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Current Dental Surface Disinfection Protocols and a Review of the
New 1-Minute Surface Disinfectants CaviCide1™ and CaviWipes1™
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Current Dental Surface Disinfection Protocols
and a Review of the New 1 Minute Surface
Disinfectants CaviCide1 and CaviWipes1
Authors: Nancy Andrews, RDHBS: Ms. Andrews graduated from, and was a clinical instructor in Dental Hygiene at University of Southern California and teaches Oral Pathology, Preventive Dentistry and Infection Control at West Coast University Dept. of Dental Hygiene. She is a nationally recognized speaker, author and consultant, focusing on infectious diseases, clinical safety, instrument sharpening, ergonomics and preventive dentistry. Ms. Andrews is a “top 100 U.S. Speaker”, and is on the California Dental Assoc., ADA and OSAP speaker’s / Consultants bureaus. Ms. Andrews has had over 80 articles published in peer reviewed professional journals, has contributed to dental textbooks and national guidance documents. She also writes regular infection control columns in dental industry publications and trains sales reps in infection control. She has presented over 350 seminars nationally and internationally on Diseases and Infection Prevention, Disaster Preparedness, Biofilms, building contamination and Dental Waterlines, Instrument Sharpening, Ultrasonic Scaling, and Ergonomics. Noel Brandon-‐Kelsch, RDHAP: Noel Brandon-‐Kelsch RDHAP is an international speaker, writer and Registered Dental Hygienist in Alternative Practice. She is passionate about oral health and has the uncanny ability to motivate and enlighten audiences through her unique humor and cutting edge information. She takes tough subject matter and presents it in such an interesting way that it becomes thought provoking even to those not involved in her industry. Her research and dedication has brought many changes about in the field of infection control. She is the infection control columnist for RDH magazine, a syndicated newspaper columnist, has been published in many books. She has brought the message of oral health to media networks from Disney Radio to ESPN. Noel has received many national awards including Colgate Bright Smiles Bright Futures, RDH Magazine Sun Star Butler Award of Distinction, USA magazine Make a Difference Day Award, President’s Service Award, Foster Parent of the Year and Hu-‐Friedy Master Clinician Award. Noel is a Past President of the California Dental Hygienist’s Association, Board Member of the Santa Barbara Ventura Dental Foundation, facilitator for Simi Valley Free Dental Clinic, Sunstar America, GC America, Philip Life Style and Total Care, Hu Friedy, Orascoptic, Dux Dental, American Eagle, Key Organization Leader, member and Newsletter Editor for the Organization for Safety and Asepsis Procedures. ©TotalCare 2012. All Rights Reserved. CaviCide, CaviWipes and TotalCare are trademarks of Metrex Research LLC.
Introduction The risk of contracting a serious infection while providing or receiving medical or dental care is a compelling concern for millions of patients and dental workers – a concern generated by media reports of healthcare-‐associated infections and deaths. It is not unreasonable for dental workers to question the effectiveness of established infection control products and practices against increasingly resistant pathogens, and to seek reliable guidance. Infection control training is based on preventing disease transmission, rather than treating infected people. Environmental asepsis, including the removal and destruction of pathogens before they infect workers or patients is a vital component of clinical safety. Knowing the properties of products and optimal techniques for effective surface cleaning and disinfection empowers the dental workers, builds trust and promotes safety. Risk of Infection in Dental Settings Disinfection of contaminated environmental surfaces and objects in all healthcare settings is an ongoing challenge and important aspect of infection prevention and patient safety. Healthcare-‐associated infections (HAI) are primarily caused by viruses, fungi, bacteria acquired while receiving treatment for other conditions. Most investigations of HAIs are conducted in medical environments, but serve as a model for understanding and controlling infections in dental settings. Some of organisms studied are less likely to be found in dental settings due to the general health of dental patients and the reduced exposure to some pathogens during dental procedures compared to those encountered during medical procedures. Safety practices in dentistry are modeled after those in medicine due to scientifically validated risk assessments; while the exact pathogens and conditions may differ, the principles of infection control are reliable. [1 , 1-‐A].
What Information is Trustworthy? Reliable Dental Safety Guidelines Dental workers often find themselves using disinfectants and techniques without completely understanding how effective or safe their efforts are. Sometimes safety and reliability is assumed, trust is given to a brand name, sales representative, or past experience with the product or practice. Infection control product selection and techniques tend to develop over time and incorporate the ideas of many people rather than clear evidence-‐based science or official guidance. Opportunities such as product promotional “deals” and prices, trends, habits, preferences, may also influence purchasing decisions. However, the risk of exposure to pathogens in dental settings is proven: reliable surface disinfectants and practices are more important than ever. Dental professionals should never be confused about the products they use and are personally responsible for successful surface asepsis. The most reliable sources for guidance are the Centers for Disease Control (CDC), members of the research, education and science community such as accredited Universities, approved testing facilities, and official agencies including the Federal Drug Administration (FDA), Environmental Protection Agency (EPA), or professional organizations utilizing peer-‐review and scientific processes such as Organization for Safety and Asepsis & Prevention. Centers for Disease Control Dental Infection Control Recommendations are based on information learned in medical settings, adapted for dental care.
