Healthy Hardware White Paper; Research, Results, Goals, and Objectives

Healthy Hardware White Paper

Heathy-Hardware-White-Paper-0825203 Download

Author: Anthony Mastroianni, Trimco Hardware, amastroainni@trimcohardware.com

EXECUTIVE SUMMARY

This white paper discusses the goals and objectives of replacing highly touched surfaces, such as stainless steel door handles that harbor harmful microorganisms with Healthy Hardware® CuVerro® EPA-registered bactericidal copper alloy door handles in the healthcare environment.

The goals are:

To reduce harmful microorganisms in the hospital
To enhance infection control practices and reduce hospital acquired infections (HAI’s)
To communicate to the community the participating companies’ investment in publichealth

While the world battles the COVID-19 pandemic, HAI’s continue to pose serious health risks to patients in healthcare settings.

Traditional touch surfaces such as stainless steel door handles “harbor microorganisms that may contribute to HAI’s.” (1)

EPA-Registered biocidal copper alloy surfaces “actively and continuously kill bacteria (*1MRSA, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, E.coli O157:H7, and VRE), 24 hours a day when cleaned regularly.” (2)

The National Institutes of Health’s (NIH) recent research, published in the New England Journal of Medicine, showed that SARS-CoV-2 was detectable for up to 2 to 3 days on stainless steel while detectable for only up to 4 hours on copper. (3)

Research funded by the U.S. Department of Defense showed an 83% reduction of bacteria on copper alloy surfaces versus traditional surfaces and a 58% reduction in HAI’s in intensive care unit (ICU) rooms that had copper versus those that had traditional surfaces. (1)

The Centers for Disease Control & Prevention (CDC) advise “it may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes.” (4)

NIH agrees: “Results… suggest that people may acquire the virus [COVID-19)] through the air and after touching contaminated objects.” (3)

1 *Laboratory testing shows that, when cleaned regularly, CuVerro surfaces kill greater than 99.9% of the following bacteria within 2 hours of exposure: Methicillin-Resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, E. coli O157:H7, and Vancomycin-Resistant Enterococcus faecalis (VRE). The use of CuVerro® bactericidal copper products is a supplement to and not a substitute for standard infection control practices; users must continue to follow all current infection control practices, including those practices related to cleaning and disinfection of environmental surfaces. This surface has been shown to reduce microbial contamination, but it does not necessarily prevent cross contamination. CuVerro® is a registered trademark of GBC Metals, LLC and is used with permission (TR-0002-1509). See www.CuVerro.com for more details.

SETTING.

Building(s): Through the building(s) of the Hospital.
Key Areas of Hospital: Entrances, Lobby, Emergency Rooms, Intensive Care Unit Rooms, and

Restrooms

PRODUCT EXAMPLES.

ABOUT TRIMCO.

Trimco® is an industry leader in high-performing door security and protection hardware for

government, commercial and institutional buildings including a wide range of Healthy

Hardware® bactericidal door hardware products. Trimco’s mission is to make a difference by

innovating, designing, and manufacturing products that make our world safer, healthier, more

accessible, and fashionable. www.trimcohardware.com

OBJECTIVES.

To identify highly touched surfaces including door handles manufactured from traditional surfaces such as stainless steel and other metals
To replace the traditional door handles with Healthy Hardware® EPA-registered copper alloy door handles
To market and publicize the use of Healthy Hardware in the Hospital to the community

RESEARCH SUMMARY ON COPPER ALLOY.

The below is an excerpt from a ‘translational science article’ published on the NIH web site that summarizes some of the key research from laboratory to clinical findings on bactericidal copper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4561453/

“Objective:

This is a translational science article that discusses copper alloys as antimicrobial environmental surfaces. Bacteria die when they come in contact with copper alloys in laboratory tests. Components made of copper alloys were also found to be efficacious in a clinical trial.

Background:

There are indications that bacteria found on frequently touched environmental surfaces play a role in infection transmission.

Methods:

In laboratory testing, copper alloy samples were inoculated with bacteria. In clinical trials, the amount of live bacteria on the surfaces of hospital components made of copper alloys, as well as those made from standard materials, was measured. Finally, infection rates were tracked in the hospital rooms with the copper components and compared to those found in the rooms containing the standard components.

