What is the N95 Respirator?
In the time of the N95 respirator’s shortage, many companies start using different decontamination methods to fill the gap and to supply N95 respirator to all health care practitioners where it is much needed. N95 respirators are included in the Personal Protective Equipment (PPE) which is strictly recommended to be used in all health care departments. N95 respirator has a filtration efficiency of 95%. It can easily filter out all non-oil-resistant particles including dust, fumes, and many infectious agents present in the air.
N95 respirators are very comfortable and can easily be worn for more than 8 hours. These respirators are specially designed to be used in medical set-ups and occupational industries where people are directly exposed to the dust particles. N95 respirators are designed to achieve a close facial fit to form a seal around the nose and the mouth.
Center for Disease Control (CDC), Food and Drug Administration (FDA), and the National Institute for Occupational Safety and Health (NIOSH) also regulates N95 respirators. These respirators are highly demanding medical products during the COVID-19 pandemic. NIOSH approved N95 respirator has more than or equal to 95% filtration efficiency. These respirators are manufactured for one-time use only which means you can only get the benefit of 95% filtration for once. With every doffing the efficiency of N95 respirators reduces.
COVID-19 pandemic has turned the whole world into a serious health crisis. A rapid increase in the number of affected persons set everything on a big question mark. The use of an N95 respirator had become the only survival kit in this life-threatening pandemic. The increase in the demand for these respirators resulted in a shortage of supply. To meet the demand and continue the supply of N95 respirators in all health care departments, many countries started using different decontamination methods. Such methods are used to preserve the effectiveness and filtration quality of N95 respirators to be used for a longer time duration.
There are different types of contamination methods including:
- UV radiations killed the virus more slowly but preserved respirator function adequately.
- The dry and wet heat method at 70 C killed the virus with similar speed to UV but it should not be used for 3 rounds.
- Boiling methods, Ethanol decontamination reduces the efficiency of N95 respirators and is not recommended.
- Vaporized hydrogen peroxide this decontamination treatment caused rapid inactivation of the SARS-CoV-2 virus and preserved the efficiency and integrity under experimental conditions for 3 uses.
Battelle’s N95 Decontamination System
Battelle’s Critical Care Decontamination System was the first decontamination method to be used in the U.S. Due to the shortage in the N95 respirator’s supply, this decontamination method was issued as an Emergency Use Authorization (EUA) by Food and Drug Administration (FDA). The main component used in Battelle’s decontamination method is vaporized hydrogen peroxide. For decontamination, all N95 respirators were placed inside the chamber and then hydrogen peroxide was vaporized in the chamber then left all respirators for some time. After some time all N95 respirators returned back to the health care departments where N95 respirators were much needed during the COVID-19 pandemic.
Why did the Battelle Institute get a Warning Letter from F.D.A?
National Nurses United (NNU) the largest labor union for registered nurses in the United States, has reviewed Battelle’s documentation and expressed some concerns on the decontamination process. The concerning questions are:
- Does Battelle inactivate the SARS-CoV-2 as well as other pathogens present in health care?
Battelle provides insufficient evidence to answer this question properly.
- Do the decontamination method impact fit, filtration efficiency, and structural integrity and performance of N95 respirators?
Battelle has not evaluated any impact of its decontamination method of N95 respirators.
- Does wearing a decontaminated N95 pose any risk to the wearer?
Battelle answered this question by saying “YES”. Hydrogen peroxide vapors are highly dangerous to breathe in. As the hydrogen peroxide is a colorless and odorless gas and can cause skin allergy.
Due to some feedback from the users of Battelle institute’s decontamination mask, Food and Drug Administration (FDA) issued a warning letter to Battelle’s institute for an authorized decontamination system used on N95 respirators and has requested a response from the Battelle Institute within 15 days and also asked for giving proper detail about how the company will correct these things and which steps will the company take to control these violations.
In this letter, the FDA also mentioned relevant reportable events including allergic reactions of eyes, or mouth, or nose irritation, evidence that decontaminated respirator is unable to perform its essential functions related to hydrogen peroxide residuals and malfunctions of the generators used in the decontamination process. Further, in that letter, the FDA also mentioned taking regulatory action without giving any further notice, if the Battelle Institute will not correct all these violations.
The FDA actions are the part of the agency’s ongoing commitment to evaluate devices for emergency use to ensure compliance with the conditions. FDA monitors all reports and takes appropriate action to ensure the safety of all medical devices, human drugs, and public health safety. Food and Drug Administration (FDA), this agency is also responsible for regulating the security and safety of dietary supplements, food, cosmetics, and tobacco products.