PathO3Gen FSD: Patented Pathogen Destroying Technology for Shoe Soles

Transcription

1 March 2018 PathO3Gen FSD: Patented Pathogen Destroying Technology for Shoe Soles Authored by Jonnie Cleveland, PhD 2017 HEPCO Medical, LLC dba Green Earth Medical Solutions (GEMS). US Patent No. 8,696,985 (2013). All Rights Reserved

2 2 Contents Page 3 Introduction Problem Solution Page 4 Target Audience Applications Page 4 Page 5 Return on Investment Related Studies Cleveland Clinic Study Systematic Review of Pathogen Resistance Department of Molecular Medicine Study, U. of South Florida Page 7 Methodology Reactive Methodology of Disinfectant Products Methodology of PathO 3Gen Footwear Sanitizing Device (FSD) Page 8 Page 9 Benefits Approach Portable Modular Units Modular Units In situ Page 12 Page 12 Page 13 Results Summary References

3 Introduction 3 This white paper is prepared from an academic perspective. The methodology is a combination of peer-reviewed article research and previously accomplished studies based on reliable and certified laboratory reports. Green Earth Medical Solutions (GEMS) became convinced that the reactive methods presently used in hospitals and public places do not adequately address the problem presented by multi-drug resistant organisms (MDRO), commonly known as super bugs, and other pathogens. The white paper will argue in favor of the PathO 3 Gen FSD, a disruptive and proactive technology versus the reactive methods commonly used, including disinfectants, air purifiers, and robot cleaning units. The GEMS SoleMate product is going through re-branding as PathO 3 Gen Solutions FSD. The term disruptive technology is used in this paper to describe innovations of a product or service that take root initially in simple applications at the bottom of a market and then relentlessly move up market, eventually displacing established competitors. Problem Healthcare-associated Infections (HAIs) levy substantial monetary penalties on the healthcare systems in the United States. According to the Centers for Disease Control, a range of estimates for the annual cost of treating HAIs in the United States is billion dollars. An estimate of billion dollars, or approximately 70% of in-hospital infections, are preventable (Scott, 2009). The role for infection control programs has grown and continues to grow as rates of antimicrobial resistance rise and HAIs lead to increasing risks to patients and rising health care costs. Modern medical care has become more invasive and therefore associated with a greater risk of infectious complications. An aging population, the AIDS epidemic, the growth of chemotherapeutic options for cancer treatment, and a growing transplant population have expanded the population at an increased risk for infection as a consequence of interactions with the health care system Both surgical care and medical care are increasingly complex and invasive and are being provided in non-acute settings, making the definition of a healthcare system more problematic (Sydnor & Perl, 2011, p. 141).

4 4 Solution The PathO 3 Gen FSD uses a patented disruptive Solestice 3/15 Technology TM. The Solestice 3/15 Technology cracks the outer capsid and kills pathogens in 4-8 seconds by penetrating MDRO and other pathogens before they can contaminate an area and spread. Target Audience Primary C-suite executives, administrators, infectious disease control offices, risk managers. Secondary insurance companies, practitioners, and patients. Applications This product has applications in the healthcare environment, such as operating rooms, clean rooms, entry ways, and ICU isolation areas. The PathO 3Gen FSD modular design can be customized for use in other locations, such as in-house pharmacies, waiting rooms, passenger elevators, patient rooms and staff locker rooms. PathO 3Gen FSD can also provide significant potential in other areas, such as Homeland Security, the Transportation Securities Administration, the Department of Defense, restaurants, food processing plants, airlines, the cruise industry, and any place that germ carrying shoes can contaminate and spread pathogens. Return on Investment From the peer-reviewed article, Health care associated infections: A meta-analysis of costs and financial impact on the US health care system (Zimlichman, Henderson, and Tamir, 2013), the following is found: Major Infections on a per-case basis: Central line-associated bloodstream infections (CLABSI): $45,814 Ventilator-associated pneumonia: $40,144 Surgical site infections (SSI): $20,785 Clostridium difficile infection $11,285

