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editorial
. 2020 Aug;110(8):1162–1164. doi: 10.2105/AJPH.2020.305753
Product Use Examples Regulatory Considerations
Ventilators Mechanical ventilation in COVID-19 Emergency Ventilator Project (Massachusetts Institute of Technology) Class II device, requires EUA
Vent splitters Enable a single ventilator to be used on multiple COVID-19 patients Prisma Health Vesper Class II device, requires EUA
N95 respirators Respiratory protection for front-line health care workers Health Halyard Frame (University of Connecticut) Class II device, requires EUA, testing in NIOSH lab
Mask frames For use when N95 straps break/nose piece degrades Class I device, FDA notification waived
Surgical/cloth masks Respiratory protection for patients, staff, community Many local projects nationally and worldwide Class I device, FDA notification waived
Nasopharyngeal swabs For use with COVID-19 diagnostic tests 3D printed swabs (formlabs, Somerville, MA) Class I device, FDA notification waived
PAPRs Respirator for use when fit testing fails or N95s are unavailable 3D printed PAPR (Duke University) Class II device, NIOSH certification
Face shields Cover face and skin from respiratory droplets, used with N95 Prusa face shield (Prusa, Czech Republic) Class I device, FDA notification waived
PPE sanitizing techniques Sterilizing/disinfecting N95s and other PPE to extend life Class II device, requires EUA, testing in NIOSH lab
Surgical/procedure gowns Covering PPE, especially during procedures like intubation Splash testing required
Hand sanitizers Topical antiseptic for use when soap is not available WHO-recommended Handrub Formulations (now produced by many distilleries) > 94.9% denatured ethanol and distilled water, verification of alcohol content
Scrubs Garments for health care workers NA

Note. EUA = emergency use authorizations; FDA = US Food and Drug Administration; NA = not applicable; NIOSH = National Institute for Occupational Safety and Health; PAPR = powered air purified respirator; PPE = personal protective equipment; WHO = World Health Organization.