May 9, 2007 (CIDRAP News) – The US Food and Drug Administration (FDA) yesterday cleared the way for two N-95 respirator models to be marketed as devices that can reduce a user's risk of becoming ill during an influenza pandemic or other public health emergency.
The respirators approved to carry the new labeling are made by 3M Co., based in St Paul, the FDA said in a press release. The models, numbered 8612F and 8670F, will be available to the public without a prescription, the FDA said.
Last week the Centers for Disease Control and Prevention (CDC) said that in the event of a flu pandemic, people who care for flu patients at home should consider wearing an N-95 respirator. The specialized masks are designed to fit tightly to the face and stop at least 95% of tiny airborne particles.
N-95 respirators are among the personal protective equipment that the US Department of Health and Human Services (HHS) is stockpiling for use by healthcare workers during a pandemic. CDC Director Julie Gerberding said last week that almost 100 million N-95 respirators had been stockpiled.
Though the nature and concentration of the pathogen in the next public health emergency may not be known, minimizing exposure to it will help reduce health risks, said Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health, in the press release.
"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," he said.
Many companies make N-95 respirators for workplaces, including healthcare settings, but the 3M models are the first to be approved for use by the general population to reduce exposure to airborne pathogens in a public health emergency, the FDA said.
Jacqueline Berry, spokesperson for 3M, told CIDRAP News the company is moving as quickly as possible to get the respirators with the new labeling on the market and anticipates that they will be available by mid to late summer. She said they will be available to government organizations and safety equipment distributors and sold to the public through retail pharmacies and mass retailers.
The products will be sold under 3M's Nexcare brand, Berry said, adding that the cost of the company's current N-95 respirator models ranges from $2 to $4.
The federal Occupational Safety and Health Administration (OSHA) requires that respirators used in workplaces be individually selected for each employee and tested to ensure a proper fit. However, the FDA said the special fit-testing procedures used in occupational settings probably wouldn't be feasible during a public health emergency.
To address fit testing concerns, the FDA said companies that want to market respirators for public health use must provide instructions for achieving a protective fit and using the devices properly. In addition, companies must show that respirators have been certified by the National Institute for Occupational Safety and Health (NIOSH) to provide adequate filtration without hampering breathing ability. Companies also must test the devices for the risk of causing allergic skin reactions.
The FDA said 3M determined that healthy adults could achieve a protective fit by following instructions on the respirator's label. The company also measured how many airborne test particles could get through small leaks between the edges of the respirator and the wearer's face. Though individual results varied, all had reductions in particle exposure, the FDA noted.
In approving the new indication for the two 3M respirator models, the FDA listed several caveats:
- The respirators are sized for adults and may not fit children properly.
- Anything that comes between the mask and the face, such as facial hair, may impair the respirator's fit.
- People who have chronic health conditions, such as heart or lung disease, may have difficulty breathing through a respirator.
- The devices are for one-time use by one person and should be discarded afterward.
The FDA said it would soon release a guidance document describing its regulatory approach to respirators intended for use during a public health emergency.
See also:
May 9 FDA press release
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01630.html
May 3 CIDRAP News story "CDC offers advice on citizen use of masks, respirators"
