Clostridium difficile (C. diff) and Candida auris (C. auris) are the cause of severe and potentially deadly infection and illness, and are often linked to healthcare settings. Products with the proven ability to disinfect surfaces contaminated with these and other pathogens are critical to protecting patients, especially the immunocompromised, in healthcare facilities.

According to Centers for Disease Control and Prevention (CDC) estimates, Clostridium difficile (C. diff), a spore forming bacterium, is the source of nearly 500,000 serious and potentially deadly hospital acquired infections in the United States each year. While there are antibiotics to treat this infection, the infection is serious and, in some cases, can be deadly.

Candida auris (C. auris), an often multi-drug resistant fungal pathogen, causes severe illness in healthcare facilities. While this pathogen is frequently multi-drug resistant, some strains are resistant to all available classes of antifungal drugs used to treat these infections. These infections spread when contact is made with a contaminated surface, as well as from person-to-person contact.

The US Environmental Protection Agency (EPA) regulates the registration of products that claim to reduce or kill C. diff and C. auris on surfaces. To successfully register products with the EPA with these claims, products must undergo C. diff efficacy testing and/or C. auris efficacy testing. Element has decades of experience supporting leading developers, manufacturers, and marketers of products with C. diff and C. auris disinfectant efficacy claims meet EPA disinfectant registration requirements.

To explore a partnership with Element for antimicrobial efficacy testing, connect with us today.

Clostridium difficile EPA claim requirements 

To obtain approval for Clostridium difficile claims, the EPA requires registrants to quantify the ability of the Sponsor's product to produce reduction of bacterial spores on hard environmental surfaces following EPA SOPs:

EPA MLB SOP MB-28 - Procedure for the Production and Storage of Spores of Clostridium difficile for Use in the Efficacy Evaluation of Antimicrobial Agents

EPA MLB SOP MB-31 - Procedure for the OECD Quantitative Method for Testing Antimicrobial Products against Spores of Clostridium difficile (ATCC 43598) on Inanimate, Hard, Non-porous Surfaces

Candida auris EPA claim requirements 

To support Candida auris claims, the EPA requires registrants to quantify the ability of the Sponsor's product to produce microbial reduction on hard environmental surfaces following EPA SOPs:

EPA MLB SOP MB-35-00 - OECD Quantitative Method for Evaluating the Efficacy of Liquid Antimicrobials against Candida auris on Hard, Non-Porous Surfaces

EPA MLB SOP MB-37-00 - Neutralization Confirmation for Evaluating the Efficacy of Liquid Antimicrobials against Candida auris using the OECD Quantitative Method on Hard, Non-Porous Surfaces.

C. diff and C. auris antimicrobial efficacy testing

Element’s extensive experience testing antimicrobial products to support C. diff and C. auris claims to support product registration with the EPA. Our knowledgeable, experienced scientists test to the following methods:

OECD Quantitative Method for Testing Antimicrobial Products against Spores of Clostridium difficile (ATCC 43598) on Inanimate, Hard, Non-Porous Surfaces - In this method, a series of stainless steel disks are inoculated with test organism. The carriers are desiccated and subsequently treated with a sample of the disinfectant. After exposure, the carriers are neutralized and quantitatively assayed for surviving test organism. The resulting plates are incubated, the number of survivors is enumerated and a Log10 reduction is determined as compared to the population control.

In order to successfully demonstrate disinfection efficacy, the product must demonstrate a 6 Log10 reduction of Clostridium difficile spores. In addition, the disinfectant must have verification testing performed resulting in a 6 Log10 reduction of Clostridium difficile spores.

OECD Quantitative Method for Evaluating Efficacy of Liquid Antimicrobials against Candida auris on Hard, Non-Porous Surfaces - In this method, a series of stainless steel disks are inoculated with test organism. The carriers are desiccated and subsequently treated with a sample of the disinfectant. After exposure, the carriers are neutralized and quantitatively assayed for surviving test organism. The resulting plates are incubated, the number of survivors is enumerated and a Log10 reduction is determined as compared to the population control.

In order to successfully demonstrate disinfection efficacy, the product must demonstrate a 5 Log10 reduction of Candida auris.

The Element advantage

The protection of patient health in healthcare settings is paramount. To protect patients from severe illness caused by pathogens such as C. diff and C. auris, antimicrobial products that effectively disinfect surfaces are essential. Element is the trusted partner for leading developers, manufacturers, and marketers of products with antimicrobial efficacy claims against C. diff and C. auris, having served as a leader in antimicrobial testing for decades.

For more information about Element’s C. diff and C. auris antimicrobial efficacy testing, contact us today.

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