Dear Editor:
There seems to be a lot of misunderstandings about N95 masks. I have quoted some information from CDC, NIOSH, OSHA, and the FDA to help clear some of the confusion.
The main issue I hear is that “only medical rated (by the FDA) N95 masks should be used to protect oneself against Coronavirus and other flu.” This is not necessarily true. The “95” part of the N95 stands for the percentage of particulate matter that the mask will filter out. The size of the test media is .03 micron. At .03 micron an N95 mask is more than capable of capturing the secretions from the flu patient. Where the “medical” rated N95 mask comes in is that it has additional safety features such as a fire safety and is rated to not only insure the safety of the person wearing it (surgeon or nurse) but also the patient. A medical rated N95 will cost more as well. I suggest that anyone buying N95s look at industrial N95 that have “for occupational use” on the box.
After the quote is a link to each source. At the end is a standard for eye protection (goggles) that people should be looking for for their PPE needs and a standard for infrared thermometer guns.
National supplies are already limiting orders on healthcare facilities so act quickly.
Sincerely – 3ADscout
N95 Mask:
From OSHA Respirator Types-
There are two main types of respirators:
air-purifying respirators, which use filters, cartridges, or canisters to remove contaminants from the air you breathe, and atmosphere-supplying respirators, which provide you with clean air from an uncontaminated source. Respirators can also be classified as tight-fitting or loose-fitting.
Loose-fitting respirators do not depend on a tight seal with the face to provide protection. Therefore, they do not need to be fittested.
There are filtering facepiece half-mask respirators, sometimes referred to as N95s. A filtering facepiece respirator covers the nose and mouth, and is a tight-fitting, air-purifying respirator in which the whole facepiece functions as the filter. Filtering facepieces may or may not have an exhalation valve to help exhaled breath exit the facepiece. They need to be fit tested, unless you are wearing them under voluntary use conditions. Filtering facepiece respirators filter out particles and do not protect against non-particulate hazards such as gases or vapors.
You may hear someone refer to a respirator as an “N95” or a “P100.” While most people use the term “N95” to refer to filtering facepiece respirators, “N95” actually describes the type of filter material and its protective properties. The filter material can be used in either a filtering facepiece respirator or in a filter cartridge that’s attached to an elastomeric respirator.
The first part of the filter’s classification uses the letters N, R, or P to indicate the filter’s ability to function when exposed to oils.
“N” means Not resistant to oil;
“R” means somewhat Resistant to oil; and
“P” means strongly resistant to oil, or oil-Proof.
This rating is only important in work settings where oils may be present, because some oils can reduce the effectiveness of the filter.
The second part of the classification — the number– refers to the filter’s ability to remove the most-penetrating particle size during “worst case” testing.
Filters that remove at least 95 percent of these particles are given a 95 rating. Those that filter out at least 99 percent receive a 99 rating, and those that filter out at least 99.97 percent – essentially 100 percent – receive a 100 rating.
Using this classification method, an N95 filter is not resistant to oil and removes at least 95 percent of the most-penetrating particles.
https://www.osha.gov/video/respiratory_protection/resptypes_transcript.html
Masks and N95 Respirators– from the FDA
Facemasks
Facemasks are not to be shared and may be labeled as surgical, isolation, dental or medical procedure masks.
If worn properly, a facemask is meant to help block large-particle droplets, splashes, sprays or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Facemasks may also help reduce exposure of your saliva and respiratory secretions to others.
While a facemask may be effective in blocking splashes and large-particle droplets, a facemask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes or certain medical procedures. Facemasks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the facemask and your face.
N95 Respirators
FDA has cleared certain filtering facepiece respirators (N95) for use by the general public.
FDA has cleared the following N95 respirators for use by the general public in public health medical emergencies:
- 3M™ Particulate Respirator 8670F
- 3M™ Particulate Respirator 8612F
- Pasture Tm F550G Respirator
- Pasture Tm A520G Respirator
These devices are labeled “NOT for occupational use.”
N95 Respirators in Industrial and Health Care Settings
Most N95 respirators are manufactured for use in construction and other industrial type jobs that expose workers to dust and small particles are regulated by the National Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC). These products are labeled “For occupational use.”
However, some N95 respirators are intended for use in a healthcare setting. Specifically, single-use, disposable respiratory protective devices used and worn by healthcare personnel during procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These N95 respirators are class II devices regulated by FDA, under 21 CFR 878.4040, and CDC NIOSH.
https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/masks-and-n95-respirators
N95 Respirators and Surgical Masks– from NIOSH Science Blog
Further, the filter’s collection efficiency is a function of the size of the particles, and is not dependent on whether they are bioaerosolsor inert particles.
The FDA does not perform an independent evaluation of surgical mask filter performance, nor does it publish manufacturers’ test results. In many cases it is difficult to find information about the filter test results for FDA-cleared surgical masks. The class of FDA-cleared surgical masks known as Surgical N95 Respirators is the one clear exception to this uncertainty of filter performance. This is the only type of surgical mask that includes evaluation to the stringent NIOSH standards. All members of this class of surgical masks have been approved by NIOSH as N95 respirators prior to their clearance by the FDA as surgical masks. The FDA, in part, accepts the NIOSH filter efficiency and breathing resistance test results as exceeding the usual surgical mask requirements.
https://blogs.cdc.gov/niosh-science-blog/2009/10/14/n95/
Respirator Trusted-Source Information, Section 3: Ancillary Respirator Information–
From CDC/NIOSH
Can we use an N95 that has not been cleared by the FDA in a patient setting?
NIOSH-certified N95 respirators that have not been cleared by the FDA can be used for respiratory protection to reduce the exposures of healthcare personnel in a patient setting to hazardous particulates. These respirators have not been evaluated by FDA to determine whether they meet the fluid and flammability resistance as required for FDA clearance as medical devices. For this reason, they are not intended for use in exposure settings where the performance of a surgical mask to maintain a sterile field is required.
Compiler’s note: All N95 mask will filter out 95% of the particulate however, medical grade N95 mask have additional capabilities for the healthcare setting such as the fluid and flammability resistance as required by the FDA mentioned above. You do not have to buy/use an FDA medical N95 mask to protect yourself against germs (coronavirus) unless you work in a medical facility.
https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/RespSource3healthcare.html
Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings
https://www.cdc.gov/niosh/topics/hcwcontrols/RecommendedGuidanceExtUse.html
Chemical Splash and Dust Protection For Eyeware:
Eyewear that meets ANSI Z87.1 requirements for droplet (splash) or dust protection will be marked with a code that begins with the letter “D”. For example:
- Eye protection that provides protection from droplets and splashes is marked with “D3”
- Eye protection that provides dust protection is labeled “D4”
- Eye protection that provides fine dust protection is labeled “D5”
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature:
ASTM E1965-98
