N95 Shortages and Use During the COVID-19 Outbreak

Unprecedented supply shortages for healthcare workers have complicated the already complex situation created by the COVID-19 outbreak. Not only are ventilators, hospital beds and other materials required for patients in short supply, but personal protective equipment (PPE) required for the safety of doctors, nurses, and other emergency responders are too. Many healthcare professionals are going to work knowing their risk of infection is high because face shields, goggles, gloves, gowns, surgical masks, and respirators might not be available to protect them.

 

The lack of respiratory protection is a health issue of particular concern because the Centers for Disease Control (CDC) and the Occupational Safety and Health Administration (OSHA) recommend healthcare workers wear a disposable N95 respirator or better when around patients with COVID-19 or the virus that causes it. The idea behind healthcare workers wearing respirators during the outbreak is to minimize and prevent exposure to the virus via airborne transmission. The virus typically spreads from person to person; respiratory droplets produced when a person talks, coughs, and sneezes contain the virus and these droplets can enter the body through the mouth, eyes, and nose. While respirators have many applications and come in different shapes and sizes, respirators cover at least the mouth and nose and either filter the air that reaches the wearer or provides the wearer with fresh air. The disposable respirators most commonly used during outbreaks are referred to as N95s.

 

N95 Overview and Shortages

Disposable N95s are considered tight-fitting, negative pressure, air-purifying respirators. When worn properly, they create a seal with the face and filter particulates and droplets (including viruses and bacteria), but not gasses or vapors. N95s are categorized as Filtering Facepiece Respirators. . The term N95 will be used in this article to refer to all FRRs.

Learn More About N95 Masks

All risk is not eliminated simply by wearing a respirator; respirators should be used in conjunction with other controls (i.e. engineering controls, administrative controls) and PPE (face shield, goggles, gowns) whenever possible. While it may seem easy to just put one on, people need to be trained on how to wear them correctly. In occupational settings, N95s must be certified by the National Institute of Occupational Safety and Health (NIOSH) and worn in accordance with regulations set forth by OSHA for respiratory protection found in 29 CFR 1910.134.. Further, N95s used in healthcare settings, called surgical N95s, must be approved by the Food and Drug Administration. You can read about the difference between N95s, surgical N95s, and surgical masks here.

Learn More About 29 CFR 1910.134

Finding respirators for purchase right now is practically impossible. While the shortage of N95s is difficult to quantify, there is no shortage of stories about healthcare workers reusing disposable respirators or going without. Additionally, workers in other industries, who rely on N95s for safety, are suffering from the lack of protection as N95s are prioritized elsewhere (i.e. construction workers who cut concrete use certain types of N95s to protect themselves from silica exposure).

 

On March 2, 2020 the FDA announced N95s intended for general industry will be permitted for use in healthcare settings, this move should give more healthcare workers access to protection. Companies like Amazon and the Home Depot have stopped all sales of N95s to the public and have reserved supplies for the healthcare industry. While White House orders, temporary changes in FDA and CDC regulations, and donations from large corporations are attempting to ease the effects of PPE shortages, it may be some time yet before the supply can meet the demand. Until this time, optimizing current stores of N95s, understanding available guidance for extended and limited reuse of N95s, and considering methods for decontaminating them will be important.

 

Strategies for N95 Use During the COVID-19 Outbreak

Under normal circumstances, disposable N95s are intended to be worn by one person and thrown out when they become dirty/contaminated, damaged, or difficult to breathe through. In healthcare settings, this can mean throwing a respirator out after seeing each patient. To extend the current supply of N95s, NIOSH has published various strategies for N95 use during pandemics. One widely cited web page is called Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings; another article, published by the CDC, is called Decontamination and Reuse of Filtering Facepiece Respirators. Additionally, COVID-19 specific optimization strategies of N95 respirators in conventional, contingency, and crisis capacity situations have been published by the CDC and are available here (and as a simple, summarized list here).

 

Extended Use and Limited Reuse of N95s

Both extending the use of and reusing N95s are pandemic strategies for PPE. In their recommended guidance (link in previous paragraph), NIOSH explains that the term “extended use”, in relation to N95 respirators, “refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several patients, without removing the respirator between patient encounters.” Basically, the mask goes on and stays on for an entire shift and is disposed of at the end. The term reuse, “refers to the practice of using the same N95 respirator for multiple encounters with patients but removing it (‘doffing’) after each encounter”. If properly cared for, reuse strategies may extend the life of a respirator for several days, though NIOSH suggests limiting the number of times a respirator is reused to 5 if no manufacturer instructions are given. Both extended use and reuse strategies are not recommended under normal circumstances as there are risks involved with each.

