#Cdiff Educating and Advocating for the Prevention, Treatments, Clinical Trials, and Environmental Safety of Clostridioides difficile (C.difficile) Infections Worldwide
Category Archives: Environmental Safety Products in Healthcare
Hemet Valley Medical Center has implemented innovative ultraviolet technology with the addition of the Clorox Healthcare® Optimum-UV® System. The system helps remove harmful bacteria and pathogens that can jeopardize health, providing patients, visitors and staff with an additional layer of safety and protection.
Today’s hospitals and clinics need solutions to address numerous threats, from seasonal challenges, such as the common cold and influenza viruses, to multi-drug resistant organisms, like Methicillin-Resistant Staphylococcus aureus (MRSA) and Clostridium difficile (C. difficile). Despite improvements over the last few years, healthcare-associated infections still pose a threat within healthcare facilities across the country. According to the U.S. Centers for Disease Control and Prevention (CDC), between 2013 and 2014 California hospitals reported a significant increase in life-threatening in C. difficile infections and 25% had standardized infection ratio (SIR) higher than the national SIR.1
Knowing this, Hemet Valley Medical Center invested in the Clorox Healthcare® Optimum-UV® System, which is used in various areas throughout the hospital including patient rooms, operating rooms and catheterization laboratories. Hemet Valley is a 417-bed hospital housing approximately 170 patients per day and over 60,000 emergency room patients per year.
The Clorox Healthcare® Optimum-UV® System works by emitting UV-C light and killing microorganisms by inactivating their DNA rendering them harmless, unable to multiply or spread. The UV-C rays extend a full 360 degrees allowing the system to disinfect areas within an 8-foot radius in just five minutes.
“Since hospitals are challenged to be as infection-free as possible, we wanted to do everything in our power to protect our patients. This initiative is what ultimately motivated our decision to invest in the Clorox Healthcare® Optimum-UV® System as we knew it would help us achieve our goal to provide the best care and protection for our patients,” said Keith Garrison, Associate Administrator, Hemet Valley Medical Center.
About Hemet Valley Medical Center
Hemet Valley Medical Center is fully licensed by the state of California and the Center for Medicare and Medicaid Services (CMS) as an acute care hospital. The hospital is accredited by The Joint Commission and governed by a managing board of local physicians.
Health care facilities everywhere have been ramping up their disinfection practices in order to prevent the spread of infectious diseases. However, when it comes to hospital mattresses, one of the biggest vectors for spreading deadly bugs, efforts are still falling short.
With health care workers using chemicals that are intended for dry surfaces, the mattresses are harboring pathogens such as Clostridium difficile (C. diff), and, as Edmond A. Hooker, MD, DrPH, professor in the Department of Health Administration at Xavier University, pointed out at the 5th Annual International C. diff Awareness & Health Expo, regulatory agencies seem to have “turned a blind eye” to the issue.
Until now.
The US Food and Drug Administration (FDA) recently released a notice on how to keep hospital mattress covers safe.
In this notice, the FDA notes safety concerns regarding hospital mattress covers, particularly that over time they can “wear out and allow blood and body fluids to penetrate and get trapped inside mattresses.” They added, “If blood or body fluids from one patient penetrate and get absorbed in a mattress, the fluids can leak out the next time the mattress is used.” If that happens, the next patient runs the risk of coming into contact with these fluids, and thus, becoming infected with pathogens from the bed’s previous occupants.
The FDA reports that this is not the first time they acknowledged these concerns; they released a safety communication in 2013 to make health care workers aware of the issue. However, the problem of contaminated hospital mattresses persists.
“There is no question there has been report after report after report of, ‘We had this outbreak. We killed all these people.’ There was just a report that came out on 18 people who were sick in a French hospital; they were on beds manufactured here in America, and 4 people were killed before they finally realized that it was the mattresses. They took all of the mattresses out of service and stopped the outbreak,” Dr. Hooker told Contagion® in an exclusive interview.