The Role of Surface Contamination in Disease transmission Infectious pathogens are transmitted by direct contact, indirect contact, ingestion, percutaneous exposure and mucosal absorption. Diseases are categorized as contact diseases, droplet diseases, airborne diseases and bloodborne diseases. It is important to consider the type of organisms encountered in dental settings and their possible routes of transmission. Pathogens that can be transmitted by contaminated surfaces must be able to survive on those surfaces, be transferred to workers or patients directly or indirectly, and may enter new hosts through non-‐intact skin, mucosal or ocular exposure, or ingestion, and in some circumstances, inhalation. [1] It is estimated that 20-‐40% of Hospital Associated Infections (HAIs) result from transmission by a healthcare worker after touching either another patient or a contaminated environmental surface [2]. The role of environmental surfaces in the transmission of disease has increased as studies have shown environmental surfaces to be a key factor in cross-‐contamination. Some of the most important healthcare-‐associated pathogens can survive on environmental surfaces for days, weeks or months [3] including enteric pathogens, bloodborne pathogens, dermal pathogens, and respiratory pathogens. Dentally relevant pathogens are any that can be expected to be present in dental settings, such as Hepatitis B virus, Hepatitis A virus, Pseudomonas aeruginosa, Methicillin Resistant Staphylococcus aureus (MRSA), Vancomycin-‐Resistant Enterococci (VRE) and other multidrug-‐resistant organisms (MDROs). [1, 6] Dental workers receive training and have written policies for controlling infection transmission, but many workers lack a true understanding of the chemical disinfectants they rely on. To insure reliable infection control, it is helpful to have knowledge of the levels of disinfection needed for the various types of microorganisms, surface disinfectant ingredients and mechanisms of action, and practical guidance for commonly encountered clinical challenges such as the role of a cleaning step prior to disinfection, contact time, and product reliability and compatibility with other materials and products. To insure effective infection control, well-‐trained workers must be must have access to effective surface disinfectants and must comply with product use recommendations using aseptic technique including personal protective equipment. [1, 1-‐A, 4]
Mechanism of Surface Disinfection Action Levels of chemical disinfection: Microorganisms vary greatly in their resistance to chemical germicides. Spaulding proposed three levels of disinfection for the treatment of devices and surfaces that do not require sterility for safe use. The disinfection levels are “high-‐level,” “intermediate-‐level,” and “low-‐level.” These levels relate to the spectrum of organisms targeted by each category of chemical germicidal agents High-‐level disinfectants are used for instruments and devices, require extended contact time, and are not safe or effective for environmental disinfection. An example of a high-‐level disinfectant is glutaraldehyde, known as “cold sterile” solution, which can also sterilize items if they are immersed for specified (extended) time periods. [5] In order to destroy the most resistant types of microorganisms, (i.e., bacterial spores), the user needs to employ exposure times and a concentration of the appropriate germicide needed to achieve complete destruction before the pathogens infect people. Except for prions, bacterial spores possess the highest innate resistance to chemical germicides. Chemicals that destroy spores are called sterilants. Just
below spores on the hierarchy is Mycobacterium tuberculosis var. bovis, (commonly referred to as TB). Germicides that kill T.B. are “intermediate–level disinfectants”, and are widely trusted to also be effective against other less resistant species (found below T.B on the hierarchy). Some pathogens, however, show greater resistance to some disinfectants, and therefore each EPA disinfectant is commonly specifically tested for effectiveness against these organisms. Pseudomonas aeruginosa is an example of such a pathogen.[6] Manufacturers of approved medical and dental surface disinfectants specifically list the organisms on product labels that the product has been tested against, and the use-‐directions (including contact time) needed to kill or deactivate the pathogen.
The chart on the left illustrates the hierarchy of organisms relative to their resistance to destruction outside the body by disinfection / sterilization. As shown, prions are the most difficult to destroy followed by spores which can only be destroyed by sterilization. Intermediate-‐level disinfection inactivates Mycobacterium tuberculosis var. bovis, which is substantially more resistant to chemical germicides than ordinary vegetative bacteria, fungi, and medium to small viruses (with or without lipid envelopes). TB is a “benchmark organism”, used to demonstrate the effectiveness of a disinfectant against TB. Products that are able to destroy or
inactivate TB are generally considered effective against microorganisms that are
more easily destroyed by chemicals outside of the body than TB. These “weaker” organisms are shown below M. tuberculosis on the chart. “TB kill time” is the contact time needed for a disinfectant to destroy TB. Products must remain wet on surfaces for the time stated on their label to achieve reliable disinfection. [1,7] Impact of surface disinfection: There is not always a direct correlation between the order of pathogen resistance illustrated in Figure 1 and the effects of infection with the listed organisms. . It is fortunate that some of the pathogens that are considered high-‐risk after they infect a host are rapidly destroyed by surface disinfectants outside the body. Examples of such organisms are Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Herpes virus and influenza viruses: these organisms are often rapidly killed with surface disinfectants, but may be difficult or impossible cure once contracted. Low-‐level disinfectants, or hospital disinfectants may destroy these important pathogens, but intermediate-‐level disinfectants offer a wider margin of safety because they are effective against a broader spectrum of pathogens. For this reason official recommendations and mandates specify use of intermediate-‐level disinfectants on contaminated clinical contact surfaces. [1,8]
Figure 1: Microbial Resistance to Chemical Germicides
Representative Pathogens & the Emergence of Drug Resistant Organisms in the Clinical Environment Antibiotics have been used for 70+ years to treat patients with infectious diseases. However, due to the broad use/over use of these antimicrobial agents, the organisms which cause these diseases are evolving and new resistant strains are becoming more prevalent in the clinical environment. Although symptomatic dental patients are usually screened and dismissed, dental management of resistant organisms is now a requirement, since these species are not limited to hospital settings and may contaminate dental surfaces. [9] The Role of Mycobacterium tuberculosis The purpose of selecting an intermediate-‐level disinfectant (effective against TB) is to insure a level of chemical activity that can be expected to kill most types of vegetative organisms (not spores) on hard non-‐porous surfaces in the time needed to kill TB. Mycobacterium tuberculosis is harder to kill than most other organisms, and is thus considered a “benchmark organism”, able to withstand weak disinfectants and survive in a dry state for weeks. [1,7,10] Currently, it is estimated that one third of the global population is infected with Mycobacterium
tuberculosis with new infections occurring at the rate of about one per second. [11] Additionally, drug resistant forms of TB have become a public health issue in some developing countries, as duration of treatment is longer and requires more expensive drugs. [12]
Despite the seriousness of TB worldwide, there is little concern of contracting M. tuberculosis from a hard surface such as a counter tops or other fomites located in a dental clinical environment for two reasons: M. tuberculosis is spread through the inhalation of infectious aerosol droplet rather than by surface contamination. Second, TB is not likely to be present in dental environments because symptomatic patients are routinely screened before treatment, (however the possibility of accommodating an infected individual must be anticipated). Surface disinfectants used on potentially contaminated clinical contact surfaces are recommended to be effective against the benchmark organism TB to provide a margin of safety, thus insuring destruction of other commonly documented pathogens that are spread by contaminated surfaces. The tuberculocidal claim allows a chemical disinfectant to be designated as a "tuberculocide" by the Environmental Protection Agency (EPA ). According to the U.S. EPA, the designation of a disinfectant that can be used in a hospital environment is one that has demonstrated effectiveness against Staphylococcus aureus, Pseudomonas aeruginosa,
and Salmonella enterica, but not M. tuberculosis. [1]
Representative Pathogens Destroyed by Intermediate-‐level Surface Disinfectants and Significance in Dental Settings Surface disinfectants are developed for use in various medical settings. Dental environments are less likely to be contaminated with some organisms that may be seen in hospitals because dental patients should be screened for symptoms of infective diseases such as febrile respiratory illnesses or acute gastrointestinal infections. Since subclinical cases may be undetected, dental workers should always select surface disinfectants that are effective against a broad spectrum of pathogens. Products should be tested against specific organisms, particularly resistant species, to validate product claims and insure reliability.
