BRIEFING
〈1072〉 Disinfectants and Antiseptics. This proposal is based on the version of the chapter official prior to 2013. The previously published proposal in PF 46(5) has been canceled, as it has been more than two years since it was presented for public comments, and is being revised based on comments received. The following revisions are being proposed:
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Remove the Definitions section. Definitions and glossary terms related to the Microbiology chapters can be found in Microbiological Chapters—Glossary 〈1117.1〉.
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Add a new section detailing methods for decontaminating large spaces, including vapor phase hydrogen peroxide and chlorine dioxide gas.
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Remove the following sections:
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Selection of an Antiseptic for Hand and Surgical Site Disinfection
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Theoretical Discussion of Disinfectant Activity
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Expand considerations for selecting disinfectants, including bioburden, spectrum of activity, and compatibility with surfaces.
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Provide clarification to Disinfectant Challenge Testing, including the recommended acceptance criteria.
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Add a 2-log acceptance criterion for fungal spores.
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Add smaller coupon sizes (e.g., 1 or 2 cm in diameter) to disinfectant efficacy testing to simplify efficacy studies.
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Update guidance for the use of disinfectants in a cleaning and sanitization program, including In Situ Qualification of Disinfectant Effectiveness and Personnel Safety.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
(GCM: L. Furr)
Case ID—SUB-1063