Reducing the Risk of Infection and Contamination in the Operating Room
SARS-CoV-2 Medical Grade Hospital Air Purifier for the mitigation of COVID-19 / Coronavirus.
Our devices have a role in the mitigation of airborne viruses and can be used within CDC guidelines for certain indications.
Dr. Rubino, Orthopedic Surgeon on using the ILLUVIA® HUAIRS in the operating room
David Kirschman, M.D.
We have received many inquiries regarding the use of Aerobiotix, Inc. systems in the Coronavirus epidemic, so we are releasing the following letter describing the scientific basis to support use within established guidelines.
GETTING FASTMD BACK TO WORK FAST
During this time of increased vigilance against infection, we are pleased to partner with Florida Advanced Spine and Sports Trauma Centers to provide Illuvia® ultraclean continuous UV air disinfection systems creating safe surgical environments for their patients.
“Installing the Illuvia® system in our locations has been the best experience. All of the staff at Aerobiotix are responsive and easy to work with. These units are a cost effective, simple, and efficient solution to reducing infection rates and providing peace of mind that our OR air quality is being addressed.”
MHA, Chief Operating Officer/ Security and Compliance Officer of FASTMD
Shortening the Pause: Calculating Aerosol Clearance for the Illuvia® System in the Operating Room Environment
During the COVID-19 pandemic, the resumption of elective procedures has required increased vigilance in reducing airborne O.R. contamination. Studies have shown that aerosol generating procedures (AGP), such as intubation, can increase the transmission rates of SARS pathogens by a factor of 13. (1)
A specific concern is O.R. turnover times and aerosol clearance between procedures. The use of Aerobiotix HEPA/UV-C Air Recirculation Systems (Illuvia®) can have a direct effect on room clearance times, compared to rooms without this technology. Illuvia® systems have been independently tested to achieve 100% single-pass virus elimination. (2)
These systems work in three ways to reduce clearance times:
- Increasing air exchange rates by 25% compared to baseline airflow.
- Reducing baseline contamination levels through continuous O.R. use by 70%.
- Allowing for relocation in close proximity to aerosol generating procedures (AGPs).
Determining baseline clearance rate
Air clearance rates are determined by the formula:
T = [ln (C2 / C1) / (Q / V)] X 60
Where T = time in minutes, C1 = initial concentration of contaminant, C2 = final concentration of contaminant, Q = air flow rate in cubic feet/hour, V = room volume in cubic feet.
At baseline, a typical O.R., with flow rate 100,000 cubic feet/hour, 4750 cubic feet volume, an initial viral concentration of 1000/cubic foot, a final concentration of 1, will have a clearance rate of 19.7 minutes.
ILLUVIA®: Reduction in initial concentration and increase in flow rate
Published studies (3) have found the Illuvia® system reduced airborne contamination levels, defined as aerosol particulates between 0.5 to 10 microns. This particulate size range has been identified as a size range for COVID-19 bioaerosols. (4)
With continuous use in the operative setting, particle contamination was reduced by 70%. Results were achieved with the unit placed 4m from the surgical table, adding an additional 27,000 cubic feet/hour of exchange capacity.
Referring to the clearance formula, addition of the Illuvia® system in the same O.R. increases flow rate to 127,000 cubic feet/hour, and reduces initial concentration to 300, resulting in a clearance rate of 12.8 minutes.
Moving the ILLUVIA® closer to contamination source will increase performance
A recent technical report (5) from the European Centre for Disease Prevention and Control indicates that in rooms where aerosol-generating procedures have been performed (including intubation and bag-valve ventilation) the use of a portable HEPA air filtration system placed in close proximity to where the patient was located is advised.
Clearance time using the Illuvia® can be further reduced by placing the unit near the area where AGPs have been performed. Aerosol concentration will be highest in this location and decrease as an inverse square of the distance from the source:
Placing the unit 1m from the AGP contamination source will capture a much higher proportion of the contamination then at 4m. Temporarily moving the unit from 4m to 1m during intubation and extubation may result in an additional 9X reduction in local aerosol concentration after an AGP is performed. Filtration systems, work more efficiently at levels of higher contamination, where a single pass through the system removes relatively more particulates in the same time period.
Referring again to the clearance formula, addition of the Illuvia® system at 1m from a known contamination source with a specific contamination event reduces initial room concentration to 33, resulting in a clearance rate of 7.8 minutes, assuming that is the only source of contamination.
There is significant variability in operating room construction, airflow, workflow and potential sources and concentrations of contamination. No engineering control can provide a guaranteed result with the inherent variability of the system.
Moving the ILLUVIA® closer to contamination source will increase performance
The use of the Illuvia® unit in a typical operating room environment will result in a potential reduction in clearance time from 19.7 minutes to 7.8-12.8 minutes. Variability is based upon room configuration and the source and level of contamination. If the source can be localized, such as with a specific AGP, higher efficiency may be achieved. It must also be noted that any environmental control system does not substitute for appropriate airborne precautions and wearing of PPE, which must be maintained in any setting where diagnosed or suspected COVID-19 patients are located.
