The Major Role of Reusable Respirators
in Increasing Respiratory Protection for
Future Infectious Disease Emergencies:
A Stakeholder Discussion
Meeting report of a stakeholder discussion organized by
the Johns Hopkins Center for Health Security
April 25, 2024
Washington, DC

Johns Hopkins Center for Health Security Project Team
Eric Toner, MD
Senior Scholar, Johns Hopkins Center for Health Security
Caitlin Walker
PhD Student, Johns Hopkins Bloomberg School of Public HealthJoel Straus
Policy Research Associate, Johns Hopkins Center for Health Security
Melissa Hopkins, JD
Health Security Policy Advisor, Johns Hopkins Center for Health Security
Tener Goodwin Veenema, PhD, MPH, MS, RN, FAAN
Senior Scholar, Johns Hopkins Center for Health Security
Anita Cicero, JD
Deputy Director, Johns Hopkins Center for Health Security
Thomas V. Inglesby, MD
Director, Johns Hopkins Center for Health Security

Acknowledgements
We would like to express our gratitude to all speakers and meeting participants. The
authors would also like to thank Andrea Lapp for logistics; Alyson Browett for editing;and Cagla Giray, Prarthana Vasudevan, and Julia Cizek for design and communications
support.
The views expressed in this publication and/or made by meeting attendees do notnecessarily reflect the official views of the US government or the Johns Hopkins Centerfor Health Security.

Suggested citation: Walker C, Straus J, Hopkins M, Veenema T, Cicero A, Inglesby T,
Toner E. The Major Role of Reusable Respirators in Increasing Respiratory Protection for
Future Infectious Disease Emergencies: A Stakeholder Discussion. Baltimore, MD: Johns
Hopkins Center for Health Security; 2024.
© 2024 The Johns Hopkins University. All rights reserved.

The Major Role of Reusable Respirators in Increasing Respiratory Protection for Future Infectious Disease Emergencies: A Stakeholder Discussion | ii

Contents
Executive Summary............................................................................................................ iv
Background & Introduction.................................................................................................1
Meeting Summary...............................................................................................................3
Need for RRs in SNS.........................................................................................................3
Adoption and Benefits of RRs in Healthcare...................................................................3
Waste Reduction and Sustainability................................................................................3
Diversity and Availability of PPE.....................................................................................4
Call to Action...................................................................................................................4
Needs & Opportunities........................................................................................................4
Immediately add RRs to PPE stockpiles, requiring new funding commitments
for the SNS.......................................................................................................................4
Innovate and design more comfortable RR models to accommodate thepreferences and needs of the healthcare worker community and otherpotential users.................................................................................................................4
Address institutional challenges with managing and cleaning RRs throughinformed implementation practices...............................................................................5
Routinely use RRs in healthcare and beyond..................................................................5
Foster cultural change, education, and training at the user level...................................6
Generate consistent industry demand signal from the government andprivate sector...................................................................................................................8
Provide support to US-based RR manufacturers.............................................................8
Determine the contributions of federal, state, local, and healthcare stockpiles............9
Key Recommendations......................................................................................................10
Conclusion.........................................................................................................................12
References..........................................................................................................................13
Appendix A: Participant List..............................................................................................14

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Executive Summary
The Johns Hopkins Center for Health Security convened an in-person, not-forattribution stakeholder discussion on April 25, 2024, to: 1) examine how reusable
respirators (RRs) used at scale would protect against supply chain shocks in large
emergencies, cost less per respirator than single-use disposable respirators over thelife of the product, and provide better protection for workers; and 2) inform a national
strategy to promote stockpiling of RRs by the US government, encourage greater
adoption of RRs by the healthcare sector, incentivize innovation in RR design, andcreate a stronger demand signal for industry.
The discussion included experts and practitioners from academia, healthcare,government, nongovernmental organizations, manufacturers, trade associations, andother private sector entities. Participants were encouraged to consider solutions to likely
challenges arising with such a strategy, including funding, user acceptance, needed
design innovation, and issues regarding RR decontamination, fit testing, and storage.
Participants consistently expressed the importance and benefits of RRs for improving
pandemic preparedness.
Key needs and opportunities identified during the meeting discussion include:
1.

