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therein. Throughout the study, a visible-light CED system was used as an adjunct to the normal OR manual cleaning and disinfection protocol. METHODS Background This study was performed between October 2015 and October 2017 at Maury Regional Health Center, a 255-bed regional hospital in Columbia, Tennessee. The hospital has 12 ORs, 3 of which are dedi- cated to orthopedic surgery and were the ORs of interest in this study. The most common procedures performed in all 3 ORs are primary joint arthroplasties (total knee, total hip, shoulder, and ankle). The use of a visible-light CED system was designed to be an additional dis- infection strategy complementary to the hospital 's standard OR cleaning and disinfection protocol and preexisting SSI bundle. The study proposal was submitted to the institutional review board as a process improvement related to the overall surgical bundle and its goal of reducing SSIs. However, as part of this effort, some nonhuman research related to the effectiveness of the technology was required. This research included the analysis required to effectively dose the room and demonstrate bacterial reduction. The institutional review board approved the proposal as a process improvement and declared it exempt from full review. A visible-light CED system (Indigo-Clean, Kenall, Kenosha, WI) was installed by the institution in one OR, hereafter referred to as OR2, on October 15, 2016. OR2 is adjacent to another OR (OR1) with which it shares a heating, ventilation, and air conditioning system. A third OR (OR3), included in the data analysis for SSIs, was across the hall from OR1 and OR2 and had a separate heating, ventilation, and air conditioning system. In all 3 ORs, airflow is via an engineered lam- inar system with a high-ef ficiency particulate air filtration system, such that the air passes through the system via returns designed to pull air away from the surgical site and back table with 30 air changes per hour. All 3 ORs are humidity-controlled and maintained between 66°F to 68°F. The hospital's standard manual cleaning protocol for all ORs involves the use of a combined cleaner and disinfectant (Oxycide, Ecolab, St Paul, MN) used in conjunction with micro fiber cloths. Each OR is cleaned between procedures and terminally at the end of the day, and the environmental services team is required to complete a checklist with each cleaning to ensure thoroughness. The hospital's SSI bundle, which was implemented and fully in effect at the start of the study (October 1, 2015), included patient- related components (eg, methicillin-resistant Staphylococcus aureus screening and decolonization of positive patients, home chlorhexi- dine gluconate bathing), preoperative components (eg, chlorhexidine gluconate skin prep with appropriate dry time, weight-based, local antibiogram-based antimicrobial prophylaxis), intraoperative compo- nents (eg, restriction of door openings once case began, appropriate facility-laundered attire including caps and hoods), and postoperative components (eg, silver-impregnated dressings, education on sterile technique for dressing changes to caregiver). Aside from implementa- tion of a visible-light CED system in one OR, no additional changes to the SSI bundle or infection prevention strategies were implemented throughout the study period. Design, installation, and operation of a visible-light CED system in the OR As far as we know, this is the first reported deployment of a visi- ble-light CED system in an OR setting, and it is important to note that it's deployment and usage is very different from portable, ultraviolet (UV) systems. As it is integrated into the overhead lighting, it requires additional considerations related to the center wavelength (per photon ef ficacy), irradiance (disinfecting power at a point in space), and number of fix- tures and layout (disinfecting power throughout the room) to ensure the proper end result. This implies that just as with UV systems, no 2 products in this category will be identical highlighting the impor- tance of clinical evidence in evaluating their true bene fits based on the manufacturer's recommended usage. These recommendations should include the total average dose to the room, the quantity of fix- tures needed, the required operation time, and clinical evidence dem- onstrating the performance using these recommendations. The manufacturer provided technical assistance before and during installation to ensure that proper illumination and disinfecting dose was achieved across the entire OR. Each unit is a ceiling-mounted lighting system measuring 2 ft £ 4 ft. Eight units were installed in the ceiling of OR2, which measured 450 square ft 2 with 9-foot ceilings. The antimicrobial light in the unit is generated from a matrix of light- emitting diodes, which emit low-irradiance violet-blue light with a narrow spectral pro file centered within 405 nm-410 nm (indigo). This light conforms to international safety guidelines for clinical use in occupied rooms. 20-21 To provide optimal illumination for surgery, each unit operates in a "white mode" that combines indigo light and white light when the room is occupied. When the room is unoccu- pied, the units switch to "In digo mode," which provides indigo light only, at approximately 4-times the dose of the white mode —and therefore, a greater degree of disinfection. An occupancy sensor switches between modes automatically but can be overridden with an emergency switch, if needed. Bacterial bioburden in the OR The effect of the visible-light CED system on bacterial levels on a variety of surfaces throughout OR1 and OR2 was studied prior to (period 1, October 4-14, 2016) and after (period 2, October 19 to November 4, 2016) installation of the visible-light CED system in OR2. To establish a baseline, surface samples were collected on 5 sep- arate occasions during period 1 in both ORs (scheduling of light installation lim ited sampling times during period 1), and the same surfaces in both ORs were then sampled on 8 different occasions dur- ing period 2. The 50 surfaces sampled were the same in both ORs, and in both periods, and included the tops and bottoms of the door handle on the inside of the main door to the OR, the door handle to the blanket storage cabinet, the computer mouse and keyboard, the inside of the phone handle, the door handle to the glove storage cabi- net, the boom light control, the right and left arms of the anesthesia chair, and the right and left edges of the anesthesia cart. Additionally, surfaces were sampled above and below the top of the intravenous warmer, the lower right and left front corners of the anesthesia