Innovative Approaches to Combat Healthcare-Associated Infections Using Efficacy Standards Developed Through Industry and Federal Collaboration

Abstract

Nation-wide, healthcare-associated infections (HAIs) infect one in every 25 hospital patients, account for more than 100,000 deaths and increase medical costs by around $96-147B, each year. Ultraviolet-C (UV-C) antimicrobial devices are shown to reduce the incidence of many of these HAIs by 35% or more, through the deactivation of the pathogen's DNA chain following irradiation with a wavelength of ~254 nm. This irradiation does not kill the cells, per se but effectively prevents the cells from multiplying. Clinical case reductions of 30-70% in Clostridium difficile (C. diff.) have been reported with similar results for methicillin-resistant Staphylococcus aureus (MRSA), and others. The methodology works, but, the adoption of UV-C technology by the healthcare industry has been sporadic. This is largely due to the lack of definitive knowledge and uniform performance standards or measures for efficacy to help healthcare managers make informed, credible investment decisions. The leveling of the playing field with scientifically certifiable data of the efficacy of antimicrobial devices will enhance acceptance by the healthcare industry and public, at large, as well as facilitate science-based decision making. The National Institute of Standards and Technology (NIST) has engaged with the International Ultra Violet Association (IUVA) and its member companies and affiliates to explore ways to develop needed standards, determine appropriate testing protocols, and transfer the technology to help to reduce these inharmonious market conditions. Collaborative efforts are underway to develop science-based answers to the healthcare industry's questions surrounding standards and measures of device disinfection efficacy, as well as reliability, operations and durability. These issues were recently discussed at the IUVA 2018 America's Conference in Redondo Beach, CA in several panel sessions. A major output of the sessions was the formation of a formal IUVA Working Group for the development of antimicrobial standards and initiatives for the healthcare industry. The goal of this working group is to provide global guidance, with specific programs and deliverables, on the use of UV technologies and standards to combat HAIs and to further the stated aims of the IUVA on its outreach to the healthcare industry. This paper reviews the strong collaboration between NIST and its industry partners pursuing the development of standards, guidelines and guidance documents related to healthcare applications that include standard methods for validating performance of UV devices and test guidelines for efficacy measurements. In addition, an overview of the issues, problems, and a summary of the needs confronting future growth and success of the UV industry in the Nation's healthcare application space is provided.

Keywords: C.diff.; HAIs; UV-C; disinfection; healthcare-associated infections; infection control; standards; ultraviolet.

Figure 1.

CDC reported top ten causes of death in 2015 compared to the reported number of HAI fatalities.

Figure 2.

Healthcare facilities are complex, with continuous operations in an environment often crowded and loaded with equipment. There are also numerous types of surfaces and materials coupled with a confluence of sick patients and persons with compromised immune systems and other vulnerabilities, leading to risk for healthcare associated infections.

Figure 3.

Hospital rooms are complex with many surfaces. UV-C devices may attack whole room surfaces. Reducing HAI strategies have focused on improving hand hygiene, however, new studies indicate the whole room must be considered (Figure 3). Both high- & low-touch contaminated surfaces can pass pathogens to patient or healthcare workers. Floor cleanliness is increasingly suspect as a major contributor.

Figure 4.

Examples of the more than 40 manufacturers of UV sterilizers. Manufacturers produce all types of devices for air, water and surfaces. More than a dozen companies manufacture UV whole-room devices.