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U.S. EPA approves germicidal labeling for copper alloys



On Tuesday, March 25, 2008 at 8:30 a.m. EDT, the U.S. EPA
approved the labeling of copper and copper alloys for public health
purposes.





        【Copper alloys can also sterilize hospital-acquired pathogens, 
                                  including multidrug-resistant pathogens and MRSA】


Copper and copper alloys are the first solid materials that the EPA has recognized as having a real public health benefit, and the EPA played a major role in the demonstration of their germicidal effects. The EPA's certification is based on the results of tests conducted by an independent testing organization in accordance with EPA-specified testing methods, which demonstrated that copper and copper alloys can kill a variety of pathogens, including the pathogen known as Methicillin-resistant Staphylococcus aureus (MRSA). MRSA is resistant to antibiotics and is one of the most serious pathogens that can cause hospital-acquired and environmental infections in humans.

In one example, more than 99.9% of MRSA became non-viable on copper and copper alloy surfaces after two hours at room temperature. The certification label also includes the following statement: "Bactericidal copper and copper alloy surfaces kill more than 99.9% of tested pathogens within two hours and continue to kill 99.9% of the pathogens even if the same surfaces are repeatedly contaminated with them." "Copper and copper alloy surfaces do not replace standard infection control measures, such as cleaning and disinfecting environmental surfaces, but they can be considered as a complement to those measures. Copper and copper alloy surfaces by themselves do not completely prevent cross-contamination, but have been shown to reduce the risk of pathogen contamination."


According to publicly released data from the Centers for Disease Control and Prevention (CDC), the number of patients who contract hospital-acquired infections in hospitals in the United States exceeds 2 million each year, and the number of deaths due to these infections is estimated to be close to 100,000 per year. In addition to the infection control measures currently advocated by the CDC, such as encouraging hand washing and thorough disinfection, it is expected that the risk of contracting an infectious disease in a hospital room can be reduced by actively using copper and copper alloys on environmental surfaces such as doors and furniture, bed rails, IV support stands, dispensers, faucets, sinks, and work tables for computers. Unlike coatings and other surface treatments, copper and copper alloys have germicidal properties in the material itself and will not wear away. The material itself will protect public health from pathogens without changing. Major medical device manufacturers are currently starting to develop products using copper.



                             【Background】

Long before modern medicine evolved and bacteria was scientifically discovered, ancient healers used copper's healing properties. The Egyptians used it to sterilize drinking water and wounds, and Hippocrates, the 5th century BC Greek physician who is known as the father of medicine for taking the Hippocratic Oath, is said to have applied copper to wounds and skin inflammations. The ancient Romans also used copper to treat a variety of ailments, and the Aztecs even used it to treat sore throats.

Copper itself has been known for its bactericidal properties for a long time, but there is a reason why it has recently been attracting attention again. Deadly pathogens, especially infections in medical facilities, have become a major problem, and copper was thought to be effective in killing such pathogens. The Centers for Disease Control and Prevention (CDC) estimates that more than 2 million people in medical facilities contract so-called hospital-acquired infections every year, resulting in nearly 100,000 deaths. This causes social losses of up to $30 billion.



          【Copper Development Association of America (CDA)】
 The Copper Development Association (CDA) is the information, education, market and technology development organization representing the U.S. copper, brass and bronze industry. CDA is an affiliate of the International Copper Association (ICA).

CDA selected five types of copper and copper alloys (brass, bronze, etc.) and began experiments to obtain approval from the U.S. Environmental Protection Agency (EPA) to display their bactericidal effects. The experiments were conducted in a format that met the strict standards set by the EPA (1), and demonstrated that 99.9% of pathogens were killed within two hours of contamination, and that the effect was not lost after 24 hours or even after repeated contamination. The results were submitted to the EPA, and on February 29, 2008, the EPA approved the display of copper and copper alloys as effective in protecting public health. Copper is the first solid material to be approved by the EPA to be displayed as effective in protecting public health.