Bactericidal / Fungicidal activity against the following organisms:
Table 1
Pathogen Destroyed by Disinfectant Significance: Pathology Associated with Pathogen Bacteria
Mycobacterium tuberculosis var: bovis (BCG) (TB)
Benchmark organism: most difficult vegetative organism to destroy (defines “intermediate-‐level disinfectant”). Tuberculosis
Staphylococcus aureus S. aureus is frequently found as part of the bacterial flora in the nose and on the skin: Causes infections such as boils, impetigo, meningitis, pneumonia, endocarditis, and Toxic Shock Syndrome. S. aureus has become rapidly resistant to antibiotics.
Methicillin Resistant Staphylococcus
aureus (MRSA) MRSA (“flesh-‐eating staph”) causes serious rapidly progressive and persistent skin infections – may spread through body and be fatal. MRSA is resistant to beta-‐lactam antibiotics such as methicillin, oxacillin, penicillin, and amoxicillin. Community-‐associated MRSA is very likely to be found in dental settings.
Methicillin Resistant Staphylococcus
epidermidis(MRSE) MRSE is a skin pathogen carried and shed by many healthcare workers, and can cause internal infections when surgical sites are contaminated.
Vancomycin Resistant Enterococcus
faecalis (VRE) VRE inhabits the gut, and is a serious problem in hospitals (less common in dentistry). Physically debilitated patients can develop endocarditis, surgical wound, urinary tract, or bloodstream infections.
Vancomycin Intermediate
Staphylococcus aureus (VISA) VISA colonizes skin and noses of carriers and can enter through wounds, surgical sites, tubes into the body, and drug use. Bacteremia or sepsis, pneumonia, endocarditis, osteomyelitis
Salmonella enteric Food poisoning, gastroenteritis. May be transmitted by oral secretions. Acinetobacter baumannii Blood stream, urinary tract infections, pneumonia Klebsiella pneumoniae Wound and urinary tract infections Bordetella pertussis Pertussis (whooping cough). Transmitted by respiratory/oral fluids.
Potentially transmitted by asymptomatic individuals. Extended spectrum beta-‐lactamase (ESBL) Escherichia coli
Multi-‐drug resistant enteric pathogen causing food poisoning, urinary and wound infections. Spread by oral fluids, fecal contamination, hand, surface, fomite transmission from infected individuals. [13]
Viruses
Hepatitis B Virus (HBV) Bloodborne pathogen capable of survival on environmental surfaces for at least 7 days and shown to transmit Hepatitis in dental settings via surfaces contaminated with bodily fluids, wet or dry.
Hepatitis C Virus (HCV) Bloodborne pathogen causing acute and chronic hepatitis, transmitted by bodily fluids, wet or dry. Due to subclinical cases and large number of undetected infective individuals HCV (+) oral fluids are likely in dental settings.
Herpes Simplex Virus (HSV) Type 1 Primary herpes simplex infection (HSV) is a florid herpetic gingivostomatitis with extensive oropharyngeal vesicular lesions. Secondary (recurrent) HSV is very common and causes labial, gingival and palatal vesicles and ulcers. Lesions are highly infective, virus may be shed without visible lesions. HSV contamination is likely in dental settings.
Herpes Simplex Virus (HSV) Type 2 Genital herpes, similar to HSV Type 1. May be found in dental settings, and shed by oral/pharyngeal secretions of infected individuals.
Human Immunodeficiency Virus (HIV) Bloodborne pathogen, causes destruction of human immune system, susceptibility to opportunistic infections, and Acquired Immune Deficiency syndrome (AIDS). Percutaneous or trans-‐mucosal exposure required for transmission in dental settings. HIV expected to be present in blood and body fluids found in dental settings.
Human Coronavirus not associated with Severe Acute Respiratory Syndrome (SARS)
Upper respiratory and gastrointestinal tract pathogen, contracted by inhalation of aerosols and mucosal contact with respiratory/GI secretions, directly or indirectly. Contaminated surfaces may transfer pathogens. Should not be common in dental settings, but may be found when asymptomatic or sub-‐clinical cases are not identified.
Norwalk virus Norwalk virus is the most common cause of acute gastroenteritis, causing community and healthcare outbreaks. Unlikely in dental settings unless infected asymptomatic patients or workers are present, but CDC recommends careful selection and use of disinfectants effective against Norwalk virus.
Rotavirus Rotavirus causes gastroenteritis (inflammation of the stomach and intestines, causing illness with diarrhea); leading cause of severe diarrhea in infants and young children worldwide. Spread by fecal-‐oral route, via contaminated hands, surfaces, objects and food. Pre-‐ and post symptomatic people may spread the virus.
