FDA Clears First Filtering Respirator for Public Use in Emergency

FDA has cleared for marketing the first respirators to be used by the public during public health emergencies, such as an influenza pandemic. Called the 3M Respirator 8612F and 8670F, these products will be available without a prescription.
These devices are N95 filtering respirators, and they were originally designed for occupational use. They are intended to filter out at least 95 percent of small airborne particulates.

    An N95 respirator can be used in different circumstances than a surgical mask, isolation mask, or dental mask. These masks protect against large airborne particulates, microorganisms and body fluids so they would be used if a person were caring for an open wound, exposed to spattered blood or vomit from someone else, or sick himself.

    The N95 respirator protects against small droplets and particulates in the air that are likely to get through a surgical mask. So they would be used if someone were exposed to small droplets caused by coughing, or caring for someone with TB.

    When used in occupational settings, each individual respirator is selected to fit the worker who will use it. This kind of fit testing is not generally employed outside the workplace now and would probably not be feasible during a public health medical emergency.

    The manufacturer, the 3M Company, did evaluate the fit in a group of healthy volunteers, and although the results did vary from person to person, everyone achieved some reduction in exposure to airborne particulates. These respirators are sized for adults and may not form a proper fit on children. In addition, anything that comes between the respirator and the face, such as facial hair, may interfere with its fit.

    There are other people who may have trouble using these devices. For example, those with pre-existing heart or lung disease may have difficulty breathing through a respirator. Finally, these respirators are for one-time use, so after they are used, they should be discarded.

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