Adding RRs in personal protective equipment (PPE) stockpiles immediately,
requiring new funding commitments for the Strategic National Stockpile (SNS).

2.

Innovating and designing more comfortable RR models to accommodate thepreferences and needs of the healthcare worker community and other potential
users.

3.

Addressing institutional challenges with managing and cleaning RRs throughinformed implementation practices.

4.

Routinely using RRs in healthcare and beyond.

5.

Fostering necessary education, training, and cultural change at the user level.

6.

Generating a consistent industry demand signal from both government and theprivate sector.

7.

Providing more support for US-based RR manufacturers, for example byprioritizing domestic purchases and upholding the Make PPE in America Act.

8.

Determining the contributions of federal, state, local, and healthcare stockpiles.

Based on these takeaways, the Center for Health Security recommends several actions toachieve each, described in detail in this report. Overall, the Center recommends:
1.

The Centers for Disease Control and Prevention (CDC) and/or the
Administration for Strategic Preparedness and Response (ASPR) commission thecreation of a new national pandemic planning scenario.

2.

The US government create a substantial stockpile of RRs sufficient to protect
essential workers in the event of a new respiratory disease emergency. An initialpurchase of 200,000 RRs should be made, at a cost of approximately $10 million,

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to cover a large portion of frontline hospital workers who would be most at riskin the first several months of a severe disease outbreak. The Department of
Defense (DOD) should also procure a substantial supply of RRs to protect DOD
personnel.
3.

Manufacturers and other research organizations develop and test innovations in
RRs.

4.

The federal government and/or Congress make funding available for research
to identify solutions regarding RR fit, cleaning/disinfection, and storage/
accessibility.

5.

The Food and Drug Administration (FDA) and National Institute for
Occupational Safety and Health (NIOSH) collaboratively establish a streamlined
approval process for RRs.

6.

Healthcare and research institutions continue to evaluate existing strategies for
implementing RRs in healthcare settings.

7.

Hospitals integrate RRs into their pandemic response plans.

8.

ASPR and/or the Hospital Preparedness Program (HPP) require Regional
Emerging Special Pathogen Treatment Centers and Special Pathogen Treatment
Centers to have RRs in sufficient quantity for a new national pandemic planningscenario.

9.

Professional organizations encourage the healthcare sector to use more RRs
during interpandemic times. This should include the Healthcare Infection
Control Practice Advisory Committee (HICPAC) examining the role of RRs anddeveloping recommendations.

