N95, FFP3, FFP2, FFP1, what's the difference?
The American Standard of respirator protection is managed by the NIOSH (part of the CDC) and the most commonly known respirator in the US is the N95. Europe uses two different standards which include the FFP (filtering face piece) and P1/P2/P3 ratings. Both are managed by the CEN (European Committee for Standardization).
Here's the breakdown:
- FFP1 filters at least 80% of particles that are 0.3 microns in diameter or larger.
- FFP2 filters at least 94% of particles that are 0.3 microns in diameter or larger.
- N95 filters at least 95% of particles that are 0.3 microns in diameter or larger.
- N99 & FFP3 filters at least 99% of particles that are 0.3 microns in diameter or larger.
So, what does that mean for protection? The closest European equivalent to the n95 is the FFP2 respirator, which is rated at 94%.
What about KN95s?
The Chinese standard that is supposed to have an equivalent specification to N95/FFP2 respirators.
Valve Vs Non-Valve Respirators?
Respirators with valves make it much easier to exhale air and makes them more comfortable to wear. The valve can also lead to less moisture build up inside the respirator, but they do NOT filter the wearer's exhalation. This provides one way protection for the wearer but puts others at risk in situations like contagious diseases. You'll never see these respirators used at hospitals or surgical centers because of this. With the shortage, it's possible this is the only kind of N95 mask in stock that you're able to find, and if that's the case, you can place a surgical mask or face covering over the valve to partially filter the exhaled breath.
Which face masks and surgical masks are medical devices regulated by the FDA?
The FDA regulates face masks, including cloth face coverings, and surgical masks as medical devices when they are marketed for medical purposes. Medical purposes include uses related to protecting against bacteria and viruses, such as face masks to help stop the spread of disease, surgical masks, and surgical masks with antimicrobial/antiviral agents. Face masks marketed to the general public for general non-medical purposes, such as for use in construction and other industrial applications, are not medical devices.
Do face masks provide protection from protecting against bacteria and viruses?
Masks may help prevent people from catching and/or spreading bacteria and viruses to others. The CDC recommends people wear face masks in public settings, especially when other social distancing measures are difficult to maintain. Wearing a face mask may limit exposure to respiratory droplets and large particles and may help prevent people who are contagious from spreading bacteria and viruses.
Are face masks, surgical masks, and respirators safe to wear?
If worn properly, face masks, surgical masks, or respirators may reduce the chance of spreading a bacteria and virus infection between you and those around you. The CDC provides information on using PPE and considerations for wearing masks.
FDA-cleared surgical masks and respirators have been used by health care personnel for years and have been worn in health care facilities during extended procedures without harm to the wearer. Health care personnel with medical conditions should discuss concerns they may have with wearing respirators with their own health care providers. Health care personnel should follow the manufacturer's instructions and their facility's policies for use of all PPE.
What does wearing a face mask for 'source control' mean?
Source control refers to use of cloth face coverings or face masks to cover a person's mouth and nose when they are talking, sneezing, or coughing to reduce the likelihood of transmission of infection by preventing the spread of respiratory secretions. Bacteria and viruses may be spread by individuals who may or may not have symptoms of certain diseases.
The general public's use of cloth face coverings made from common, easily accessible materials are an additional voluntary public health approach to help slow the spread of bacteria and viruses. The CDC has information on the use of masks to help slow the spread of bacteria and viruses for the general public.
Face masks intended for a medical purpose, such as prevention of infectious disease transmission, are subject to FDA regulation. The FDA has issued an emergency use authorization (EUA) as well as guidance on regulatory flexibility for such products.
During a public health emergency, when should health care personnel wear face masks or respirators?
During a pandemic, public health emergency, the CDC always recommends health care personnel wear face masks while they are in the health care facility, including in breakrooms or common areas where they might encounter co-workers or visitors.
