The U.S. Food and Drug Administration (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, manufactured by St. Paul,
Minn.-based 3M
TM Company (and called the 3M
TM Respirator 8612F and 8670F), will
be available to the general public without a prescription.
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 face mask that fits
tightly over the nose and mouth. It is made of fibrous material that is
designed to filter out at least 95 percent of very small airborne particles.
The filter and a proper fit determine the effectiveness of the product.
"While the exact nature and concentration of the biological agent or germ
may not be known in a public health medical emergency, we believe that
minimizing exposure will help reduce risk," said Daniel Schultz, M.D.,
director, FDA's Center for Devices and Radiological Health. "These
respirators are only one part of a combination of approaches that can be
used to help reduce the spread of infection between individuals during such
events."
Many companies make N95 respirators for workplaces, including health care
settings. However, the 3M
TM 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.
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 now and would
probably not be feasible during a public health medical emergency.
FDA is requiring those who want to market respirators for use during public
health medical emergencies to assure that they are certified by NIOSH to
provide adequate filtration without hampering people's 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 that 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
TM 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 pre-existing 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.
Inhaling particles is just one route of exposure to disease-causing
organisms. Others include touching contaminated surfaces and coming into
close contact with those who have infectious diseases. A total approach to
personal protection includes hand hygiene, cough etiquette and other
protection practices such as avoiding crowded settings.
