FDA approves first-time use of protective masks for public health emergencies

A protective mask that can be used during a public health medical emergency, such as during an outbreak of influenza, to help reduce the exposure of airborne microorganisms in suspension, was first approved by the US Food and Drug Administration (FDA).

The two disposable protective masks are manufactured by 3M Company of St. Paul, Minnesota, USA (known as 3M protective masks 8612F and 8679F) and are available to the general public as non-prescription products.

These protective masks have also been certified by the National Institute of Occupational Safety and Health (NIOSH) N95 protective masks. NIOSH provides certification for respiratory protection products used in the workplace. Occupational protection applications for protective masks must follow an appropriate respiratory protection plan.

The N95 Respirator is a type of mask that covers the mouth and nose area and is tightly fitted to the face. It is made of a fiber-type material designed to filter out at least 95% of the fine particles in the air. The effectiveness of the product depends on the filter material and the proper seal.

“In the case of public health medical emergencies, because the exact nature and concentration of microorganisms or bacteria are unknown, we believe that reducing exposure will help reduce risk,” said Dr. Daniel Schultz, MD, FDA's Center for Equipment and Radiological Health. Protective masks are an integral part of the comprehensive measures that can be used to reduce the transmission of infection among individuals in similar incidents."

Many companies produce N95 respirator masks for use in the workplace. However, 3M's respirator masks are the first FDA approved and can be used by the public to reduce the exposure of airborne microorganisms to public health emergencies.

In accordance with the requirements of the Occupational Safety and Health Administration and other occupational health regulations, protective masks used in the workplace must be individually selected for each worker and tested to ensure suitability. Currently outside the workplace, such suitability tests are usually not used, and this method may not be applicable during a public health medical incident.

The FDA asks those manufacturers to operate protective masks that can be used during public health medical emergencies, and to ensure that protective masks can not only be certified by NIOSH for correct filtration efficiency without compromising the respiratory capacity of users. , must also carry out appropriate evaluation tests, conduct bio-adaptability tests to reduce skin allergies, and provide instructions for use, so that users can obtain a protective fit, and can use correctly.

3M conducted evaluation of the appropriate characteristics of the product in a healthy adult population, and determined that the user can obtain effective suitability when operating in accordance with the instructions on the label. They tested how much airborne suspended particulates could enter the protective mask from tiny leaks between the edges of the protective mask and the user's face. Despite the differences in test results, all those who participated in the test had some reduction in the exposure of test particles in the air.

The size of the 3M protective mask is suitable for adults, but it may not be possible for children to obtain correct fit. Any obstacle between the protective mask and the face, such as facial hair, will undermine suitability. People who have heart or lung disease, or who have other health problems, may feel difficulty breathing when using respirator masks. Protective masks are disposable and users should not clean, disinfect, reuse, or share protective masks with others. Protective masks should be discarded after use.

FDA will soon publish a guidance document outlining the legal approval steps for such new equipment.