1. Environmental Disinfection ~ A Review of Hydrogen Peroxide Vapor Technology Lessons from a Community Hospital Nancy Iversen, RN, CIC Director, Patient Safety & Infection Control Billings Clinic niversen@billingsclinic.org 406-657-4823 niversen@billingsclinic.org

2.  Not-for-profit, community owned and governed  Multi-specialty Physician Group Practice  3,750 employees  260 employed physicians representing 50 specialties  285-bed hospital, 90-bed LTCF  7 regional branch clinic locations  Multi-state management affiliations and support services  Member of Mayo Clinic Care Network

3. Health Care, Education and Research Learner Objectives 1.Describe two unique characteristics, changing epidemiology, and environmental persistence of Clostridium difficile bacteria 2.Discuss two strategies that prevent the transmission of healthcare-associated Clostridium difficile and other pathogens 3.Describe the current environmental disinfection strategies and application of hydrogen peroxide vapor ~ BIOQUELL 4.Discuss advantages and disadvantages of hydrogen peroxide vapor disinfection technology

4. Health Care, Education and Research Examples of The Unseen What You Learn Will Creep You Out! The Dust Mite Photo courtesy of Janet Stout, PhD, Special Pathogens Lab

5. Health Care, Education and Research About Unseen Dust Mites A typical mattress may have anywhere from 100,000 to 10 million mites inside. 10% of the weight of a two-year old pillow can be composed of dead mites and their droppings. Photo courtesy of Janet Stout, PhD, Special Pathogens Lab

6. Background Environmental contamination contributes to transmission of healthcare-associated pathogens 1 There is increased risk of acquisition of multidrug-resistant organisms in rooms where the previous occupant was colonized or infected with the organism 2,3, 1. Weber D et el. Am J Infect Control 2010;38:25-33 2. Drees M et al. Clin Infect Dis 2008;46:678-85 3. Datta M et al. Arch Intern Med 2011;171:491-494 4. Nseir S et al. Clin Microbiol Infect 2010;Nov 4

7. Background Standard methods of cleaning and disinfecting surfaces in hospitalized patient’s rooms are sub-optimal 1,2 Novel technologies used to decontaminate patient rooms include 3,4 –Hydrogen Peroxide Vapor (BioQuell) –Ultraviolet Light (UV-C Radiation) 1. Boyce JM et al. Infect Control Hosp Epidemiol 2010;31:99-101 2. Carling PC. J Hosp Infect 2008;68:273-274 3. Nerandzic MM et al. BMC Infect Dis 2010;10:197 4. Boyce JM et al. Infect Control Hosp Epidemiol 2008;29:723-729 5. Havill NL. Infect Control Hosp Epidemiol 2012; 33(5):000-000

8. Contaminated Surfaces Can Contribute to transmission Contaminated environmental surfaces can contribute to transmission of pathogens –By serving as a source from which healthcare workers contaminate their hands or gloves Contaminated medical equipment that comes into direct contact with the patient can serve as a source of transmission Boyce JM et al. Infection Control Hosp Epidemiology 1997; 28:1142 Bhalla A et al. Infection Control Hosp Epidemiology 2004; 25:164 Hayden MK et al. Infection Control Hosp Epidemiology 2008; 29:149 Passaretti CL, Clin Infect Dis; 2013; 56(1): 27-35

9. Pathogens that survive well in the environment include:  Clostridium difficile  MRSA  VRE  Acinetobacter  Norovirus Survival of Pathogens in the Environment Hota B., et al. Clin Infect Dis 2004; 39:1182 Kramer A., et al. BMC Infect Dis 2006; 6:130

10. CDI Epidemiology / Issues Rates Increasing world wide and in US –Outpacing MRSA Healthcare-associated Infections Common epidemic C. difficile strain continues to be reported from hospitals in expanding list of states More severe disease with –higher mortality – 6.9% (30 days), 16.7% at one year –higher readmissions –higher rates of colectomy in the elderly continues Point-source outbreaks well described Environment plays a role in transmission to other patients –Environmental survival of C. difficile spores is 5 months

11. Clostridium difficile Infection (CDI) 2007 – December 31, 2014 Problem / Opportunity Published incidence rate: 3.8-9.5 cases per 10,000 patient days (SHEA / IDSA Practice Guideline 2010). Cost: $7179 / case (Scott, DR, Direct Medical Costs of HAI in US Hospitals, CDC, March 2009)

12. Vancomycin Resistant Enterococcus (VRE) 1997 – March 31, 2011 2010 VRE Outbreak Investigation 6 new HA VRE cases June 2010 – October 2010 (no HAI VRE cases Jan – June ’10) 3 HA colonizations (transmissions) 3 HA infections PFGE Typing conducted suggested cross-transmission

