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Elaine L. Larson Lectureship Disinfection and Sterilization: From Benchtop to Bedside

Elaine L. Larson Lectureship Disinfection and Sterilization: From Benchtop to Bedside. William A. Rutala, Ph.D., M.P.H., C.I.C. University of North Carolina (UNC) Health Care and UNC at Chapel Hill, NC. Disinfection and Sterilization: From Benchtop to Bedside.

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Elaine L. Larson Lectureship Disinfection and Sterilization: From Benchtop to Bedside

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  1. Elaine L. Larson LectureshipDisinfection and Sterilization:From Benchtop to Bedside William A. Rutala, Ph.D., M.P.H., C.I.C. University of North Carolina (UNC) Health Care and UNC at Chapel Hill, NC

  2. Disinfection and Sterilization:From Benchtop to Bedside • Improved products/processes/technologies • Low-temperature sterilization technology, rapid readout BIs, improved HLD/LLD, wipes, microfiber • Improved knowledge • Emerging pathogens-C. difficile, Norovirus, MDROs • The role of the environment in disease transmission • Guidelines-integration of science into practice and improved patient care

  3. DISCLOSURES • Consultation • Advanced Sterilization Products, Clorox • Honoraria (speaking) • Advanced Sterilization Products, 3M • Grants • CDC

  4. Disinfection and Sterilization:From Benchtop to Bedside • Improved products/processes/technologies • Low-temperature sterilization technology, rapid readout BIs, improved HLD/LLD, wipes, microfiber • Improved knowledge • Emerging pathogens-C. difficile, Norovirus, MDROs • The role of the environment in disease transmission • Guidelines-integration of science into practice and improved patient care

  5. DISINFECTION AND STERILIZATION • EH Spaulding believed that how an object will be disinfected depended on the object’s intended use • CRITICAL- objects which enter normally sterile tissue or the vascular system or through which blood flows should be sterile • SEMICRITICAL - objects that touch mucous membranes or skin that is not intact require a disinfection process (high-level disinfection[HLD]) that kills all microorganisms but high numbers of bacterial spores • NONCRITICAL - objects that touch only intact skin require low-level disinfection

  6. New Trends in Sterilization of Patient Equipment • Alternatives to ETO-CFC ETO-CO2, ETO-HCFC, 100% ETO • New Low Temperature Sterilization Technology Hydrogen Peroxide Gas Plasma-most common Vaporized hydrogen peroxide Ozone

  7. Rapid Readout BIs for Steam Required a 1-3h Readout Compared to 24-48h

  8. DISINFECTION AND STERILIZATION • EH Spaulding believed that how an object will be disinfected depended on the object’s intended use • CRITICAL - objects which enter normally sterile tissue or the vascular system or through which blood flows should be sterile • SEMICRITICAL - objects that touch mucous membranes or skin that is not intact require a disinfection process (high-level disinfection[HLD]) that kills all microorganisms but high numbers of bacterial spores • NONCRITICAL - objects that touch only intact skin require low-level disinfection

  9. High-Level Disinfection of “Semicritical Objects” Exposure Time > 8m-45m (US), 20oC Germicide Concentration_____ Glutaraldehyde > 2.0% Ortho-phthalaldehyde 0.55% Hydrogen peroxide* 7.5% Hydrogen peroxide and peracetic acid* 1.0%/0.08% Hydrogen peroxide and peracetic acid* 7.5%/0.23% Hypochlorite (free chlorine)* 650-675 ppm Accelerated hydrogen peroxide 2.0% Peracetic acid 0.2% Glut and isopropanol 3.4%/26% Glut and phenol/phenate** 1.21%/1.93%___ *May cause cosmetic and functional damage; **efficacy not verified

  10. DISINFECTION AND STERILIZATIONRutala, Weber, HICPAC. 2008. www.cdc.gov • EH Spaulding believed that how an object will be disinfected depended on the object’s intended use • CRITICAL - objects which enter normally sterile tissue or the vascular system or through which blood flows should be sterile • SEMICRITICAL - objects that touch mucous membranes or skin that is not intact require a disinfection process (high-level disinfection[HLD]) that kills all microorganisms but high numbers of bacterial spores • NONCRITICAL- objects that touch only intact skin require low-level disinfection

