Cindy Winfrey MSN, RN, CIC Infection Transmission Is A Contact Sport Environmental Disinfection Making the Right Choice Cindy Winfrey MSN, RN, CIC

Program Objectives Understand EPA regulations and requirements for surface disinfectants Comprehend disinfectant label claims Identify Influencing factors for disinfection efficacy Describe recommendations for special pathogens. Discuss factors to consider when choosing disinfectants

Is Infection Transmission A Contact Sport? Patient contact with contaminated surfaces or medical equipment Contamination of the environment & poor hand hygiene contribute to the spread of resistant pathogens such as MRSA, VRE and other significant pathogens Hands of healthcare workers come in contact with a contaminated surface and patients Environmental surfaces/inanimate objects (fomites) serve as reservoirs

The Dirty Dozen 7. Women’s purses (makeup;bottom) 8. Playgrounds 9. Health club (mats/machines) 10. Your bathtub 11. Your office telephone 12. Hotel Room Remote 1. Kitchen Sink >500,000 bacteria per sq.in. drain 2. Airplane bathrooms 3. Wet laundry 4. Public drinking fountains 5. Shopping cart handles 6. ATM buttons

Healthcare Environmental Hygiene Study Group 23 Acute Care Hospitals (16 East; 7 West) 106 to 709 Beds (mean 252 beds) Evaluated terminal cleaning of rooms using a solution that fluoresces brightly when exposed to ultraviolet light Targeted ICUs and regular units Highest Risk Objects: sinks; toilet seats, toilet hand bars, bedside tables, tray tables, doorknobs, BR light switches, etc. Carling P.C. et al. Identifying Opportunities to Enhance Environmental Cleaning In 23 Acute Care Hospitals, ICHE, January 2008.

Figure 1. Overall percentage of high risk objects determined to have been cleaned in each of the 23 acute care hospitals From Infection Control and Hospital Epidemiology 29(1):1–7. © 2007 by The Society for Healthcare Epidemiology of America..

UNDERSTANDING REGULATIONS What does this mean to You?

Rules & Regulations for Surface Disinfectants Environmental Protection Agency (EPA) Classifies public health antimicrobials into categories that depend on the stringency of tests the product has passed EPA Categories: -Disinfectants -Sanitizers -Sterilants EPA and FDA In the United States, chemical germicides formulated as sanitizers, disinfectants, or sterilants are regulated in interstate commerce by the Antimicrobials Division, Office of Pesticides Program, EPA, under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of 1947, as amended 792. Under FIFRA, any substance or mixture of substances intended to prevent, destroy, repel, or mitigate any pest (including microorganisms but excluding those in or on living humans or animals) must be registered before sale or distribution. To obtain a registration, a manufacturer must submit specific data about the safety and effectiveness of each product. For example, EPA requires manufacturers of sanitizers, disinfectants, or chemical sterilants to test formulations by using accepted methods for microbiocidal activity, stability, and toxicity to animals and humans. The manufacturers submit these data to EPA along with proposed labeling. If EPA concludes the product can be used without causing “unreasonable adverse effects,” then the product and its labeling are registered, and the manufacturer can sell and distribute the product in the United States. In general, EPA regulates disinfectants and sterilants used on environmental surfaces, and not those used on critical or semicritical medical devices; the latter are regulated by FDA. In June 1993, FDA and EPA issued a “Memorandum of Understanding” that divided responsibility for review and surveillance of chemical germicides between the two agencies. Under the agreement, FDA regulates liquid chemical sterilants used on critical and semicritical devices, and EPA regulates disinfectants used on noncritical surfaces and gaseous sterilants 793. In 1996, Congress passed the Food Quality Protection Act (FQPA). This act amended FIFRA in regard to several types of products regulated by both EPA and FDA. One provision of FQPA removed regulation of liquid chemical sterilants used on critical and semicritical medical devices from EPA’s jurisdiction, and it now rests solely with FDA 792, 794. EPA continues to register nonmedical chemical sterilants. FDA and EPA have considered the impact of FQPA, and in January 2000, FDA published its final guidance document on product submissions and labeling. Antiseptics are considered antimicrobial drugs used on living tissue and thus are regulated by FDA under the Food, Drug and Cosmetic Act. FDA regulates liquid chemical sterilants and high-level disinfectants intended to process critical and semicritical devices. FDA has published recommendations on the types of test methods that manufacturers should submit to FDA for 510[k] clearance for such agents.

