FDA Approves Respirators for Use in Public Health Medical Emergencies

Key Point

For the first time, respirators for use by the general public in the event of a medical emergency have been approved by the FDA.

The FDA has cleared for marketing the first respirators that can help reduce the user’s exposure to airborne germs during a public health medical emergency, such as an influenza pandemic.

These two filtering facepiece respirators—called the 3M Respirator 8612F and 8670F—will be available to the general public without a prescription. Manufactured by the 3M Company, the devices are also certified as N95 filtering facepiece respirators by the National Institute for Occupational Safety and Health (NIOSH). NIOSH certifies respirators for use in occupational settings in accordance with an appropriate respiratory protection program.

An N95 filtering facepiece respirator is a type of facemask that fits tightly over the nose and mouth. It is made of fibrous material that is designed to filter out at least 95% of very small airborne particles. The filter and a proper fit determine the effectiveness of the product.

Many companies make N95 respirators for workplaces, including health care settings. However, the 3M respirators are the first devices to receive FDA clearance for use by the public during public health medical emergencies to reduce exposure to airborne germs.

A Perfect Fit?

Under Occupational Safety and Health Administration and other occupational health regulations, respirators used in the workplace must be individually selected for each worker and tested to ensure a proper fit. This kind of fit testing is not generally employed outside the workplace and would probably not be feasible during a public health medical emergency.

The FDA is requiring those who want to market respirators for use during public health medical emergencies to ensure that they are certified by NIOSH to provide adequate filtration without hampering the ability to breathe. In addition, companies must conduct fit assessment testing, conduct biocompatibility testing to reduce the chance for allergic skin reaction, and provide instructions that will enable wearers to achieve a protective fit and use the devices properly.

3M evaluated fit characteristics in healthy adults to determine whether a user could achieve a protective fit following the instructions on the label. They measured how many airborne test particles were able to get inside the respirator through small leaks between the edges of the respirator and the wearer’s face. While individual results varied, all participants tested achieved some reduction in exposure to airborne test particles.

The 3M respirators are sized for adults and may not form a proper fit on children. Anything that comes between the respirator and the face, such as facial hair, may interfere with its fit. Persons with preexisting heart or lung disease or other health conditions may have difficulty breathing through a respirator. The devices are for single use. Wearers should not wash, disinfect, reuse, or share their respirator with others. The respirators should be discarded after use.            

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