1. Fowler RA, Guest CB, Lapinsky SE. Transmission of severe acute respiratory syndrome during intubation and mechanical ventilation. Am J Respir Crit Care Med. 2004 Jun 1;169(11):1198-202.
2. Data on file, Aerobiotix, Inc.
3. Curtis GL, Faour M, Jawad M, Klika AK, Barsoum WK, Higuera CA. Reduction of Particles in the Operating Room Using Ultraviolet Air Disinfection and Recirculation Units. J Arthroplasty. 2018 Jul; 33(7S):S196-S200
4. Wang J, Du G. COVID-19 may transmit though aerosol. Ir J Med Sci. 2020: Mar 24 1-2.
5. European Centre for Disease Prevention and Control. Disinfection of environments in healthcare and non-healthcare settings potentially contaminated with SARS-CoV-2. ECDC: Stockholm; 2020.
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Minnesota Orthopedic Center using Illuvia HUAIRS® to kill viruses in operating rooms as elective procedures resume.
O’Neill said they also are using new Aerobiotix machines in the operating room. “It’s a special device that turns the air over even more frequently in the operating room,” O’Neill explained. “It’s actually got ultraviolet light associated with it and so it kills any virus that may be in the OR.”
Dr. Owen O’Neill, an orthopedic surgeon at Twin Cities Orthopedics
Resumption of Elective Surgeries in the COVID-19 Pandemic: The Role of Aerobiotix in Reducing O.R. Airborne Pathogen Transmission
SARS-CoV-2 is a novel coronavirus which originated in China in late 2019. Since that time, it has grown into a global COVID-19 pandemic, causing pneumonia and respiratory failure in certain patient populations. The virus can be spread via direct contact, respiratory droplet, feces and bioaerosol.
Due to the pandemic, elective surgical procedures including joint replacement have been curtailed in much of the world. This is due to reallocation of healthcare resources and the risk of viral transmission to patients and caregivers. Furthermore, social distancing restrictions have precluded patients from undergoing non-emergent procedures.
The delay in elective procedures has caused a backlog of patients needing surgical treatment. In many cases these patients have been suffering with prolonged pain, limitations of activity and other symptomology for extended periods. As restrictions are gradually lifted, opportunities will arise to treat this population in need. However, facilities including acute care hospitals, surgical hospitals and ambulatory surgical centers need to be prepared for the resumption of procedures in a higher-risk environment. Even though the acute phase of the pandemic may be declining, there will still be significant risk for community and hospital transmission of Covid, and additional precautions must be taken. The use of additional environmental controls in the O.R. setting will reduce the barriers to resumption of elective procedures.
Can SARS-CoV-2 be transmitted via an airborne route?
Yes. SARS-CoV-2 has been shown to be transmitted through the air in several studies. The virus can be spread by both large respiratory droplets and smaller bioaerosols which can remain airborne for extended periods. There is particular risk from respiratory secretions expelled during aerosol- generating procedures, such as surgical intubation, extubation and bag mask ventilation.
Can operating rooms be contaminated with airborne SARS-CoV-2?
Yes. Care areas exposed to SARS-CoV-2 positive patients or staff are likely to have airborne contamination with bioaerosols or respiratory droplets. Global studies detected the presence of persistent airborne virus in care, staff, and auxiliary areas.
What can be done to increase O.R. safety from potential airborne SARS-CoV-2?
Preoperative SARS-CoV-2 testing for all patients should be considered. However, many asymptomatic or convalescent patients have been exposed to the virus, including those carrying antibodies or viral fragments. The contagiousness and immunity status of this growing patient population is unknown. The best policy is to treat every patient as if they are SARS-CoV-2 positive, at least until the natural history of the infection is better understood.
Personal protective equipment (PPE) must be worn throughout the entire perioperative process. However, in the context of elective surgical procedures, full airborne isolation equipment such as respirators may not be functional or practical.
How will SARS-Cov-2 affect operating room ventilation and pressure relationships?
Operating rooms typically operate under positive pressure, with additional laminar flow systems employed in certain orthopedic procedures. Positive pressure prevents external airborne pathogens, traditionally bacteria, from entering the operating room and causing surgical site infections.
In the context of a patient with a suspected or diagnosed SARS-CoV-2, the role of positive pressure becomes controversial, since it can spread bioaerosols to surrounding perioperative areas. Some operating rooms allow for reversal of flow to negative pressure; however, this will increase the risk of bacterial surgical site infections, which may have greater morbidity than SARS-CoV-2. A possible compromise option is maintaining normal O.R. pressure, i.e. neither positive nor negative.