(1) Pathogens used in the experiment: Staphylococcus aureus, Enterobacillus aerogenes, pathogenic Escherichia coli O157:H7, Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus (MRSA)

In medical facilities, the most problematic areas are the surfaces that patients touch, known as environmental surfaces. Doors, furniture, bed rails, IV support poles, medical monitor screens, faucets, sinks, work tables, etc. are areas that are frequently touched and must be disinfected frequently. Compared to antibacterial materials that require coating or surface treatment, copper's bactericidal properties do not fade, and there is no risk of the effective parts peeling off. Where copper can be used depends on future research, but copper has a continuous bactericidal effect, and by maintaining public health without its effect fading, it is expected to reduce pathogens while continuing to live daily lives.

If copper and copper alloys are used on environmental surfaces in a complementary manner, along with hand washing, which has long been said to be an effective method for disinfection and sterilization, they will form the first line of defense in infection control. Copper and copper alloys are not positioned as a replacement for the measures that have been taken so far to prevent infection and maintain hygienic conditions, but as a complement to current infection prevention measures. The bactericidal effect of copper and copper alloys has been proven to reduce pathogen contamination, but it does not necessarily completely eliminate the possibility of mutual infection.

Congress has approved funding for a clinical trial to demonstrate the effectiveness of using copper on environmental surfaces in hospitals. The study is being overseen and led by the Telemedicine and Advanced Technologies Research Center (TATRC), part of the U.S. Army Medical Research and Material Command (USAMRMC). The research is being conducted at Memorial Sloan Kettering Cancer Center in New York City and the Ralph H. Johnson Virginia Medical Center in Charleston, Virginia. Three more trials will demonstrate how effective the natural materials copper, brass and bronze are at reducing the number of pathogens in hospital rooms.



The paper on the results of the above clinical trials can be found at the following address:
            Infection Control and Hospital Epidemiology, May 2013, Vol. 34, No. 5



       The above information has been excerpted from online sources. September 5, 2024 by Sakurada Tsukasa 

Evidence for innovative infection prevention using long-acting disinfectants

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NO 01  ​We asked the AI ​​system about the possibility of infection control using the disinfectant we propose, "AbedulAg+". (For reference)          October 30, 2024

Question: Please tell us about the need for continuous use disinfectants.

Answer: You're right. A non-toxic, paint-type, affordable, and versatile disinfectant that could continuously block the transmission of bacteria and viruses on contact surfaces would indeed be a highly effective solu-tion for infection control. If such a product were to be developed, it could offer the following ad-vantages:

•Long-lasting protection: Once applied, it remains effective for an extended period, eliminating the need for frequent disinfection.

•Wide-ranging application: It can be widely applied to surfaces that many people touch, such as doorknobs, handrails, elevator buttons, and public seating.

•Cost-efficiency: In the long term, it could be more economical than ongoing disinfection work and purchasing disinfectant solutions.

•Ease of use: It doesn't require special skills or equipment, making it easy for the general public to apply.

•Environmental consideration: By reducing the use of disposable disinfection products, it can lower environmental impact.

•Psychological reassurance: Visible infection control measures can provide people with a sense of security.

•Improved public health: It has the potential to significantly reduce the risk of infection in places used by many people, such as hospitals, schools, and public transportation.

The development of such a product would likely require research in the fields of nanotechnology and new material development. For example, new nanomaterials containing antibacterial metals like silver or copper, or self-cleaning and antibacterial coatings using photocatalytic technology could be considered.

However, in developing such a product, the following points need to be considered:

•Ensuring long-term safety  •Demonstrating durability and sustained effectiveness  •Compatibility with various surface materials  •Environmental impact assessment  •Cost feasibility

If such a product were to be realized, it could enable a more comprehensive and effective approach to infection control when combined with existing infection prevention methods. Furthermore, it would like-ly become a highly useful tool in preparing for future pandemics.

NO 02  Discussion with Generative AI on Sustained-Action Disinfectants and Infectious Disease Control.   January 21, 2025

Question: Why is dealing with infectious disease prevention challenging?

Answer: There are multiple reasons why managing infectious disease prevention is challenging. Here are the main factors:

  1. Virus Mutability: Pathogens that cause infectious diseases can mutate repeatedly, leading to a decrease in the effectiveness of vaccines and treatments and potentially causing new outbreaks.