 

“Extending” the use of a respirator is often preferred over “reuse” because the risk of contaminating the inside of the mask or contacting the virus as the respirator is handled, donned, and doffed is reduced. The SARS-CoV-2 virus can last up to 72 hours on surfaces. One strategy suggested by the CDC for reuse is to give each worker who cares for COVID-19 patients 5 respirators, have them wear one respirator a day, and properly store each respirator for five days before wearing it again with the hopes that the viruses will not survive. Before implementing strategies like this, methods need to be well researched, documented and trained on. In both extended and reuse situations, N95s need to be thrown out when damaged, soiled, or have contact with blood or mucus. Disposable respirators should not be used by more than one person. Great care needs to be taken when donning and doffing respirators to avoid contracting the virus, even in situations where respirators have not been worn for 5 days. Face shields and other PPE should be worn to protect workers and respirators from splashes.

 

N95 Optimization

During normal or conventional capacity circumstances, N95 optimization strategies include things like limiting the number of healthcare professionals who work with and are in contact with patients, limiting face-to-face encounters with patients, and utilizing telemedicine options to reduce the number of N95s needed. Additionally, non-disposable respirators can and should be used. These include half face, full-face, and powered air purifying respirators. Qualitative, instead of quantitative fit-testing methods can be used so masks are not ruined unnecessarily.

 

Under contingency capacity circumstances, unused but expired respirators can be used for training and fit-testing purposes. Hospital stays for stable patients can be limited, and extended use and limited re-use policies for N95s can be implemented. During crisis capacity circumstances, considerations can be made for using respirators past their use-by date. The use of masks may need to be prioritized based on activity type (i.e. reserving surgical N95s for those in surgery). Additionally, when respirator supplies are very low, respirators similar to NIOSH approved N95s, that meet standards in other countries, can be used as long as the masks are approved by the FDA. When there are no respirators left, administrative decisions and engineering controls will become even more crucial. All optimization strategies suggested by the CDC are not mentioned in this article and more can be found on their website.

 

Decontaminating N95s

Can N95s be decontaminated? The answer is complicated. Under normal circumstances, N95s should be disposed of if there is any question as to whether they are contaminated or not. No OSHA, NIOSH, FDA, or CDC methods for the decontamination of N95s are approved for routine use. However, with PPE in short supply, decontamination of N95s is being talked about like never before. It would not be surprising if multiple options are approved in the near future. The FDA, who has the power to grant Emergency Use Authorizations (EUA) for medical devices, has approved the use of at least one company’s decontamination method. If more options are approved, they will be available on the FDA website.

 

Effective decontamination needs to both inactivate the SARS-CoV-2 virus and maintain the integrity of the mask. Battelle Memorial Institute created the system now approved by the FDA under the EUA. It uses vapor phase hydrogen peroxide to decontaminate N95s in what they call a Critical Care Decontamination System. The system is now being used in Ohio to decontaminate thousands of N95s at a time and will likely be replicated in other locations.

 

The CDC has released an excellent summary of research in addition to recommendations for crisis use and decontamination of N95s, which can be accessed here.  The CDC reminds us that research is limited, but  admits decontamination methods may need to be considered as a crisis capacity strategy to ensure supplies are available. The CDC’s webpage states, “vaporous hydrogen peroxide, ultraviolet germicidal irradiation, and moist heat are the most promising FFR decontamination methods.” This is similar to information published by a California public benefit corporation called N95DECON, Inc. N95DECON has published technical reports and fact sheets to aid those looking to develop and implement decontamination methods. Any method not approved by the FDA is essentially done at personal risk.

 

Expired N95s

Many companies, federal organizations, and states have N95s in storage which have passed their manufacturer-designated shelf life. Typically, respirators should not be used past their expiration date because over time parts of the mask can deteriorate, which impact their effectiveness. However, the CDC has released guidelines for when using respirators past their shelf life should be considered (i.e. expired masks are better than using bandanas) and which models can be considered for use passed shelf life. Information regarding the CDC’s guidance can be found here. The decision by federal and state agencies to release stockpiled N95s may free up respirators and provide some relief to the current deficit.

 

Summary

While the shortage of PPE is felt heavily around the country, healthcare managers and occupational health and safety professionals can implement practices that will extend the life of precious resources. This includes engineering and administrative controls, optimization strategies, extended use and reuse of respirators, possible decontamination of N95s, and considering the use of expired N95s. This article covers only some aspects of the broader PPE shortage and recommended guidance from government agencies are being updated daily.

 

A great FDA resource for questions regarding the use of PPE with current shortages, is called FAQs on Shortages of Surgical Masks and Gowns.

 

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This article was written by Alexandra Cox