Terminology – EPA Categories Sterilant: An agent that destroys or eliminates all forms of microbial life in the inanimate environment, including all forms of vegetative bacteria, bacterial spores, fungi, fungal spores, and viruses Non-liquid chemical sterilants (e.g., ethylene oxide) and liquid chemical sterilants used on surfaces or objects that are not critical or semi-critical devices (e.g. veterinary equip.) FDA regulates liquid chemical sterilants for medical

Terminology – EPA Categories Disinfectant: an agent that destroys or irreversibly inactivates infectious or other undesirable bacteria, pathogenic, or viruses, but not necessarily bacterial spores, on surfaces or inanimate objects EPA registers three types of disinfectant products (based upon submitted and reviewed efficacy data)

Limited Disinfectant Agent limited to either gram-positive or gram-negative microorganisms Example: some pine oil toilet bowel products are only effective against gram-negative bacteria

General or Broad-spectrum Disinfectant An agent that is effective against both gram-positive and gram-negative bacteria Most household disinfectants fall in this group Major uses for general disinfectants are swimming pools and water purifiers

Hospital Disinfectant Agent effective against : Gram negative and Gram positive organisms (Staphylococcus aureus; Salmonella choleraesuis) plus Pseudomonas aeruginosa Used in hospitals, clinics, dental offices, and other healthcare facilities A registrant that wants to market a hospital disinfectant as a virucide must provide data to EPA showing the product is effective against specific virus the company wishes to list on label Same for tuberculocide – product effective against a Mycobacterium that EPA accepts as a surrogate for the actual tuberculosis bacterium

Terminology – EPA Categories Sanitizer: Agent that reduces, but does not necessarily eliminate, the microorganisms in the inanimate environment to levels considered safe by public health codes or other regulations EPA registers many sanitizers i.e., non food contact surfaces, food contact surfaces Performance standard for food contact surfaces is 99.999% (5-log reduction) within 30 sec; for non-food use sanitizer the standard is 99.9% (3-log) reduction in 5 min.

LOG REDUCTION 1 Log reduction = 90% 2 Log reduction = 99.0% 3 Log reduction = 99.9 % 4 Log reduction = 99.99% 5 log reduction = 99.999%

Magnitude of Log Reduction 1 log10 = reduced by 90% (90% of 100,000 organisms = 90,000 killed, leaves 10,000 on skin) 2 log10 = reduced by 99%(1,000 left) 3 log10 = reduced by 99.9% (100 left) 4 log10 = reduced by 99.99% (10 left)

Key Information to Look for on Disinfectant Labels Germicidal as Bacterialcidal, Tuberculocidal, Virucidal (May list pathogens) Active ingredients Cautions Areas of Use Directions for Use Contact time Special Instructions Disposal, Storage Precautionary/Safety statements First Aid EPA registration number

Kill Claims vs. Contact Times Kill Claim is defined when a disinfectant product is tested to have 100% efficacy against a specific organism at a determined contact time; and the testing data has been accepted by the EPA Bridging of Data for Label Claims – What does this mean? Kill Claim is defined when a disinfectant product is tested to have 100% efficacy against a specific organism at a determined contact time; and the testing data has been accepted by the EPA

Kill Claims vs. Contact Times continued Contact Time is the time needed for the germicide solution to remain wet on the surface to achieve disinfection of the stated kill claims on the manufacturer’s label For general directions for use, manufacturers are required to put the highest contact time in those directions. There is usually a different shorter contact time in the “Special Instructions for Bloodborne Pathogens” directions for use section of the product label

Contact Time “ Disinfect noncritical surfaces with an EPA-registered hospital disinfectant using the label’s safety precautions and use directions. Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, many scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, the user must follow all applicable label instructions on EPA-registered products. If the user selects exposure conditions that differ from those of EPA-registered products label, the user assumes liability for any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA” Rutala, W. Disinfection, Sterilization and Antisepsis Principles, Practices, Current Issues and New Research. APIC Conference Proceedings, 2006. Page 103.

Influencing Factors for Disinfection Efficacy Cleaning of object (clean vs. disinfect) Remove Bioburden (organic or inorganic load present) Type and level of contamination Concentration of and exposure time Nature of object Temperature and relative humidity Efficacy of These Processes Can be Affected By: Concentration and Duration of Contact Type and Number of Pathogens Surface Areas to Treat Temperature of the Environment Presence of Soap Presence of Organic Materials

Disinfectants Used in Healthcare* (Intermediate-Low level) Phenolics Quaternary ammonium compounds Iodophors Alcohols Chlorine and chlorine compounds Combination e.g., Alc/Quat * Disinfectants are not interchangeable. Select an appropriate disinfectant for any item and use. Cautions with some disinfectant use causing breathing problems e.g. chlorines.

