The 24th CE Leader of the Year
The 24th CE Leader of the Year
In the 20th century, significant progress has been made in health care and biological sciences worldwide. Important milestones include the discovery of penicillin by Alexander Fleming in 1928, which heralded the arrival of the era of antibiotics, in which more and more antibiotics can be used to treat debilitating and potentially fatal infections. 1 The development of vaccines and their use in the global immunization program has also led to the prevention of many diseases through direct contact, indirect contact, blood transmission, air transmission, water transmission, droplets and vector transmission of microorganisms. 2,3 However, existing diseases have become a threat again, such as drug resistance and measles due to multi-vaccination hesitation. 4,5 The emergence of new diseases, including HIV/AIDS; H1N1; SARS; Middle East Respiratory Syndrome; recently, COVID-19 has also highlighted loopholes. In addition, the risks of zoonotic diseases, epidemics and pandemics are increasing because the burden of population growth is too heavy, forcing people to live closer to animals, and the environment is not suitable. 6 It is also very clear that the interconnected world promotes communication.
Disease transmission in the medical environment
In medical institutions, the transmission methods of medical staff and patients include direct contact, indirect contact with contaminated surfaces or objects (pollutants), droplets, blood transmission and air transmission. 7,8 Diseases can occur when there are sufficient levels of a specific pathogen. 7 In a hospital, 1 in 25 patients is affected by at least one hospital-acquired infection (HAI). 9 Many HAIs are caused by antibiotic-resistant microorganisms, often referred to as "super bacteria", and can cause sepsis or death. 10 In the dental environment, the confirmed diagnosis of acquired infection among patients and/or dental health workers is due to the contamination of water in the waterline of dental equipment, failure to comply with the requirements of blood-borne pathogen standards, and the failure of contaminated equipment. Correct/inadequate reprocessing. 7,8,11 Other risks include contaminated clinical contact surfaces, direct contact, and airborne transmission.
Examples of airborne microorganisms include the highly infectious measles virus and Mycobacterium tuberculosis, and Candida auris. 12-15 The airborne transmission of SARS was confirmed more than ten years ago. 16 In air sampling studies of hospital air, infected patients stay overnight, and PCR is used to detect microorganisms. 17 In these studies, the air sampled contained varicella-zoster virus, measles virus, Mycobacterium tuberculosis, influenza virus, respiratory syncytial virus, rhinovirus, adenovirus, Mycoplasma pneumoniae, and other microorganisms. For many people, the size of the particles is less than 5 microns. There was also evidence of airborne transmission during the SARS-CoV outbreak. 18 For some microorganisms, although one mode of transmission may be dominant, other modes of transmission may also occur: for example, MRSA (which can be transmitted through direct and indirect contact). Exposure to pollutants), varicella-zoster and Pseudomonas aeruginosa. The latest from 19-21 is SARS-CoV-2. It is now generally believed that SARS-CoV-2 mainly involves airborne transmission, and there are far fewer cases related to close contact with droplet transmission or contaminated surfaces.
There are different understandings about airborne transmission. Aerosols contain particles ≤50 μm in the gas-in the current situation, in the air. Infectious aerosols contain pathogens in particles in the air. It is generally believed that larger particles have ballistic properties and will settle quickly when approaching. This includes splashes, which contain particles larger than 50 μm and droplets in aerosols> 20 μm. 16,22 However, in a study on breathing and exhalation, it was found that droplets between 60 and 100 μm were carried 6 m away. 23 In addition, when droplets are rapidly dehydrated in the air, this produces air-borne droplet nuclei, most of which are ≤5 μm, but may be as large as 10 μm. 16 Small particles can move with the airflow, stay in the air longer, and larger particles spread farther. 24 The time required for particle sedimentation varies with particle size, airflow, and the height of the area where sedimentation occurs. The study used the diameter of a unit-density sphere to estimate the settling time at the same velocity as the actual particle under study (Figure 1).
In addition, although particles passing in the turbulent air close to the horizontal surface can settle, other particles will continue to be disturbed and remain in the air for a long time. 24 In addition, particles that settle on the surface may also become particles in the air. Whether this happens depends on the size of the particles, the adhesion to the surface, and the energy and airflow reaching the space. 24 A recent report pointed out that microorganisms on the floor in a hospital environment may be resuspended in the air, such as when walking, with the potential for transmission and surface contamination. 25 The report also cited earlier studies that showed that floors were contaminated with Clostridium difficile, Vancomycin-resistant Enterococcus, and MRSA. The particle size also determines the depth at which pathogens can reach the respiratory tract, and smaller aerosol particles can penetrate deep into the lungs. In studies analyzing cough and breathing aerosols, particles of Mycobacterium tuberculosis, Pseudomonas aeruginosa, and many viruses were found to be smaller than 5 microns. 17 Particles smaller than 10 microns can easily reach below the glottis of the larynx; those smaller than 5 μm can easily be inhaled into the lower respiratory tract 16, 17, 26 (Figure 2).