Results:

Greater than a 99.9% reduction in live bacteria was realized in laboratory tests. In the clinical trials, an 83% reduction in bacteria was seen on the copper alloy components, when compared to the surfaces made from standard materials in the control rooms. Finally, the infection rates were found to be reduced by 58% in patient rooms with components made of copper, when compared to patients’ rooms with components made of standard materials.

Conclusions:

Bacteria die on copper alloy surfaces in both the laboratory and the hospital rooms. Infection rates were lowered in those hospital rooms containing copper components. Thus, based on the presented information, the placement of copper alloy components, in the built environment, may have the potential to reduce not only hospital-acquired infections but also patient treatment costs.” (1)

LABORATORY RESEARCH ON COPPER ALLOY & BACTERIA.

The following details the rigorous EPA-Registration test results for CuVerro’s copper alloy:

(2)

“EPA Registration & Tests (2)

CuVerro® bactericidal copper surfaces represent the first class of solid-surface EPA-registered

1
materials that actively and continuously kill bacteria , 24 hours a day when cleaned regularly.

EPA Tests

CuVerro alloys have been put through rigorous GLP (Good Laboratory Practices) testing by the EPA to evaluate their effectiveness in killing bacteria responsible for many hospital acquired infections (HAIs). The three GLP test protocols used to support EPA registration of antimicrobial copper alloys with public health claims and associated findings:

1. Efficacy as a Sanitizer
CuVerro surfaces kill bacteria within two hours, proving its efficacy as a sanitizer.

Wear Test:
CuVerro efficacy does not wear out or wear down over time and continues to help inhibit the buildup and growth of bacteria between routine cleaning and sanitizing steps.
Repeated Contamination Test:
CuVerro surfaces work continuously to kill more than 99% bacteria, 24 hours a day, even after repeated contamination.

These EPA tests used stainless steel as the control since it represents the most common material used in hospital and surgical settings. The data shows that copper efficacy significantly outperformed stainless steel in all three tests.

Public Health Claims

Based on EPA Registration, products made with CuVerro can be marketed with the following public health claims:

Laboratory testing has shown that when cleaned regularly, this surface:

Continuously reduces bacterial contamination, achieving 99.9% reduction within two hours of exposure, when cleaned regularly.
Kills greater than 99.9% of Gram-negative and Gram-positive bacteria within two hours of exposure.
Delivers continuous and ongoing antibacterial action, remaining effective in killing greater than 99.9% of bacteria within two hours.
Kills greater than 99.9% of bacteria within two hours, and continues to kill more than 99% of bacteria even after repeated contamination.
Helps inhibit the buildup and growth of bacteria within two hours of exposure between routine cleaning and sanitizing steps.CuVerro is proven effective against the following bacteria:
E. coli O157:H7, a food-borne pathogen that has been associated with large-scale food recalls
Methicillin-Resistant Staphylococcus aureus (MRSA), one of the most virulent strains ofantibiotic-resistant bacteria and a common culprit of hospital- and community-acquired infections
Staphylococcus aureus, the most common of all bacterial staphylococcus (i.e. staph) infections that can cause life-threatening diseases, including pneumonia and meningitis
Vancomycin-Resistant Enterococcus faecalis (VRE), an antibiotic-resistant organism responsible for 4% of all HAIs
Enterobacter aerogenes, a pathogenic bacterium commonly found in hospitals that causes opportunistic skin infections and impacts other body tissues
Pseudomonas aeruginosa, a bacterium that infects the pulmonary tracts, urinary tracts, blood and skin of immunocompromised individuals” (2)(End of section on EPA Registration Tests)

LABORATORY RESEARCH ON COPPER & SARS-COV-2.The NIH conducted a study to determine the aerosol and surface stability of SARS-CoV-2 and here are the results:From the New England Journal of Medicine:

“A U.S. government-funded study published and conducted by researchers at the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) reported that the SARS-CoV-2 virus remained viable for up to 2 to 3 days on plastic and stainless steel surfaces vs. up to 4 hours on copper.” (9)

“SARS-CoV-2 was more stable on plastic and stainless steel than on copper and cardboard, and

viable virus was detected up to 72 hours after application to these surfaces (Fig. 1A), although

the virus titer was greatly reduced (from 103.7 to 100.6 TCID50 per milliliter of medium after 72

hours on plastic and from 103.7 to 100.6 TCID50 per milliliter after 48 hours on stainless steel).

