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.