Infection control plan and guidance in the dental environment
The CDC provides recommendations for standard precautions and additional protocols for infection control. CDC's guidance for the healthcare environment during COVID-19 includes (but is not limited to) classification of patients, social distancing, source control, changes to PPE for protection, and recommendations to select EPA-registered hospital-grade disinfectants from EPA List N. 27 In the dental environment, key guidance includes the use of mass evacuation, rubber dams (if possible), and specific recommendations for PPE in the process of generating aerosols. Other devices, such as extra-oral suction, can also reduce aerosolization by capturing, while changing the power level, size, configuration, noise level, and handling of the captured aerosol. 28 A layered approach is recommended. This approach includes the use of ventilation and consideration of auxiliary equipment, especially high-efficiency particulate air (HEPA) filtration and ultraviolet germicidal radiation (UVGI). 29 HEPA filter and UVGI13 on the upper layer of the room continue to work when there are people in the room to provide continuous auxiliary infection control. The new Food and Drug Administration (FDA) approved medical devices can also be used in the dental environment, which we will discuss later in this article.
It is worth noting that the use of ozone generator air purifiers is not recommended. Although ozone is a high-concentration fungicide, it is also toxic. OSHA's allowable ozone level is 0.10 ppm (0.2 mg/m3) airborne exposure limit for an 8-hour work shift (one day of exposure). The upper limit recommended by the National Institute of Occupational Safety and Health is 0.10 ppm, which should not be exceeded at any time. 30,31 The California Air Resources Board (CARB) is responsible for overseeing California's air pollution control work to achieve and maintain health-based on air quality standards, other government organizations recommend not to use such ozone generators in spaces occupied by humans or animals . 32,33 According to evidence, ozone concentrations within allowable levels cannot effectively remove microorganisms, as well as many odor-causing chemicals, and need to be much higher to kill microorganisms in the air. 31
"Air changes per hour" (ACH) indicates the number of times the air in the designated space is replaced, provided that the air is well mixed. CDC defined at least 6 ACHs as standards for effective ventilation systems in 2003, and for spread-based preventive measures, it stated that at least 12 ACHs should be ensured. 34 A minimum of 6 ACHs are under review. As reported by the American Society of Heating, Refrigeration, and Air-Conditioning Engineers (ASHRAE), the assumption in the past was that the air was ideally mixed and there were no airflow obstacles, such as dental chairs. It was also pointed out that this was based on the fact that there was no “exhaust air polluting the room again”. 35 The purpose of increasing room ventilation is to provide more clean air, thereby reducing the concentration of pollutants. The goal is to keep this below the threshold that may cause injury/illness. It has also been shown that a relative humidity lower than 40% can increase the survival rate of some airborne microorganisms and increase their spread. 35
One way to evaluate ventilation is to use a carbon dioxide monitor. These determine the concentration of carbon dioxide in an area, and readings below 800 ppm are considered the target baseline for good ventilation. Periodic assessments of carbon dioxide levels in specific spaces can provide information about the need (or no need) to adjust ventilation. If used properly, it can provide an early warning system. 36
According to CDC guidelines, options including opening windows-even slightly open if possible-help ventilation. A fan can be used to increase the flow of outside air into the area. Another option is to consult an HVAC expert to further open the outdoor air damper of the HVAC and help ensure that the HVAC is working properly and adjusted to obtain the best airflow. 27 Other ways to adjust ventilation can be found on the CDC website.