The stability kinetics of SARS-CoV-1 were similar (from 103.4 to 100.7 TCID50 per milliliter

after 72 hours on plastic and from 103.6 to 100.6 TCID50 per milliliter after 48 hours on

stainless steel). On copper, no viable SARS-CoV-2 was measured after 4 hours and no viable

SARS-CoV-1 was measured after 8 hours. On cardboard, no viable SARS-CoV-2 was measured

after 24 hours and no viable SARS-CoV-1 was measured after 8 hours (Fig. 1A).” (10)

From the NIH:

“The results provide key information about the stability of SARS-CoV-2, which causes COVID-

19 disease, and suggests that people may acquire the virus through the air and after touching

contaminated objects. The study information was widely shared during the past two weeks after

the researchers placed the contents on a preprint server to quickly share their data with

colleagues.” (3)

“In contrast to SARS-CoV-1, most secondary cases of virus transmission of SARS-CoV-2

appear to be occurring in community settings rather than healthcare settings. However,

healthcare settings are also vulnerable to the introduction and spread of SARS-CoV-2, and the

stability of SARS-CoV-2 in aerosols and on surfaces likely contributes to transmission of the

virus in healthcare settings.” (3)

Figure 2: Viability of SARS-CoV-1 and SARS-CoV-2 in Aerosols and on Various Surfaces

(10)

Figure 3. MRSA Survival on Copper, Stainless Steel and Silver-Coated Surfaces

IN-HOSPITAL ICU RESEARCH ON COPPER VS BACTERIA AND HAIs.

“A multihospital clinical trial was conducted in the Medical Intensive Care Units (ICUs) of three

hospitals: Memorial Sloan Kettering Cancer Center, in New York City, NY; Medical University

of South Carolina, in Charleston, SC; and Ralph H. Johnson Veterans Administration Medical

Center, Charleston, SC. Each hospital’s institutional review board for the conduct of studies

involving human subjects, as well as the U.S. Army’s Office of Risk Protection, approved the

study as was indicated in the initial publications of the clinical trial results.”

Description of results from the clinical trials research at the three hospitals:

“RESULTS. The rate of HAI and/or MRSA or VRE colonization in ICU rooms with copper alloy surfaces was significantly lower than that in standard ICU rooms (0.071 vs 0.123). For HAI Pp.020 only, the rate was reduced from 0.081 to 0.034 (Pp.013).
CONCLUSIONS. Patients cared for in ICU rooms with copper alloy surfaces had a significantly lower rate of incident HAI and/or colonization with MRSA or VRE than did patients treated in standard rooms.” (11)

“Results:

GRINNELL REGIONAL MEDICAL CENTER STUDY.

Grinnell Regional Medical Center conducted a study in which it replaced commonly touched traditional surfaces such as door handles, bed rails, and grab bars with copper alloy products into patient rooms. The study established a standard of 250 CFU/cm2 threshold concentration recommended for at-risk components immediately upon completion of terminal cleaning. (12)

The study found that, in occupied rooms, 55% of traditional surfaces exceeded the 250 CFU/cm2 level of risk while only 12% of copper alloy surfaces exceeded the 250 CFU/cm2 level of risk. (12)

In unoccupied rooms, 51% of traditional surfaces exceeded the 250 CFU/cm2 level of risk while only 7% of copper alloy surfaces exceeded the 250 CFU/cm2 level of risk. (12)

Figure 4. Infographics summarizing Grinnell Regional Medical Center Study

RESEARCH ON COPPER AND INFLUENZA A.

The following summarizes research on the inactivation of Influenza A Virus on copper versus stainless steel:

“Influenza A virus particles (2 x 106) were inoculated onto copper or stainless steel and incubated at 22°C at 50 to 60% relative humidity. Infectivity of survivors was determined by utilizing a defined monolayer with fluorescent microscopy analysis. After incubation for 24 h on stainless steel, 500,000 virus particles were still infectious. After incubation for 6 h on copper, only 500 particles were active.”

