Becoming the Gold Standard in UV Room Disinfection: The Importance of Randomized Clinical Trials

Posted by Tru-D SmartUVC 11.17.15

In 2007, the first UV disinfection robot entered the health care market as a new technology, pioneering a new way to battle health care-associated infections. Yet, minimal scientific endorsement delayed its acceptance as a gold standard in infection prevention, leaving many patients at serious risk of developing deadly, but preventable, infections – until now.

Fast forward eight years to the recent release of the results of the first ever randomized clinical trial on UV disinfection, Benefits of Enhanced Terminal Room Disinfection (BETR-D). Funded by the Centers for Disease Control and Prevention, the trial utilized the first disinfection device to hit the market, Tru-D SmartUVC, to prove that using measured germicidal doses of UV light in health care settings can reduce the risk of infection caused by multi-drug resistant organisms by 30 percent.

The trial – totaling four years of rigorous planning, methodic execution and detailed evaluation – not only statistically proved the real-world impact that Tru-D has on patient outcomes, but it also validated the method of measured germicidal UV disinfection, used by Tru-D SmartUVC, which helped to position this technology as the gold standard in UV disinfection.

Because of the strict requirements for qualifying scenarios and protocols, as well as blind participation, randomized clinical trials are the most arduous way to determine the cause-effect relationship between a treatment and outcome and to determine the consequent cost effectiveness of that treatment. Therefore, treatments that are often studied in randomized clinical trials must have validated merit in smaller third-party trials. Tru-D was the only treatment technology selected for the BETR-D study due to its unique, proven ability to reduce environmental pathogens by measuring the necessary reflective dose required to thoroughly disinfect a hospital room.

Prior to the conclusion of the BETR-D study, Tru-D’s measured germicidal UV disinfection had been validated in multiple third-party studies. In 2010, the study “Room Decontamination with UV Radiation,” showcased the effectiveness of this measured germicidal UV–emitting device in eliminating nosocomial pathogens found in contaminated hospital rooms. By measuring the Clostridium difficile (C-diff), Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE) counts in patient rooms before and after patient occupation, researchers from this study concluded that measured germicidal UV disinfection was effective in eliminating these deadly pathogens. Specifically, Tru-D destroyed vegetative bacteria & bacterial spores on contaminated surfaces both in direct sight, as well as behind objects via measured reflected UV dose. Furthermore, Tru-D was validated in a pre-study conducted by BETR-D study researchers to determine if it qualified for their formal randomized clinical trial. Tru-D qualified for the study when researchers saw more than 90 percent of pathogenic bacteria eradicated using only measured germicidal UV light with no manual pre-cleaning in real-world settings.

“Many leaders in infection prevention across the country were waiting for a randomized clinical trial to be announced for UV disinfection, so this was a big win accelerating adoption of Tru-D technology in the fight against infections across many levels of health care in the U.S.,” said Chuck Dunn, president and CEO of Tru-D SmartUVC.

For the BETR-D study, infection control researchers from Duke University Medical Center in Durham, North Carolina, and The University of North Carolina at Chapel Hill collected data across nine hospitals and 24,589 eligible patients for 122,873 patient days. Researchers compared four different cleaning and disinfection scenarios: two of which included terminal disinfection of the patient room with the Tru-D system.. Each hospital randomly rotated through the four cleaning protocols in each of the four seven-month phases. Researchers eliminated confounding factors that may skew the results and concluded Tru-D integration into terminal cleaning protocols reduced healthcare associate infection (HAI) up to 30 percent.

While the costs and consequences of HAIs continue to increase, hospital leaders are now armed with statistically sound proof that measured germicidal UV light is an effective solution for reducing the risk of infection caused by target multi-drug resistant organisms.

“This is revolutionary news to infection preventionists and health care leaders around the world,” Dunn added. “But, we’ve understood the potential impact that Tru-D could have on health care-associated infections since we launched the device eight years ago, which is why we put Tru-D in the hands of every credible independent researcher we could find. And, that work has paid off.”

Posted 11.17.15
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