“There’s a reason that it’s an under reported problem; hospitals don’t want to say, ‘Hey, we just killed a bunch of people. We kill 29,000 people a year with C. difficile infections. Do you hear that? I mean, that’s like crashing a plane every day and we do nothing about it. We just act like it didn’t happen.”
In an effort to address the issue, the FDA has released recommendations based on Centers for Disease Control and Prevention (CDC) guidelines for environmental infection control in health care facilities; they include:
Develop an inspection plan for all hospital mattresses and mattress covers in the facility. Learn the time of life for all mattresses/mattress covers by checking the manufacturer’s guidelines; follow any other recommendations that the manufacturers list. If you have any additional questions, contact the mattress manufacturer.
Inspect each hospital mattress for visible signs of damage, which can include: cuts, tears, cracks, pinholes, snags, or stains. On a routine basis, remove mattress covers and check the inside. With the cover removed, check the mattress for wet spots, staining, or other signs of damage. Be sure to check all sides of the mattress as well as underneath. You will not be able to effectively inspect the mattress with the cover on.
Remove any mattresses that are damaged, appear worn, or are visibly stained and immediately replace any mattress covers that are damaged.
Maintain your mattresses and mattress covers by cleaning and disinfecting them “according to the manufacturer’s guidelines.” DO NOT stick needles into the hospital mattress through the cover, the FDA stresses.
“The FDA notice about mattress failures is an important first step. However, much more needs to be done. Most failures are not being reported to FDA, and the 700 reports that they have represents an industry-wide problem. Up to one-third of hospital mattresses currently in service in hospitals have failed. Also, the ones that have not failed are not being cleaned,”
Dr. Hooker stressed to Contagion® in a follow-up interview. “These mattresses quickly get fissures and microscopic cracks that allow bacteria to remain on the surface during terminal cleaning. The next patient is then exposed to those bacteria and gets a hospital-acquired infection. The CDC needs to mandate better cleaning practices nationwide, which they can do.
The CDC needs to also mandate inspection of every mattress after every patient. Damaged mattresses should be removed from service immediately.”
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On September 29, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobial products against Clostridium difficile (C. diff) spores.
C. diff is an anaerobic, spore-forming bacterium and a leading hospital-acquired infection. The spores survive on hard surfaces such as glass, metals, and plastics that are commonly found in health-care settings.
Antimicrobial pesticides are used to reduce the number of spores on environmental surfaces. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the registrant of an antimicrobial product with a public health claim is required to submit efficacy data to EPA in support of the product’s registration.
EPA MLB SOP MB-28 describes the test methodology for producing and storing standardized spore suspensions of C. diff based on ASTM E2839, Standard Test Method for Production of C. difficile Spores for Use in Efficacy Evaluation of Antimicrobial Agents (ASTM International). A spore suspension should be developed and qualified according to EPA MLB SOP MB-28 before an efficacy evaluation can be performed using method EPA MLB SOP MB-31. EPA MLB SOP MB-31 describes a quantitative method intended for evaluating the sporicidal efficacy of liquid disinfectants against spores of C. diff on inanimate, hard, non-porous surfaces.
EPA solicited comments on the clarity of the test method SOPs and the regulatory guidance in December 2016. EPA received comments from twelve entities and revised the drafts to incorporate suggested changes. EPA posted its response to those comments in Docket No. EPA-HQ-OPP-2016-0753-0026. EPA also is working with ASTM International, a standard-setting organization, on adoption of these test methods as official ASTM standards.
The scientific evidence has clearly established that in the hospital environment, microorganisms such as Clostridium difficile (C.diff), Methicillin-resistant Staphylococcus aureus (MRSA) and carbapenem-resistant Enterobacteriaceae (CRE) are responsible for the infections that kill nearly 300
people in the U.S. every day.