When available, surgical masks (a specific type of face mask) are preferred over cloth face coverings for health care personnel as surgical masks offer both source control and protection for the wearer against exposure to splashes and sprays of infectious material from others.
- Cloth face coverings should NOT be worn instead of a respirator or surgical mask if more than source control is needed.
- Wear an N95 or equivalent or higher-level respirator, instead of a face mask, for:
- Aerosol generating procedures (refer to "Which procedures are considered aerosol generating procedures in healthcare settings?" on the CDC's Clinical Questions about diseases: Questions and Answers page).
- Surgical procedures that might pose a higher risk for transmission if the patient has a disease (for example that generate potentially infectious aerosols or involve anatomic regions where viral loads might be higher, such as the nose and throat, oropharynx, or respiratory tract). Refer to "During a pandemic, are there special considerations for surgical and other procedural care settings, including performance of aerosol-generating procedures (AGPs)?" on the CDC's Clinical Questions about diseases: Questions and Answers page.
- Health care personnel should consult their institutional policies for further guidance on what type of face mask or respirator to use.
Can we use expired face masks or surgical masks? Do they offer the protection needed?
Face masks and surgical masks are designed to serve as protective barriers and may still offer some protection even if they are used beyond the manufacturer's designated shelf life or expiration date. If there is no date available on the face mask label or packaging, facilities should contact the manufacturer. The user should inspect all masks prior to use and, if there are concerns such as degraded materials (such as elastic) or visible tears, the product should be discarded.
Can we reuse disposable surgical masks during a Pandemic?
The CDC does not recommend the reuse of disposable surgical masks that are intended to be used once. The FDA recognizes that there may be availability concerns with surgical masks during a public health emergency, but there are strategies to conserve surgical masks.
Can filtering facepiece respirators (FFRs) such as N95s be reused during a shortage?
The CDC considers N95-type FFRs a one-time-use product and recommends that cleaning, decontamination, and subsequent reuse of FFRs should only be used when there is a critical shortage of FFRs and should only be performed on NIOSH-approved FFRs without exhalation valves.
The FDA has issued Emergency Use Authorizations (EUAs) for devices that decontaminate certain respirators. Health care facilities should check the Decontamination Systems for Personal Protective Equipment EUAs for the most up-to-date information.
FFR decontamination may be an effective method of reducing the pathogen burden. The process used by EUA-authorized decontamination devices should not harm the fit or filtration performance of the FFR and should present no residual chemical hazard to the FFR user.
Why does the FDA issue Emergency Use Authorizations (EUAs)?
EUAs authorize the use of medical devices that are not FDA-cleared or approved. The EUA authority allows the FDA to help strengthen the nation's public health protections against emerging infectious disease threats by facilitating the availability and use of medical devices needed during public health emergencies.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may authorize the emergency use of an unapproved or uncleared medical product or an unapproved / uncleared use of an approved/cleared medical product for certain emergency circumstances after the HHS Secretary has made a declaration of emergency or threat justifying emergency use. The FDA Commissioner may issue an EUA to authorize a medical product for use in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, or available alternatives. The Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and therapeutic medical devices that the FDA has issued related to a deadly outbreak may be revised, terminated, or revoked as needed.
How can I tell if the face masks, surgical masks, or respirators I want to purchase are counterfeit or fraudulent?
The FDA does not have a list of all counterfeit or fraudulent products. To report fraudulent medical products to the FDA, email FDA-COVID-19-Fraudulent-Products@fda.hhs.gov. The CDC provides information on identifying counterfeit respirators at Counterfeit Respirators / Misrepresentation of NIOSH-Approval.
How do I report a problem with face masks, surgical masks, or respirators?
The FDA encourages reporting of any adverse events or suspected adverse events experienced with face masks, surgical masks, or respirators.
- In general, device manufacturers, importers, and device user facilities (health care facilities) must comply with the applicable medical device Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities.
- Health care personnel employed by organizations that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their organizations.