What are the FDA’s protocols for sterilization of n95 masks?

PPE (personal protective equipment) for healthcare settings used to be found very easily for sale online, and any regular person could buy it, even in bulk and wholesale. Now, with the COVID-19 pandemic, it has become very difficult to find, and healthcare centers are struggling to get enough supplies. N95 respirators in particular have been scarce, and even the popular 3M N95 masks in the models 3M 8210 and 3M 8511 have been hard to find.

These shortages severely affect healthcare providers during this public health emergency, having to work in high-exposure environments without the necessary protection. This is why the Food and Drug Administration (FDA) has a series of protocols and recommendations to sterilize N95 masks, along with other tips to make as much use of the existing PPE as possible.

The FDA’s protocols for sterilization of N95 masks

Emergency Use Authorizations, also known as EUAs, are, as the name suggests, authorizations given by the FDA to equipment or processes that weren’t cleared by them before, but are now necessary to be used very quickly in times of emergency, like the COVID-19 pandemic.

The FDA has issued EUAs for decontamination systems for certain respirators that are used in healthcare settings when the supplies of respirators isn’t sufficient as a result of the COVID-19 pandemic. However, they always state that the use of new N95 respirators or other types of respirators that are authorized by NIOSH or the FDA is always the first choice before the use of decontaminated respirators.

Certain EUAs have been reissued because of concerns about public health and safety regarding the appropriateness of these decontamination systems. This specifies which respirators can be decontaminated. The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) found after testing certain respirators that there are certain respirators manufactured in China that vary in their performance and design, so now the FDA does not support the decontamination of these respirators.

As of June 6 of this year, respirators manufactured in China that are not approved by NIOSH, and respirators with exhalation valves are not authorized to be decontaminated with any of the systems approved under the EUAs. Respirators approved by NIOSH before decontamination will only retain this status after decontamination if the manufacturer permits that specific decontamination method with that specific cycle and parameters in that specific respirator model.

Anand Shah, FDA Deputy Commissioner for Medical and Scientific Affairs, 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.”

These decontamination systems can also only be used in respirators that don’t contain cellulose, approved by the FDA or NIOSH. Healthcare providers therefore can’t reuse respirators that aren’t compatible with the authorized decontamination systems but have been decontaminated nonetheless.

What is a filtering facepiece?

The FDA refers to respirators on their website as FFPs, and you might have heard or read that term being used before during the last several months. They’ve been featured on the news a lot lately because of the shortages of this item, particularly of N95 respirators, which has been a source for concern and the focus of many engineering developments for a reusable N95 mask.

FFP is an acronym that stands for filtering facepiece, and can sometimes be referred to as FFR as well, meaning filtering facepiece respirators. It’s used to talk about respirators, as defined by the FDA, in which the filter media is an integral part of the facepiece (the mask itself) or in which the whole respirator is made up of filter material. This means the mask or facepiece isn’t separate from the filter, as opposed to face masks with exhalation valves in which they’re two separate things.

The definition given by the FDA also includes that the respirator must be a negative-pressure particulate respirator. This means that, when the wearer inhales, a negative pressure is created, and the air pressure on the inside of the mask is negative in comparison to the air pressure on the outside of the mask. This ensures all the air goes through the filter media and all the particles are being filtered.

All FFPs or FFRs in the USA must be approved by the National Institute for Occupational Safety and Health (NIOSH) to make sure it meets their standards of filtration. They’re items that are used in many different types of work settings in which respiratory hazards, particles that are harmful to the human body when inhaled during prolonged periods, are present. These particles can be very varied, and among the most common ones we can name smoke or dust, common in construction sites, or microorganisms like the flu virus or the coronavirus, present mostly in healthcare settings.

We would like to end this informative piece by reminding our readers that the medical-grace face masks mentioned in this article need to be reserved for healthcare providers and other frontline workers. The general public has been urged by the CDC to wear alternatives, like reusable cloth masks, which are available in many online stores. Kids over the age of 2 years old are recommended to wear face masks as well, in a size that fits their face properly.

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