Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies

Crisis/Alternate Strategies

These crisis capacity or alternate strategies accompany and build on the conventional and contingency capacity strategies. The following measures are not commensurate with current U.S. standards of care. However, individual measures or a combination of these measures may need to be considered during periods of expected or known N95 respirator shortages. It is important to consult with entities that include some combination of: local healthcare coalitions, federal, state, or local public health officials, appropriate state agencies that are managing the overall emergency response related to COVID-19, and state crisis standards of care committees. Even when state/local healthcare coalitions or public health authorities can shift resources between health care facilities, these strategies may still be necessary.

When N95 Supplies are Running Low

Personal Protective Equipment and Respiratory Protection

Use of respirators beyond the manufacturer-designated shelf life for healthcare delivery

Consideration can be made to use N95 respirators beyond the manufacturer-designated shelf life for care of patients with COVID-19, tuberculosis, measles, and varicella. However, respirators beyond the manufacturer-designated shelf life may not perform to the requirements for which they were certified. Over time, components such as the straps and nose bridge material may degrade, which can affect the quality of the fit and seal. Many models found in U.S. stockpiles and stockpiles of healthcare facilities have been found to continue to perform in accordance with NIOSH performance standards. However, fluid resistance and flammability were not assessed. Use of the N95 respirators recommended in Release of Stockpiled N95 Filtering Facepiece Respirators Beyond the Manufacturer-Designated Shelf Life: Considerations for the COVID-19 Response can be considered. It is optimal to use these respirators in the context of a respiratory protection program that includes medical evaluation, training, and fit testing. If used in healthcare delivery, it is particularly important that HCP perform the expected seal check, prior to entering a patient care area. CDC does not recommend using N95s beyond the manufacturer-designated shelf life in surgical settings.

Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators

Other countries approve respirators for occupational use and approve respirators to these standards. These products are evaluated using some methods similar to those used by NIOSH, and some methods that are different, but are expected to protect HCPs. These respirators are expected to provide protection to workers. Those with equivalent or similar protection to NIOSH-approved respirators may be available to provide respiratory protection to workers exposed to harmful airborne particulate matter. These devices are expected to be suitable alternatives to provide protection during the COVID-19 response when supplies are short. The country, conformity assessment standards, acceptable product classifications, standards and guidance documents, and protection factor determination are provided in alphabetical order. All of these respirators have protection factors of at least 10 in the countries listed below, as outlined in the standards and guidance documents specified.

Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators
Country Performance Standard Acceptable product classifications Standards/Guidance Documents Protection Factor ≥ 10
Australia AS/NZS 1716:2012 P3

P2

AS/NZS 1715:2009 YES
Brazil ABNT/NBR 13698:2011 PFF3

PFF2

Fundacentro CDU 614.894 YES
China GB 2626-2006 KN 100 KP100

KN95 KP95

GB/T 18664—2002 YES
Europe EN 149-2001 FFP3

FFP2

EN 529:2005 YES
Japan JMHLW-2000 DS/DL3

DS/DL2

JIS T8150: 2006 YES
Korea KMOEL-2017-64 Special

1st

KOSHA GUIDE H-82-2015 YES
Mexico NOM-116-2009 N100, P100, R100

N99, P99, R99

N95, P95, R95

NOM-116 YES
US NIOSH Requirements NIOSH approved
42 CFR 84
N100, P100, R100
N99, P99, R99
N95, P95, R95
OSHA 29CFR1910.134 YES
Limited re-use of N95 respirators for COVID-19 patients

Limited re-use of N95 respirators when caring for patients with COVID-19 might become necessary. However, it is unknown what the potential contribution of contact transmission is for SARS-CoV-2, and caution should be used. Re-use should be implemented according to CDC guidance. Re-use has been recommended as an option for conserving respirators during previous respiratory pathogen outbreaks and pandemics. It may also be necessary to re-use N95 respirators when caring for patients with varicella or measles, although contact transmission poses a risk to HCP who implement this practice.

Use of additional respirators beyond the manufacturer-designated shelf life for healthcare delivery

Use of additional N95 respirators beyond the manufacturer-designated shelf life for care of patients with COVID-19, tuberculosis, measles, and varicella can be considered. However, respirators beyond the manufacturer-designated shelf life may not perform to the requirements for which they were certified. Over time, components such as the straps and nose bridge material may degrade, which can affect the quality of the fit and seal. Some models have been found NOT to perform in accordance with NIOSH performances standards, and consideration may be given to use these respirators as identified in Release of Stockpiled N95 Filtering Facepiece Respirators Beyond the Manufacturer-Designated Shelf Life: Considerations for the COVID-19 Response. In addition, consideration can be given to use N95 respirators beyond the manufacturer-designated shelf life that have not been evaluated by NIOSH. It is optimal to use these respirators in the context of a respiratory protection program that includes medical evaluation, training, and fit testing. It is particularly important that HCP perform the expected seal check, prior to entering a patient care area.

