What are the FDA’s protocols for decontaminating n95 masks?

Healthcare settings are needing personal protective equipment (PPE) now more than ever for virus protection. Before the pandemic, anyone, including regular people who didn’t work in healthcare centers, could buy these items in bulk or wholesale, but now they’re very hard to find for sale online. Healthcare centers are struggling to get enough supplies to keep them safe during work, and particularly N95 masks have been scarce and are crucial for the protection of these workers. Popular models like the 3M 8210 and the 3M 8511, both 3M N95 masks, have also been hard to find. Other scarce items include face shields, surgical masks, gowns, and gloves.

Shortages of these items are severely affecting healthcare providers around the United States, since they’re in environments with high exposure to the virus, and they need more protection than the one the general public needs. For this reason, the Food and Drug Administration (FDA) has a series of recommendations and protocols to follow when it comes to decontaminating respirators, a practice needed right now to reuse the available respirators which are usually disposable face masks and can only be used once. 

The FDA’s protocols for decontamination of N95 masks

The FDA grants Emergency Use Authorizations (EUAs) to equipment, processes, systems, and other medical-related items that weren’t previously cleared by them to be used during public health emergencies, just like the one we’re facing right now with the COVID-19 pandemic, so that they can be cleared quickly for their use.

Since earlier in the year, the FDA has issued some EUAs for decontamination systems that can be used in respirators, also known as FFPs (filtering facepieces) or FFRs (filtering facepiece respirators) by the administration. The FDA always states, however, that it’s always the first choice to use new N95 respirators or any other type of NIOSH or FDA-approved respirators before reusing decontaminated ones.

In June, concern about public health and safety surrounding how appropriate the decontamination systems approved by the FDA under their EUAs lead to the administration reissuing these authorizations. They now specify which respirators can be potentially decontaminated using these systems, after the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) tested them and found that certain FFPs manufactured in China could vary in their design and performance.

So, as of June 6, the FDA doesn’t support the use of their approved decontamination systems on respirators that have been manufactured in China without NIOSH-approval. These reissued EUAs also leave out FFRs with an exhalation valve. Additionally, the FDA states that respirators with approval by NIOSH, after being decontaminated with these systems, could only retain this approval status if the manufacturer of that specific FFR model permits that specific decontamination method with the specific cycle and parameters used.

Also, according to the FDA, these systems are only compatible with respirators without cellulose contained in them which are approved by either NIOSH or the FDA. Respirators that aren’t compatible with these terms and guidelines established by the FDA shouldn’t be used after decontamination by healthcare providers.

About all this, the FDA’s Deputy Commissioner for Medical and Scientific Affairs, Anand Shah, said: “During this unprecedented global pandemic, the FDA continues to provide flexibility and adapt to the evolving needs of Americans based on data and science. We are committed to carefully evaluating available information and will continue to take action when there is a need to do so to protect the public health. While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected. As part of those efforts, we are announcing that we have revised and reissued several EUAs to amend which respirators are authorized to be decontaminated.”

Understanding what a filtering facepiece is

According to the FDA, an FFP or FFR is an acronym that stands for filtering facepiece or filtering facepiece respirator. They define them as any type of respirator where the filtering material is either an integral part or makes up the entirety of the facepiece, which is the term used to refer to the mask itself. This means, in other words, that the filter and the mask or facepiece aren’t separate from each other, they’re the same. Some examples of respirators that don’t meet this requirement are those with exhalation valves in them, in which the filter is separate from the mask.

The FDA also includes in their definition that the respirator must be what is known as a negative pressure respirator, which means that a negative pressure is created when the wearer inhales, making the air pressure on the inside of the respirator negative in comparison to the air pressure on the outside. This makes all the air go through the filter media, ensuring all of it is getting filtered.  

NIOSH must test and approve all the respirators manufactured inside the USA, making sure they meet their filtration standard. This is because these respirators are used widely in different work settings in which respiratory hazards, like dust, smoke, or viruses like the flu, are present and the workers must be protected against them. Some of the most widely used ones are the N95 masks, which have great antiviral properties.

We would like to finish this article by reminding our readers to stay protected with non-medical face masks like the reusable cloth masks the CDC is urging the general public to wear, leaving medical-grade respirators to the workers on the frontlines. Kids over the age of 2 years old can wear these face masks, but they need to be in the corresponding size that will fit them properly.

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