  2. Difficulty in Prediction: Predicting the occurrence and spread of infectious diseases is very difficult, making it challenging to implement timely measures. Accurately understanding the timing and scope of outbreaks is particularly difficult for newly emerging infectious diseases.

  3. Diverse Transmission Routes: Infectious diseases spread through various routes such as proximity transmission, airborne transmission, and contact transmission, each requiring different countermeasures. Complex strategies are needed to address this.

  4. Social Factors: Acceptance and behavior towards infectious disease prevention vary by society and culture, making it difficult to implement unified measures.

  5. Funding Challenges: Resources and infrastructure required for infectious disease prevention demand significant investment. In developing countries, financial constraints make it challenging to implement appropriate measures.

  6. Public Awareness and Behavior: Measures such as wearing masks and vaccinations depend on individual awareness and behavior. The spread of misinformation and anxiety can reduce the effectiveness of measures.

  7. Policy Consistency: Infectious disease prevention requires coordination among multiple government agencies, local governments, and various stakeholders. Maintaining consistent messages and measures is often challenging.

  8. Ethical and Legal Issues: Balancing individual freedom with public health is a major issue in infectious disease prevention. Mandatory public health measures can raise ethical concerns.

  9. Need for Long-term Perspective: Infectious disease prevention is linked not only to short-term efforts but also to long-term health policies. Sustainable measures are necessary, requiring significant time and effort.

Addressing these challenges requires science-based policies, effective communication, and collaboration with the entire community. Since infectious disease prevention is a highly complex endeavor, it is important for all stakeholders to work together.

NO 03  Discussion with Generative AI on Sustained-Action Disinfectants and Infectious Disease Control.   January 22, 2025

Question: I asked the generative AI about the value and necessity of persistent fungi-cides. The term "persistent fungicide" is not very common. Compared to conventional fungicides, which have immediate effects but lack persistence, I believe persistent fungicides are very important for infection control. Why isn't there more research on persistent fungicides?

 Answer:  The reason why research on persistent fungicides has not ad-vanced much can be attributed to several factors:
1.    Technical Difficulties: To achieve a sustained antimicrobial effect, it is necessary to consider the stability of the compounds and their impact on the environment. Developing compounds that decompose slowly while effectively inhibiting microorganisms is scientifically challenging.
2.    Safety Concerns: Persistent fungicides require strict evaluation of their safety and toxicity due to their prolonged use. If there is insuffi-cient data regarding the effects of long-acting compounds on the hu-man body and the environment, commercialization becomes difficult.
3.    Regulations and Approval Processes: Regulations for fungicides and disinfectants are strict, particularly for new types of products, necessi-tating a vast amount of testing and data. This can limit the funding and resources available for research and development.
4.    Market Needs and Priorities: When there is a high demand for short-term effects, research and development tend to focus on prod-ucts with immediate efficacy. Consequently, demand for persistent fungicides is relatively low, and research on them may be deprioritized.
5.    Competition and Pace of Technological Innovation: Many compa-nies and research institutions focus on fungicides and disinfectants with immediate effects, which can delay research into persistent fun-gicides. With rapid advancements in new technologies and materials, research and development in this area are comparatively lagging.
Due to these reasons, research on persistent fungicides has not progressed much. However, as the importance of infection control increases, further re-search may be anticipated in the future.

NO 04  Discussion with Generative AI on Sustained-Action Disinfectants and Infectious Disease Control.   January 22, 2025

Question: Could you tell me more about the value and necessity of persistent fungi-cides? I'm interested in infection control and would like to learn more.