However, the current study shows that copper surfaces may contribute to the number of control barriers able to reduce transmission of the virus, particularly in facilities, such as schools and health care units, where viral contamination has the ability to cause serious infection. (13)

Figure 2: Effect on influenza A virus infectivity after a 6-h or 24-h exposure to stainless steel. (13)

Figure 3: Effect on influenza A virus infectivity after a 60-min or 6-h exposure to copper (13)

See Exhibit C for a copy of the proposed New York State Senate Bill.

RECENT GOVERNMENT LEGISLATION REGARDING COPPER ALLOY

The New York State Senate has proposed a new bill (S8180) that would “require the use of an antimicrobial copper alloy for touch surfaces in new construction.” (14)

The stated purpose of the bill is: “To require the use of an antimicrobial copper alloy that is

recognized by the US environmental Protection Agency for touch surfaces in new, publicly

funded construction projects in order to reduce the presence of disease-causing bacteria, viruses,

and yeasts on commonly used touch surfaces and therefore protect public health.” (14)

See Exhibit C for a copy of the proposed New York State Senate Bill.

TESTIMONIALS

“Incorporating new technology shows our commitment to providing a safe environment for patient care,” said Director of Infection Prevention and Control Sarah Bishop, A.P.R.N., at UofL Hospital. “I’m proud to work for an organization that is an early adopter of these emerging technologies.” The new technologies are CuVerro (Healthy Hardware) Bactericidal Copper Surfaces…” (5)

“HAIs can happen in any health care facility,” said university of Louisville Hospital Chief

Medical Officer Jason Smith, M.D., Ph.D., including hospitals, ambulatory surgical centers,

long-term care facilities and others. “They are caused by bacteria, fungi, viruses or other less

common pathogens. The new systems (Healthy Hardware and other CuVerro copper alloy touch

surfaces) installed at UofL Hospital will have a significant impact in reducing the incidence of

HAIs.” (6)

Ed Harrich, chief of surgical services (Pullman Regional Hospital), and his staff have been

methodically installing the hardware [copper alloy]. He persuaded hospital administrators to

approve another $10,000 for more items. “If you looked at my cabinet pulls, they look like

stainless steel, but we still get copper’s killing properties,” he said. “We’re still continuing to

clean everything we can. But this is our little helper behind the scenes.” (7)

“We’ve known for a long time that copper and other metals are effective in killing microbes, so it

wasn’t a great leap to incorporate copper surfaces into hospitals,” said John Lynch, medical

director of infection control at Harborview Medical Center in Seattle, which is redesigning a

waste-disposal room to incorporate copper on light switches and door handles. (7)

Figure 7. Excerpt from Lexington Medical Center’s Official Blog:

“It’s [Healthy Hardware] always working, it requires no human intervention, no supervision, and

it’s acting continuously,” said Michael Schmidt, a microbiology professor at the Medical

University of South Carolina and one of the researchers who conducted the first and largest

study of copper surfaces in hospitals. (7)

“It’s [Healthy Hardware] such an elegant solution to help support improving the cleanliness of

hospitals, because it cleans 24/7,” said Todd Linden, Grinnell’s CEO. “You don’t have to teach

it how to wash its hands.” (8)

COMMUNICATING HEALTHY HARDWARE IN THE HOSPITAL.

Figure 8. Healthy Hardware Signage Example

HEALTHY HARDWARE INSTALLATION PICTURES.

Figure 9. Parkview Health – Parkview Medical Center – Indiana

Figure 10. Lexington Medical Center – South Carolina

WHAT DOES HEALTHY HARDWARE LOOK LIKE?

Healthy Hardware looks like stainless steel or brushed nickel.

HOW TO CLEAN HEALTHY HARDWARE?

See Exhibit B for cleaning instructions. The Hospital will be able to continue its standard cleaning practices and will not have to make modifications.

References

1. From Laboratory Research to a Clinical Trial. Harold T. Michels, MS, PhD, PE,1 C. William Keevil, PhD,2 Cassandra D. Salgado, MD, MS, FIDSA, FSHEA,3 and Michael G. Schmidt, MA, PhD3. s.l. : SAGE, 2015.

