The following is a list of resources assembled to help anyone experiencing a shortage of disposable facemasks or respirators.
Food and Drug Administration (FDA)
On March 2nd, 2020, the U.S. FDA issued a letter to the CDC authorizing emergency use of:
- All disposable filtering facepiece respirators (FFRs or respirators) approved by the National Institute for Occupational Safety and Health (NIOSH) as non-powered air-purifying particulate FFRs
- FFRs that were NIOSH-approved but have since passed the manufacturers’ recommended shelf-life, for use in healthcare settings by healthcare personnel (HCP)
to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the Coronavirus Disease 2019 (COVID-19) outbreak.
On March 27th, 2020 the FDA issued an amendment to the letter to “additionally authorize the use of authorized respirators that have been decontaminated.” The ammendment revised the language to inlcude:
- Non-powered air-purifying particulate FFRs and reusable respirators such as elastomeric half and full facepiece respirators, approved by NIOSH and listed on the NIOSH Certified Equipment list (CEL) for non-powered air purifying respirators with particulate protection
- Other powered air purifying respirators (PAPRs) approved by NIOSH and that are listed on the NIOSH CEL for PAPRs with particulate protection
- FFRs that were NIOSH-approved but have since passed the manufacturers’ recommended shelf-life, are not damaged, and have been held in accordance with manufacturers’ storage conditions in strategic stockpiles
- Any authorized respirator under (1) or (3) above that has been decontaminated pursuant to the terms and conditions of an authorized decontamination system
Center for Disease Control (CDC)
The CDC has also discussed use of alternatives to N95 respirators here, specifically noting “Use NIOSH approved alternatives to N95 respirators where feasible. These include other classes of filtering facepiece respirators, elastomeric half-mask and full facepiece air purifying respirators, powered air purifying respirators (PAPRs). All of these alternatives will provide equivalent or higher protection than N95 respirators when properly worn. NIOSH maintains a searchable, online version of the certified equipment list identifying all NIOSH-approved respirators.” Additionally, the CDC states “Every other NIOSH approved filtering facepiece respirators is at least as protective as the N95. These include N99, N100, P95, P99, P100, R95, R99, and R100. Many filtering facepiece respirators have exhalation valves and should not be used in surgical settings as unfiltered exhaled breath would compromise the sterile field. On March 2, 2020, FDA issued an Emergency Use Authorization (EUA) authorizing the use of certain NIOSH-approved respirator models in healthcare settings”.
Lastly, in an older communication, the CDC explained the benefits of elastomeric face masks citing their comfort over standard N95 disposable masks when worn for extended periods of time, the reduction of medical waste, and decrease in cost over time.
Occupational Health and Safety Administration (OSHA)
It is important to note that the CDC does state “ Similar to N95 respirators, elastomeric respirators require annual fit testing”. However, regulation of this testing is a duty of the Occupational Health and Safety Administration (OSHA). OSHA explicitly states that employees may use their own personal respirators. During the COVID-19 pandemic, OSHA has given temporary enforcement discretion regarding the “fit test” requirement.
3M has published a continuously updated technical bulletin titled “Cleaning and Disinfecting 3M Reusable Elastomeric Half and Full Facepiece Respirators following Potential Exposure to Coronaviruses“. Contained in this bulletin is some guidance regarding the cleaning of masks and filters.
Cleaning Filters and Cartridges
3M does NOT recommend cleaning or disinfecting filters ,which are sold as disc-style filters and white pre-filter pads (see images below). However, some 3M filters are encased in hard plastic (see image). The bulletin states ” This hard case can be cleaned by wiping the outside surface with a damp cloth soaked in disinfecting solution until visibly wet for the appropriate contact time and then removing the disinfecting solution with a clean, water-soaked cloth and air drying. Do not allow the disinfecting solution to reach the internal filter media and do not submerge the hard-case filters in the disinfecting solution or water. Utilize the same disinfection solutions as recommended for 3M facepieces”.
Cleaning Respirator Facepieces
Two methods of disinfection of masks are listed in the technical bulletin.
- Sodium hypochlorite solution (at a free chlorine concentration of 5,000 ppm) with 1-minute contact time (1:10 household bleach mixture)
- 70% Isopropanol solution with 5-minute contact time
However, the bulletin does note that the EPA has complied a list of disinfectant for use against SARS-CoV-2 (the virus that causes COVID-19) along with a list of contact time, here. For example: CaviWipes are listed as an approved disinfectant with a contact time of 3 minutes.
The 3M recommended procedure for cleaning a mask is:
- Cleaning is recommended after each use. Nitrile or vinyl gloves should be worn during cleaning as well as other personal protective equipment (PPE) as indicated.
- Remove any filters or cartridges. The facepiece may be further disassembled as necessary.
- Inspect the facepiece per the User Instructions to identify any damage or excessive wear. Replace components or the entire facepiece as necessary.
- Clean the facepiece by immersing it in warm water not to exceed 120°F (49°C), and scrub with soft brush until clean. Add neutral detergent if necessary. Do not use cleaners containing lanolin or other oils. NOTE: Solvents and strong detergents may damage 3M facepieces and should not be used for cleaning.
- Rinse thoroughly with fresh warm water.
- Disinfect by soaking the facepiece according to the user instructions for the selected disinfectant, including usability, application and contact time.
- Rinse thoroughly with fresh warm water.
- Air dry in a non-contaminated area.
- Inspect and reassemble the respirator as described in the User Instructions.
- A pictorial list of 3M filters and mask types with model numbers: Selection Guide for 3M™ Reusable Respirators
- An excellent resource on cleaning respirators from Dr. Howard Mell, Dr. Christopher Guyer, and Mary-J Thompson, CSP, CHMM: Google Doc
- An example of a homemade cover for a disc-style 3M filter: P100 Filter Cover
- 3M technical bulletin on mixing bleach: Disinfection With Bleach
- Instructions for mixing bleach from a health unit in London: Mixing of Chlorine Bleach for Disinfecting
- A chlorine dilution calculator from Ontario: Chlorine Dilution Calculator
- Prototype instructions for 3D printing a face shield: Prusa Face Shield
- Alternate instructions for 3D printing a face shield: Levi Raskin
- An example of the type of clear plastic material required to make a face shield: Amazon