5 5 Catheter-associated urinary tract infections $896 The total annual costs for the 5 major infections were $9.8 billion dollars. While quality improvement initiatives have decreased HAI incidence and costs, much more remains to be done. As hospitals realize savings from prevention of these complications under payment reforms, they may be more likely to invest in such strategies (Zimlichman et al., 2013, p. 2039). From the peer-reviewed article, The direct medical costs of HAIs in U.S. hospitals and the benefits of prevention (Scott, 2009), the following summary was given: The overall annual direct medical costs of HAIs to U.S. hospitals ranges from $28.4 to $33.8 billion for urban and $35.7 billion to $45 billion for in-patient hospital services...after adjusting for the range of effectiveness of possible infection control interventions, the benefits of prevention range from a low of $5.7 to $6.8 billion (20 percent of infections preventable, CPI for all urban consumers) to a high of $25.0 to $31.5 billion (70 percent of infections preventable, CPI for inpatient hospital services). Related Studies Cleveland Clinic Study According to Dr. Desphande, M.D, Ph. D., Department of Infectious Disease at the Cleveland Clinic, the source of infection from hospital floors has received scant and inadequate attention. A 2017 study conducted by Dr. Deshphande and published in The American Journal of Infection Control (Deshphande et al.) revealed that floors in patient rooms were frequently contaminated with health care-associated pathogens. The potential for indirect transfer of pathogens to hands from fomites placed on the floor was confirmed. A study of five Cleveland- area hospitals in which 318 samples were collected from floors in patient rooms and bathrooms revealed the following: The frequency of contamination was analogous across the five hospitals. C. difficile spores were retrieved from the floors of 47%-55% of rooms. MRSA was retrieved from the floors of 8%-32% of rooms, and the bacteria resistant vancomycin-resistant enterococci (VRE) were

6 recovered from the floors of 13%-30% of rooms (Deshpande et al., 2017, p. 337). Also,...floors are a potential source of transmission because they are often contacted by objects that are subsequently touched by hands, e.g., shoes (p. 336). 6 Systematic Review of Pathogen Persistence As noted by researchers Kramer, Schwebke, and Gunter, The role of surface disinfection for the control of nosocomial (Hospital Acquired Infections) pathogens has been a contentious issue for some time. Routine treatment of clean floors with various types of surface disinfectants (some of them had rather poor bactericidal activity) has been described to have no significant impact on the incidence of nosocomial infections Most nosocomial pathogens can persist on inanimate surfaces for weeks or even months (Kramer et al., 2006, Discussion section, para. 1). Department of Molecular Medicine Studies, USF Dr. Dao, Associate Professor at the Department of Cell Biology, Microbiology, and Molecular Biology College of Arts and Sciences, the University of South Florida, conducted three separate studies concerning the efficacy of the PathO 3Gen FSD in destroying pathogens, in-lab during 2012 and 2017, and in-hospital in Certified Laboratory Study. Dr. Dao tested the microbial activity of GEMS technology under laboratory conditions, resulting in the following statement by Dr. Dao, The microbial activity of the GEMS SSD has been tested and confirmed to eliminate over 99.6% of the six modal microorganisms that cause severe disease, including the following: E. coli, S. pyroxenes, MRSA, M. smegmatis, related to tuberculosis, C. albicans, and B. subtillis. Result: Over 99% of these microorganisms were killed within an exposure time of 4-8 seconds of the GEMS SSD proprietary combination of elements with B. subtillis spores requiring the longest exposure time (Dao, 2012) Certified Laboratory Study. Dr. Dao tested the microbial activity of GEMS PathO 3Gen FSD technology again in 2017 to determine if, after significant changes in the technology, the kill efficacy of pathogens increased and the time required for kill had decreased from the results obtained in the 2012 study, resulting in the following conclusion by Dr. Dao: "The microbicidal activity of the GEMS SSD was tested and confirmed to eliminate over 99.6% of the six modal microorganisms that cause severe disease (see above). Over 99% of these microorganisms were killed within an exposure time ranging from 4-8 seconds GEMS SSD proprietary combination of elements, with B. subtillis spores requiring the longest exposure time (Dao, 2017).

7 In-Hospital Study. The following procedure was deployed: Participants were randomly selected (n=90) at a total of 4 locations within a selected hospital site with a total of 540 samples collected from 90 shoe soles (6 samples per shoe sole: 3 before and 3 after exposure to the PathO 3 Gen FSD). Samples were collected from the left shoe sole of randomly selected participants at a hospital site by the rolling swab method and transported to specialized laboratories for processing. Culture plates were photographed, target bacterial colonies were counted, and the results were compared between plates that were spread with shoe sole samples collected before, and plates that were spread with shoe sole samples that were collected after, the participants stepped on the PathO 3 Gen FSD. The activity of the GEMS PathO 3 Gen FSD was established under controlled conditions in research laboratories at USF (Dr. Xingmin Suns Laboratory, Department of Molecular Medicine, Morsani College of Medicine, USF) by a plate assay as well as shoe sole contamination assay on a variety of pathogenic microbes, including bacteria and fungi. Over 77% of the shoe soles walking into the selected hospital site contained MRSA and C. diff in a hospital environment. Two hundred and seventy (270) samples were analyzed for the presence of MRSA and 270 for the presence of C. diff. Conclusion: The efficacy of the PathO 3Gen FSD was demonstrated, as over 98.55% of bacteria, viruses, and fungus, including MSRA and C. diff, were killed within a range of 4-8 seconds of exposure time (Dao, 2017).