Provides a minimum efficiency report value (MERV) rating for the filter. 37 The higher the MERV rating, the higher the efficiency of the filter. For example, the particle size efficiency of the MERV 14 filter is 76% to 84% for particles from 0.3-μm to 1.0-μm, and 90% or higher for particles from 1.0-μm to 3.0-μm. On the other hand, the MERV 12 filter has a particle size efficiency of 80% to 89.9% for 1-μm to 3-μm particles, and a particle size efficiency of 90% or higher for 3-μm to 10-μm particles. Currently, ASHRAE recommends the use of MERV 13 filters for HVAC systems (at least 85% efficiency in capturing particles in the size range of 1 to 3 microns), and points out that MERV 14 or better filters are the first choice. 38 It also states that a given HVAC system must be considered and may not be able to accommodate the MERV 13 filter. Higher efficiency generally increases the pressure drop, which, in turn, may reduce airflow through the system and/or increase energy use. 37
CDC recommends considering the use of portable HEPA filters to purify the air, preferably those with electric fans. 27 HEPA filter can theoretically capture at least 99.97% of 0.3-μm particles, which is the most penetrating particle size and therefore the most difficult. 39,40 When choosing a HEPA filter, it is recommended to use a highly clean air delivery Rate (CADR) filter. This defines the cubic feet of air that the filter can process per minute. The location of the equipment should be such that air is drawn in from the direction of the patient and the clinical team, avoiding the inhalation of contaminated air. When determining the required HEPA filter capacity or whether multiple HEPA filters are required, the size and capacity of the room must be considered.
Although some devices on the market may be advertised as "HEPA-Rx", "True HEPA" or "Medical Grade HEPA" filters, these are not recognized HEPA categories.
Many newer technologies and equipment are now sold as auxiliary equipment for air purification. These provide the capture of microorganisms and their destruction in the device and/or the air in different ways. Before deciding whether to buy these products, several factors need to be considered. First, you need one, is it effective, is it safe? During the COVID-19 public health emergency, according to the FDA's Sterilizer, Disinfection Equipment, and Air Purifier Enforcement Policy, has the device been approved by the FDA or will be on the market during COVID-19? Is it CARB certified (required for California)? Other factors include whether there are independent studies that have proven effective against microorganisms. Another consideration is the availability of research information in a healthcare environment that supports efficacy. Does the equipment operate intermittently or continuously, including safe operation when there are people in the room/area? Other considerations beyond the scope of this article include specifications, size, capacity, performance, ease of use, cost, maintenance, and ongoing support.
ActivePure Medical Guardian: ActivePure Medical Guardian was approved by the FDA as a Class II medical device and obtained CARB certification. The device is portable and the system is designed for use in rooms up to 3,000 cubic feet. This technology is an advanced form of technology developed and used in NASA's space program and is included in the Space Foundation Technology Hall of Fame. It provides continuous air and surface purification, and uses 3 technologies to work in 2 stages. The first stage uses a patented process, including the ultraviolet light source and titanium dioxide in the equipment as a photocatalyst, which is used to produce gaseous hydrogen peroxide and other oxidants. These then leave the equipment and enter the air. The oxidant interacts with the cell membranes of bacteria and fungi as well as the outer shell of viruses and destroys them. This can lead to the death of microorganisms. In the second stage, the air is sucked into the equipment along with the pollutants and oxidants present in the air. The pollutants are then ionized and negatively charged, captured by the positively charged filter media, and filtered by the HEPA filter. In addition, the presence of oxidants will kill the trapped and filtered microorganisms.
Test results: The technology has been researched in laboratories and healthcare environments. Tests with FDA Class II medical device approval showed that airborne RNA MS2 bacteriophages decreased by 5 (99.999%) logarithmically within 30 minutes.
At the University of Texas Medical Branch, the first phase of an independent laboratory study of ActivePure using only ActivePure technology (no filters or ionizers) was conducted using SARS-CoV-2.41. The test protocol is designed to provide 29 ft3 of air flow per minute (lowest setting). Within 3 minutes, the logarithmic decrease was found to be ≥2.87 to ≥3.38, which is equivalent to a SARS-CoV-2 concentration decrease of ≥99.87% to ≥99.96%. It is pointed out that since the detection level is reached, the actual reduction may be 99.99% or more.
In a second independent study, a sealed bioaerosol chamber was used in the laboratory with a temperature of approximately 70.6°F, a relative humidity of 36%, and an indoor temperature of 75°F and 50%, respectively. 41 Use a nebulizer containing approximately 50 mL of biological stock solution and run at 50 psi for 20 or 25 minutes (depending on the organism) to generate the bioaerosol. Use 2 impactors to collect aerosol samples and collect them for 90 minutes at baseline and 15-minute intervals. The test microorganisms are Staphylococcus epidermidis, Erwinia herbicola, RNA MS2 and DNA Phi X174 phage, Aspergillus niger and Bacillus subtilis. These are agents/replacement microorganisms of known pathogens, among which are Staphylococcus aureus; Yersinia pestis (black plague); influenza virus and norovirus; HCV, HCB and HIV; Stachybotrys chartarumand (a poisonous black Mold); and Bacillus anthracis (anthracis) (Table 1).