Xenex Disinfection Services’ LightStrike Robot with pulsed xenon ultraviolet-C (UV-C) light technology is a proven solution that quickly destroys deadly viruses, bacteria and spores before they pose a threat to patients and healthcare workers. LightStrike Robots help healthcare facilities reduce their HAI rates by destroying the microscopic germs that may be missed during the manual cleaning process. Xenex robots use pulsed xenon, a noble gas, to create Full Spectrum, high intensity UV light that quickly destroys infectious germs in less than five minutes. Hospitals using Xenex devices have published clinical outcome studies in peer-reviewed journals showing 50-100 percent reductions in C.diff, MRSA and Surgical Site Infection rates when those hospitals used LightStrike Robots to disinfect rooms.
Ingenia MR-OR intraoperative MRI delivers high-quality images during neurosurgical procedures. It helps you gain up-to-date insight on surgical procedures & tumor resection & supports smooth, in-line patient transfer between the OR and Philips Ingenia MR
Now, for the first time, hospitals can utilize the power of
LightStrike Germ-Zapping Robots to quickly disinfect mobile equipment just as effectively as they disinfect rooms within their facility. Pathogens like C.diff, Acinetobacter baumannii, MRSA and Vancomycin-Resistant Enterococci (VRE) can travel throughout a healthcare facility on mobile equipment.
To address this gap in the infection control process, Xenex recently partnered with an industry leader in containment units, Mintie Technologies, Inc., to create the LightStrike Disinfection Pod.
Designed to quickly disinfect reusable mobile equipment such as isolettes, ventilators, pressure monitors, wheelchairs and workstations, the
LightStrike Disinfection Pod enables the power of the LightStrike Robot’s intense, germicidal light to be used anywhere in a facility.
The Pod is collapsible, mobile and can be positioned in a hospital hallway or other areas without disrupting or impeding daily workflow. Its proprietary design integrates reflective interior fabric ensuring 360 degrees of UV light coverage over difficult-to-clean equipment including anesthesia carts, ventilators, and mobile imaging machines.
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TOMI Environmental Solutions, Inc. (“TOMI”) a global decontamination and infection prevention company that specializes in disinfection/decontamination sales and services, including the manufacturing, sale and licensing of its SteraMist, a hydrogen peroxide-based mist/fog that is registered with the U.S. Environmental Protection Agency (“EPA”), announced the publication of a peer reviewed paper titled “Use of Novel Approaches to Reduce Clostridium Difficile in an Inner City Hospital,” which concluded that the use of TOMI’s SteraMist BIT contributed to the substantial reduction in a Wilmington, Delaware hospital’s Clostridium Difficile (C. Diff) burden. The paper was written by Dr. Helene Paxton, MS, MT (ASCP), PhD, CIC, Infection Preventionist, Bio Guidance, LLC and member of TOMI’s Science Advisory Board, and outlines the incorporation of SteraMist BIT into everyday disinfection protocols of a healthcare facility. This paper was peer reviewed by Dr. Uyen Nguyen.
“In the healthcare space, TOMI has been making strides to continuously demonstrate the efficacy of SteraMist in combating and reducing hospital infections,” said Dr. Halden Shane, CEO and Chairman of TOMI Environmental Solutions, Inc. “This further review and publication of the efficacy of TOMI’s SteraMist is an important verification in our battle to address the increase in C. diff infections, which lead to thousands of deaths in the U.S. each year.”
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Nearly 300 people die in the U.S. every day from an infection they acquired during their hospital stay, and the death toll is even higher internationally. Healthcare Associated Infections (HAIs),including Methicillin-resistant Staphylococcus aureus (MRSA), are becoming an international crisis. Bacterial spores such as C. diff have become an even larger problem in hospitals and in their respective communities, and it is estimated that nearly half a million Americans contract C. diff every year.
TOMI’s EPA registered BIT (Binary Ionization Technology®), branded as SteraMist, converts a low percentage hydrogen peroxide into a hydroxyl radical by passing the liquid through an atmospheric cold plasma arc, a technology initially developed under the sponsorship of the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense. SteraMist BIT quickly destroys deadly viruses, bacteria and spores before they pose a threat to patients, healthcare workers and their communities.