machine, the handle of the fluid collection machine and on the left and right sides of the laundry bin lid, the top of the OR chair, the com- puter keyboard and top of the computer, the front of the anesthesia screen, the top of the syringe bin, the front of the bovie machine, the top of the fluid collection machine, the anesthesia monitor, and the blood pressure button. The director of infection prevention and control collected all sam- ples in both ORs and periods between 5 AM and 6 AM, prior to the first room entry and after the room had been terminally cleaned the previous evening. Samples were collected using 15 mm £ 65 mm Baird-Parker agar (BPA) with egg yolk tellurite contact plates (Hardy Diagnostics, Santa Maria, CA). Nonflat surfaces were sampled using the roll plate technique and flat surfaces were sampled by directly pressing plates against the surface. Each sample was taken directly to the laboratory for a 48-hour incubation period at 35°C. Following incubation, enumeration of total colony-forming units (CFU) from each plate was made by a blinded microbiology technician and results were tallied to create a total CFU count for each OR on the date of collection. ARTICLE IN PRESS 2 L.J. Murrell et al. / American Journal of Infection Control 00 (2018) 1 −7 Indigo-Clean Is A Ceiling Mounted Light Fixture That Is… • Clinically proven to reduce SSIs by 73% * • Clinically proven to reduce harmful bacteria by 88%* • Safe – does not contain UV • Automatic – requires no additional staff or training *Murrell, L.J., Hamilton, E.K., Johnson, H.B., Spencer M., "Influence of a visible-light continuous environmental disinfection system on microbial contamination and surgical site infections in an orthopedic operating room", Am J Infec Control, (2019), In Press Join me in reducing HAI's Clinically Proven Technology Reduces Surgical Site Infections by 73% A 12-month study conducted by Maury Regional Medical Center showed a 73% reduction in surgical site infections * with our patented, continuous visible light disinfection technology. Read the AJIC PEER-reviewed article at www.indigo-clean.com Major Article Influence of a visible-light continuous environmental disinfection system on microbial contamination and surgical site infections in an orthopedic operating room Lynnelle J. Murrell BSN, RN, CIC a , Erin Kinzel Hamilton PhD b , Helen Boehm Johnson MD c, *, Maureen Spencer BSN, RN, MEd, CIC, FAPIC d a Department of Infection Prevention and Control, Maury Regional Health Center, Columbia, TN b Kinzel-Hamilton, Louisville, KY c SeaHawk Biomedical, Vero Beach, FL d Infection Prevention Consultant, Weymouth, MA Background: A growing body of research has demonstrated that manual cleaning and disinfection of the operating room (OR) is suboptimal. Residual environmental contamination may pose an infection risk to the surgical wound. This study evaluates the impact of a visible-light continuous environmental disinfection (CED) system on microbial surface contamination and surgical site infections (SSI) in an OR. Methods: Samples from 25 surfaces within 2 contiguous ORs sharing an air supply were obtained after man- ual cleaning on multiple days before and after a visible-light CED system installation in 1 of the ORs. Samples were incubated and enumerated as total colony-forming units. SSIs in both ORs, and a distant OR, were tracked for 1 year prior to and 1 year after the visible-light CED system installation. Results: There was an 81% (P = .017) and 49% (P = .015) reduction in total colony-forming units after the visi- ble-light CED system installation in the OR in which the system was installed, and in the contiguous OR, respectively. In the OR with the visible-light CED system, SSIs decreased from 1.4% in the year prior to instal- lation to 0.4% following installation (P = .029). Conclusions: A visible-light CED system, used in conjunction with manual cleaning, resulted in significant reductions in both microbial surface contamination and SSIs in the OR. © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license. (http://creativecommons.org/licenses/by-nc-nd/4.0/) Key Words: Environmental disinfection Visible light continuous environmental disinfection Surgical site infections Automated disinfection Visible light decontamination Surgical site infections (SSI) continue to place a substantial burden on the US health care system. 1 They are among the most common health care−associated infections, accounting for a major source of periopera- tive morbidity, prolonged hospitalizations, and health care expendi- tures. 1-3 This is particularly true for SSIs involving an implant, such as periprosthetic joint infections (PJI), which have been associated with a cost of $389,307-$474,004 per infection, a mortality rate of 2%-7%, and a 5-year survival rate— that is worse than many cancers. 4-6 Traditional stratification of SSI risk begins with the patient's own microbiome, followed by perioperative practice variables including surgical technique, attire and instrument sterility, and operating room (OR) environment. 7 The latter, however, is increasingly recognized as a potentially significant reservoir for pathogens. Multiple studies have demonstrated the presence of organisms commonly associated with SSIs in the air and on surfa- ces within the OR, despite regular manual cleaning, 8-11 underscor- ing the idea that many traditional manual disinfection and decontamination protocols are suboptimal in achieving a truly "clean" OR environment. 11-15 Residual contamination can pose an infection risk via the complex interplay of surface and air dynamics in an occupied OR. Staff and equipment movement can disturb residual organisms and particulates on surfaces leading to their aerosolization and potential settling onto high-touch surfaces, sterile equipment, and into the surgical wound. 15-19 The present study was a 2-pronged investigation to assess the effi- cacy of a visible-light continuous environmental disinfection (CED) sys- tem in (1) reducing bacterial contamination on surfaces within an orthopedic OR, and (2) impacting SSI rates for procedures performed * Address correspondence to Helen Boehm Johnson, MD, SeaHawk Biomedical, 1321 Sea Hawk Ln, Vero Beach, FL 32963. E-mail address: HBoehm705@aol.com (H.B. Johnson). Conflicts of interest: None to report. https://doi.org/10.1016/j.ajic.2018.12.002 0196-6553/© 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license. (http://creativecommons.org/licenses/by-nc-nd/4.0/) American Journal of Infection Control 000 (2018) 1−7 Contents lists available at ScienceDirect American Journal of Infection Control j o u r n a l h o m e p a g e : w w w . a j i c j o u r n a l . o r g www.indigo-clean.com