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

Decontamination

Decontamination means cleaning, purifying, or killing off bacteria. Decontaminating N95 respirators means cleaning or purifying the surface of the N95 respirator by cleaning it. There are numerous ways to decontaminate an N95 respirator. Decontamination methods include ultraviolet germicidal irradiation, dry heat treatment, steam treatment, and time decontamination, etc. Decontamination is also known as sterilization. We decontaminate an N95 respirator to reuse it. 

FDA

FDA—which stands for Food and Drug Administration—is a federal agency of the U.S. whose main objective is to ensure the safety and protection of products. These products include human drugs, tobacco, food, veterinary drugs, vaccines, medicines, cosmetics, biological products, and many more products that emit radiation. The FDA is working with the CDC to tackle this fatal pandemic—which is the novel coronavirus. It is a credible agency to determine whether products are safe for us or not. 

N95 respirator

The main objective of the N95 respirator is to protect the wearer from hazardous particulate matter since it could cause several diseases to the user. The N95 respirator guards the user against germs, bacteria, respiratory droplets, and a plethora of harmful fine particles. Since the N95 respirator is relatively better than surgical masks and cloth masks, medical personnel prefers to use them since they offer more protection than other face masks. It is a part of Personal Protective Equipment—PPE. 

FDA policies for the decontamination of N95 respirators 

The FDA has got a very accurate understanding of the design and performance of the N95 respirator. They worked with the CDC (Centers for Disease Control and Prevention) and NIOSH (National Institute for Occupational Safety and Health) to determine that some N95 respirators should not be decontaminated. These N95 respirators include face masks that were imported from China. Since Chinese N95 respirators have a different design and performance than American respirators, they should not be decontaminated. 

Since Chinese N95 respirators are different from the American ones, they vary in performance and design. They are different from American N95 respirators, and decontaminating these N95 respirators could result in deteriorating their performance and efficiency. Therefore, Chinese-manufactured N95 respirators should not be decontaminated. Because of the scarcity of N95 respirators, people have started decontaminating N95 respirators especially healthcare personnel. 

Several healthcare facilities in the United States did not have an ample number of N95 respirators. Therefore, their employees had to decontaminate N95 respirators to reuse them. Hence, a group of nurses and scientists arose the question of whether they should decontaminate an N95 respirator or not. The majority of the N95 respirators have been manufactured in China that is circulating across the United States. Therefore, people must check whether their N95 respirators have been made in China or not. 

After that, they should think of either decontaminating or discarding them. The FDA cleared the confusion and said that the recommendations from the CDC say that surgical masks can be sanitized. They never said anything about FDA-cleared N95 respirators. However, after a few days, the FDA said that the N95 respirators that have been approved by NIOSH and cleared by FDA can be reused and cleaned. These N95 respirators are permitted to be cleaned and reused. 

The face masks that have not been approved by NIOSH or cleared by FDA should not be decontaminated; this is because nothing can be said about the effectiveness of those face masks. The FDA says that healthcare workers must use NIOSH-approved N95 respirators or FDA-cleared face masks for protection while treating patients who have been infected with contagious diseases. Hence, medical personnel should use such N95 respirators as nothing can be said about the efficacy of such respirators or face masks. 

The same goes for the general public of the United States. They should wear NIOSH-approved N95 respirators or FDA-cleared face masks for protection against COVID-19. If they do not wear such face masks, they could be putting their lives at risk. Non-approved face masks are not effective at the filtration of coronavirus particles. Therefore, everyone must use NIOSH-approved or FDA-cleared face masks. The usage of non-approved face masks could be fatal for a person who does not use approved face masks.

Decontamination methods urged by the FDA

Because of the severe scarcity of N95 respirators, a slew of healthcare facilities has got less number of N95 respirators in stock. Therefore, employees have to sterilize N95 respirators for reuse since they do not have sufficient numbers of N95 respirators in stock. The FDA says that what those employees are doing is heroic, and they salute them for showing this much dedication. Risking your lives for the sake of protecting others is something we admire. 

The FDA recommends the use of various decontamination methods like the use of vaporized hydrogen peroxide and gas plasma sterilization. All of these methods require equipment that is not generally present at healthcare facilities. Therefore, smaller healthcare facilities and the public can use decontamination methods like dry heat treatment, steam treatment, and time decontamination as these methods do not require heavy equipment. Time decontamination is time-consuming, but it can decontaminate your N95 respirator as well. 

Conclusion

The FDA—Food and Drug Administration—says that Chinese-manufactured N95 respirators should not be decontaminated; this is because the design and performance of those N95 respirators are different from the N95 respirators of America. Therefore, decontamination of Chinese N95 respirators could worsen the condition, performance, and design of their N95 respirators. 

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