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Antiseptic WASH TEsting
Antiseptic washes are products intended for use with water, meaning that they are designed for rinse off after use. OTC antiseptic products are divided into two categories - those that are intended for use in health care settings or consumer settings. This distinction is reflective of the fact that these settings present different levels of risk of acquiring infections with serious outcomes, populations with disparate susceptibiliy to infection, and target populations with dramatically different use patterns.
Methods for Evaluating Antimicrobial Efficacy of Antiseptic Washes
The antimicrobial efficacy of consumer or health care personnel antiseptic handwash formulations may evaluated using one of the following test methods offered by Vivo:
•ASTM E1174 - Evaluation of Health Care Personnel Handwash Forumulations
•ASTM E2276 - Determining Bactericidal Properties Using Fingerpads
•ASTM E2613 - Determining Fugicidal Properties Using Fingerpads
•ASTM E1838 - Determining Virucidal Properties Using Fingerpads
•ASTM E2011 - Determining Virucidal Properties Using the Entire Hand
•ASTM E2870 - Determining Antimicrobial Properties Using the Palmar Surface
•ASTM E2784 - Determining Antimicrobial Properties Using the Paper Towel Method
•ASTM E1327 - Determining Antimicrobial Properties Using Fingernail Region
FDA Product Performance Criteria for Antiseptic Washes
As outlined in their respective guidance documents, the product performance requirements for consumer and health care antiseptic washes is specified below:
How to Design a Robust Study for Your Antiseptic Wash Project
In addition to revising the log10 reduction criteria for antiseptic wash formulations in the recent Proposed New Rule guidance, FDA has also asserted experimental controls that should be incorporated into these studies. Vivo has a deep understanding of satisying the FDA’s requirements for designing scientifically defensible studies and accounting for variability between study subjects by incorporating the following controls or elements in our studies, as appropriate:
•Neutralization verification control
•Negative and/or vehicle control
•Positive (i.e. reference or active) control
•A sample size large enough to achieve statistically sensitive results
•Adequate randomization of test or control article distribution
•Analysis of the proportion of subjects who meet the log reduction criteria based on a two-sided statistical test and a 95% confidence interval
FDA's Final Rule on Consumer Antiseptic Washes (Issued September 2016)
As per the FDA’s final rule addressing antimicrobial hand wash products used in consumer settings, FDA determined that the data currently collected on the following active ingredients does not adequately support that they are appropriate for use in consumer hand wash formulations: Cloflucarban, Fluorosalan, Hexachlorophene, Hexylresorcinol, Iodophors, Methylbenzethonium chloride, Phenol, Secondary amyltricresols, Sodium oxychlorosene, Tribromsalan, Triclocarban, Triclosan, and Triple dye.
Accordingly, consumer antiseptic wash products with these active ingredients are now classified by FDA as new drugs, meaning that approved new drug applications are required before marketing. FDA’s current rationale for changing the status of these active ingredients is that the existing data is insufficient in demonstrating that these products impart enough of an added benefit over plain non-antibacterial soaps. Furthermore the widespread use of these products may carry unnecessary risks (e.g. toxicity or promoting development of bacterial resistence) given that their clinical benefits are unproven for general consumer use.
Additionally, the FDA’s 2013 Consumer Wash Proposed Rule identified several other active ingredients that are currently not considered appropriate for use in consumer hand wash formulations: Alcohol (ethyl alcohol), Benzalkonium cetyl phosphate, Cetylpyridinium chloride, Chlorhexidine gluconate, Isopropyl alcohol, Polyhexamethylene biguanide, Salicylic acid, Sodium hypochlorite, Tea tree oil, Combination of potassium oil solution, phosphate sequestering agent, and triethanolamine.
Currently the FDA has deferred on changing the safety and efficacy status of consumer antiseptic wash formulations with benzalkonium chloride, benzethonium chloride, or chloroxyenol active ingredients. The FDA is reviewing these products on a case-by-case basis and is currently reviewing safety and efficacy data gaps for these ingredients.