Influenza A, H3N2 Virus Seasonal influenza, transmitted by contact, droplets and aerosols. Symptomatic individuals should not be present in dental settings (should be screened and dismissed), but asymptomatic people may be present. Surface contamination is a route of transmission.
Adenovirus Type II Very common pathogen, causing upper respiratory tract infections, tonsillitis, conjunctivitis. Contaminated ocular, nasal, oral-‐pharyngeal and respiratory secretions are likely to be present in dental settings, and can be spread easily by contact with contaminated surfaces.
Fungus/Yeast
Trichophyton mentagrophytes Human and zoonotic dermal pathogen, causing cutaneous infections such as ring-‐worm, “athlete’s foot” (may infect hands between fingers, under jewelry or around finger-‐nails). Due to moisture, use of closed gloves and compromised skin, dental workers are at risk for exposure to this keratinophylic fungus belonging to a homogeneous group of fungi called the dermatophytes. Contaminated surfaces are a route of transmission.
Candida albicans Candida albicans is a yeast, commonly present in the environment. C. albicans causes candidiasis or moniliasis, called “thrush” in susceptible individuals: babies, immunocompromised people, and those taking certain drugs that interfere with the balance of the oral flora. C. albicans is generally not spread easily by contaminated surfaces.
[3,10,11,13,14,15]
Regulation of Chemical Disinfectants Chemical disinfectants are a vital component of standard precautions. Even when surface barriers are used, cleaning and disinfecting practices must be performed correctly to achieve clinical safety. Surfaces in the dental operatory have been divided into 2 categories: noncritical surfaces such as housekeeping surfaces, and clinical contact surfaces. Clinical contact surfaces are those that might be
touched frequently with gloved hands during patient care or that might become contaminated with blood or other potentially infectious material and subsequently contact instruments, hands, gloves, or devices (e.g., light handles, switches, dental X-‐ ray equipment, chair-‐side computers). One method of working with these surfaces is barrier protective coverings (e.g., clear plastic wraps). This can be an advantage for surfaces that are difficult to clean such the chair, light handles, and complex surfaces. This also limits exposure to chemicals for the staff and patients and saves time and energy. The barriers are simply changed between patients. The covered surfaces (under barriers) should be cleaned and disinfected at the end of the day or when barriers are changed if the barrier is compromised and/or contamination is evident. If and where barrier protection is not utilized, it is necessary to clean and disinfect clinical contact surfaces between patients. This should be done utilizing an intermediate-‐level disinfectant (i.e., Environmental Protection Agency (EPA)-‐registered disinfectant for use in a hospital environment with tuberculocidal claim) or low-‐level disinfectant (i.e., EPA-‐ registered disinfectant for use in a hospital environment with an HBV and HIV label claim). [1,8] What is an EPA disinfectant? The purpose of the Environmental Protection Agency (EPA) is making sure that pesticides are safe and effective when used as directed. Antimicrobial pesticides are substances or mixtures of substances used to destroy or suppress the growth of harmful microorganisms (including bacteria, viruses, or fungi) on inanimate objects and surfaces. Every pesticide (including disinfectants and sanitizers) sold in the United States must be registered with the Environmental Protection Agency (EPA). The EPA registration number can be found on the label. It is a violation of Federal Law to use an EPA registered product in a manner inconsistent with its printed directions. Off label use can render a product inert or ineffective, or pose personal or environmental risks. Note: product labels are continually updated as new research is done and should be read prior to use. [16]
Overview of Chemical Agents Used for Hard, Non-‐porous Surface Disinfection There are several different types of antimicrobial agents that can be used to achieve hard non-‐porous surface disinfection. The chemical agents can affect microorganisms through different mechanisms, such as disruption of the bacterial cell wall and outer membranes. Other chemical agents function as chelators which prevent the organism from replicating. Selection of surface disinfectant chemicals is a complex subject as one must take into consideration where the product will be used, what organisms are being targeted (e.g. Staph aureus versus Mycobacterium species), the desired contact time (e.g. 1 minute versus 5 minutes), what surfaces the product will be used on (materials compatibility) and target temperature range for use. It is important to note that surface disinfectants are approved for use on hard, non-‐porous surfaces. Surfaces such as upholstery are not included in this definition, but dental workers generally use disinfectants on chairs and other materials that may, over time, be damaged by the chemical contact and possibly build-‐up. All surface disinfectants indicate a contact temperature and time on the product label. These parameters are essential to abide by in order to achieve proper disinfection of a hard non-‐porous surface. For surface disinfectants (spray solutions or wipes) the maximum allowable time is 10 minutes as established by the EPA. In many instances, a surface will not remain wet for a period of 10 minutes due to other environmental conditions such as ambient temperature, humidity, or air flow. Additionally, the practicality and ability to leave a surface wet for 10 minutes is challenging if not impossible in a busy clinical environment, especially if the disinfectant contains a high percentage of
alcohol, which evaporates quickly. As a consequence, users of surface disinfectants seek out products with shorter contact times for disinfection. The ideal surface disinfectant would be broad spectrum, fast acting, active in the presence of organic matter (effective in a “one-‐step” protocol), non-‐toxic, non-‐allergenic, non-‐damaging to surfaces such as metal, cloth, rubber or plastics, leave no residual effect on treated surfaces, be easy to use and economic. Unfortunately, there is no ideal surface disinfectant. Each product has some limitations, but if users know the active ingredients and features of their product they can maximize the features that are important for their use and setting. Table 2: Key active ingredients of chemical disinfectants
Chemistry Category Example(s) Activity Phenols Phenol
Product Examples: Birex, ProSpray
Phenols also have antifungal and antiviral properties: historically used for antiseptic, disinfectant, or preservative properties.