10. Congress allocate funding to advance research on PPE through centers of
excellence established by NIOSH.
11. The Occupational Health and Safety Administration (OSHA), trade associations,and private sector and nonprofit leaders encourage businesses andorganizations that employ critical workers to stockpile RRs.
12. Purchases of RRs for the SNS be spread over the timeframe of each product’s
shelf life to maintain a consistent and multiyear demand signal.
13. The demand signal generated by purchases for the SNS include specific details
and specify the appropriate NIOSH and/or FDA approvals.
14. The federal government uphold the requirements of the Make PPE in AmericaAct.
15. The government evaluate the effectiveness of incentives for purchasing US-madesupplies.
16. The Department of Health and Human Services (HHS) develop an overall
respiratory protection plan for infectious disease emergencies. The agency
can provide clarity and advice to healthcare systems about the expectations offederal government responsibilities and hospital responsibilities for PPE.
17. ASPR clarify the functions and contributions of stockpiles at different levels.
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Background & Introduction
Personal protective equipment (PPE) can reduce pathogen transmission and saves lives
during a pandemic. Several types of PPE can be used to limit respiratory transmission
among the healthcare workforce, other essential workers, and the public. Respiratory
protection includes disposable items, such as surgical masks and N95 respirators, andreusable items, such as elastomeric half-mask respirators (EHMRs) and powered airpurifying respirators (PAPRs).1 Throughout this report, “reusable respirators (RRs)”
refers to existing EHMRs and PAPRs as well as not-yet-developed innovative reusable
products.
Major infectious disease pandemics over the past 20 years have required the use of
PPE to minimize transmission risk, particularly for healthcare workers (HCWs) caring
for patients. These events create high demand for PPE, often leading to local or evenglobal shortages that leave HCWs less protected.2 Shortages of respiratory protection
were widespread during the COVID-19 pandemic. The majority of respiratory PPE bothstockpiled and currently in use is single-use and disposable. Despite these lessons, thedemands for respiratory PPE during another pandemic, particularly early on, likely will
far exceed both the supply in the Strategic National Stockpile (SNS) and the amount thatcan be produced by scaling up manufacturing.
A growing body of literature and recommendations support the need for greater use
and stockpiling of RRs in the US. In 2008, a US government interagency working
group (Project BREATHE) was convened with the aim of developing consensus
recommendations to improve respiratory protection for the healthcare workforce.
This group identified recommendations for manufacturers, researchers, standards
developers, respirator users, and employers. Areas for recommended action related to 4
desired characteristics: safety and effectiveness; lack of interference with occupational
activities; comfort; and compliance with standards, guidelines, and policies.3 In early
2019, the National Academies of Sciences, Engineering, and Medicine released a
consensus study report on RRs for the healthcare workforce, focused on economic,
policy, and implementation challenges and opportunities. The report presents 3 keyrecommendations: 1) increase research to improve respiratory protection, including for
RRs; 2) ensure robust respiratory protection programs and training for HCWs; and 3)
harmonize standards among authorities, from the international to the local levels, andclarify guidelines and responsibilities, including for stockpiles.4 Actions are still neededto achieve these recommendations.
The benefits of RRs, along with recommendations for federal action to increase
pandemic preparedness, also were outlined in a 2021 report by the Johns Hopkins
Center for Health Security.1 The report makes several recommendations regarding
RRs in healthcare, including that the federal government purchase EHMRs for HCWs
for inclusion in the SNS; the Assistant Secretary for Preparedness and Response(now Administration for Strategic Preparedness and Response; ASPR) encourage RR
use in hospital respiratory protection programs and commission scenario-driven
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modeling studies to inform stockpile plans; and the Biomedical Advanced Researchand Development Authority (BARDA) support design innovation and domestic
manufacturing of respiratory protective devices.1 The criticality of ensuring adequate
PPE availability for pandemic preparedness has since been recognized in the National
Biodefense Strategy, which highlights the need for “a resilient and scalable supply of
personal protective equipment.”5 In order to achieve this aim, further actions toward theaforementioned recommendations are required.
Recent work by Gryphon Scientific (since acquired by Deloitte) has generated additional
recommendations to improve the PPE ecosystem for pandemic preparedness. A key
finding of the research is that EHMRs offer greater respiratory protection, higher costeffectiveness over their lifecycle, and have better fit and usability characteristics whencompared to N95 respirators.6 While PAPRs are more expensive, the report suggests
they are required for a proportion of the essential workforce for whom EHMRs are
unsuitable. A resulting recommendation was therefore that government-managed
stockpiles consist of 90% reusable EHMRs and 10% PAPRs. Gryphon Scientific also
recommends that stockpiles hold sufficient respiratory protection for the essential
workforce for 150 days, which equates to 58 million elastomeric units for the US,
accounting for some loss or damage.7
In addition to government stockpiles, there is a growing case for use and storage of RRs
within hospitals. According to research conducted in medical systems that adopted
RRs, HCWs preferred RRs compared to N95 respirators in high-risk scenarios, such as
caring for a patient with active pulmonary tuberculosis or during the H1N1 influenza
or SARS pandemics. This preference existed despite challenges with comfort andcommunication.2
In light of this previous work, the Johns Hopkins Center for Health Security convened
a not-for-attribution stakeholder meeting to discuss increasing the availability of
RRs for the next pandemic on April 25, 2024. Participants included experts andpractitioners from academia, healthcare, government, nongovernmental organizations,manufacturers, trade associations, and other private sector entities. A list ofparticipants is provided in Appendix A. The meeting featured presentations on researchsupporting increased numbers of RRs in the SNS, challenges and opportunities for
ASPR, experiences of HCWs with RRs, the benefits of government demand signals to
manufacturers, and the National Biodefense Strategy. The rest of the meeting consistedof discussion, providing opportunities for participants to reflect on the presentations
and respond to others’ comments. For this meeting, the discussion was confined to theuse of RRs in healthcare settings.
This report provides an overview of key points raised by meeting participants, resulting
needs and opportunities, and recommendations for actions by the federal government,
the healthcare sector, including hospitals, trade associations, and business leaders.