2. CUVERRO. EPA Registration & Tests. CUVERRO BACTERICIDAL COPPER SURFACES. [Online] CUVERRO, 2020. [Cited: JULY 27, 2020.] https://cuverro.com/epa-registration-tests.

3. New coronavirus stable for hours on surfaces. National Institutes of Health. [Online] March 17, 2020. [Cited: July 27, 2020.] https://www.nih.gov/news-events/news-releases/new-coronavirus- stable-hours-surfaces.

4. How COVID-19 Spreads. CDC Web Site. [Online] Centers for Disease Control & Prevention, June 16, 2020. [Cited: 7 27, 2020.] https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how- covid-spreads.html.

5. Acting on and investing in the commitment to reduce patient infection. University of Louisville Hospital. [Online] July 30, 2020. https://www.uoflhospital.org/news/acting-and-investing- commitment-reduce-patient-infection.

6. CuVerro. CuVerro copper plays role in infection prevention in University of Louisville Hospital’s Bone Marrow Transplantation Unit. cuverro.com. [Online] December 1, 2017. [Cited: July 29, 2020.] https://cuverro.com/about-cuverro/news/cuverro-copper-plays-role-infection-prevention-university- louisville-hospital’s.

7. Sun, Author Lena H. Hospitals’ new ‘little helper’ in killing bacteria: copper surfaces . NCHI NEWS. [Online] Washington Post, 9 22, 2015. [Cited: July 29, 2020.] https://www.cnhinews.com/article_d25f8544-60bc-11e5-b4ff-0f2edc184366.html.

8. Whitman, Elizabeth. Best Practices: Using copper to fight infections. Modernhealthcare.com. [Online] November 5, 2016. [Cited: July 30, 2020.] https://www.modernhealthcare.com/article/20161105/MAGAZINE/311059997/best-practices-using- copper-to-fight-infections.

9. Copper Development Association, Inc. CDA . CDA’s Position on Coronavirus (COVID-19) and Copper’s Antimicrobial Properties. [Online] April 2020. [Cited: July 28, 2020.] http://www.magnetmail.net/actions/email_web_version.cfm?ep=jOg50leOn8o_Adv9Ru0YJb7LnOy12 k3rRoPx5YyffTO9J4DiyDSHoN3nI3NUNkZvJaOLjCkdtYtKQqBgGWyxGOzUMLjJkRMwZYWrbO2PskObZv JodzovpWtMvedIQ44x.

10. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N van Doremalen, et al. s.l. : The New England Journal of Medicine, 2020.

11. Copper Surfaces Reduce the Rate of Healthcare-Acquired Infections in the Intensive Care Unit. Cassandra D. Salgado MD, Kent A. Sepkowitz MD, Joseph F. John MD, J. Robert Cantey MD, Hubert H. Attaway MS, Katherine D. Freeman DrPH, Peter A. Sharpe MBA, Harold T. Michels PhD and Michael G. Schmidt PhD. 2013, The Society for Healthcare Epidemiology of America, p. 2.

12. Shannon M. Hinsa-Leasure, PhD, Michael G. Schmidt, PhD, Justin Vaverka, BA, Queenster Nartey, BA. Copper alloy surfaces sustain terminal cleaning levels in a rural hospital. American Journal of Infection Control. [Online] November 1, 2016. [Cited: July 30, 2020.] https://www.ajicjournal.org/article/S0196-6553(16)30751-9/fulltext.

13. Inactivation of Influenza A Virus on Copper versus Stainless Steel Surfaces. J. O. Noyce, H. Michels, and C. W. Keevil. 8, s.l. : APPLIED AND ENVIRONMENTAL MICROBIOLOGY, 2006, Vol. 73.

14. New York State Senate. www.nysenate.gov. Senate Bill S8180. [Online] April 13, 2020. [Cited: August 3, 2020.] https://www.nysenate.gov/legislation/bills/2019/s8180.

15. New coronavirus stable for hours on surfaces. National Institutes of Health Web Site. [Online] March 17, 2020. [Cited: July 28, 2020.] https://www.nih.gov/news-events/news-releases/new- coronavirus-stable-hours-surfaces.

EXHIBIT A – HEALTHY HARDWARE / CUVERRO RECOMMENDED CLEANING INSTRUCTIONS