CMS SOM App. H, Tag V321

494.50(b)(1)

Page 131 of 420

8.2 Storage area

Reprocessing materials, hemodialyzers awaiting reprocessing, and reprocessed

hemodialyzers should be stored so as to minimize deterioration, contamination, or

breakage. New, used, and reprocessed dialyzers should be segregated to make clear the

status of each group of dialyzers. Environmental contamination of the storage area should

be controlled and monitored, if the personnel determine those actions to be necessary.

Storage areas for new dialyzers and reprocessing materials should be designed to facilitate

rotation of stock and cleaning. Storage arrangements should also take into account fire

safety considerations, OSHA regulations, and other appropriate regulations.

Interpretive Guidance § 494.50(b)(1)

“Clean” and “dirty” dialyzers must be stored separately; the reprocessing cycle status of any

dialyzer must be clearly apparent at all times. Stock must be organized to allow rotation and

prevent use of out-of-date materials. Reprocessed dialyzers in storage should be protected from

unauthorized access to prevent tampering and any potential damage from manipulation by

untrained users.