Excellent cleaning capabilities – may require rinsing. Typically 10 minute TB Kill
Surface-‐active agents (surfactants)
Quaternary Ammonium Compounds
Product Example: Sani-‐Cloth® HB
Quaternary ammonium compounds are widely used as disinfectants. Membrane active agents: inactivate energy-‐
producing enzymes, denature essential cell proteins, and disrupt cell membranes. Simple quaternary ammoniums are considered
low level disinfectants
Alcohols ethyl alcohol, isopropyl alcohol, n-‐
propanol
Product Example: Rubbing Alcohol
Alcohols exhibit rapid broad-‐spectrum antimicrobial activity against vegetative bacteria (including Mycobacterium), viruses, and fungi but are not sporicidal. Alcohols demonstrate poor cleaning capabilities for organic contaminants. Variable TB kill times: 1 – 10 minutes. Pure alcohols are not approved for
environmental surface disinfection. Alcohols are added to other compounds.
Surface-‐active agents (surfactants) &
Alcohols
Quaternary Ammonium -‐ alcohol
compounds
Product Examples: CaviWipes / CaviCide, SaniCloth Plus, PDCare
Wipes
Quaternary ammonium-‐alcohol compounds are synergistic broad spectrum disinfectants. Quaternary ammoniums provide
excellent cleaning capabilities, denature essential cell proteins, and disrupt cell membranes. Alcohols rapidly enter and destroy pathogens. % of alcohol impacts TB kill times. Lower alcohol (water-‐based) formulations usually demonstrate superior cleaning capabilities. Variable (1-‐10 minute) TB kill times.
Halogen-‐Releasing Agents
Bleach sodium hypochlorite Chlorine dioxide
Product Example:
Bleach
Chlorine-‐ and iodine-‐based compounds are the most significant antimicrobial halogens used in the clinical environment and have
been traditionally used for both antiseptic and disinfectant purposes. Halogen-‐releasing agents possess bactericidal and
virucidal activities and at higher concentrations can be Sporicidal.
Oxidizers Hydrogen Peroxide
Hydrogen peroxide works by producing destructive hydroxyl free radicals & can attack vital microorganism cell components.
Product Examples: Optim 33
Hydrogen peroxide is active against a wide range of microorganisms, including bacteria, yeasts, fungi, viruses, and
spores. 5 minute TB kill time. Many workers are confused about the disinfectant products they use. It is important to understand the limitations of a product, such as which surfaces it is compatible with, toxicity on skin, use-‐life, contact time, and compatibility with other chemicals or materials. Manufacturers sometimes issue confusing messages, and workers may confuse traditional home use of similar janitorial products with professional disinfection protocol. For example, a popular domestic aerosol disinfectant is often used as both a surface disinfectant and an air freshener or air “disinfectant”. In dental settings workers may rely on this product for asepsis without understanding the limitations of a 10 minute contact time for TB efficacy, poor cleaning capabilities due to high alcohol content, and the lack of scientific evidence that the product is effective in reducing airborne pathogens when sprayed in the air. Additionally, some dental workers purchase domestic cleaning or disinfection products that are not EPA or FDA cleared for use in medical settings. This practice reduces reliability of successful infection control. Some opinion leaders have indicated that adequate surface disinfection can be achieved from one application, allowing the surface to dry within one minute. However, not all products are made the same, and thus, this theory does not apply to all disinfectants. Eliminating the cleaning step and allowing only one minute contact time can be a deviation from the product label and can introduce a risk of inadequate disinfection unless the surface is truly clean and the product has an approved 1-‐minute TB kill time. [1,7] Table 3
Five Concepts to Consider When Choosing a Surface Disinfectant
1. Time: How quickly does it kill TB? Does the contact time match the amount of time available between patients? 2. Scope and Testing: What are the scope and efficacy claims? ·∙ Bactericidal ·∙ Fungicidal ·∙ Virucidal ·∙ Tuberculocidal Is the product EPA registered? 3. Clean and Disinfect: Does the product have good/excellent cleaning capabilities? (product will both clean and disinfect) If not: is there a compatible pre-‐cleaner? 4. Shelf Life and Ease of Handling: Does this product have a limited use-‐life and require frequent replacement? How is the product disposed once it is expired?
Is this product premixed or does it require mixing and dispensing? Is the product irritating, toxic, or strongly scented? Does the product require specific ventilation? Is it compatible with the surface it will be used on? 5. Cost: How much does it cost per patient to utilize this product, considering time, product cost and supplemental products such as paper towels? Ref: [1,7] Efficacy and Practical considerations of Quaternary Ammonium-‐ Alcohol Products Quaternary Ammonium compounds (Quats) with moderate to high-‐levels of alcohol are frequently used disinfectants in dentistry. Quaternary ammonium compounds are cationic detergents that kill pathogens by inactivating energy-‐producing enzymes, denaturing essential cell proteins, and disrupting cell membranes, thus changing the cells permeability resulting in a loss of essential cytoplasmic constituents such as potassium. [16,17] Quats are highly effective against gram-‐positive bacteria and less active against gram-‐negative bacteria. When mixed with alcohol, the synergistic affect results in accelerated and more effective disinfection. The combination of quaternary ammonium-‐ alcohol is lethal to even some of the most resistant organisms, including Mycobacterium tuberculosis. The percentage of quaternary ammonium and alcohol may vary by manufacturer, and the percentage is specified in parts per million (ppm) and listed in the product’s MSDS. Because alcohol has rapid action against microorganisms, the higher percentage of alcohol in the chemical formulation generally contributes to the faster kill times. [18] For example, a 55% isopropyl alcohol and 0.5% quaternary ammonium chloride formulation is fungicidal, bactericidal, virucidal, and tuberculocidal, killing 26 microorganisms in two minutes or less. Conversely, some quaternary ammonium-‐alcohols with higher alcohol concentration (above 55%) list a 10 minute TB kill time.