Prioritize the use of N95 respirators and facemasks by activity type

The number of infectious particles required to cause an infection (infectious dose) is often uncertain or unknown for respiratory pathogens. Further, there is often uncertainty about the influence of factors such as exposure duration and nature of clinical symptoms on the likelihood of infection transmission from person-to-person. When facemasks must be used by HCP entering a patient care area, source control (i.e. masking of symptomatic patients) and maintaining distance from the patient are particularly important to reduce the risk of transmission.

This prioritization approach to conservation is intended to be used when N95 respirators are so limited that routinely practiced standards of care for all HCP wearing N95 respirators when caring for a COVID-19 patient are no longer possible. N95 respirators beyond their manufacture-designated shelf life, when available, are preferable to use of facemasks. The use of N95s or elastomeric respirators or PAPRs should be prioritized for HCP with the highest potential exposures including being present in the room during aerosol generating procedures performed on symptomatic persons.

Suggested facemask or respirator use, based upon distance from a patient with suspected or known COVID-19 and use of source control*

Prioritize the use of N95 respirators and facemasks by activity type
HCP planned proximity to the case patient during encounter Facemask or respirator determination
Patient masked for entire encounter (i.e., with source control) Unmasked patient or mask needs to be removed for any period of time during the patient encounter
HCP will remain at greater than 6 feet from symptomatic patient HCP remaining at this distance from the patient should not need to enter the patient care area; if entry required: no facemask or respirator HCP remaining at this distance from the patient should not need to enter the patient care area; if entry required: no facemask or respirator
HCP will be within 3 to 6 feet of symptomatic patient HCP remaining at this distance from the patient should not need to enter the patient care area; if entry required: facemask HCP remaining at this distance from the patient should not need to enter the patient care area; if entry required: facemask
HCP will be within 3 feet of symptomatic patient, including providing direct patient care Facemask N95 respirator/ elastomeric /PAPR, based on availability
HCP will be present in the room during aerosol generating procedures performed on symptomatic persons N95 respirator/ elastomeric /PAPR, based on availability N95 respirator/ elastomeric /PAPR, based on availability

*Based on availability, organizations may require and/or individuals may voluntarily choose to utilize higher levels of protection

When No Respirators are Left

Administrative Controls

Exclude HCP at higher risk for severe illness from COVID-19 from contact with known or suspected COVID-19 patients

During severe resource limitations, consider excluding HCP who may be at higher risk for severe illness from COVID-19, such as those of older age, those with chronic medical conditions, or those who may be pregnant, from caring for patients with confirmed or suspected COVID-19 infection.

Designate convalescent HCP for provision of care to known or suspected COVID-19 patients

It may be possible to designate HCP who have clinically recovered from COVID-19 to preferentially provide care for additional patients with COVID-19. Individuals who have recovered from COVID-19 infection may have developed some protective immunity, but this has not yet been confirmed.

Engineering Controls

Expedient patient isolation rooms for risk-reduction

Portable fan devices with high-efficiency particulate air (HEPA) filtration that are carefully placed can increase the effective air changes per hour of clean air to the patient room, reducing risk to individuals entering the room without respiratory protection. NIOSH has developed guidance for using portable HEPA filtration systems to create expedient patient isolation rooms. The expedient patient isolation room approach involves establishing a high-ventilation-rate, negative pressure, inner isolation zone that sits within a “clean” larger ventilated zone. In the absence of any remaining supply of N95 respirators, it may be possible to use this technology in conjunction with HCP wearing facemasks.

Ventilated Headboards

NIOSH has developed the ventilated headboard that draws exhaled air from a patient in bed into a HEPA filter, decreasing risk of HCP exposure to patient-generated aerosol. This technology consists of lightweight, sturdy, and adjustable aluminum framing with a retractable plastic canopy. The ventilated headboard can be deployed in combination with HEPA fan/filter units to provide surge isolation capacity within a variety of environments, from traditional patient rooms to triage stations, and emergency medical shelters. In the absence of any remaining supply of N95 respirators, it may be possible to use this technology in conjunction with HCP and/or patients wearing facemasks.

Personal Protective Equipment and Respiratory Protection

HCP use of non-NIOSH approved masks or homemade masks

In settings where N95 respirators are so limited that routinely practiced standards of care for wearing N95 respirators and equivalent or higher level of protection respirators are no longer possible, and surgical masks are not available, as a last resort, it may be necessary for HCP to use masks that have never been evaluated or approved by NIOSH or homemade masks. It may be considered to use these masks for care of patients with COVID-19, tuberculosis, measles, and varicella. However, caution should be exercised when considering this option.1,2

References

  1. Dato, VM, Hostler, D, and Hahn, ME. Simple Respiratory Maskexternal icon, Emerg Infect Dis. 2006;12(6):1033–1034.
  2.  Rengasamy S, Eimer B, and Shaffer R. Simple respiratory protection-evaluation of the filtration performance of cloth masks and common fabric materials against 20-1000 nm size particlesexternal icon, Ann Occup Hyg. 2010;54(7):789-98.