Frequently Asked Questions about the Use of Stockpiled N95 Filtering Facepiece Respirators for Protection from COVID-19 Beyond the Manufacturer-Designated Shelf Life
Please refer to CDC Guidance and Cal/OSHA "Guidance on Novel Coronavirus (COVID-19) for Health Care Facilities: Efficient Use of Respirator Supplies."
Note: this guidance is subject to change as the situation evolves.
Q&A:
1. QUESTION: Under what circumstances can facilities use respirators that are past their expiration dates?
Prior to using expired N95 filtering facepiece respirators, health care facilities should take appropriate measures to maximize respirator supplies and reduce the need for respirator use. Facility infection preventionists, occupational health staff, and respiratory protection program managers should implement CDC's "Strategies for Optimizing the Supply of N95 Respirators", and Cal/OSHA "Guidance on Novel Coronavirus (COVID-19) for Health Care Facilities: Efficient Use of Respirator Supplies" first to conserve supplies of respirators. These strategies include implementing engineering and administrative controls to limit the number of health care staff exposed to suspect or confirmed COVID-19 cases within a facility. Health care facilities should prioritize use of respirators in their supplies that are not expired. When these non-expired respirators are exhausted, N95 filtering facepiece respirators may be used (including those from the state stockpile), as long as they are models that have been tested by CDC/National Institute for Occupational Safety and Health (NIOSH) researchers and are listed on CDC's topic page, "Release of Stockpiled N95 Filtering Facepiece Respirators Beyond the Manufacturer-Designated Shelf Life: Considerations for the COVID-19 Response".
2. QUESTION: For what procedures should health care personnel not use N95 respirators that are past their expiration dates?
Under the Cal/OSHA Aerosol Transmissible Diseases (ATD) standard, N95 respirators should never be used by health care staff performing high-hazard aerosol-generating procedures for patients with a suspected or confirmed airborne infectious disease. Under the ATD standard, respiratory protection at a higher level than N95, such as powered air purifying respirators (PAPRs) must be worn for high-hazard procedures, including sputum induction and use of Bilevel Positive Airway Pressure (BiPAP).
3. QUESTION: Can we use the expired N95 filtering facepiece respirators that are on CDC's list for fit testing and training?
Yes, respirator models that are on CDC's list and are expired may be used for fit testing and training.
4. QUESTION: Which manufacturers and models of expired respirators are ok to use?
Despite being past their manufacturer-designated shelf life, CDC/NIOSH has approved use of specific N95 respirators, if the storage conditions have generally been in accordance with the manufacturer-recommended storage conditions and an OSHA-compliant respiratory protection program is used by employers. In alphabetical order, the models are:
- 3M 1860
- 3M 1870
- 3M 8210
- 3M 9010
3M 8000 [note: although this model is on the NIOSH list, it is no longer in production and should not be used because it has a low fit-testing success rate.]
- Gerson 1730
- Medline/Alpha Protech NON27501
- Moldex 1512
- Moldex 2201
5. QUESTION: If we have expired N95 filtering facepiece respirators that are not on CDC's list, can our facility still use them?
No, other respirators that do not appear on the list have not yet been tested to ensure that they continue to meet NIOSH performance standards for filtration efficiency and inhalation/exhalation resistance. Non-tested N95s that are not on CDC's list that are past their manufacturer-designated shelf life are no longer considered NIOSH-approved.
6. QUESTION: Should I prioritize use of expired respirators (from the state stockpile or facility stockpile) before using the unexpired respirators stored in our facility?
No, because respirators past their expiration date may not provide the protection for which they were certified. The goal is to ensure non-expired respirators are used for the higher risk encounters. The following priority should be followed:
a. Health care facilities with employees that provide care to suspected or confirmed COVID-19 patients must exhaust all other respiratory protection options available (such as reusable respirator supplies) before using expired respirators.
b. Primary care physicians and other referring employers should use expired respirators as needed to conserve respirator supplies in the state.
7. QUESTION: The Gerson 1730 and the Medline/Alpha Protech NON27501 models do not have a manufacturer-designated shelf life. Is it ok to use these?
Yes, the Gerson 1730 and the Medline/Alpha Protech NON27501 are on CDC's list which means they have been tested and found they meet NIOSH's performance standards for filtration efficiency and inhalation/exhalation resistance.
8. QUESTION: Where do I find shelf life and expiration date for our N95 filtering facepiece respirators?
According to 3M FAQ (PDF), the shelf life information is usually found on the side or bottom of the primary box. "The shelf life for the health care NIOSH-approved respirators is in the form of a "use by" date such as "YYYY-MM-DD" (year-month-day) and should be located near the hourglass icon."
9. QUESTION: If an N95 filtering facepiece respirator does not have an expiration date, is it ok to use it?
Of the respirators in the state stockpile, only the Gerson 1730 and the Medline/Alpha Protech NON27501 respirators do not have an expiration date. These respirators are on CDC's list and have been tested and found they meet NIOSH's performance standards for filtration efficiency and inhalation/exhalation resistance.
For respirators in your facility's supplies that are not labeled with shelf life information, the date of manufacture can be found on the label or printed information located on the primary box. 3M recommends that their N95 filtering facepiece respirators no longer be used if five years have passed since the date of manufacture.
10. QUESTION: What products does CDPH currently have in its state stockpile inventory?
- 3M 1860 N95 Healthcare Particulate Respirator and Surgical Mask
- 3M 1860S N95 Healthcare Particulate Respirator and Surgical Mask
- 3M 1870 N95 Healthcare Particulate Respirator and Surgical Mask
Standard N95 Respirators are NIOSH certified to provide respiratory protection against inhaled particles. Healthcare N95 Particulate Respirator and Surgical Mask are both NIOSH certified and FDA-cleared as surgical mask to provide protection against from both inhaled particles and fluid hazards (e.g., splashes, sprays). Note: Since NIOSH did not assess the fluid resistance of expired respirators approved as Particulate Respirator and Surgical Mask, these expired respirators should not be used for surgical procedures.
Based on feedback from previous users it appears that the 3M 1860, 3M 1860S and 3M 1870 are the easiest N95s to fit test.
11. QUESTION: How do I order PPE in the state stockpile?
Requestors should use the process outlined in the California Public Health and Medical Emergency Operations Manual (EOM). Facilities should contact their Medical Health Operational Area Coordinator (MHOAC) for more information. Please specify models requested/acceptable. Please specify number of respirators desired.
12. QUESTION: How much should be ordered?
Requestors should request no more than a 30-day supply of the above. Any supplies shipped are non-returnable so consideration should be given to storage capabilities.ā