The year 2020, has been a challenging year not only for the US but also for the countries around the world. The coronavirus pandemic has currently affected hundreds of millions of people, with over a million deaths. It has affected a lot of small and big businesses and millions of people lose their jobs.
Until today, the medical and healthcare workers continue to fight and help save people. In order for them to continue fulfilling their duties, they need to stay healthy and safe from the virus. And one way to protect themselves is to wear the N95 respirator.
What is an N95 respirator?
An N95 respirator or N95 mask is a type of disposable face mask that is used widely in the medical and construction industries. The N95 respirator has 95% filtering efficiency, which means it can filter small air particles. Aside from small particles, the N95 respirator can also effectively filter smoke and small respiratory droplets. The N designation of the N95 respirator means that the mask is not resistant to oil and is not suitable to be used in environments where the user is exposed to oil-based elements.
The N95 respirator is approved and regulated by the United States National Institute for Occupational Safety and Health (NIOSH). Aside from the N95 respirator, NIOSH also regulates other types of filtering masks such as N99, N100, R95, P95, P99, P100 respirators.
3M is one of the well-known and trusted brands when it comes to N95 respirators. The brand is known for its durable and reliable N95 respirators that are also lightweight and comfortable. Popular 3M N95 face mask models include the 3M 1860 N95 respirator, 3M 8511 N95 respirator, and 3M 8210 N95 respirator. The different 3M N95 respirator models are not suitable for kids.
The Battelle Critical Care Decontamination System
Because there is a shortage of N95 respirators, the government needs to come up with solutions or alternatives on how to address the low supply of N95 respirators. One solution is to reuse and extend the use of the N95 respirator. In the medical and healthcare industry, the N95 respirator needs to be decontaminated.
FDA is working with Battelle Memorial Institute, a nonprofit institution, in the decontamination of the N95 respirators. Battelle's Critical Care Decontamination System is said to have the capacity to sanitize 80,000 N95 respirators per day per unit.
Battelle’s failure to comply with the requirements
Battelle received a warning letter from the Food and Drug Administration (FDA) because it failed to establish a proper protocol in terms of reporting the adverse events that occur when users used the decontaminated N95 respirator cleaned by the Battelle Critical Care Decontamination System. The non-profit institution failed to comply with a few important regulatory requirements mentioned in the Emergency Use Authorization (EUA).
In the letter, the FDA mentions a few samples of adverse events that should be reported. These adverse events include but are not limited to shrunken or misshapen of the N95 respirator, allergic reaction, poor fit of the N95 respirators, peeling and shredding of the N95 respirators, discoloration, odor issues, skin irritation, and breaking of the N95 respirator straps.
Adverse events and other problems should be reported to assure the safety and performance of the decontaminated N95 respirator.
Battelle is given 15 days from the receipt of the warning letter to respond. Failure to correct the violations could cause the FDA to do regulatory action without any further notice.
Is it okay to reuse or extend the use of the N95 respirator?
The N95 respirator is a disposable type of face mask. Thus, it should not be reused, just like what the healthcare workers are doing now. However, because of the high demand for N95 respirators, healthcare institutions and hospitals are left with no other options.
The decontamination of the N95 respirator has sparked a lot of issues. Some healthcare experts and even the nurses and doctors are worried about the reuse of the N95 respirator. They are worried that the N95 respirator will lose its filtering efficiency once it is decontaminated and reused several times. Despite the issues, the FDA allowed the decontamination of the N95 respirator and thus, working with Battelle.
Is there still a shortage of N95 respirators?
After more than 6 months since the pandemic started, there is still a shortage of N95 respirators in the US. The government already imported millions of N95 masks, and the domestic manufacturers have increased their production, but the supply is still not enough. The experts said that billions of N95 respirators are needed for this year, but until now, the numbers are still very far from the actual goal.
Aside from the decontamination of the N95 respirator, the FDA has also approved several KN95 masks and other N95 respirator models for medical use. The list of the approved KN95 masks and N95 respirator models is available on the official website of the FDA and the NIOSH.
Because there is still no vaccine available for the coronavirus, everyone is encouraged to be careful and mindful of their health. When going outside, people are encouraged to practice social distancing and wear face masks all the time. In some states, wearing a mask is mandatory.
Since the NIOSH-approved N95 respirator is not suitable for kids, parents are encouraged to let their kids use reusable cloth masks. There are also KN95 masks that are meant for the kids. These KN95 masks for kids come in a much smaller size than the regular ones and they are available in different colors.