Cleaning Evaluation -‐ A Comparative Overview of Surface Disinfectant Products In order to disinfect a surface, the cleaning solution must be in contact with the surface without interferences from soils. The soils encountered in dental and medical applications, such as blood and mucus, tend to have high concentrations of proteins and fats which can interfere with the surface disinfectant liquids by preventing contact with the surfaces which require disinfection. The disinfecting liquid may be blocked by the soil from wetting the surface, protecting the microorganisms from inactivation, and the soil itself may harbor pathogens. Pre-‐saturated wipes are a popular alternative to spray liquids because they are a superior way of decreasing microbial bioburden on surfaces when used properly, and reduce aerosolization of chemicals and excess pooling of liquids [20] Introduction to Surface Disinfection Ready-‐to-‐Use Solution Evaluation The primary task of surface disinfectants is to disinfect hard, non-‐porous surfaces. A well designed surface disinfectant product should solubilize (clean) the soil prior to wiping, and not promote soil
binding to the surface. The capacity of the disinfectant to solubilize the soil can be measured quantitatively using % weight of the soil removed after immersion of pre-‐soiled test coupons (1”x2” stainless steel strips) into the solution.
Clinical Evaluation of Cleaning Capability of a New Product In response to the expressed need for a reliable disinfectant with the combined qualities of rapid TB effectiveness, and excellent cleaning ability, recent studies and product reformulation of CaviCide and CaviWipes were completed. The active ingredients in CaviCide and CaviWipes are quaternary ammonium and low levels of alcohol. CaviCide1 and CaviWipes1 have slightly higher alcohol content and a 1 minute TB contact time. Products with a moderate to high alcohol content have previously been shown to demonstrate poor cleaning capabilities compared to low alcohol disinfectants due to alcohol’s tendency to precipitate proteins on surfaces.[19] CaviCide1 and CaviWipes1 were evaluated for cleaning effectiveness. CaviCide is an example of a surface disinfectant with a well-‐established history in medical settings against significant pathogens. This product has been updated and re-‐tested against an expanded list of pathogens, making it more reliable in both medical and dental settings. The new CaviCide1 product is active against clinically significant pathogens with only a 1 minute exposure (TB kill) time. CaviCide1/CaviWipes1 are EPA approved intermediate-‐level disinfectants. Since CaviCide1/CaviWipes1 have indications for disinfection of non-‐critical medical devices, they are also regulated by the United States Food and Drug Administration (US FDA) as medical devices. CaviCide1/ CaviWIpes1 can also be used to clean semi-‐critical or critical medical devices (followed by appropriate high-‐level disinfection or sterilization). Methods Used A comparative cleaning evaluation was conducted using Metrex’s CaviCide1 and CaviCide versus a high alcohol (63.25%) competitive spray surface disinfectant product. In this trial, a blood-‐based fatty soil was affixed to stainless steel test coupons, allowed to dry and weighed. Next, these coupons were subjected to a standardized soil removal protocol and then were weighed again at the conclusion of the trial (Figure 2).
Figure 2: Images of the Quantitative Cleaning Test: Fatty Blood Soil
Discussion of Fatty Blood Soil Test Results CaviCide1 demonstrated slightly better performance than tap water with respect to removal of
fatty blood soil from the test coupons. CaviCide1 was formulated to proactively remove (not bind) fat and proteins from hard, non-‐porous surfaces.
The high alcohol product (63.25% isopropyl alcohol) appeared to bind soil to the coupon. It has been previously reported that high alcohol concentrations bind proteins to surfaces.[19]
Surface Disinfection Wipes Cleaning Evaluation Products were tested with repeatable very consistent side-‐by-‐side, or “paired mechanical system, which used a compressed air linear actuator cylinder mounted perpendicularly to the sleds, removed the human variability in the testing. Methods Used A comparative cleaning evaluation was conducted using Metrex’s CaviWipes1 and CaviWipes versus four competitive brands of surface disinfectant wipes. Side-‐by-‐side comparative trials (using CaviWipes as the reference) were conducted using weighted test “sleds” to control variables such as pressure, texture and wipe area on glazed tiles (Figure 3). These tiles were coated with pre-‐dosed amounts of clotting whole blood. Two sleds were pushed in parallel across the soiled tile surface using a pneumatic linear actuator cylinder to remove the human variability from the process.
Figure 3: Surface Disinfection Wipes Evaluation Test Platform
Sled pads (10 cm x 17 cm) shown inverted with towelette in place and a hand for scale.
10 cmTowelette
clamped betweenweighted platen and pad, then
WEIGHTS
Pusher arm transits sleds simultaneously at the same speed for matched comparisons.
16 in. x 16 in. tile
Sled construction: each towelette contacts the tile with identical surface area with matching force from the weights transmitted through a metal plate and a flexible elastomer pad which presses it onto the tile surface. Sleds are not attached to each other or the pusher arm.
Discussion of Wipes and Solution Cleaning Test Results CaviWipes1 was judged to offer superior cleaning performance in this evaluation over those of both the high alcohol wipe products and the intermediate level alcohol wipe products tested (Figure 4).
When higher alcohol (>50%) surface disinfectant products come into contact with blood soil, they do not remove the blood soil from the test surfaces. These observations suggest that this binding may occur across a variety of materials, even when manufactured with smooth surfaces, consistent with previously published literature.
CaviWipes1 consistently cleaned and removed the clotting blood soil in each experiment and demonstrated equivalent cleaning performance to both: (a) the reference product, CaviWipes, and (b) the hydrogen peroxide wipes product tested.
Figure 4: Results of Paired Surface Disinfection Wipe Cleaning Evaluation
Conclusion of CaviCide / CaviWipes1 studies: CaviCide1 and CaviWipes1 have solved some of the most important clinical challenges. The products are effective cleaners in the presence of organic matter such as blood and sputum. These products may be used for cleaning as well as disinfection without the need to select a separate pre-‐cleaning product. The contact time for disinfection is 1 minute, which matches the clinical needs of dental workers. The demonstration test indicates that on essentially clean surfaces that are not contaminated with gross debris or materials, CaviCide1 and CaviWipes1 can be expected to achieve reliable disinfection in one step. However, following recommended best practices, and providing the highest margin of safety and reliability, CaviCide1 and CaviWipes1 should be used in the recommended protocol of two steps: cleaning step followed by a disinfecting step.