13. Billings Clinic Hospital Study (August 2010) Phase 1: Baseline Environmental Cleaning Evaluation Study Design: Marked 120 high-touch surfaces in 10 Patient Rooms IPS (2 rooms, N & S) IPM (2 rooms, N & S) ICC (1 room) ATU (1 room) ICU (1 room) ICC (1 room) SSU (1 room) ED (2 rooms) Cleaned & empty room identified Rooms marked with fluorescent marker DAZO, (Ecolab) Room evaluated Terminal cleaning after 2 patient cycles

14. Health Care, Education and Research Study Results High Touch Surfaces Cleaning Study – Hospital Baseline ~ August 2010 High Touch Surfaces cleaned61%(73/120) High Touch Surfaces not cleaned39%(47/120) High Touch Surfaces cleaned 93.2%(2116/2270) High Touch Surfaces not cleaned6.8% (154/2270) Ongoing Performance ~ January - December 2013

15. Footboard Control Panel After Cleaning ~ Fluorescent marks remain

16. Computer Keyboard After Cleaning ~ Fluorescent marks remain

17. High Touch Environmental Surfaces Cleaning Verification Currently, DAZO fluorescent marking system is being used for EVS training and patient room disinfection verification. Process improvement ongoing. January – April 15, 2014 98.0% (1505/1536)

18. High Touch Environmental Surfaces Cleaning Verification

19. Hydrogen Peroxide Vapor (BIOQUELL) UV-C Radiation (Tru-D) Efficacy  Complete surface sterilization ensuring total elimination of pathogens  EPA-registered room sterilant  No verification of complete surface sterilization ~ 2- 4 log kill (no higher than 4)  Not EPA registered Inactivates  Inactivates bacteria, virus’, fungi  C. difficile (20 minutes), VRE, Norovirus, MRSA, Acinetobacter (60 minutes), other Gram negs.  Log reduction of bacteria, virus’, fungi Validation Methodology Yes. Inactivation of 6-log Geobacillus stearothermophilus biological indicator (same method used to validate steam sterilizers) No. Biological Indicators not used to verify efficacy. Reference published studies to verify efficacy Sporicical Yes ~ Kills C. difficile in 20 minutesNo. 4 log reduction C. difficile in 50 minutes Compatibility Safe for porous (fabrics, curtains) and non- porous materials & electronics Literature Support Substantial peer-reviewed, published scientific papers, abstracts Little scientific evidence. Limited application in HC Comparison of Disinfection Technology

20. Hydrogen Peroxide Vapor (BIOQUELL) UV-C Radiation (Tru-D) Purchase Price / Lease Option $56k (lease to own option available) Includes Training $125k Ongoing Operational Expense $20k Hydrogen peroxide Tape $5k Bulbs Data Tracking System Included YesNo Education & Training Provided On-site Support Provided On-site Support Additional Uses Odor Safe in REI / IVF Laboratories Does not produce off-gassing ~ will not harm embryos Light hydrogen peroxide odor Safe in REI / IVF Laboratories Does not produce off-gassing ~ will not harm embryos Lingering odor ~ electrical fire Comparison of Disinfection Technology

21. Bacterial Growth Before & after Decontamination ~ HPV vs. UV-C Number of positive samples 70 68 5 33 N = 75 HPV vs. UVC (p <0.0001) Havill NL, Moore BA, Boyce JM, Infect Control Hosp Epidemiol 2012;33(5):000-000

22. Bacterial Growth After Decontamination 5 Surfaces using HPV vs. UV-C Number of positive samples Cultures with no growth before decontamination excluded 2 4 0 2 1 5 1 12 1 10 HPV: Shadowed vs. non-shadowed (p =1) UVC: Shadowed vs. non-shadowed (p <0.0001) Non-shadowed Shadowed Havill NL, Moore BA, Boyce JM, Hosp Infect Control Epidemiol 2012;33(5):000-000

23. C. difficile Log Reductions Achieved Log reductions 2.5 3.0 2.2 1.7 1.8 Havill NL, Moore BA, Boyce JM, Infect Control Hosp Epidemiol. 2012;33(5):000-000

24. Hydrogen Peroxide Vapor (Bioquell) Process Evaluation Period Feb. 2011 Room cleaned of visible soil Ventilation & doorways sealed Generator creates HPV from 35% Hydrogen Peroxide Aeration unit catalytically converts HPV to oxygen and water vapor Computer allows for process control and auto shut off

25. BioQuell Q-10 Room Sterilization System Hydrogen Peroxide Vapor (HPV)

26. Biological Indicator ~ Test Organism Geobacillus stearothermophilus Purchase HPV 10 6 BI’s from outside lab Run quarterly testing to verify efficacy Expose 4-5 HPV BI discs to 10 grams Hydrogen Peroxide Incubate at 55-60 0 C for 7 days Chemical indicator pilot Ongoing verification of 10 6 log reduction

27. BIOQUELL Unit ~ Vent Sealing Device One to three units per room

28. BioQuell Unit in Use ~ ICU Room 2117 10 min. set-up; 90 min. cycle time; 5 min. tear down

29. BioQuell Trial ~ ICU Room 2117 10 min. set-up; 90 min. cycle time; 5 min. tear down (ICC Room ~ 4466 = 2 hrs, 40 min. / ICU 2114 = 75 min.)