  11. LOW-LEVEL DISINFECTION FOR NONCRITICAL EQUIPMENT AND SURFACES Exposure time > 1 min Germicide Use Concentration Ethyl or isopropyl alcohol 70-90% Chlorine 100ppm (1:500 dilution) Phenolic UD Iodophor UD Quaternary ammonium UD Improved hydrogen peroxide (HP) 0.5%, 1.4% ____________________________________________________ UD=Manufacturer’s recommended use dilution

  12. IMPROVED HYDROGEN PEROXIDE (HP) SURFACE DISINFECTANT • Advantages • 30 sec -1 min bactericidal and virucidal claim (fastest non-bleach contact time) • 5 min mycobactericidal claim • Safe for workers (lowest EPA toxicity category, IV) • Benign for the environment; noncorrosive; surface compatible • One step cleaner-disinfectant • No harsh chemical odor • EPA registered (0.5% RTU, 1.4% RTU, wet wipe) • Disadvantages • More expensive than QUAT

  13. BACTERICIDAL ACTIVITY OF DISINFECTANTS (log10 reduction) WITH A CONTACT TIME OF 1m WITH/WITHOUT FCS. Rutala et al. ICHE. In press Improved hydrogen peroxide is significantly superior to standard HP at same concentration and superior or similar to the QUAT tested

  14. CONTACT TIMES • Follow the EPA-registered contact times, ideally • Some products have achievable contact times for bacteria/viruses (30 seconds-2 minutes) • Other products have non-achievable contact times • If use a product with non-achievable contact time • Use >1 minutes based on CDC guideline and scientific literature • Prepare a risk assessment

  15. Hospital Privacy Curtains(sprayed “grab area” 3x from 6-8” with IHP and allowed 2 minute contact)

  16. Decontamination of Curtains with Improved HPRutala, Gergen, Weber. 2012 * All isolates after disinfection were Bacillus sp

  17. WipesCotton, Disposable, Microfiber Wipe should have sufficient wetness to achieve the disinfectant contact time. Discontinue use of the wipe if no longer leaves the surface visibly wet for > 1m

  18. SURFACE DISINFECTIONEffectiveness of Different Methods, Rutala et al. 2012

  19. MicrofiberMicrofiber demonstrated superior microbial removal compared to cotton mop with detergent; use of disinfectant did not improve microbial elimination demonstrated by the microfiber

  20. Disinfection and Sterilization:From Benchtop to Bedside • Improved products/processes/technologies • Low-temperature sterilization technology, rapid readout BIs, improved HLD/LLD, wipes, microfiber • Improved knowledge • Emerging pathogens-C. difficile, Norovirus, MDROs • The role of the environment in disease transmission • Guidelines-integration of science into practice and improved patient care

  21. Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants Prions Spores (C. difficile) Mycobacteria Non-Enveloped Viruses (norovirus) Fungi Bacteria (MRSA, VRE,Acinetobacter) Enveloped Viruses Most Resistant Most Susceptible

  22. DISINFECTANTS AND ANTISEPSISC. difficile spores at 10 and 20 min, Rutala et al, 2006 • ~4 log10 reduction (3 C. difficile strains including BI-9) • Clorox, 1:10, ~6,000 ppm chlorine (but not 1:50) • Clorox Clean-up, ~19,100 ppm chlorine • Tilex, ~25,000 ppm chlorine • Steris 20 sterilant, 0.35% peracetic acid • Cidex, 2.4% glutaraldehyde • Cidex-OPA, 0.55% OPA • Wavicide, 2.65% glutaraldehyde • Aldahol, 3.4% glutaraldehyde and 26% alcohol

  23. C. difficile CONTROL MEASURESOrenstein et al. ICHE 2011;32:1137 • In units with high endemic C. difficile infection rates or in an outbreak setting, use dilute solutions of 5.25-6.15% sodium hypochlorite (e.g., 1:10 dilution of bleach) for routine disinfection. (Category II). • We now use chlorine solution in all CDI rooms for routine daily and terminal cleaning (formerly used QUAT in patient rooms with sporadic CDI). One application of an effective product covering all surfaces to allow a sufficient wetness for > 1 minute contact time. Chlorine solution normally takes 1-3 minutes to dry. • For semicritical equipment, glutaraldehyde (20m), OPA (12m) and peracetic acid (12m) reliably kills C. difficile spores using normal exposure times