Three test trials and one control trial were conducted. The results showed that the overall average net logarithm decreased by 4.8 ± 0.74, representing a decrease of more than 99.99%. For Staphylococcus epidermidis, less than 1.2% of aerosol bacteria are alive at 15 minutes. At 60 minutes, the average net log reduction is 5.95 ± 0.34, which is equivalent to a reduction of nearly 99.9999%. For E herbicola, the average reduction at 15 minutes was >99.99%, and at 75 minutes, the average net log reduction obtained was 5.36 ± 0.37. For MS2 phage, within 15 minutes, an average of 99.999% was removed, and by 60 minutes, an average log reduction of 5.58 ± 0.43 was observed. Testing with Phi X174 phage produced an average net log reduction of 4.05 ± 0.27 at 60 minutes. For both phages, the reduction reached the detection limit. For Bacillus subtilis, it was found that the spores were reduced by 98.91% at 15 minutes, and the net logarithm was reduced by 4.23 ± 0.31 at 90 minutes. Was observed. Finally, Aniger’s 15-minute reduction rate was 99.71%, and by 60 minutes, the average net log reduction was found to be 4.12 ± 0.10 (Figure 3). At the 60-minute sampling point, the log reduction ranged from log 4 reduction (99.99% reduction) to log 6 reduction (99.9999% reduction) 41 (Figure 3) compared to the obtained samples.
Brondell Pro disinfecting air purifier with AG+ technology: This device was approved by the FDA as a medical device in January 2021, and it has obtained CARB certification. It contains a pre-filter, proprietary HEPA filter and nanocrystalline filter. The HEPA filter is described as anti-virus; the nanocrystalline filter removes gas and odor; the inside of the device uses ultraviolet light to help disinfect the surface of the filter, the device, and the air in it. The plasma generator generates negative ions, which leave the equipment with clean air, aiming to destroy the microorganisms in the room air. In an independent laboratory test using a testing room, it was found that the H1N1 and H3N2 influenza viruses were reduced by 99.9% within 1 hour. In a second independent laboratory test, it was found that SARS-CoV-2 was reduced by 99.9% after 15 minutes. At the time of writing, no research has been found in the healthcare environment.
Molekule Air Pro RX air purifier: This is an FDA approved medical device and CARB certification. It contains a pre-filter and a photoelectrochemical oxidation (PECO) filter. The fibers of the PECO filter are coated with a nano-catalyst, which is activated by ultraviolet rays and generates hydroxyl radicals in a closed chamber to destroy the microorganisms trapped in the fibers of the PECO filter. In an independent laboratory test using 4 filter samples at each time point, the company's PECO filter was evaluated for the reduction of RNA virus MS2 (a SARS-CoV-2.42 proxy virus). At 1 hour, a decrease of 99.95% was observed, and at 24 hours, a decrease of 99.9994% was observed.
Radic8: The Radic8 device was originally developed in South Korea during the SARS outbreak and was widely used there. This air purifier has 2 main stages. 43 After inhaling air, it passes through the pre-filter, HEPA filter and activated carbon filter. UV-C light and titanium dioxide are used to generate hydroxyl radicals-they stay in closed rooms and kill microorganisms there. Then release the treated air into the room. The device has a "single pass" kill rate of 99.9999% for viruses similar to SARS-CoV-2, which means that the kill rate is based on the air passing through the device once. This technology has been proven in laboratory tests and can kill SARS-CoV-2, bacteria and fungi in aerosols. Although Radic8 is not an FDA-approved medical device, it is currently sold in accordance with the FDA's disinfection, disinfection equipment and air purifier implementation policy during the 2019 Coronavirus Disease (COVID-19) public health emergency.
In general, emerging and re-emerging diseases have led people to pay more attention to infection control and regularly change infection control guidelines and practices. What is particularly worrisome is that we have now entered the so-called post-antibiotic era, in which our ability to fight many infectious diseases has been compromised by the reduction in the supply of effective antibiotics. Our understanding of airborne transmission is also getting more and more attention. During COVID-19, it is recommended to adopt a layered approach, including ventilation, and consider HEPA filtration and UVGI. There are many new types of auxiliary equipment on the market. When looking at newer equipment, if you consider using it, you need to carefully review and due diligence to determine its effectiveness, safety, and applicability.