Approach to Disinfection and Sterilization Spaulding’s Classification - >30 yrs old Critical Items – High risk of infection – sterile tissue Semicritical items – Contact with mucous membranes or nonintact skin Noncritical items – Contact with intact skin (environmental disinfection; inanimate objects) Dr. Earle H. Spaulding was the first and only leader to formalize a classification system for disinfection and sterilization. He believed that how an object will be disinfected depended on the object’s intended use. Spaulding’s approach to disinfecting objects is divided into three categories: Critical, Semi-critical, and Noncritical. Spaulding’s approach has been retained and refined and successfully used by IP’s and others when planning methods for disinfection and sterilization

Levels of Disinfection Sterilization High-level disinfection (expected to destroy all microorganisms except high numbers of bacterial spores) Intermediate-level disinfection (inactivates Mycobacterium tuberculosis, vegetative bacteria, most viruses, most fungi) Low-level disinfection (can kill most bacteria, some viruses, and some fungi, but cannot be relied on to kill resistant microorganisms such as tubercle bacilli or bacterial spores)

APIC HIERARCHY OF PATHOGENS Prions Descending Order of Resistance to Germicidal Chemicals. Rutala, W. APIC Guideline for Selection & Use of Disinfectants-1996

Pathogens of Concern

Viruses Non-enveloped (non lipid) Enveloped (lipid) Generally transmitted by fecal-oral route and contaminated fomites Sturdy Can withstand drying, the effects of detergents, and extremes of pH and temperature Can withstand acid environment of stomach Fragile (they require an intact envelop for infectivity) Must remain wet and are spread in: (1) Respiratory droplets, blood, mucus, saliva, and semen (2) injection (3) organ transplants) Murphy, Rosenthal, Pfaller. Medical Microbiology 5th Ed Chapter 29, pp. 499-500. 2005.

Viruses Non-enveloped (non lipid) Norwalk Virus (Caliciviridae) Parvovirus Enterovirus Rhinovirus Rotavirus Hep A Enveloped (lipid) Herpes Simplex HIV CMG Influenza Coronavirus Hep B, C RSV

ESBL producing E. Coli; Klebsiella pneumoniae Vegetative Bacteria MRSA VRE ESBL producing E. Coli; Klebsiella pneumoniae Carbapenem-Resistant Enterobacteriaceae (CRE) Acinetobacter baumanii ; A. calcoaceticus; A. lwoffii Pseudomonas aeruginosa E. Coli 0157:H7 CRKP is resistant to almost all available antimicrobial agents, and infections with CRKP have been associated with high rates of morbidity and mortality, particularly among persons with prolonged hospitalization and those who are critically ill and exposed to invasive devices (e.g., ventilators or central venous catheters).

Rutala’s Computer Keyboard Study ICHE – April, 2006 Increase use of computers in patient care areas has led to contamination of keyboards as reservoirs of pathogens Study examined the efficacy of different disinfectants on the keyboard Determined if there was cosmetic (key lettering removed) or functional changes after 300 wipes

Rutala’s Computer Keyboard Study ICHE – 2006; 27:372 All tested products were effective in removing or inactivating test pathogens MRSA, P. aeruginosa, VRE Contact time with disinfectant: 5 sec wipe and air dry Quats demonstrated excellent sustained activity against VRE and antimicrobial activity was maintained over the 48hr test period

Transmission of A. baumannii AJIC - 2008 Argentina Study: Barbolla et. al. Molecular epidemiology of Acinetobacter baumannii spread in an adult intensive care unit under an endemic setting. AJIC. August, 2008. 1042 Screening samples – 159 positive Ab (Clone “If” found in all types of samples : 56.9% patients, 66.7% staff hands and 84.1 environment samples) 30.8% Surfaces of handrub antiseptic dispenser; 39% Bed Rails; 12% Surfaces of mechanical vent equip Frequently touched surfaces close to contaminated patients seemed to have role in transmission

Clostridia difficile

Inactivation of C. difficile C. difficile spores are more resistant than vegetative cells to commonly used surface disinfectants Environment may be an important source of C. difficile spores Two EPA-registered products specific for inactivating C. difficile spores Recommendations: Use of diluted sodium hypochlorite (1:10 dilution of bleach) in units with high endemic rates and outbreaks1 Chlorox Ultra (6.15% sodium hypochlorite). Household bleach is 5.25%. Contact time is 10 min. Kimtech wipe; Peracetic acid 0.1 – 0.3 %, Hydrogen Peroxide 4 – 5 %, acetic acid 4 – 5 % contact time 6 min. 1Rutala, W. Disinfection, Sterilization and Antisepsis Principles, Practices, Current Issues and New Research. APIC Conference Proceedings, 2006. Page 98.