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Meeting Summary
Participants from multiple sectors repeatedly emphasized the importance of RRs
both in routine use and for pandemic preparedness. Widespread agreement on thebenefits and cost-effectiveness of RRs was echoed throughout the meeting. Participants
noted that the PPE shortages experienced during the early months of the COVID-19
pandemic exemplified the need for increasing the use and availability of RRs. They also
underscored how adequate PPE is critical for responding to any type of pandemic event.

Need for RRs in SNS
The meeting opened with an expert presentation on the need for RRs within the SNS.
Using different pandemic modeling scenarios, the presenter showed that obtaining
and sustaining a good fit of an N95 provides sufficient protection for workers in mostscenarios except when they share a workspace for extended periods. However, many
workers lack access to occupational health teams that can support them in finding agood N95 fit, and fit can be lost for many reasons. Participants noted that obtaining agood fit with EHMRs is easier than for N95s, but getting and maintaining that fit may
be more challenging outside healthcare settings where occupational health support
is limited. The presentation concluded that EHMRs offer greater protection acrossdifferent scenarios due to reduced leakage around the sides of the device (rather thandifferences in filter penetration).

Adoption and Benefits of RRs in Healthcare
A healthcare sector participant provided an overview of RR adoption at several US
medical system sites, demonstrating both feasibility and acceptability. Trials of EHMRs
and PAPRs found several benefits, including increased protection and comfort, fewer
associated injuries, and more reliable availability during emergencies compared to
N95 respirators. A 2016 survey of 1,152 HCWs found preferences for EHMRs over N95s
in high-risk scenarios, indicating that user acceptance is not a barrier in healthcare
settings.2 A larger 2021 survey found that approximately half of HCWs preferred EHMRs
or PAPRs to N95s, with communication challenges being the most cited disadvantage ofelastomeric respirators.

Waste Reduction and Sustainability
Waste reduction and sustainability were discussed as benefits of RRs. The reuse of RRs
results in fewer total items required, and fewer RRs are wasted during fit testing sincedisposable respirators must be discarded after each test. This leads to greater costeffectiveness of RRs compared to N95s over their lifecycle (with N95s estimated to cost
$62.50–$392.50 per individual per year during a pandemic, compared to $30–$180 for
an EHMR).6 The difference in cost is further widened due to the greater amount of spacerequired to stockpile sufficient N95s compared with EMHRs.

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Diversity and Availability of PPE
Participants frequently remarked on the value of having multiple PPE types available
and noted the advantages of having both disposable and reusable options. PAPRs andEHMRs offer different benefits, including integrated eye protection and cooling airflow
in PAPRs and an ability to better accommodate cultural, ethnic, and functional needs,
such as beards or headwear. Notably, hospitals with diverse options in their respiratory
programs, including EHMRs and PAPRs, were initially better able to handle their own
needs during the early COVID-19 pandemic and did not require additional supplies
from manufacturers until later.

Call to Action
The meeting concluded with a strong call to action. Several participants emphasizedthat discussions on the need for more RRs have been ongoing for more than 2 decades.
Numerous participants said immediate action is necessary and cyclical conversations
without concrete outcomes must be avoided.