8 Methodology 8 Reactive Methodology of Disinfectant Products To help hospitals cope with the 39% increase in the incidence of HAIs in the last 20 years, a number of companies have entered the marketplace with products that use either UV-C light, air purification, disinfectants or a combination of all. However, the products are reactive, meaning they are used after contamination has occurred, rather than before. While these products are used to disinfect pathogens transmitted on surfaces or in the air, none address the problem of deadly bacteria entering and exiting the hospital facility via the transmission of bacteria on the footwear of doctors, staff and visitors. Patented Proactive Methodology of the PathO3Gen FSD The first in-market product for GEMS is a footwear sanitizing device, branded the PathO 3Gen FSD, that will be used initially within the hospital segment. The PathO 3Gen FSD product sanitizes the soles on the bottom of shoes to prevent life- threatening foot borne pathogens from entering the hospital, spreading, and contaminating critical care areas within the hospital, like the operating room and the ICU, that are prone to higher infection rates. Hallways and storage areas surrounding operating rooms and ICU s can be a source of contamination that may be tracked into the OR s and isolation rooms by foot traffic (Kowaliski, 2012, p. 195). The PathO 3Gen FSD uses a patented proactive technology that harnesses a unique combination of natural elements to kill pathogen transmission by destroying the outer capsid and DNA of 97-99% of MRSA, C. diff, E. coli, Candida, and other pathogens in seconds. The PathO 3Gen FSD utilizes Solestice 3/15 Technology. The PathO 3Gen FSD uses low voltage, does not use heat or steam, and poses no harm to humans. It is natural, green, sustainable, and free of chemicals. With its low implementation costs and modular design, it can be configured for any facility and conforms to ADA (Americans with Disabilities Act of 1990) standards. The PathO 3Gen FSD can be integrated into the hospitals current Infection Prevention Program to reduce the incidence of HAI and subsequent costs for patients, staff and communities. The sanitizing effectiveness of robots, air purification systems, and general housekeeping cleaning offer short term effectiveness and have no significant impact on the incidence of nosocomial infections (Kramer et al., 2006). The PathO 3Gen FSD kills pathogens 24/7 and does not require patient rooms and other critical care areas of the hospital be taken out of service.

9 Benefits 9 Effective and proactive, not reactive. Unlike other products that are used after contamination has occurred, the technology kills pathogens before they enter and spread throughout the hospital or other healthcare facilities. Measured Results. Three separate studies at the Department of Cell Biology, Microbiology, and Molecular Biology, College of Arts and Sciences at USF showed the efficacy of the PathO 3Gen FSD in destroying pathogens. Natural, green, and sustainable. The patented technology employs a unique combination of natural elements. There are no chemicals and no harm to humans or the environment. The PathO 3Gen FSD is a safe, user friendly, step-on, stand, and step-off product, with a 24" X 24" Core Active Module (CAM) that kills pathogens. Users (1) stepon the PathO 3Gen FSD CAM, (2) stand for a few seconds, and (3) step-off; effectively eliminating shoe borne pathogens from contaminating floors. Approach The PathO 3Gen FSD is designed to operate and be configured to meet the needs of any healthcare or public facility. GEMS will work with clients to find the best use of the PathO 3Gen FSD and Solestice 3/15 Technology to help solve their specific HAI problem. GEMS will collaborate with potential clients to conduct an initial assessment of the target areas and the development of specifications according to their needs. Following implementation, GEMS provides ongoing service programs for

10 10 maintenance, warranty and support in the field. Product developments include automated data capture to provide better analytics around utilization and remote monitoring of unit performance. Portable Modular Units The PathO 3Gen FSD is designed to operate on a modular basis which will facilitate a variety of configurations, depending on the physical characteristics of the target environment. To enable the free circulation of hospital staff, patients, and visitors, the PathO 3Gen FSD prototype module is complemented by components such as ramps and guide rails to provide effective, but minimally intrusive solutions. This configuration fulfills the requirements of the Americans with Disabilities Act of 1990.