  24. INACTIVATION OF MURINEAND HUMAN NOROVIRUES Rutala WA, Folan MP, Tallon LA, Lyman WH, Park GW, Sobsey MD, Weber DJ. 2007

  25. WOULD OUR QUAT KILL MRSA?Rutala et al. J Clin Microbiol. 1983;18:683

  26. SUSCEPTIBILITY OF RESISTANT BACTERIA TO DISINFECTANTSRutala et al. ICHE 1997;18:417 No relationship between antibiotic resistance and disinfectant resistance

  27. EFFECTIVENESS OF DISINFECTANTS AGAINST MRSA AND VRE Antibiotic resistance does not correlate to increased resistance to disinfectants Rutala WA, et al. Infect Control Hosp Epidemiol 2000;21:33-38.

  28. Disinfection and Sterilization:From Benchtop to Bedside • Improved products/processes/technologies • Low-temperature sterilization technology, rapid readout BIs, improved HLD/LLD, wipes, microfiber • Improved knowledge • Emerging pathogens-C. difficile, Norovirus, MDROs • The role of the environment in disease transmission • Guidelines-integration of science into practice and improved patient care

  29. ENVIRONMENTAL CONTAMINATION LEADS TO HAIs • There is increasing evidence to support the contribution of the environment to disease transmission • This supports comprehensive disinfecting regimens (goal is not sterilization) to reduce the risk of acquiring a pathogen from the healthcare environment

  30. KEY PATHOGENS WHERE ENVIRONMENTIAL SURFACES PLAY A ROLE IN TRANSMISSION • MRSA • VRE • Acinetobacter spp. • Clostridium difficile • Norovirus • Rotavirus • SARS

  31. Thoroughness of Environmental CleaningCarling et al. ECCMID, Milan, Italy, May 2011 >110,000 Objects Mean = 32%

  32. ENVIRONMENTAL CONTAMINATION LEADS TO HAIsWeber, Rutala, Miller et al. AJIC 2010;38:S25 • Microbial persistence in the environment • In vitro studies and environmental samples • MRSA, VRE, AB, CDI • Frequent environmental contamination • MRSA, VRE, AB, CDI • HCW hand contamination • MRSA, VRE, AB, CDI • Relationship between level of environmental contamination and hand contamination • CDI

  33. ENVIRONMENTAL CONTAMINATION LEADS TO HAIS Weber, Rutala, Miller et al. AJIC 2010;38:S25 • Person-to-person transmission • Molecular link • MRSA, VRE, AB, CDI • Housing in a room previously occupied by a patient with the pathogen of interest is a risk factor for disease • MRSA, VRE, CDI • Improved surface cleaning/disinfection reduces disease incidence • MRSA, VRE, CDI

  34. C. difficile Environmental ContaminationRutala, Weber. SHEA. 3rd Edition. 2010 • Frequency of sites found contaminated~10->50% from 13 studies-stethoscopes, bed frames/rails, call buttons, sinks, hospital charts, toys, floors, windowsills, commodes, toilets, bedsheets, scales, blood pressure cuffs, phones, door handles, electronic thermometers, flow-control devices for IV catheter, feeding tube equipment, bedpan hoppers • C. difficile spore load is low; 7 studies assessed the spore load and most found <10 colonies on surfaces found to be contaminated. Two studies reported >100; one reported a range of “1->200” and one study sampled several sites with a sponge and found 1,300 colonies C. difficile.

  35. FREQUENCY OF ACQUISITION OF MRSA ON GLOVED HANDS AFTER CONTACT WITH SKIN AND ENVIRONMENTAL SITES No significant difference on contamination rates of gloved hands after contact with skin or environmental surfaces (40% vs 45%; p=0.59) Stiefel U, et al. ICHE 2011;32:185-187

  36. Risk of Acquiring MRSA and VREfrom Prior Room Occupants • Admission to a room previously occupied by an MRSA-positive patient or VRE-positive patient significantly increased the odds of acquisition for MRSA and VRE (although this route is a minor contributor to overall transmission). Arch Intern Med 2006;166:1945. • Prior environmental contamination, whether measured via environmental cultures or prior room occupancy by VRE-colonized patients, increases the risk of acquisition of VRE. Clin Infect Dis 2008;46:678. • Prior room occupant with CDAD is a significant risk for CDAD acquisition. Shaughnessy et al. ICHE 2011;32:201

  37. TRANSMISSION MECHANISMS INVOLVING THE SURFACE ENVIRONMENT Rutala WA, Weber DJ. In:”SHEA Practical Healthcare Epidemiology” (Lautenbach E, Woeltje KF, Malani PN, eds), 3rd ed, 2010.