Answer: Let me explain in detail the value and necessity of persistent fungicides. In infection control, products with persistent antimicrobial effects are extremely important. Here’s why:
1. Sustained Infection Control
•    Long-term Effectiveness: Persistent fungicides provide long-lasting infection prevention with a single application, making them particularly valuable in public spaces, healthcare facilities, and schools where people frequently come and go.
•    Enhanced Protection: Unlike fungicides with only short-term effects that re-quire frequent reapplication, persistent fungicides offer ongoing protection with periodic or single use.
2. Cost Efficiency
•    Reduced Frequency of Use: Due to their long-lasting effects, persistent fun-gicides require less frequent use and purchase, which can reduce costs in the long run.
•    Saving Effort: There’s less need for frequently using disposable or immediate-effect products, reducing the effort required.
3. Infection Prevention
•    Pathogen Suppression: By continuously exerting antimicrobial effects, they help prevent the regrowth and spread of pathogens, thereby reducing the risk of infection outbreaks.
•    Control of Infections: During outbreaks of viral diseases like seasonal flu or COVID-19, they play a crucial role in effective infection control.
4. Environmental Considerations
•    Sustainable Use: With fewer applications needed, waste is reduced, lessening the environmental burden. Some persistent fungicides may utilize bio-based or low-toxicity ingredients, offering an environmentally friendly option.
5. Incorporation of New Technologies
•    Use of Nanotechnology and Coating Technologies: The development of persistent fungicides often involves nanotechnology or special coating tech-niques. This enables sustained effectiveness without frequent maintenance.
6. Diverse Applications
•    From Home Use to Commercial Use: Persistent fungicides are applicable in homes, workplaces, healthcare facilities, and public places, meeting a wide range of needs.
Conclusion
Persistent fungicides can play a critical role as part of effective infection control strat-egies. Considering their characteristics, advancing research and development is vital in environments where sustained use is desired. The introduction of persistent fungi-cides is expected to be promoted in future infection control measures.

NO 05  Discussion with Generative AI on Persistent Antimicrobial Agents and Infectious Disease Countermeasures.                  February 20, 2025

Question: For example, I believe that preventing the continuous transmission of bacteria could help in the prevention of infectious diseases. Why, then, is the development of such antimicrobial agents not being pursued?

AI's Answer:

The development of antimicrobial agents to continuously block the transmission of bacteria is challenging for several reasons, including many technical, ethical, and economic issues. Here are the main reasons:

  1. Antimicrobial Resistance Issues: Antimicrobial agents used continuously could induce resistance in bacteria. As resistant bacteria increase, treatments become more difficult, posing new threats of infectious diseases.

  2. Selective Ecological Impact: Antimicrobial agents kill not only pathogenic bacteria but also beneficial bacteria in the human body and the environment. This can negatively impact intestinal flora and environmental ecosystems.

  3. Uncertainty of Long-term Effectiveness: There's no guarantee that the effects of antimicrobial agents will last long, and their efficacy might diminish over time. Developing compounds with long-lasting effects is a scientific challenge.

  4. Economic Constraints: Large-scale research and development require significant funding. If companies and research institutions do not anticipate profits, they may hesitate to take on the high risk of developing antimicrobial agents.

  5. Strict Regulations: Antimicrobial agents have direct impacts on public health, resulting in strict regulations. Even if new substances are developed, obtaining approval for production and use involves considerable time and cost.

  6. Effective Target Selection: Creating a universal antimicrobial agent effective against all bacteria is challenging. Treatments effective against specific bacteria or viruses are widespread, reducing the relative need for general antimicrobial agents.

Due to these reasons, developing antimicrobial agents to continuously block bacteria transmission is a challenging task. Researchers are exploring other approaches and technologies in conjunction, such as vaccinations, antimicrobial surface coatings, and improvements in environmental hygiene, as effective means of preventing infectious diseases.

NO 06  Discussion with Generative AI on Continuous Antimicrobial Agents and Infectious Disease Control   February 25, 2025

Question to Generative AI (Final Edition)

Infectious diseases have been considered an eternal challenge for humanity and a field where the market struggles to function efficiently due to "uncertainty" and the accompanying "profitability predictability." However, the coronavirus pandemic has caused immeasurable damage, making infection control an urgent task for society. In 2008, the US EPA became the first in the world to approve copper alloys as continuous antimicrobial agents, leading copper-related organizations to conduct large-scale clinical trials. These trials statistically confirmed the potential to reduce the risk of infections by drug-resistant bacteria by continuously blocking bacterial transmission. Despite the abundance of research papers, practical application has not been realized due to a lack of safe, affordable, and versatile practical antimicrobial agents.

