Why does the AATCC 100 test method hold the FDA’s attention when evaluating the efficacy of wound care products?

In the realm of wound care, the prevention of infections is paramount for supporting patient healing. According to Abdullah Ibn Mafiz, PhD, and Principal Investigator at iFyber, antimicrobial wound care products act as defenders of the healing process by inhibiting or eliminating harmful microorganisms that can impede recovery and lead to complications. Ensuring the efficacy of these products is vital, and standardized testing methods, such as AATCC Test Method 100, play a crucial role in this evaluation. Recognized by the FDA, AATCC 100 is considered an acceptable method to assess the antimicrobial efficacy of various wound care products.

AATCC 100:  A Gold Standard for Antimicrobial Evaluation

Abdullah relates to us that among the various testing methods available, AATCC Test Method 100 stands out as a gold standard for evaluating the antimicrobial properties of textile materials. This method, developed by the American Association of Textile Chemists and Colorists (AATCC), provides a quantitative assessment of the ability of a fabric to inhibit microbial growth and/or kill microbes over a 24-hour period. Its standardized approach makes it a reliable test for manufacturers to assess the effectiveness of their antimicrobial wound care products. 

Why AATCC 100 Matters in Wound Care?

The importance of the AATCC 100 Test Method in the wound care industry is multifaceted:

Preventing Infection and Promoting Healing: In the world of wound care, stopping bacterial infections is crucial for successful healing and patient comfort. AATCC 100, as Abdullah explains, “lets manufacturers check out how good their products are at taking down those nasty microorganisms, making sure they create the best environment for healing.”

Meeting Regulatory Requirements and Assuring Efficacy: Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), recognize the importance of AATCC 100 Test Method as a means to demonstrate the efficacy of antimicrobial wound care products. This method helps manufacturers meet regulatory requirements and assure healthcare professionals and patients regarding the effectiveness of their products.

Developing Reliable and Effective Wound Care Products: Abdullah highlights, “AATCC Test Method 100 isn’t just about ticking boxes—it’s a fundamental assay in defining the antimicrobial claims of wound care products that you can rely on. It helps in developing wound care products that prevent or treat infections, speed up the healing process, and make patients’ lives better overall. By setting a standard for checking antimicrobial efficacy, this method enables innovative technologies and improvements in the world of wound care technology.

Suitable Materials for AATCC 100 Test Method

According to Abdullah, “Method 100 was originally designed for textile materials; however, now is recognized in evaluating a broad range of wound care products. This includes wound dressing fabrics like gauzes, bandages, and advanced dressings like gels, ointments, powders, and thin films Furthermore, “it applies to textiles treated with antimicrobial coatings, such as medical gowns, apparel, and surgical drapes. It is also relevant for compression bandages, commonly employed for conditions like venous leg ulcers and lymphedema, as well as collagen-based wound dressings known for promoting tissue regeneration and other natural tissue components.”

Understanding FDA Requirements for Antimicrobial Efficacy Claims

Though the method is recognized by the FDA, there are several ways in which the method could be run or applied. According to the FDA, for a medical device to make an antimicrobial claim, it must show a greater than 4 log10 CFU reduction in microbial populations using a modified AATCC 100. In simpler terms, the device needs to prove that it can reduce the number of viable microorganisms by at least 99.99%. This is assessed by testing against a panel of three Gram-positive bacteria, three Gram-negative bacteria, one yeast, and one mold. When asked which species and isolates the FDA recognizes, Abdullah responded, “There is some flexibility in the exact species and strains the agency would accommodate, but the best scenario is to evaluate organisms that are common in wound environments.”

Additionally, the FDA requires an evaluation of antimicrobial efficacy under worst-case scenarios. According to Abdullah, “To simulate this, it’s crucial to consider not only the product’s usage time but also to use a relevant test matrix. For instance, the test matrix for a sweat-wicking fabric won’t be the same as that for wound dressings.” Abdullah emphasizes the importance of selecting a test matrix that accurately reflects real-world conditions. For instance, he states, “In the case of antimicrobial sweat-wicking fabric, the matrix should mirror sweat composition. Conversely, products designed for wound beds require a test matrix that replicates the composition of an actual wound bed, and this can be achieved by using appropriate simulated wound fluid.” Abdullah also recommends choosing a simulated wound fluid recipe acknowledged by the FDA. At iFyber, we adhere to an FDA-recognized recipe for simulated wound fluid with the appropriate protein and salt components.

In summary, AATCC 100 is a widely accepted method for evaluating the antimicrobial efficacy of wound care products, gaining the FDA’s recognition. The method’s versatility extends to different materials, aligning with FDA requirements for antimicrobial claims. Collaborating with the right team to assess your product’s antimicrobial effectiveness through AATCC Test Method 100 can streamline your journey to FDA clearance. Contact an expert at iFyber today for more information.