What are the FDA’s guidelines for n95 masks/

At the beginning of this year, many of the medical PPE could be easily found for sale online in the United States, with options to buy in bulk and wholesale. But, after nine months of the COVID-19 pandemic, most of it is hard to find, particularly N95 masks. With the devastating shortages of medical supplies in the USA, including face shields, KN95 masks, gloves, and others, it’s important to listen to the guidelines published by authorities like the Food and Drug Administration (FDA) to maximize the use of these crucial supplies.

FDA guidelines

It’s important to learn what authorities like the FDA say about wearing N95 masks, which are considered to be the best disposable face mask for virus protection due to their high antiviral effectiveness. Inside the FDA website, you can find all this information in more detail, here are some of the highlights.

  • General precautions

The FDA points out that in people with certain medical conditions with pre-existing difficulty breathing, the use of these respirators can exacerbate this difficulty, or develop it if it wasn’t there before. These medical conditions include respiratory, cardiac, and other conditions as well. For them, checking with a healthcare provider before using the respirators might be necessary.

Models with exhalation valves can make breathing easier in these people, but they’re not good options to be used in conditions where a sterile field is necessary. Exhalation valves are also known as one-way-valves, as they only filter out the air that is being inhaled but not the one that is being exhaled. This way, they protect the wearer from inhaling harmful particles, including viruses, but it doesn’t prevent the wearer from releasing those particles into the air, which is why they’re not good options for virus control.

The FDA also points out that N95 respirators cleared by them are single-use and disposable face masks. This means that they can’t be shared with other people and that they should be properly discarded once the worker has finished using it. They should also remove and replace the respirator if it becomes damaged or wet, or if breathing with it is becoming difficult. Like with other disposable face masks, before and after handling them, washing the hands is recommended.

Lastly, they state that these respirators don’t fit properly in kids and adults with facial hair. For the respirator to be effective, it needs to tightly seal around the face, and facial hair can difficult this, leaving room for air leakage. Kids also have smaller heads, and the size of these respirators doesn’t allow for a tight fit on them either.

  • Similarities and differences with surgical masks

Surgical face masks are loose-fitting masks that act primarily as a physical barrier against fluids in the form of sprays, droplets, splashes, or splatter, which may carry dangerous pathogens, and their filtering properties are limited. N95 masks, on the other hand, can filter out at least 95% of the non-oil-based airborne particles in the air, which includes dust, smoke, and viruses and bacteria, and they fit tightly around the face. These are their differences.

However, the FDA establishes two main similarities between the two:

  1. They’re both disposable face masks, which means either of them should be reused or shared
  2. Both are tested for flammability, biocompatibility, filtration efficacy, and fluid resistance.

Surgical masks shouldn’t be confused with surgical N95 FFPs (filtering facepiece respirators), which are a subset of the N95 FFP, commonly used in healthcare settings during procedures in which the wearer is in high exposure to airborne particles.

  • Who should wear them?

The FDA reinforces the recommendations made by the Centers for Disease Control and Prevention (CDC) about the general public not wearing N95 masks for virus protection, including COVID-19 and the flu. This is because N95 masks are one of the most effective masks, and they need to be prioritized for healthcare workers who are at higher exposure to the virus, and this face mask is already hard to find. The general public has been urged to use reusable cloth masks for virus control.

N95 respirators are designed, for the most part, with more uses other than being part of the medical PPE (personal protective equipment). Workplaces like construction sites and other industrial jobs have respiratory hazards present, like dust or smoke, which can be detrimental to the worker’s health when inhaled either acutely or chronically.

These 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 CDC. N95 masks intended for medical use have to be regulated also by the FDA, aside from the NIOSH regulation.

  • Decontamination of N95 masks

Before the pandemic, there were no decontamination processes or systems for N95 masks that were cleared by the FDA. N95 respirators are single-use disposable face masks, and therefore shouldn’t be reused. However, with the public health crisis we’ve been dealing with, the FDA has issued EUAs (Emergency Use Authorizations) for many decontamination systems developed during the pandemic as a result of the devastating shortages caused by the increase in the demand for this face mask.

They point out that these decontamination processes are always an option only if a NIOSH-approved or FDA-cleared respirator isn’t available at the moment. They also point out that these NIOSH-approved respirators will only maintain this approval after being decontaminated if the manufacturer permits the use of this decontamination method.

Although we should prioritize N95 masks, including 3M N95 masks like the 3M 8210 and the 3M 8511, there are other alternatives the general public can use for virus protection. Make sure to stay protected to help out the most vulnerable people in your community.

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