  38. Thoroughness of Environmental CleaningCarling et al. ECCMID, Milan, Italy, May 2011 >110,000 Objects Mean = 32%

  39. MONITORING THE EFFECTIVENESS OF CLEANINGCooper et al. AJIC 2007;35:338 • Visual assessment-not a reliable indicator of surface cleanliness • ATP bioluminescence-measures organic debris (each unit has own reading scale, <250-500 RLU) • Microbiological methods-<2.5CFUs/cm2-pass; can be costly and pathogen specific • Fluorescent marker

  40. TERMINAL ROOM CLEANING: DEMONSTRATION OF IMPROVED CLEANING • Evaluated cleaning before and after an intervention to improve cleaning • 36 US acute care hospitals • Assessed cleaning using a fluorescent dye • Interventions • Increased education of environmental service workers • Feedback to environmental service workers †Regularly change “dotted” items to prevent targeting objects Carling PC, et al. ICHE 2008;29:1035-41

  41. ROOM DECONTAMINATION UNITSRutala, Weber. ICHE. 2011;32:743

  42. UV Room Decontamination • Fully automated, self calibrates, activated by hand-held remote • Room ventilation does not need to be modified • Uses UV-C (254 nm range) to decontaminate surfaces • Measures UV reflected from walls, ceilings, floors or other treated areas and calculates the operation time to deliver the programmed lethal dose for pathogens. • UV sensors determines and targets highly-shadowed areas to deliver measured dose of UV energy (12,000µWs/cm2 bacteria) • After UV dose delivered, will power-down and audibly notify the operator • Reduces colony counts of pathogens by >99.9% within 20-25m

  43. EFFECTIVENESS OF UV ROOM DECONTAMINATION Rutala WA, et al. Infect Control Hosp Epidemiol. 2010;31:1025-1029.

  44. HP SYSTEMS FOR DECONTAMINATION OF THE HOSPITAL ENVIRONMENT Falagas, et al. J Hosp Infect. 2011;78:171.

  45. ROOM DECONTAMINATION WITH HPV • Study design • Before and after study of HPV • Outcome • C. difficile incidence • Results • HPV decreased environmental contamination with C. difficile (p<0.001), rates on high incidence floors from 2.28 to 1.28 cases per 1,000 pt days (p=0.047), and throughout the hospital from 1.36 to 0.84 cases per 1,000 pt days (p=0.26) Boyce JM, et al. Infect Control Hosp Epidemiol. 2008;29:723-729.

  46. UV ROOM DECONTAMINATIONRutala, Weber. ICHE. 2011;32:744

  47. HP ROOM DECONTAMINATIIONRutala, Weber. ICHE. 2011;32:743

  48. A Four-Arm Prospective, Multicenter Study to Assess Efficacy, Effectiveness and Feasibility of Enhanced Room Disinfection with Chlorine and UV Light Using Clinical and Microbiologic Outcomes

  49. Rapid Hospital Room Decontamination Using UV Light With a Nanoscale Reflective Coating • Assessed the time required to kill HAI pathogens in a room with standard white paint (2-5% reflective) versus walls coated with an agent formulated to be reflective to UV-C wavelengths (65% reflective) • Coating uses nanoscale metal oxides whose crystal structures are reflective to UV-C • Coating is white in appearance and can be applied with a brush or roller in the same way as any common interior latex paint • Cost to coat walls used in this study was estimated to be <$300.

  50. UV Reflective CoatingRutala, Gergen, Tande, Weber. 2012 With the nanoscale reflective coating, cycle times were 5-10m (~80% reduction) which would substantially reduce the turnover time of the room

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