Needs & Opportunities
Building on the discussions about the benefits and implementation of RRs, themeeting highlighted 8 fundamental needs and opportunities to enhance pandemic
preparedness and ensure the effective use of RRs.

Immediately add RRs to PPE stockpiles, requiring new funding
commitments for the SNS
Despite broad recognition of the importance of federal PPE stockpiling, participants
frequently discussed the challenge of securing sufficient and sustained funding.
Historically, the mandate of the SNS has been to stockpile products that have nocommercial alternatives, such as vaccines and therapeutics, with no specific mandate
to include PPE. As a result, purchasing PPE relied on supplemental funding, which is
no longer available. A key challenge identified is how to include PPE within the SNS
while balancing the trade-off of stockpiling other items given limited funding. ASPR iscurrently exploring options for PPE stockpiling, including RRs.

Innovate and design more comfortable RR models to accommodate
the preferences and needs of the healthcare worker communityand other potential users
Participants acknowledged several limitations in the design of current RR models,
including the inability of EHMRs to meet all the cultural, ethnic, and functional needsof the diverse HCW and essential worker communities, communication challenges,
and the inability to instantaneously assess fit and monitor for loss of fit. Given these
design limitations, several areas for innovation were identified. For example, an expert

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from the healthcare sector commented that measuring fit at the point of use would begroundbreaking, potentially eliminating the need for occupational health assistancewith fit testing. An existing device that provides an immediate measure of the pressure
differential across the mask was also discussed. Additionally, fit in combination with eye
protection was noted as a challenge and an area for further innovation.
Innovation is needed to develop equipment that is more appropriate for theworkforce, given the need for respirators to fit diverse faces and suit various workplacedemands. This challenge was highlighted during the COVID-19 pandemic. In terms ofcommunication challenges, speaking diaphragms and clear facemasks were discussed
as examples of existing solutions. Ongoing innovation by manufacturers is crucial toaddress these limitations and improve the effectiveness of RRs in protecting the broad
range of essential workers.

Address institutional challenges with managing and cleaning RRs
through informed implementation practices
Many participants identified implementation as the greatest challenge to increasing
RR use but noted that it is not insurmountable, with valuable lessons learned fromhealthcare systems that have already adopted RRs. The 2 key implementation
challenges discussed were decontamination and accessibility of RRs.
Different models of cleaning and decontamination practices have been trialed,
including individuals being responsible for cleaning their own respirators and acentralized system where HCWs return respirators for disinfection at the end of a shift
and later collect a different respirator. Research presented at the meeting found thatcleaning and disinfection practices were inadequate when left to individuals.8 Similar
challenges have been encountered with accessing respirators when needed, often due toinconvenient storage.9
Potential solutions discussed included a shared supply system with a centralized
disinfection process,10 using a central sterile processing department or vending
machines for depositing and collecting respirators. While protocols and solutions exist
for decontamination, there is a need for more evidence and solutions to ensure readyaccess to RRs when and where needed.

Routinely use RRs in healthcare and beyond
Participants identified a need to normalize the use of RRs outside of pandemics toincrease familiarity, acceptance, and trust among HCWs. They also expressed theimportance of establishing infrastructure and protocols for assigning, using, andcleaning elastomeric respirators prior to an emergency.
One participant suggested that without common use of RRs in the medical system,
the devices would need to be 100% centrally stockpiled because low routine use would