Overview of Compatibility Testing CaviCide1 solution was tested and found to be compatible with the materials shown below. Materials were exposed to 14 days (336 hours) of continuous contact with CaviCide1 with no effect unless otherwise noted. This contact time equates to 20,160 applications of CaviCide1 based on the product contact time. CaviCide1 and CaviWipes1 are classified as low alcohol (22.5%) surface disinfectants and offer materials compatibility with the following materials:
Figure 5: Compatibility Summary of CaviCide1 and CaviWipes1 Notes: 1 -‐ slight darkening when campared to control 2 -‐ slight lightening when compared to control 3 -‐ areas of spotting observed 4 -‐ areas of discoloration
Acrylic NaugahydePolystyrene Formica (white)
PVC Formica (black)Neoprene1 Brass2
Polypropylene Glass3
High density polyethylene (HDPE) Copper4
Epoxy counter tops Stainless SteelSilicone Stainless Steel
EPO TEK 353 Chrome Plated BrassNaugahyde
CaviCide1 and CaviWipes1 Compatibility
CaviCide1 and CaviWipes1 are compatible with the following materials:
Test Surface
Compatibility Summary
CaviCide CaviCide1
Low pH Peroxide Product Spray
0.65% Bleach Product Spray
Acrylic
Polystyrene
PVC
Neoprene
Kraton G
Silicone
EPO TEK 353
Naugahyde
Formica (white)
Formica (black)
Aluminum
Brass
Carbon Steel
Chrome Plated Brass
Copper
Nickel Plated Brass
Stainless Steel
Glass
CaviWipes1 Evaluation Results Discussion Tests demonstrated that the both CaviCide1 and CaviWipes1 clean efficiently and effectively in the presence of organic soil. This finding allows the products to be utilized effectively as both a cleaner and a quick acting disinfectant. Pre-‐cleaning with a separate product is not necessary. The one-‐minute contact time eliminates the need to spend time extra time between patients waiting for the disinfection process to occur. These products were found to be compatible with most materials that make up the surfaces that must be disinfected in dentistry.
Frequently Asked Questions About Disinfectants
1. IF I do not see contamination on a surface do I have to do 2 steps? Not all contamination is visible to the naked eye. Clinical contact surfaces can inadvertently become contaminated during patient care and can be a reservoir for microbial contamination. It is important to evaluate the exposure level of all surfaces and treat them accordingly. Cleaning is a form of decontamination. Without cleaning you cannot inactivate microbes. The cleaning step removes salts, visible soils and organic matter that you may or may not see. The action of scrubbing with detergents and surfactants removes a large numbers of microbes on its own. If you skip the step of cleaning the disinfection step can be compromised because debris protects underlying microorganisms from the disinfectant [22]. 2. Can I just use one towelette to both clean and disinfect? No. The first step of the process is for cleaning and the next step is for disinfection. Each of those steps must have a fresh towelette to insure predictable results consistent with EPA product testing. Testing has shown that this is a 2-‐step process utilizing one towelette for cleaning, discarding that and using one towelette for disinfection. 3. If I wipe with the first step and then immediately wipe again when can I start counting the 1-‐minute contact time? For a single surface, calculate contact time starting with the disinfecting step. The area must be cleaned before the disinfection action can start. If debris is present and the area has not been cleaned then it may not be able to access the microbes. 4. How long does it have to stay wet for the first (cleaning) step? The first step is a cleaning step and does not require the area to be wet for a specified period of time. It was designed to clean and remove the debris that could be affecting impact of the disinfectant. The second step is the step that requires the area to be wet for a length of time. It is important to read the label to understand what is required of the product. 5. Do I need to use the same product to clean as I use to disinfect a surface? Using separate cleaning and disinfectant products is an acceptable practice, but some chemicals are incompatible. Chemical incompatibility may result in damage to surfaces, personal risk. It is important to know the active ingredients of the disinfectant and select the same or neutral chemical cleaner. Some manufacturers, particularly manufacturers of high alcohol products known to be poor cleaners, make or recommend a separate cleaning product. Contact the manufacture or use the product listed on the label that is compatible. To be more efficient in your approach choose a product that accomplishes both functions, for example CaviCide / CaviWipes. 6. What personal protective equipment do I need to wear to work with surface disinfectants? Because of the risk associated with chemical disinfectants each label should contain the personal protective equipment required as well as the allowable time of exposure (if applicable). Patient exam gloves have not been proven to protect against chemicals and punctures. Chemical and puncture resistant gloves should be worn. The Center for Disease Control states, “Ensure that workers wear appropriate PPE to preclude exposure to infectious agents or chemicals through the respiratory system, skin, or mucous membranes of the eyes, nose, or mouth. Personal protective equipment can include gloves, gowns, masks, and eye protection. The exact type of PPE depends on the infectious or chemical agent and the anticipated duration of exposure. The employer is responsible for making such equipment and training available.” “Use appropriate gloves (e.g., puncture-‐ and chemical-‐resistant utility gloves)
