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 Responsecan 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	P3P2	AS/NZS 1715:2009	YES
Brazil	ABNT/NBR 13698:2011	PFF3PFF2	Fundacentro CDU 614.894	YES
China	GB 2626-2006	KN 100 KP100KN95 KP95	GB/T 18664—2002	YES
Europe	EN 149-2001	FFP3FFP2	EN 529:2005	YES
Japan	JMHLW-2000	DS/DL3DS/DL2	JIS T8150: 2006	YES
Korea	KMOEL-2017-64	Special1st	KOSHA GUIDE H-82-2015	YES
Mexico	NOM-116-2009	N100, P100, R100N99, 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

References

https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html

Comparison of FFP2, KN95, and N95 and Other Filtering Facepiece
Respirator Classes

Filtering facepiece respirators (FFR), which are sometimes called disposable respirators, are subject to various regulatory standards around the world. These standards specify certain required physical properties and performance characteristics in order for respirators to claim compliance with the particular standard. During pandemic or emergency situations, health authorities often reference these standards when making respirator recommendations, stating, for example, that certain populations should use an “N95, FFP2, or equivalent” respirator.

This document is only intended to help clarify some key similarities between such references, specifically to the following FFR
performance standards:
• N95 (United States NIOSH-42CFR84)
• FFP2 (Europe EN 149-2001)
• KN95 (China GB2626-2006)
• P2 (Australia/New Zealand AS/NZA 1716:2012)
• Korea 1st class (Korea KMOEL – 2017-64)
• DS (Japan JMHLW-Notification 214, 2018)

Certification/Class(Standard)	N95(NIOSH-42CFR84)	FFP2 (EN149-2001)	KN95(GB2626-2006)	P2 (AS/NZ1716:2012)	Korea 1st Class(KMOEL -2017-64)	DS (Japan JMHLW Notification 214, 2018)
Filter performance –(must be ≥ X% efficient)	≥ 95%	≥ 94%	≥ 95%	≥ 94%	≥ 94%	≥ 95%
Test agent	NaCl	NaCl and paraffin oil	NaCl CDU 614.894	NaCl	NaCl and paraffin oil	NaCl
Flow rate	85 L/min	95 L/min	85 L/min	95 L/min	95 L/min	85 L/min
Total inward leakage (TIL)* – tested on human subjects each performing exercises	N/A	≤ 8% leakage (arithmetic mean)	≤ 8% leakage(arithmetic mean)	≤ 8% leakage (individual and arithmetic mean)	≤ 8% leakage (arithmetic mean)	Inward Leakage measured and included in User Instructions
Inhalation resistance – max pressure drop	≤ 343 Pa ≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min) ≤ 500 Pa (clogging)	≤ 350 Pa	≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min)	≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min)	≤ 70 Pa (w/valve)	≤ 50 Pa (no valve)
Flow rate	85 L/min	Varied – see above	85 L/min	Varied – see above	aried – see above	40 L/min
Exhalation resistance – max pressure drop	≤ 245 Pa	≤ 300 Pa	≤ 250 Pa	≤ 120 Pa	≤ 300 Pa	≤ 70 Pa (w/valve) ≤ 50 Pa (no valve)
Flow rate	85 L/min	160 L/min	85 L/min	85 L/min	60 L/min	140 L/min
Exhalation valve leakage requirement	Leak rate ≤ 30 mL/min	N/A	Depressurization to 0 Pa ≥ 20sec	Leak rate ≤ 30 mL/min	visual inspection after 300 L /min for 30 sec	Depressurization to 0 Pa ≥ 15sec
Force applied	-245 Pa	N/A	-1180 Pa	-250 Pa	N/A	-1,470 Pa
CO2 clearance requirement	N/A	≤ 1%	≤ 1%	≤ 1%	≤ 1%	≤ 1%

REFERENCES

https://multimedia.3m.com/mws/media/1791500O/comparison-ffp2-kn95-n95-filtering-facepiece-respirator-classes-tb.pdf