TOMI’s SteraMist helps hospitals reduce their HAI rates by destroying the microscopic germs that may be missed during the manual cleaning process. TOMI’s germ fighting technology uses an environmentally-friendly process, the only by-product of which is oxygen and humidity. The SteraMist aerosol quickly destroys infectious germs in less than five seconds. Hospitals using SteraMist devices have reported and published outcomes in papers and in a peer-reviewed journal showing significant decreases in C. diff rooms after the use of SteraMist.
Dr. Shane further stated: “Hospitals can and should do more to keep patients safe. No one wants a loved one to go to the hospital and contract C. diff or any hospital acquired infection. Hospitals routinely using SteraMist have repeatedly demonstrated lower infection rates, which leads to enhanced patient and employee safety. Hospitals using our technology can stop the spread of infections while improving their bottom line.”
Uniquely designed for ease of use and portability, a hospital’s environmental services staff can operate SteraMist quickly without disrupting hospital operations. With a five second exposure time, the surface unit can disinfect a hospital room’s high touch surfaces and delicate medical equipment in less than 10 minutes. SteraMist is designed to go in, above, beyond, under and around objects in patient rooms, operating rooms, equipment rooms, emergency rooms, intensive care units and public areas. SteraMist does not damage medical equipment. Many hospitals in the U.S., Europe, West Africa, Central America and Asia have used SteraMist in their decontamination protocols. SteraMistis also used in skilled nursing facilities, ambulatory surgery centers, long term acute care facilities and childcare facilities.
About TOMI Environmental Solutions, Inc.
TOMI Environmental Solutions, Inc. (OTCQX:TOMZ) is a global decontamination and infection prevention company, providing eco-friendly environmental solutions for indoor surface disinfection through manufacturing, sales and licensing of its premier Binary Ionization Technology® (BIT) platform, which was invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense. BIT uses a low percentage Hydrogen Peroxide as its only active ingredient to produce a hydroxyl radical (OH ion) and is represented by the TOMI SteraMist brand of products, which produce a germ-killing aerosol that behaves like a gas.
TOMI’s products are designed to service a broad spectrum of commercial structures including hospitals and medical facilities, cruise ships, office buildings, hotel and motel rooms, schools, restaurants, for non-food safety in meat and produce processing facilities, military barracks, and athletic facilities. TOMI’s products and services have also been used in single-family homes and multi-unit residences.
TOMI also develops training programs and application protocols for its clients and is a member in good standing of The American Biological Safety Association, The American Association of Tissue Banks, Association for Professionals in Infection Control and Epidemiology, Society for Healthcare Epidemiology of America and The Restoration Industry Association. For additional information, visit www.tomimist.com or contact us at info@tomimist.com.
Certain written and oral statements made by us may constitute “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 (the “Reform Act”). Forward-looking statements are identified by such words and phrases as “we expect,” “expected to,” “estimates,” “estimated,” “current outlook,” “we look forward to,” “would equate to,” “projects,” “projections,” “projected to be,” “anticipates,” “anticipated,” “we believe,” “could be,” and other similar phrases. All statements addressing operating performance, events, or developments that we expect or anticipate will occur in the future, including statements relating to revenue growth, earnings, earnings-per-share growth, or similar projections, are forward-looking statements within the meaning of the Reform Act. They are forward-looking, and they should be evaluated in light of important risk factors that could cause our actual results to differ materially from our anticipated results. The information provided in this document is based upon the facts and circumstances known at this time. We undertake no obligation to update these forward-looking statements after the date of this release.
DISCLAIMER
“The C Diff Foundation’s mission is to educate and advocate for Clostridium difficile infection prevention, treatments, support, and environmental safety worldwide.
The C Diff Foundation’s organization is comprised of 100% volunteering members who are dedicated to our mission and adhere to the Foundation’s Code of Ethics
which prohibits the endorsement and promotion of products, services, medications, or clinical studies in progress.
All website entries, public presentations, and workshops are to raise C. diff. infection awareness in all areas of the C Diff Foundation’s mission statement, including infection prevention, sepsis, healthcare-associated infections, antimicrobial resistance, antibiotic stewardship and provide education on all the above.”
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