11 GEMS White Paper: PathO3Gen FSD 11 Modular Units In situ The PathO3Gen FSD may be installed permanently in all areas of health-care or other facilities, including high traffic areas of hospital lobbies, elevators, patient rooms, critical care areas, and operating rooms.

12 Results 12 A search of related literature revealed that healthcare-associated infections (HAIs) are a serious and growing problem for healthcare facilities. HAIs levy substantial monetary penalties on the healthcare systems of the United States. Reactive methods presently used in hospitals and public places do not adequately address the problem presented by MDRO, commonly referred to as super bugs and other pathogens. Two certified laboratory test studies and an in-hospital study showed the efficacy of PathO 3Gen FSD, a natural, green, and sustainable sole sanitizing device, to destroy over 98.55% of bacteria, viruses, and fungus, in 4-8 seconds by penetrating MDRO and other pathogens before they could contaminate an area and spread. Summary Findings suggest that 100% prevention of HAIs may not be attainable with current evidence-based prevention strategies; however, comprehensive implementation of such strategies could prevent hundreds of thousands of HAIs and save tens of thousands of lives and billions of dollars. Approximately 70% of in-hospital infections are preventable. The PathO 3Gen FSD uses a patented disruptive and proactive technology to continuously destroy pathogens by penetrating and destroying the outer capsid and DNA of 97-99% of pathogens in seconds. The PathO 3Gen FSD is designed to operate on a modular basis and will facilitate a variety of configurations, depending on the physical characteristics of the target environment.

13 References 13 CDC National Center for Emerging and Zoonotic Infectious Diseases [PowerPoint Slides] (n.d.). HAI: Winnable Battle. Retrieved from Dao, M. L. (2012) Microbial Activity of HEPCO Medical, LLC GEMS (Green Earth Medical Solutions) SoleMate Sanitizing Device, University of South Florida, Department of Cell Biology, Microbiology, and Molecular Biology. Dao, M. L. (2017). Microbial Activity of HEPCO Medical, LLC GEMS; Prevalence of methicillin-resistant staphylococcus aureus (MSERA) and clostridium difficile (C. diff) on shoe soles, and effect of their exposure to the GEMS s SoleMate sanitizing device, University of South Florida, Department of Cell Biology, Microbiology and Molecular Biology. Deshpande, A., Cadnum, J. L., Fertelli, D., Sitzlar, B., Thota, P., Mana, T. S., Jencson, A., Alhimidi, H., Koganti, S., Donsky, C. J. (2017). Are hospital floors an underappreciated reservoir for transmission of health care-associated pathogens? American Journal of Infection Control 45(3), Kowaliski, W., (2012). Hospital airborne infections control. Boca Raton, FL: Taylor & Francis. Kramer, A., Schwebke, I., & Gunter, K. (2006). How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infectious Diseases, 6, 130. McNair, P. D., Luft, H. S., Bindman, A. B. (2009). Medicare policy not to pay for treating hospitalacquired conditions: The impact. Health Affairs (Millwood), 28(5), Scott, R.D.S. II (2009). The direct medical Costs of Healthcare-associated infections in U.S. hospitals and the benefits of prevention. National Center for Preparedness, Detection, and Control of Infectious Diseases Coordinating Center for Infectious Diseases Centers for Disease Control and Prevention. Summary retrieved from cdc.gov. Sydnor, E. R. M., & Perl, T. M. (2011). Hospital epidemiology and infection control in acute-care settings. Clinical Microbiology Review, 24(1), Umscheid, C. A., Mitchell, M. D., Doshi, J. A., Agarwal, R., Williams, K., Brennan, P. J. (2011). Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infection Control Hospital Epidemiology, 32(2), Zimlichman, E., Henderston, D., Tamir, O. (2013). Health care associated infections: A meta-analysis of costs and financial impact on the U. S. healthcare system. JAMA InternMed, 173, HEPCO Medical, LLC dba GEMS. All Rights Reserved. GEMS, PathO3Gen FSD, and Solestice 3/15 Technology are trademarks of Green Earth Medical Solutions, December 2017 info@patho3gensolutions.com patho3gensolutions.com 200 Central Ave., Suite 2200, St. Petersburg, FL