keywords: Aerosol Hood, Covid-19, Disposable incubator, Neonatal intensive care incubator, Breegi scientific
The novel coronavirus, (nCoV) was first detected in Wuhan City, Hubei Province, China, in 2019. The virus is now named SARS-CoV-2, which causes the illness COVID-19. COVID-19 is a highly contagious, infectious disease and is currently a global pandemic. HCP such as doctors and nurses are at an increased risk of exposure to COVID-19 due to close proximity of infected patients, coupled with lack of available or sufficient PPE.
A public health emergency has been declared by the Secretary of Health and Human Services (HHS) on February 4, 2020 justifying the authorization of emergency use of protective barrier enclosure, such as SteriDome, as an extra layer of protection in addition to standard PPE for protection of HCP against COVID-19 aerosol exposure.
Risk of exposure to COVID-19 becomes even greater when performing procedures on critically ill patients, such as intubation. According to a study performed on SARS-CoV-1, the most comparable human coronavirus to COVID-19, nurses assisting in intubation were found to have 13.29 times the risk of developing SARS-CoV-1, compared to nurses not assisting in intubation. Across multiple studies, intubation was consistently found to have an increased risk of aerosol transmitted infection to HCP. A recent trial conducted in Wuhan, China posted on the Center for Disease Control (CDC) website provides further unsettling results about transmission of COVID-19. These results show that COVID-19 was widely distributed in the air, particularly in the ICU. Results also conclude that the transmission distance of COVID-19 might actually be 12 feet rather than the suggested 6 feet. The COVID-19 crisis has led to shortage of PPE, forcing the CDC to provide HCP with recommendations such as using PPE beyond single patient contact and considering the use of PPE beyond manufacture-designated shelf life. All of these studies suggest a need for product innovation aside from typical PPE. BSI believes that the SteriDome may assist in the reduction of aerosol exposure for HCPs during medical procedures such as intubation and lack of PPE.
APPROVED/CLEARED ALTERNATIVE PRODUCTS
Breegi Scientific, Inc. plans to distribute the SteriDome as an additional layer of protection along with standard PPE, to protect HCP against pathogenic aerosols in individuals meeting CDC’s confirmed or suspected COVID-19 clinical and/or epidemiological criteria. SteriDome is intended to expand domestic readiness within the United States and its territories by expanding HCP protection capabilities against COVID-19 aerosols during the COVID-19 public health emergency.
Currently no protective barrier enclosure systems, such as SteriDome, have been approved/cleared by the FDA for containment of pathogenic aerosols produced during high-risk procedures by patients with confirmed or suspected COVID-19. SteriDome is intended to provide an aerosol containment environment during aerosol producing procedures performed on adult patients with confirmed or suspected COVID-19. It is intended for use by qualified and trained HCP under the direction or supervision of a physician or other certified HCP in professional healthcare settings. SteriDome has not been approved for use in or has been used by any foreign country or international organization for either the proposed use or another use.