30. Consumables (tape) from one room

31. UV-C Process Room cleaned of visible soil UVC device placed in the center of the room Door closed UVC (254 nm range) delivers 22,000 uW sec/cm 2 Hand held device controls settings monitors the process

32. Tru-D Unit Setup ~ ICC Room 4465 5 min. set-up; 90 min. cycle time; 10 min. tear down

33. Tru-D Unit In-Use ~ ICU Room 2121 12 min. set-up; 54 min. cycle time; 10 min. tear down

34. Conclusions HPV and UV-C significantly reduce bacterial contamination in patient rooms HPV is significantly more effective than UV-C for the eradication of bacteria, including spores UV-C is significantly less effective in shadowed areas from the device

35. Recommendation Acquire BioQuell Q-10 Unit (HPV) technology for terminal room disinfection Adopt objective measurement for cleaning & disinfection processes (e.g. fluorescent marker, ATP) – CDC recommendation, CMS requirement Priority Applications ~ Terminal Disinfection –C. difficile rooms –VRE rooms –IVF Laboratory –Equipment Disinfection ~ create BioQuell Room –Norovirus –Unused supplies in isolation rooms

36. Current Applications Priority Applications ~ Terminal Disinfection –Clostridium difficile rooms (20 minute kill time) –VRE rooms –Norovirus –Emerging Multi-drug Resistant Organisms (MDRO) ESBL, CRE Acinetobacter (BIOQUELL kill time 60 minutes) Other Resistant Gram-negative bacteria –IVF Laboratory in Surgery Center –Disinfection of Equipment / Unused Supplies Unused medical supplies in isolation rooms Otter JA, Infect Control Hosp Epidemiol May 2013, Vol. 34, No.5. 7-9% contamination VRE/MDRO, None of the items were contaminated after HPV (p<.02) Annual cost of supplies discarded at hospital discharge was $387,055. –Currently run cycles in equipment storage rooms, gait belts.

37. Health Care, Education and Research BIOQUELL Cost Per Patient Room $56.00 per 500ml bottle of peroxide 2 – 500ml bottles per room 1 tech at $17.00/hour plus benefits Average time per room start to finish 3.5 hours (set up 30 minutes) Total cost per room = $185.00 Updated 2014 : $220.00 new larger rooms –Room size ranges 40-172 m 3

38. Health Care, Education and Research BIOQUELL ~ 1 Year Cost 281 patient rooms 281 rooms at $185 per room $51,985.00 $5,000 Annual P.M. and training Total Annual Cost: $56,985.00 $13,500/month or Total Annual Cost: $162,000 Internally Managed Program BIOQUELL Managed Program Projected 2014 cost (larger rooms)  25 rooms / month ~ 300 / year  $220.00 per room + $5,000 annual P.M.  Total Annual Cost: $71,000

39. BIOQUELL Use Summary Began November 1, 2011 793 applications –75% C. difficile rooms –20% cycle cleans –4% other MDRO’s ~ VRE, Norovirus, ESBL –1% other (IVF, equipment rooms) Average cycle time 3.5 - 4 hours, 30 min. set-up Perform initial terminal clean with bleach disinfectant Run BI’s quarterly, evaluating CI’s (12 rooms)

40. Lessons Learned Advantages  Efficacy  Efficacy validated  Retain EVS personnel  Decontamination Specialists  Substantial salary increase  Staff acceptance high  Gait belts  Equipment storage areas Disadvantages  Customer service decline  Recent breakdowns  Longer room turnover  Missed decontaminations  High census, velocity  Breakdowns

41. Health Care, Education and Research Learner Objectives 1.Describe two unique characteristics, changing epidemiology, and environmental persistance of Clostridium difficile bacteria 2.Discuss two strategies that prevent the transmission of healthcare-associated Clostridium difficile and other pathogens 3.Describe the current environmental disinfection strategies and application of hydrogen peroxide vapor ~ BIOQUELL 4.Discuss advantages and disadvantages of hydrogen peroxide vapor disinfection technology

42. Questions?

43. Inter-rater Reliability Study November 2013 – February 28, 2014 UnitResults ATU56% (51/91) ED71% (85/119) FBC/LDRP73% (19/26) ICC66% (59/89) ICU71% (49/69) IPM74% (185/250) IPS63% (95/150) NICU76% (25/33) SSU75% (53/71) Aspen81% (44/54) TCU33% (22/67) Dialysis69% (20/29) Radiology45% (5/11) Surgery Center58% (11/19) Overall Performance67% (712/1058) Hand Hygiene Study