocessing should

be specified in the dialyzer reprocessing manual, established before the initiation of a

reprocessing program, and maintained thereafter. The manufacturer or designer’s

recommendations for the water supply should be followed. Provision should also be made

for adequate drains, ventilation, and electrical power.

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Interpretive Guidance § 494.50(b)(1)

In the reprocessing area, there must be sufficient drains to accommodate the reprocessing

systems, air ventilation equipment to minimize exposure to germicide vapors (as listed in AAMI

8.1 "Reprocessing area and ventilation"), and an adequate number of electrical outlets for the

equipment in use.

The pressure of the water used for reprocessing should be monitored. There should be a pressure

gauge in the water line of any sink used for dialyzer rinsing, with defined parameters for the

accepted pressures to use during that procedure. Dialyzer manufacturers specify maximum

pressures for rinsing; exceeding those pressures can result in rupture of the dialyzer membranes

and potential blood leaks. Use this tag if there is no pressure gauge in the water line at the rinse

sink; use V332 if the manufacturer’s specified pressures are exceeded.