Clostridia difficile continued 2008 EPA Mandates EPA has determined all pesticide products that are registered for use against C. difficile must demonstrate efficacious performance against the spore form EPA believes claims of efficacy against the vegetative form is not the organism of concern for infection control processes Efficacy testing performed on the vegetative form of the organism will not support a claim for C. difficile spores Manufacturers with vegetative label claims were notified by letter to remove these claims EPA has developed guidelines to address label claims for C. difficile spores

CDC Recommendations Clean noncritical medical equipment surfaces with a detergent/disinfectant. This may be followed by an application of an EPA-registered hospital disinfectant with or without a tuberculocidal claim (depending on the nature of the surface and the degree of contamination), in accordance with germicide label instructions

CDC Recommendations Cont. Do not use alcohol to disinfect large environmental surfaces Clean and disinfect high-touch surfaces (e.g., doorknobs, bed rails, light switches, and surfaces in and around toilets in patients' rooms) on a more frequent schedule than minimal- touch housekeeping surfaces.

CDC Recommendations for Special Organisms Thoroughly clean and disinfect environmental and medical equipment surfaces on a regular basis by using EPA-registered disinfectants in accordance with manufacturers' instructions Do not use high-level disinfectants (i.e., liquid chemical sterilants) on environmental surfaces; such use is inconsistent with label instructions because of the toxicity of the chemicals

Special Organisms Cont. Use standard cleaning and disinfection protocols to control environmental contamination with antibiotic-resistant, gram-positive cocci (e.g MRSA, VRE) In units with high rates of endemic Clostridium difficile infection or in an outbreak setting, use dilute solutions of 5.25%–6.15% sodium hypochlorite (e.g., 1:10 dilution of household bleach) for routine environmental disinfection.

ASHES 2008 Practice Guidelines Establish cleaning checklists Prefer pour spouts not spays (cotton decreases efficacy of Quats) Never re-immerse cloth (cloth & bucket systems) Training Establish who cleans what Understand which products are compatible with equipment Clean and disinfect as usual for C. diff and then wipe high touch areas with bleach. American Society for Healthcare Environmental Services (ASHES) of the American Hospital Association http://www.ashes.org

Selecting the Right Disinfectant

Current Disinfectants Quaternary ammonium compounds Quat/Alcohol formulations Sodium hypochlorite formulations (bleach) Phenolics New Technology: Accelerated Hydrogen Peroxide; Silver

Selecting Disinfectants A dilemma for Facilities - Many types of equipment and end users - Confusion about regulatory compliance (CMS, TJC) - IC involvement in product / equipment selection? Focus on Practice or Product or Both? - Monitor Practices - Education of staff and their involvement in prevention initiatives - Who is responsible for cleaning/disinfecting environmental surfaces and equipment?

Selecting Disinfectants continued Should one disinfectant be used hospital-wide? Medical equipment specifying specific product to use e.g., IV pumps, Patient Monitoring Equipment Consider safety and precautionary factors Consider stability and shelf life of product Consider convenience and ease of use

Going Green? Hospitals moving toward green initiatives - building materials - lighting - water usage (more efficient toilets, faucets) Insuring “green” initiatives don’t inadvertently place infection control and prevention efforts at risk Green cleaners are “cleaners”, but don’t disinfect Summer 2008 Prevention Strategist (APIC), “Finding a Balance”.

Summary The environment and fomites play a role in infection transmission thus a “contact sport”. Understanding the rules and regulations for surface disinfectants, kill claims, contact times and product labels is key to making good choices in selecting disinfectants. In dealing with problem pathogens, understand that it is important to focus on practices & products.

Questions??????

THANK YOU

References CDC Guideline for disinfection and sterilization in healthcare facilities., 2008 . Available at: http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf CDC Guidelines for environmental infection control in healthcare facilities. MMWR 2003:52(RR 10):1-42. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm Murphy, Rosenthal, Pfaller. Medical Microbiology 5th Ed Chapter 29, pp. 499-500. 2005. Rutala, W. APIC Guideline for Selection & Use of Disinfectants-1996 Spaulding EH. Chemical disinfection of medical and surgical materials. In: Lawrence C, Block S S, eds. Disinfection, Sterilization and Preservation. Philadelphia: Lea & Febiger, 1968:517-531.