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Title:

Masks and Respirators for the 21st Century: Policy Changes Needed to Save Lives and Prevent Societal Disruption

Masks and Respirators for the 21st Century: Policy Changes Needed to Save Lives and Prevent Societal Disruption
Authors:
Eric Toner, Tener Veenema, Amesh Adalja, Matthew Watson, Clint Haines, Anita Cicero
Date posted:
October 05, 2021
Publication type:
Report
Publisher:
The Johns Hopkins Center for Health Security
See also:
Introduction:

Masks and respirators have played an essential role in the response to the COVID-19 pandemic for both healthcare workers and the public. However, the masks and respirators that both healthcare workers and the public have needed to rely upon leave much to be desired. Despite drawbacks in terms of comfort and fit, the ubiquitous disposable masks and disposable N95 respirators used by the vast majority of healthcare workers have not appreciably improved since the mid-1990s. During the COVID-19 pandemic, the public has been advised to wear masks as well. Masks have long been known to be effective means of “source control” (ie, reducing transmission of respiratory droplets from the wearer to others). More recently evidence has accumulated that properly constructed and worn masks as well as respirators afford a limited but not inconsequential degree of protection to the wearer as well. Existing masks and respirators run the gamut in terms of effectiveness and wearability. In a future large-scale outbreak or pandemic, it is possible to increase the protection of healthcare workers and the public from infection through more efficient, well-fitting, and comfortable masks. The design and manufacture of better masks and respirators are possible by harnessing emerging technologies, the innovative research and development spirit evidenced since the early days of the COVID-19 pandemic, and the availability of resources to support technological innovation.

In this report, we provide an overview of the history and types of masks and respirators that exist and consider the development, manufacture, approval, and stockpiling of better respiratory protection for healthcare workers, the nonhealthcare workforce, and the public in the United States. We address issues related to acceptance and willingness to wear face coverings, masks, or respirators. We discuss ways to foster ingenuity in designs of new devices, promote advanced development, obtain regulatory approval, and stockpile a reasonable number of devices.

We have found that better medical masks and respirators (collectively referred to as devices) than the ones we have been using for decades are possible, but progress in their development and manufacture is blocked by a confluence of factors including industrial inertia, lack of competition, complacent consumers (health systems prior to COVID-19), regulatory barriers, an uncertain market, and lack of US government policy. Widespread public use of effective, commercially available masks and respirators could help save many thousands of lives during the next severe pandemic of a respiratory pathogen and reduce the resulting economic damage. It is important to have a ready supply and surge manufacturing capacity of high-quality devices when severe or catastrophic respiratory epidemics emerge. Widespread public use of effective, commercially available masks during periods of other respiratory disease would reduce transmission of common respiratory pathogens such as influenza that kills on average more than 15,000 Americans per year.

Based on the following general principles, we make recommendations for federal action below.

General Principles

  • Improved masks and respirators whether for medical or public use should block both outgoing and incoming respiratory droplets and aerosols consistent with or better than current relevant standards, be cost-effective, and offer a significant advance in fit, wearability, communication, reusability, shelf life, and/or supply-chain reliability.
  • The devices should be multipurpose and multihazard, providing source control as well as protecting against respiratory transmissible diseases and aerosolized intentional agents.
  • They should combine ease of use and wearability with providing high-level protection.
  • Disposable, single-use devices are not as cost-effective and may be more dependent on a long and fragile supply chain than some reusable devices; therefore, a shift to greater use of improved reusable devices (such as elastomeric respirators) in healthcare facilities is needed.
  • Innovation in device design is occurring and should be encouraged by federal policies. To account for ongoing innovation, the office of the Assistant Secretary for Preparedness and Response should use a recurring competitive procurement process for devices purchased for the Strategic National Stockpile.
  • Stockpiling alone cannot be the sole solution since it is not realistic to stockpile enough devices for every scenario. A robust end-to-end manufacturing supply chain that can rapidly surge to supplement the stockpile is also needed. Additionally, all devices deteriorate over time and the Strategic National Stockpile must identify and implement strategies to use them before they expire.
  • Increased use of masks by the public to prevent routine illness (eg, influenza, other respiratory viruses, seasonal allergies, dust, and smoke) would help to maintain an active market needed to sustain manufacturing capacity.

Recommendations for Federal Action

  1. Over the next year the Strategic National Stockpile should supplement its supply of N95 filtering facepiece respirators with the purchase of reusable elastomeric half-mask respirators to be available now to healthcare workers in an unanticipated emergency.
  2. The Assistant Secretary for Preparedness and Response should commission scenario-driven modeling studies that consider the possibility of a severe pandemic to determine the number of reusable respirators and disposable N95 filtering facepiece respirators to purchase for the Strategic National Stockpile.
  3. The Strategic National Stockpile should use a recurring biennial competitive procurement process of increasingly demanding requirements as it purchases new respirators for healthcare workers and other high-risk essential workers.
  4. The Biomedical Advanced Research and Development Authority should foster the development of better medical masks, respirators, and public use masks by continuing to issue challenges and establishing target product profiles.
  5. The Biomedical Advanced Research and Development Authority should explore means of providing financial incentives or supports to domestic companies
    to scale up and maintain production once devices meeting the target product profiles are developed.
  6. The Strategic National Stockpile should establish a program to rotate its stockpiles of medical masks and respirators through hospitals so that the Strategic National Stockpile would always have unexpired materiel and participating hospitals could reduce their supply costs.
  7. The US Centers for Disease Control and Prevention and Assistant Secretary for Preparedness and Response should work with professional organizations, accrediting bodies, and the Centers for Medicare and Medicaid Services to find ways to encourage hospital respiratory protection programs to move toward greater use of reusable respirators as part of a multipronged approach to routine respiratory protection.
  8. The US Centers for Disease Control and Prevention should have a sustained national communications campaign to prevent illness by encouraging mask use by the public during influenza season, when having a respiratory infection or seasonal allergies, or when there is high levels of smoke or dust.

 

 

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