Issue 5: FDA and CDC guidance on masking (APRIL 3, 2020)

FDA GUIDANCE ON APPROPRIATE MASKING1

  • FDA has issued guidance to help expand availability of general use face masks for the general public, and particulate filtering facepiece respirators for health care professionals during the COVID-19 pandemic.
  • FDA-regulated devices are shown in  table 1.
  • FDA recommends that devices used have the following:
    1. Labeling that accurately describes the product as a face mask and includes a list of the body-contacting materials (which does not include any drugs or biologics);
    2. Labeling with recommendations that would reduce sufficiently the risk of use (e.g.,  recommendations against use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high) or where use is not intended or approved.
  • FDA recognizes that when alternatives are unavailable, individuals, including healthcare professionals, might improvise PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.
  • FDA has authorized an Emergency Use Authorization (EUA) for the emergency use of the Battelle# CCDS Critical Care Decontamination System™ for use in decontaminating compatible N95 or N95-equivalent respirators, for reuse by healthcare personnel.
  • Healthcare personnel should follow manufacturer’s instructions, as well as procedures at individual facilities.

 

CDC GUIDANCE ON N95 RESPIRATOR REUSE/EXTENDED USE2,*

  • Supplies of N95 respirators can become depleted during an influenza pandemic or wide-spread outbreaks of other infectious respiratory illnesses.
  • There is no way of determining the maximum possible number of safe reuses for an N95 respirator as a generic number to be applied in all cases. Safe N95 reuse is affected by a number of variables that impact respirator function and contamination over time.
  • CDC guidelines recommend:
    1. Minimizing the number of individuals who need to use respiratory protection through the preferential use of engineering and administrative controls;
    2. Using alternatives to N95 respirators (e.g., other classes of filtering facepiece respirators) where feasible;
    3. Implementing practices allowing extended use and/or limited reuse of N95 respirators, when acceptable;
    4. Prioritizing use of N95 respirators for those personnel at the highest risk of contracting or experiencing complications of infection.
    5. Discard N95 respirators following use during aerosol generating procedures.
    6. Discard N95 respirators contaminated with blood, respiratory 1. or nasal secretions, or other bodily fluids from patients.
    7. Discard N95 respirators following close contact with any patient co-infected with an infectious disease requiring contact precautions.
    8. Discard any respirator that is obviously damaged or becomes hard to breathe through.
    9. Hang used respirators in a designated storage area or keep  in a clean, breathable container (e.g., a paper bag) between uses. Ensure that the “respirator-person” pair is clearly identified.
    10. Minimize potential cross-contamination by storing respirators so they do not touch each other.  Storage containers should be disposed of or cleaned regularly.
    11. Avoid touching the inside of the respirator.

#Battelle Contact: 1-800-201-2011 or solutions@battelle.org

*Extended use refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several patients, without removing the respirator between patient encounters .Reuse refers to the practice of using the same N95 respirator for multiple encounters with patients but removing it (‘doffing’) after each encounter. The respirator is stored in between encounters to be put on again (‘donned’) prior to the next encounter with a patient.

REFERENCES:

  1. Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency , Guidance for Industry and Food and Drug Administration Staff, March 2020.
  2. https://www.cdc.gov/niosh/topics/hcwcontrols/recommendedguidanceextuse.html Accessed March 31, 2020. Cortegiani  et al.,J. Crit Care 2020.
  3. https://coronavirus.jhu.edu/map.html