Antimicrobial Resistance: An Overview      

by | Jan 21, 2025 | FDA, Healthcare, Quality, Quality Systems, WHO

Evolution is the process by which species change over time in response to environmental pressures. Often referred to as “Survival of the Fittest,” this concept is most famously associated with Charles Darwin. While evolution occurs across all species, its most concerning impact is seen in microorganisms, particularly when their genomes adapt to resist antimicrobial products. These products are crucial for treating infections, sterilizing surfaces, and preventing the spread of harmful pathogens. As a result, antimicrobial resistance (AMR) has become a pressing global issue, with the Centers for Disease Control and Prevention (CDC) estimating that each year, at least 2.8 million AMR-related infections occur in the U.S., leading to 35,000 deaths (United States Food and Drug Administration, 2022). Globally, the World Health Organization (WHO) also emphasizes the significance of this growing concern (World Health Organization, 2021).

Both the U.S. Food and Drug Administration (FDA) and the WHO have made fighting AMR a top priority due to its potential to undermine the effectiveness of essential medical treatments. To combat this, the FDA has assembled a task force focused on detecting, preventing, and minimizing the impact of AMR. This task force works on multiple fronts, including improving the development of diagnostic tools to identify resistant pathogens, enhancing current antimicrobial strategies, and supporting the creation of new drugs and cleaning products that can better address AMR.

In industrial settings, microbial activity is also a major challenge, especially in environments where product quality must be maintained. Controlling microbial contamination is essential, and this includes the implementation of effective cleaning protocols. One common practice to prevent resistance is rotating cleaning agents. This strategy helps prevent microorganisms from developing resistance to any single agent, ensuring that cleaning remains effective over time. Areas that are especially critical, such as sterility hoods and clean rooms, require stringent cleaning practices to maintain a controlled and safe environment. A well-structured environmental monitoring program is necessary to ensure that microbial contamination is minimized, thereby ensuring the production of high-quality, sterile products.

For organizations looking to develop or improve their cleaning programs to prevent AMR buildup and maintain environmental quality, EMMA International offers expert guidance. Our team can assist in creating a comprehensive cleaning and monitoring system that supports compliance and ensures a controlled environment. To learn more about how we can help, contact us at 248-987-4497 or email us at info@emmainternational.com.

United States Food and Drug Administration. (2022, September 6). Focus Area: Antimicrobial Resistance.
World Health Organization. (2021, November 17). Antimicrobial Resistance.

EMMA International

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

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