Hand Hygiene

Hand hygiene is a general term that applies to (1) handwashing; (2) hand antisepsis, i.e., antiseptic handwash and antiseptic handrub; and (3) surgical hand antisepsis.1,3,5,6 Performing hand hygiene is indicated (1) when hands are visibly soiled, (2) after barehanded touching of inanimate objects likely to be contaminated by blood and OPIM such as saliva or respiratory secretions, (3) before and after treating each patient, (4) before donning gloves, and (5) immediately after removing gloves.

Products used for hand hygiene in healthcare settings include detergents and antiseptic agents. Detergents contain esterified fatty acids and sodium or potassium hydroxide and are often referred to as “soaps.” Plain soap does not contain an antimicrobial agent or contains low concentrations of an antimicrobial agent that is effective solely as a preservative.1 The cleaning activity of plain soap results in the removal of dirt, soil, and various organic substances from the hands.

Antiseptic agents (Table 1) in hand hygiene products used in healthcare settings should have a broad spectrum, be fast acting, reduce the number of microorganisms on intact skin to an initial baseline level (i.e., by 2-log10 or 99% on each hand within 5 minute after the first use of a product and by 3-log10 or 99.9% on each hand within 5 minutes after the tenth use) after adequate washing, rinsing and/or rubbing and drying; and should have persistent or residual activity.1,24

Table 1. Microbial spectrum of various antiseptic agents.*
ClassGram-positive bacteriaGram-negative bacteriaMBT1VirusesFungiOnset of action
Ethanol (60 to 95%)+++++++++++++++Fast
Iodophors (5 to 10%)+++++++++++Intermediate
Chlorhexidine (2 to 4%)+++++++++++Intermediate
Triclosan+++++++++-Intermediate
Phenol derivatives+++++++Intermediate
Quaternary ammonium compounds+++--+Slow

Note: 1Mycobacterium tuberculosis
+++ = excellent; ++ = good; + = fair; - = no activity or not sufficient
*Hexachlorophene is not included because it is no longer an acceptable ingredient of hand disinfectants

Persistence is characterized by prolonged antimicrobial activity that prevents or inhibits the survival or proliferation of microorganisms after application of the product. Some antiseptic products also demonstrate substantivity, i.e., they adhere to the stratum corneum of the skin and continue to provide an inhibitory effect on microbial growth after rinsing or drying. However, substantivity is not an absolute requirement for an agent to lower the number of bacteria following hand hygiene.

The FDA classifies antiseptic agents (Table 2) 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. Based on available evidence, the FDA concluded that only ethanol (60 to 95%) and povidone iodine (5 to 10%) formulations meet the test and product labeling requirements as antiseptic agents.24

Table 2. The FDA classification of healthcare antiseptic agents.24
Active ingredientsHand antisepsisSurgical hand antisepsis
Alcohol (ethanol), 60 to 95%II
Povidone iodine, 5 to 10%II
HexachloropheneIIII
Isopropyl alcohol, 70 to 91.3%IIIE1IIIE1
ChloroxylenolIIISE1IIISE1
TriclosanIIISE1IIISE1
Quaternary ammonium compounds (benzalkonium chloride)IIISE1IIISE1
Chlorhexidine gluconate, 4%22

1S-safety and E-efficacy;
2Determined to be a “new drug” as a healthcare antiseptic agent and was not included in the FDA’s Tentative Final Monograph for Healthcare Antiseptic Drug Products (TFM).24