Frequently Asked Questions
As we understand the FDA’s Guidance, the Emergency Use Authorization (“EUA”) is directed primarily to non-medical-device manufacturers that, because of the Covid-19 pandemic, are temporarily shifting from their traditional production to the manufacture of Personal Protective Equipment (“PPE”). These manufacturers cannot comply with the FDA’s labeling and good manufacturing standards, among other FDA requirements. Because of the emergency, the FDA has waived many of its requirements and allowed this PPE to be sold under the EUA.
Augustine Surgical, Inc. is a medical device manufacturer, experienced in meeting all FDA requirements. As such, it has no need of the waivers provided by the EUA.
Prior to this emergency, ASI was not in the business of manufacturing and selling personal protective equipment (“PPE”). Shortly after the Covid-19 virus began affecting people in the United States, however, Dr. Scott Augustine, ASI’s CEO and the inventor of HotDog patient warming, Bair Hugger forced-air warming, Ranger fluid warming and numerous other medical devices, turned his attention to PPE. Within a few days, the first prototype of the COVEX Face Shield was produced; full-scale manufacturing of the device began less than three weeks later.
Each medical institution sets its own protocols regarding when face masks should be replaced; those protocols, ASI believes, would apply to the Filter of the COVEX Face Shield as well. Generally, such protection is replaced at least daily.
ASI is collecting data regarding the life-expectancy of the Shield. It is likely, however, that life-expectancy will vary widely, depending on the care and usage. It is ASI’s hope, however, that the reusable portion will last 1 to 2 months before needing to be replaced.
The definition of “respirator” used by the CDC is as follows:
CDC/NIOSH: What is a respirator and what is a NIOSH-approved N-95 respirator?
A respirator is a personal protective device that is worn on the face, covers at least the nose and mouth, and is used to reduce the wearer’s risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases, or vapors. The many types of respirators available include (1) particulate respirators, which filter out airborne particles; (2) “gas masks,” which filter out chemicals and gases; (3) airline respirators, which use compressed air from a remote source; and (4) self-contained breathing apparatus, which include their own air supply. The category of particulate respirator can be further divided into (1) disposable or filtering facepiece respirators, where the entire respirator is discarded when it becomes unsuitable for further use due to excessive resistance, sorbent exhaustion, or physical damage; (2) reusable or elastomeric respirators, where the facepiece is cleaned and reused but the filter cartridges are discarded and replaced when they become unsuitable for further use; and (3) powered air purifying respirators (PAPRs), where a battery-powered blower moves the air flow through the filters.
ASI believes that the COVEX Face Shield meets this definition.
Face shields intended for a medical purpose are regulated by FDA under 21 CFR 878.4040 – Surgical apparel. These devices are classified as class I (general controls) and are exempt from the premarket notification requirements in 21 CFR Part 807 (“510(k) clearance”).
There is currently no universal standard for face/eye protection from biological hazards.1 Nevertheless, OSHA’s applicable standard (1910:1030 subpart (d)(3)(i)) states as follows: “Masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated.”2
The FDA has issued guidelines applicable during the current emergency: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-respirators-during-coronavirus-disease-covid-19-public-health?utm_campaign=2020-04-02%20COVID-19%20Face%20Mask%20Webinar&utm_medium=email&utm_source=Eloqua
ASI believes that the portion of the device referred to as the “respirator” complies with the following CDC/NIOSH definition of the term: “A respirator is a personal protective device that is worn on the face or head and covers at least the nose and mouth.”
The COVEX Shield is not recommended for use by the surgeon during surgery. The exhalation valve does not filter air exiting the mask. However, the exhalation valve can be taped shut and exhaled air will vent out of the filter media. This may increase humidity within the respirator, but that is similar to other surgical respirator masks.
It is an exhalation valve that reduces moisture build-up and protects the integrity of the filter and comfort of the user.
To check the seal, exhale sharply while wearing the COVEX Shield. If air leaks around nose or the edges, readjust the position and the tightness. If you CANNOT achieve a proper seal, DO NOT enter a contaminated area.
There are three sizes of masks depending on availability. The mask should provide a seal around the nose and mouth while resting above the base of the chin. Use the size that best fits your face.
The Shield may be wiped with any standard disinfectant solution or wipes, or washed with soap and water between exposures or as often as necessary. The filter is not washable.
- International Safety Equipment Association (ISEA) [accessed July 14, 2015];Draft ISEA 119: Standard for eye and Face Protection against Biological Hazards. Available at https://safetyequipment.org/userfiles/File/Background_statement.pdf.
- Occupational Health and Safety Administration (OSHA) Blood Borne Pathogens Standard 1910.1030. [accessed July 14, 2015]; Available at https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.