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2. Centers for Disease Control and Prevention. ACIP's vaccine recommendations and guidelines. Updated on July 16, 2013. Available from the following website: https://www.cdc.gov/vaccines/hcp/acip-recs/index.html
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12. Hotez P. The new normal in the United States and Europe: the return of vaccine-preventable diseases. Pediatric Research 2019;85(7):912-4. doi:10.1038/s41390-019-0354-3
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14. Centers for Disease Control and Prevention. Candida. Updated on July 22, 2021. Available from the following website: https://www.cdc.gov/fungal/candida-auris/
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24. Barron P. Centers for Disease Control and Prevention. The generation and behavior of particles (aerosols) in the air. Available at: https://www.cdc.gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf
25. Teska P. Pathogens under the feet can infect patients and medical staff. Infection control today. March 28, 2021. Available at: https://www.infectioncontroltoday.com/view/pathogens-underfoot-can-floor-patients-health-care-workers
26. Siegel JD, Rhinehart E, Jackson M, etc.; Health Care Infection Control Practice Advisory Committee. 2007 Isolation Preventive Measures Guidelines: Preventing the spread of infectious pathogens in health care facilities. Am J infection control. 2007; 35 (10 Supplement 2): S65-164. doi:10.1016/j.ajic.2007.10.007
27. Centers for Disease Control and Prevention. COVID-19: A guide to dental settings. Updated on December 4, 2020. Available from the following website: https://www.cdc.gov/coronavirus/2019-ncov/hcp/dental-settings.html
28. American Academy of Oral and Maxillofacial Surgery. Intraoral and extraoral suction devices. A review of the effectiveness of the device in capturing aerosols. June 2, 2020. Available at: https://www.aaoms.org/docs/COVID-19/Intraoral_vs_Extraoral_Suction_Devices.pdf
29. Centers for Disease Control and Prevention. Ventilation of the building. Updated on June 2, 2021. Available from the following website: https://www.cdc.gov/coronavirus/2019-ncov/community/ventilation.html
30. US Department of Labor: Occupational Safety and Health Administration. Standard 1910.1000-Air Pollutants. Updated on March 26, 2015. It can be obtained from the following website: https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1000
31. Environmental Protection Agency. Indoor Air Quality (IAQ): An ozone generator sold as an air purifier. Website: https://www.epa.gov/indoor-air-quality-iaq/ozone-generators-are-sold-air-cleaners
32. California Air Resources Board. About the California Air Resources Board. Available at: https://ww2.arb.ca.gov/about
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35. American Society of Heating, Refrigeration and Air-Conditioning Engineers. ASHRAE Epidemiology Working Group: Dental Facilities. Updated on April 21, 2021. Available from the following URL: https://www.ashrae.org/file%20library/technical%20resources/covid-19/ashrae-dental-c19-guide.pdf
36. National Environmental Sanitation Cooperation Center. Indoor CO2 sensors used to mitigate the risk of COVID-19: current guidelines and restrictions. Released in May 2021. Located at: https://ncceh.ca/sites/default/files/FINAL%20-%20Using%20Indoor%20CO2%20Sensors%20for%20COVID%20MAY%2017%202021.pdf
37. Environmental Protection Agency. Indoor air quality (IAQ). What is a HEPA filter? Available at: https://www.epa.gov/indoor-air-quality-iaq/what-hepa-filter-1
38. American Society of Heating, Refrigeration and Air-Conditioning Engineers. Frequently asked questions about filtration and disinfection. Available at: https://www.ashrae.org/technical-resources/filtering-and-disinfection-faq
39. Ash. Air filtration. Updated in 2014. Available at: https://www.ashe.org/compliance/ec_02_05_01/01/airfilter
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41. ActivePure medical files. File information.
42. Balarashti J, Conley Z. The killing kinetics of the catalytic filter used in the Molekule® Air Pro RX equipment against MS2 phage. Aerosol research and engineering laboratory.
43. Radic8. VK 401. radic8.com/products/vk401.
Dr. Collins graduated from the University of Glasgow in Scotland as a general dentist and holds an MBA and a master's degree from Boston University. She is a published author and international speaker on topics including infection control and OSHA. She is a consultant; the editor of Dental World; a coach; and a CE writer, editor and peer reviewer. She is an ADA representative of the Association for the Advancement of Medical Devices (AAMI), the Chicago Dental Association, the Organization for Safety, Sterility and Prevention (OSAP), a participant in the standards working group, and a researcher at the Pierre Fauchard College. You can contact her via email drfionacollins@gmail.com.
Disclosure: The Dr. Collins report did not disclose.
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