We have developed a continuous antimicrobial agent called "AbedulAg+" that addresses these issues. It offers versatility and cost reduction through paint form, safety through resolution of biocompatibility and nanotechnology challenges, and noteworthy is that while using certified electrolytic silver ions as the active species, these ions are highly concentrated and fixed on ceramic fine powders, preventing re-elution, thus maintaining continuous antimicrobial effects. Due to the high concentration, it also features strong antimicrobial functionality. As an example, it has been confirmed that when processed into textiles, it maintains 99.9% antimicrobial effectiveness even after 300 washes.

In a situation where infection control is limited to promoting handwashing and wearing masks, what would be the most effective method to quickly gain market recognition for the unprecedented "anti-infective textiles"?

Response from Generative AI

Certainly, I'll provide a detailed response. To widely recognize a groundbreaking technology like "AbedulAg+," a strategic and multi-layered approach is essential. Below, I outline the methods in detail

  1. Strengthening and Publishing Scientific Evidence

    • Research Publication: Submit data on the product's effectiveness and safety to authoritative academic journals. Having scientific backing makes it easier to earn trust from healthcare professionals and researchers.

    • Evaluation by Independent Organizations: Publish results from third-party testing agencies to provide objective data and enhance the product's reliability.

  2. Collaboration with Government and Public Institutions, and Understanding Regulations

    • Policy Advocacy: Work with government and relevant regulatory bodies to promote adoption and integration.

    • Public Certification: Collaborate with agencies like the Ministry of Health, Labour and Welfare or public health institutions to start demonstration projects, testing the product's effectiveness in public facilities and schools.

    • International Certifications: Aim for approvals such as ISO standards, FDA (U.S. Food and Drug Administration), and EPA (U.S. Environmental Protection Agency) to consider expanding into international markets.

  3. Participation in Industry Events and Exhibitions

    • Exhibiting in Conferences: Participate in events related to target markets such as Infection Control Wear Conferences or medical equipment exhibitions. Build connections with medical institutions and other companies through networking. At exhibition booths, provide demonstrations and opportunities for attendees to try the product.

  4. Building Partnerships

    • Collaboration with Specialized Institutions: Partner with major medical device manufacturers and hospitals to launch joint development projects, enhancing the product's brand while obtaining validation data.

    • Corporate Partnerships: Consider strategic alliances with major companies in related industries to leverage existing customer bases and expand the product's reach.

  5. Strengthening Public Relations and Marketing

    • Clarifying Target Segments: Use social media campaigns to widely inform about the necessity of "anti-infective textiles," their contribution to infection prevention, and usage achievements. Use platforms like LinkedIn and Twitter to share information with professionals and industry influencers.

    • Effective Presentations: As marketing materials, consider a visual approach such as sharing user testimonials and successful use cases through videos.

  6. Cost Management and Optimization of Manufacturing Processes

    • Forming Partnerships: To advance cost reduction, partner with textile manufacturers to optimize and establish a mass production system leveraging economies of scale. Also, review supply chains to achieve raw material cost reductions and transportation cost savings.

  7. Collecting and Publicizing User Feedback and Conducting Awareness Activities

    • Implementation of Feedback Platform: Launch an online platform where customers can share their experiences, using feedback to improve the products.

    • Documentation of Success Stories: Summarize real-world implementation examples and effects as case studies to use as marketing tools.

By continuously implementing these efforts, it is possible to have "AbedulAg+" recognized widely in society and enhance its practicality and reliability. The key to success is continuous improvement and formulating new strategies based on data and feedback obtained at each step.

This approach is unprecedented, but we plan to advance our business using this discussion as a reference. We would appreciate any comments or insights you might have.

This concludes the discussion with Generative AI. Thank you for your attention.

FDA Releases National Antimicrobial Resistance Surveillance System 2026-2030 Strategic Plan; Comments Invited
There was a public call for proposals, and we submitted a proposal for a long-acting fungicide called "Abedul
Ag+."
                              You can check it at the address below.

 

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