To date there have been no formal recommendations on this topic. However, a pending publication by Dr. Javad Parvizi and colleagues at the Rothman Institute states that filtration of the operating room with devices that intake the air and remove micro-organisms may be preferable to positive pressure laminar flow.
A recent technical report from the European Centre for Disease Prevention and Control indicates that in rooms where aerosol-generating procedures have been performed (including intubation and bag- valve ventilation) high-efficiency particulate air (HEPA) filtration should be utilized, including using a portable HEPA air filtration system placed in close proximity to where the patient was located.
What is the role of Aerobiotix Air Decontamination systems during SARS-CoV-2 response?
The use of Aerobiotix intraoperative air decontamination systems has been shown in multiple peer- reviewed publications to reduce particulate contamination levels, including large and small viable particles which harbor microorganisms.
High-grade HEPA filtration has long been the gold-standard for clearance of airborne viruses. Aerobiotix units combine HEPA filtration with ultraviolet germicidal irradiation in a free-standing air decontamination device with non-turbulent air outflow for use in procedural environments. The Illuvia® system is an FDA registered Class-II medical device which is labeled to reduce the risk of airborne infections in the surgical patient. Aerobiotix devices have undergone independent testing by the Center for Aerobiology at the Research Triangle Institute, demonstrating 100% inactivation efficiency in single-pass virus testing, using MS2 virus at 450 cubic feet of air per minute. Coronaviruses are larger and more radiosensitive than MS2, making them potentially more vulnerable to ultraviolet and mechanical filtration than the MS2 test organism.
Illuvia® systems also perform real-time monitoring and logging of O.R. airborne particulate levels, to provide functional feedback to caregivers and perioperative staff regarding environmental cleanliness.
It should be reiterated that surgical patients will still be at risk for traditional bacterial surgical site infections, and the treatment of these infections will be complicated by ongoing challenges with care access and resources. Additional precautionary measures are warranted.
Can commercial-grade air HEPA purifiers be used to mitigate SARS-CoV-2?
Under the SARS-CoV-2 pandemic, some hospitals and surgery centers have resorted to using residential and construction-grade air purifiers in patient care areas. Caution must be advised since they create turbulent outflow and are not compliant for electromagnetic compatibility (EMC) for use in hospitals. The Illuvia® system is specifically designed for medical environments and has been tested to the global IEC 60601-1-2 standard for EMC.
The resumption of elective surgical procedures during the SARS-CoV-2 pandemic will represent significant duties and challenges for the surgical community. This will not be “business as usual” and new procedures and resources will need to be employed to improve safety for patients and caregivers. Utilization of new technologies, such as Aerobiotix, will facilitate this transition and drive a higher standard of care in the post-pandemic world.
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Aerobiotix and Public Health and
Social Services Emergency Fund (CARES Act)
There have been questions whether the costs of acquisition and use of Aerobiotix air decontamination products constitute eligible expenses under the Public Health and Social Services Emergency Fund (CARES Act).
The terms and conditions of the relief fund state that the funds can only be used “to prevent, prepare for, and respond to coronavirus, and that the payment shall reimburse the recipient only for health care related expenses or lost revenues that are attributable to coronavirus.” Additionally, the funds “cannot be used to reimburse expenses or losses that have been reimbursed from other sources or that other sources are obligated to reimburse.”
Eligible recipients for funding must have billed Medicare in 2019; provided after January 31, 2020 diagnoses, testing, or care for individuals with possible or actual cases of COVID-19; and are not currently terminated from participation in federal health programs.
Aerobiotix air decontamination systems are FDA regulated medical devices which use a combination of HEPA filtration and UV radiation to decontaminate the airborne environment, creating an area free of pathogens, including validation for removal of viral contamination. As such:
- Aerobiotix devices satisfy the requirement to “prevent, prepare for, and respond” to the coronavirus pandemic;
- Aerobiotix devices are not patient-specific or prescriptive devices, and are therefore not reimbursable through other sources, such as private health insurance, Medicare, Medicaid or other insurance providers.
Therefore, it is our position that Aerobiotix devices ARE an eligible, reimbursable expense under the Public Health and Social Services Emergency Fund (CARES Act). Please contact us at email@example.com for any further questions.
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Current Studies on CoV-19
The Journal of Arthroplasty
…filtration of the operating room with devices that intake the air and remove the micro-organisms may be preferable to the positive pressure laminar flow settings.
Joshua L. Santarpia, et al
The shedding of CoV-19 during respiration, toileting and fomite contact indicates infection may occur in both direct and indirect contact.
European Centre for Disease Prevention and Control (ECDC)
Where aerosol generating procedures are being performed, HEPA filtration should be used for the recycled air, including “using a portable HEPA air filtration system placed in close proximity to where the patient was located."
Preparing your ASC Post-COVID-19
With the recently announced Hospitals without Walls initiative from CMS, increased safety and reduced risk has never been more important to your center.