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Taming the Wild West: Innovative Approaches to Combat Healthcare-Associated Infections using Efficacy Standards Developed through Industry and Federal Collaboration

19 Mar 2018 6:29 PM | Gary Cohen (Administrator)

Imagine a world where healthcare-associated infections are just a concern of the past. It could happen, but unfortunately today that is not the case. Nation-wide, healthcare-associated infections (HAIs) infect one in every 25 hospital patients, account for more than 99,000 deaths and increase medical costs by more than $35B, 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 by irradiating it with a wavelength of ~254 nm. Recently, automated UV-C-emitting devices have been shown to decrease the bioburden of important pathogens in hospital rooms (Anderson et al., 2013). The irradiation effectively prevents the cells from multiplying. Such DNA damage can result in a permanent arrest of DNA replication and/or transcription, which leads to cell death (Friedberg, 2001). 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, largely due to confusion, the lack of definitive knowledge and uniform performance standards or measures for efficacy to help healthcare managers make informed, credible investment decisions. Therefore, maintaining the status quo seems to be the most effective and safest investment approach. However, 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 International Ultra Violet Association (IUVA) and its member companies feel it is incumbent upon them to recognize this knowledge and metrology gap – and act. IUVA is also exploring ways to reduce these “wild” inharmonious market conditions, while developing science-based answers to the healthcare industry’s questions surrounding standards and measures of device disinfection efficacy, as well as reliability, operations and durability.

The overall confusion stems from several reasons. The first and foremost is that there are more than 40 manufacturers of “ultraviolet (UV) sterilizers” producing products, which include all types of designs for: air, water and surface sterilization, and there are at least 12 manufacturers of at least that many antimicrobial devices. Depending upon the model and design the UV-C light sources, each can differ greatly in spectral bandwidth and power outputs. Instrument comparisons are difficult, if not impossible, and no standardized testing procedures are in place to compare or measure the performance of these devices.

The lack of regulation and standards has also allowed each of the 40+ companies to develop their own unique testing and evaluation programs, often using different pathogens, concentrations, testing methodologies and more importantly efficacy criteria. The over abiding result is that there is no clear-cut means for comparison of one unit against another, thus often allowing cost to be the deciding factor for an administrator. But, is that the proper metric? Is advertising and marketing more important than independent-based research for the health of the patients? But, what of the patient’s needs? Clearly lawsuits have occurred between competing companies contesting various performance and operational claims. Past experience has shown that it is necessary to measure the proper performance parameters and justify these measurements with data and not just claims. This “wild-west” mentality in the healthcare market must be corralled so that the market can successfully grow, before something occurs that ruins the industry, for all involved.

As stated above, the IUVA has begun an effort to develop answers to the healthcare industry’s questions surrounding standards and measures of device disinfection efficacy. Standards development activities have proven to have a pronounced effect on product development and the success of businesses in the marketplace. Implementing standards and science-based metrology to ensure product compliance, and other requirements for trade, have been met has been shown to streamline manufacturing processes and trim costs which then leads to increased market share and an improved bottom line.

The development of UV light measurements and standards is critically needed to grow and expand UV technology in all phases of disinfection. Industry wide collaboration and cooperation is needed. The first step is to identify the main needs and then determine positive solutions. It is clear that consensus-based measurements and standards are needed in the UV technology sector; they are infrastructural and typically, if designed properly, pose no competitive advantage to one single company. Companies can openly and readily cooperate together at that level. Once the required solutions are identified to address the infrastructural measurement and standards needed, the solutions can be taken back “behind the curtain” and developed and applied to proprietary processes throughout the industry at the discretion of individual companies. This approach has been extremely successful for the semiconductor and other industries and can be readily applied to the UV industry.

These issues were recently discussed at the IUVA 2018 America’s Conference in Redondo Beach, CA in several HAI panels. An output of the HAI panels was the formation of a formal IUVA Working Group for the Development of Antimicrobial Standards and Initiatives for the Healthcare Industry. The goal 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.

The working group will develop a set 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, as well as discussing the development of a UV roadmap for overall healthcare to include outlines of issues, problems, potential solutions and needs for the future growth and success of the UV industry in healthcare application space.

Fundamental change can be effected through a path of advancing UV efficacy standards and testing protocols to demonstrate UV’s advantages while advocating its increased implementation through education and outreach programs targeting the Nation’s healthcare sector.

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