when cleaning instruments and performing housekeeping tasks involving contact with blood or other potentially infectious materials.”[23] The Occupational Safety and Health Administration’s stand on the subject is, “The person handling the instruments through removal, cleaning, packaging and sterilization needs to use heavy-‐duty gloves to help prevent injury with sharp contaminated instruments.” Puncture-‐resistant utility gloves are designed to provide more protection for hands during operatory cleanup and processing of instruments that the thin patient care gloves can provide [1]. Many chemicals have adverse affects to human organs. Because there is a risk of splash and splatter face protection and a gown should be worn. It is the responsibility of the employer to establish a program for monitoring occupational exposure to regulated chemicals (e.g., formaldehyde, EtO) that adheres to state and federal regulations, to provide personal protective equipment and to train employees of the use of the chemicals [4]. 7. Why can't I make my own wipes by putting cotton 2x2's in a container and covering them with a disinfectant approved by the EPA for use in a medical, dental or clinical environment? OSAP's Infection Control In Practice: Managing Environmental Surfaces manual states: In general, cotton fibers contained in gauze may shorten the effectiveness of some disinfecting agents when stored in containers together. Germicides, especially iodophors or chlorines, may be inactivated or absorbed by the gauze. If you use gauze to apply disinfectant to surfaces, saturate the gauze with the disinfecting agent at the time of use. I then confirmed this by looking it up in the book "Practical Infection Control in Dentistry." It states that disinfectants should not be stored in containers with gauze because this may shorten the effective life of the disinfectant.2 There is currently no study that tells how long one can soak disinfecting agents in cotton and render it ineffective. It is known that the products used in manufacturing cotton, such as bleach, can inhibit the disinfectant. The material used to make disinfectant wipes approved for use in a dental, medical or clinical environment was developed specifically for those uses, and is completely different than cotton. Making your own wipes is an off-‐label use, and the manufacturer is only able to state that it is a disinfectant approved for the aforementioned environments if you follow the label use. Keep in mind as you use a product that you are replicating, how it was used in science-‐based testing and approved as a disinfectant for use in the dental, medical or clinical environment, those instructions are on the label. The disinfectant is tested to be used in these clinical environments under very specific conditions. You must follow the directions to create those conditions. Off-‐label uses do not guarantee that a product will be effective; in fact, it probably won't be. If you are not following the directions, you may be putting people at risk. [4,5]
Conclusion Disinfection of contaminated environmental surfaces and objects in all healthcare settings is an ongoing challenge and important aspect of infection prevention and patient safety. Environmental asepsis, including the cleaning and disinfection is a vital component of clinical safety against a growing list of infectious diseases. The risk of exposure to pathogens, including resistant organisms such as MRSA, in dental settings is proven. Dental workers must understand and follow product use-‐directions to prevent clinical infections. Optimal features of a surface disinfectant include rapid effectiveness against TB along with excellent cleaning capability while not harming office materials. Two new products, CaviCide1 and CaviWipes1 have a rapid (1 minute) TB contact time. They were evaluated for cleaning ability and
compatibility with environmental surfaces and found to demonstrate excellent cleaning ability and material compatibility. References: [1] Centers for Disease Contgrol and Prevention. Guidelines for Infection Control in Dental Health-‐Care Settings – 2003. MMWR 2003;52(No.RR-‐17) [1-‐A] CDC National Center for Emerging and Zoonotic Infectious Diseases, Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care. (pg.11) http://www.cdc.gov/HAI/prevent/prevent_pubs.html [2] Jasmer R, Nahid P, Hopewell P. Clinical practice. Latent tuberculosis infection. N Engl J Med. 347(23): 1860-‐6 [3] Forbes B, Sahm D, Weissfeld A. Bailey and Scott’s Diagnostic Microbiology, 11th ed. 537-‐45, 2002
[4] U.S. Dept of Labor, Occupational Safety and Health Administration (1992, rev: 4/3/2006). 29-‐CFR, Bloodborne Pathogens, 1910.1030 [5] Table 22, Levels of disinfection by type of microorganism, CDC Guidelines for Environmental Infection Control in Health-‐Care Facilities, p. 72. (2003). [6] CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, p. 33 (2008) [7] Molinari, J. A., & Harte, J. A. (Ed.). (2010). Cottone’s Practical Infection Control in Dentistry, (3rd ed.). Baltimore, MD: Lippincott Williams & Wilkins. [8] CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, p. -‐-‐-‐ (2008) [9] Chambers H. The changing epidemiology of Staphylococcus aureus? Emerg Infect Dis 7(2) 178-‐82 (2001) [10] Parish T, Stoker N. Mycobacteria: bugs and bugbears (two steps forward and one step back). Mol Biotechnol 13(3): 191-‐200 (1999) [11] Ryan K, Ray C (Editors) Sherris Medical Microbiology (4th ed.). McGraw Hill. ISBN 0838585299 [12] World Health Organization Fact Sheet.104. Tuberculosis. http://www.who.int/mediacentre/factsheets/fs104/en/ accessed March, 2012 [13] Shuttleworth, A. The rising incidence of antibiotic-‐resistant ESBL-‐producing E. Coli. NursingTimes.net. 100 (31) page 30. (2004) [14] John T. Redd, MD, MPH et.al, J Infect Dis. (2007) 195 (9): 1311-‐1314. doi: 10.1086/513435
Ref: norovirus. (Category IC) (Key Question 3.C.12.e.1) [15] CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, p. 31 (2008) [16] Rutala W. Disinfection, Sterilization and Antisepsis Principles, Practices, Current Issues and New Research. APIC Conference Proceedings, 2006, APIC. Page 13. [17] Microbiology: an Introduction, Gerard J. Tortura, Funke, Berdell R., Christine L. Case, 8th Ed. [18] Infection Control Today June 2009: The Benefits of Alcohol-‐Quaternary Ammonium Germicidal Wipes, Jean Fleming, RN, MPM, CIC. [19] Prior, A., et al. Alcoholic fixation of blood to surgical instruments-‐a possible factor in the surgical transmission of CJD? J Hosp Infection 58 78-‐80 (2004) [20] www.cardiff.ac.uk, accessed 12/09/11 [21] OSAP's Infection Control in Practice: Managing Environmental Surfaces. Vol. 3, No. 3 April 2004. [22] Weber DJ, Rutala WA, Miller MB, et al. Role of hospital surfaces in the transmission of emerging health care-‐associated pathogens: Norovirus, Clostridium difficileand Acinetobacterspecies. Am J Infect Control. 2010;38 (5 Suppl 1):S25-‐S33. [23] Kramer A, et. al. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infect Dis. 2006;6:130.
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About TotalCare
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California, and our state-‐of-‐the-‐art manufacturing facility is in Romulus, Michigan. At TotalCare, we're all
about protecting people by providing high-‐quality infection-‐prevention products, including a complete
line of pre-‐cleaners and enzymatic detergents, high-‐level disinfectants, surface disinfectants, liquid
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