Healthcare antiseptics
This article was originally published in The Rose Sheet
Executive Summary
Persistence/cumulative testing requirement should be eliminated for alcohol hand antiseptics in the Healthcare Antiseptic Drug Products Tentative Final Monograph for the antiseptic handwash/health care personnel handwash category, Elaine Larson, RN, PhD, Columbia University, states in comments to FDA July 30. Performance criteria threaten the availability of alcohol-based hand disinfectants, she says. Although ethyl and isopropyl alcohol are Category I for safety and efficacy in the 1994 TFM, the Health Care Personnel Handwash test outlined in the monograph requires products to exhibit cumulative ("persistent" or "residual") antimicrobial effect. Alcohol-based products, however, lack this effect, Larson adds, noting these items therefore must be reformulated to contain biocidal ingredients to display a cumulative effect. Comments respond to FDA's reopening of the administrative record for the topical antimicrobial drug products monograph in May (1"The Rose Sheet" June 2, 2003, In Brief)...