US · guidance
CMS SOM App. H, Tag V320
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR §
494.50(b)(1)
8.4 Personnel protection: gear
Personnel shall wear durable gloves and protective clothing when handling the dialyzer
during initiation and termination of dialysis and during the reprocessing procedure.
Standard Precautions shall be observed.
Personnel shall wear eye protection when performing steps that may result in spills or
splashes of substances of known or suspected toxicity. These agents shall be handled only in
areas with adequate ventilation, washing facilities, eyewash stations, appropriate
respirators, and spill control materials. When personnel are handling concentrated toxic
substances, they shall wear aprons impervious to these substances.
Interpretive Guidance § 494.50(b)(1)
Reprocessing personnel and patient care staff must wear PPE appropriate to the risk of potential
exposure to germicide, blood, and other potentially infectious substances for the tasks
performed.
Various germicides require different precautions as to PPE, eyewash, respirators, and spill
control materials. The germicide manufacturer’s guidance or the MSDS provide this specific
information.
The supplies for managing a minor germicide spill (containment materials, additional protective
equipment, etc.) must be easily accessible from the reuse room.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
8eeb65ed3192bc8721d8f386125391c580e4273463ccb93d24b88a8855a2e134
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