Hand antisepsis refers to either (1) antiseptic handwash or (2) antiseptic hand rub performed by HCWs. Antiseptic handwash is defined as washing hands with soap containing an antiseptic agent and water. Antiseptic hand rub is defined as applying an antiseptic hand rub product or waterless antiseptic agent (i.e., an antiseptic agent that does not require use of exogenous water) to the hands. In the United States, all such preparations approved for use in healthcare settings contain ethanol alone or in combination with isopropyl alcohol (i.e., alcohol-based hand rub). Surgical hand antisepsis is defined as either (1) a surgical antiseptic handwash or (2) a two-stage surgical hand antisepsis performed preoperatively by surgical personnel.
Antiseptic agents are regulated by the FDA's Division of Over-the-Counter (OTC) Drug Products. Requirement for in vitro and in vivo testing and criteria for the classification of such products are outlined in the FDA Tentative Final Monograph for Healthcare Antiseptic Drug Products (TFM).26 The FDA TFM of 1994 classifies antiseptic agents as Category I, i.e., generally recognized as safe and effective and not misbranded; as Category II, i.e., not generally recognized as safe and effective or misbranded; or as Category III, available data are insufficient to classify as safe and effective, and further testing is required. Based on available evidence, the FDA TFM 1994 concluded that only ethanol, 60 to 95%, and povidone iodine, 5 to 10%, formulations have meet the test and product labeling requirements as antiseptic agents for hand antisepsis and surgical hand antisepsis in healthcare settings (Table 2).26