Topical Antiseptics in Healthcare

Michelle M Jackson

doi:10.29074/ascls.18.3.160

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Michelle M Jackson, PhD⇑
1. is a Microbiologist at the Food and Drug Administration at Rockville, MD

Address for correspondence: Michelle M Jackson PhD, Microbiologist, Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Office of Nonprescription Products, 5600 Fishers Lane, HFD-560, Rockville MD 20857. (301) 827-2284. jacksonm{at}cder.fda.gov

Define transient flora and resident flora and compare the two groups in terms of ease of removal.
Describe the FDA regulatory approval process for a drug product.
Define the following terms: antimicrobial soap, skin antiseptic, healthcare personnel handwash, surgical hand scrub, and patient preoperative skin preparation.
Identify the types of healthcare topical antiseptic currently available on the market.
Identify factors that may influence the antimicrobial action of an antiseptic.

Extract

Topical antiseptics are essential for infection control. Antiseptic formulations employ a variety of mechanisms, act at various rates and persistence intervals, demonstrate various levels of toxicity, and are more or less likely to trigger resistance. The desired characteristics are considered when selecting antiseptics for hand washing, surgical scrubbing, and patient preoperative skin preparation. The selection process requires evidence of product safety and efficacy. This article explores currently available topical antimicrobial agents used in medical settings.

INTRODUCTION Topical antiseptics are antimicrobial agents that kill, inhibit, or reduce the number of microorganisms on the skin.¹ The human skin is colonized by a wide variety of microorganisms that may provide a protective mechanism to the host but also serve as a source of infection. Organisms that do not cause disease are called the “usual or normal flora”. Normal flora on the skin are “transient” or “resident”. Transient flora are contracted from the environment or from other people. In most cases, these organisms are not part of the established normal flora.² Healthcare professionals, for example, acquire microbes including methicillin-resistant Staphylococcus aureus (MRSA) during contact with patients or contaminated surfaces. Although transient organisms are easily removed from the upper layer of the skin along with dirt particles and oil, they may become part of the resident established flora of individuals. Resident flora can be persistently isolated from the hands of most people. These organisms include coagulase-negative staphylococci, Corynebacterium (diptheroids or coryneforms), Proprionibacterium, and Acinetobacter species.

Topical antiseptics are active against both resident and transient flora…

ABBREVIATIONS: CHG = chlorhexidine gluconate; FDA = Food and Drug Administration; FR = Federal Register; GRASE = generally recognized as safe and effective; MRSA = methicillin resistant Staphylococcus aureus; NDA = new drug application; OTC = over-the-counter; PCMX = chloroxylenol; RASE = recognized as safe and effective; TFM = tentative final monograph; USP = United States Pharmacopeia.

Define transient flora and resident flora and compare the two groups in terms of ease of removal.
Describe the FDA regulatory approval process for a drug product.
Define the following terms: antimicrobial soap, skin antiseptic, healthcare personnel handwash, surgical hand scrub, and patient preoperative skin preparation.
Identify the types of healthcare topical antiseptic currently available on the market.
Identify factors that may influence the antimicrobial action of an antiseptic.