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prevent rotation through a supply bubble such as vendor-managed or distributormanaged inventories. Similarly, participants noted that incorporating RRs into routine
use in healthcare settings would reduce pressure on stockpiles. Evidence from hospitals
that have already adopted RR strategies shows the feasibility of this approach.
Strategies for achieving widespread use were discussed. For example, piloting
elastomeric respirators in more healthcare settings could increase familiarity andrecognition of their benefits. Several participants highlighted education settings
as opportunities to introduce RRs, such as providing and fitting new RRs to every
graduating medical, paramedic, nursing, or allied health student. This aligns well with
the National Institute for Occupational Safety and Health (NIOSH) Safe, Skilled, Ready
Workforce Program.
In addition to the challenges of disinfection and accessibility, there is a lack of incentive
for hospitals to move away from N95s, which are often considered the gold standard
despite providing lower protection than RRs. One participant suggested that educating
HCWs about different respiratory protection options and incentivizing the use of
all respirators, not only surgical N95s, are necessary actions. Another participant
recommended funding or other incentives to promote the benefits of RRs at thehospital level.
Participants also noted the importance of providing and fitting elastomeric respirators
for all essential workers—not only for those in healthcare or during pandemics—
due to persistent respiratory hazards such as wildfire smoke, poor air quality, or coldand flu season. Although a few RR models have been used in healthcare settings for
decades, the use of novel RRs in medical settings is currently only permitted under an
Emergency Use Authorization (EUA). Full approval of these products by the Food andDrug Administration (FDA) and streamlining the approval process in collaboration with
NIOSH would reduce the regulatory burden for innovative designs.
In addition to the disinfection and accessibility challenges discussed above, hospitals
lack incentives to move away from N95s. One participant suggested that education
about different respiratory protection options is needed for HCWs alongside incentives
to use all types of respirators. Another participant mentioned that funding or otherincentives, and promotion of the benefits of RRs, are needed at the hospital level.

Foster cultural change, education, and training at the user level
Participants emphasized the need for cultural changes, education, and training at
the user level to make progress toward the routine adoption of RRs. They expressed
the importance of beginning this education and training now to normalize RR before
another emergency arises. Additionally, they recommended developing just-in-timetraining for safe donning and doffing of PAPRs.
Participants discussed several specific cultural changes. For example, one participant
noted the need to overcome the culture of individual ownership of specific items if a
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centralized system is used for disinfection and cleaning. They pointed out that otherindustries, such as firefighting, have successfully implemented pooled equipment
supplies and that a rigorous cleaning process can increase trust in the shared items.
Another cultural shift discussed was using appropriate protective equipment basedon an activity’s level of risk, thereby acknowledging the complementary role ofdisposable and reusable respirators. Participants also suggested employing and clearlycommunicating the precautionary principle regarding the respiratory protection needed
for a given activity, meaning more protective measures (including wearing respirators)
should be taken in environments where risks are unknown and then potentially deescalated when more information about a hazard becomes available. To employ the
precautionary principle, one participant stressed the need to have a sufficient number
of RRs prior to an emergency.
Participants also discussed the need to change the expectations that employees havefor protection, drawing comparisons to other industries or activities where protective
measures have become the norm, such as preventing forest fires and wearing seatbelts.
They also raised the challenge of public opposition to respiratory protection and theneed to restore public trust. Potential strategies to generate such cultural change
included identifying younger change agents, implementing ad campaigns and othereducational communication efforts from those outside of government, and taking
action while the experiences of the COVID-19 pandemic are still fresh.
Another valuable area for change is in the measuring and reporting of fit andeffectiveness. Participants expressed the need for an imperfect use index, similar tothat used for birth control. This metric would recognize that people do not always use
PPE correctly, provide metrics for protection in real-world conditions, and facilitate
more informed choices and education about respiratory protection. One participant
noted that such an index should include measures of effectiveness without fit testing or
when minimal training is given. Another participant mentioned the value of conducting
future studies to compare the effectiveness of N95 respirators to reusable types using
an imperfect use index, which may provide additional support for RR use given that
EHMRs are both more likely to pass an initial fit test and maintain fit over time.6
Several participants discussed the benefits that centers of excellence could generate.
These specialized programs, which involve a high concentration of expertise andresources for specific medical areas11 and are usually located at US academic
institutions, could focus on: improving communications about PPE and the utility of
RRs; educating healthcare institutions on leadership practices; supporting employers
in the selection, use, and maintenance of RRs; and building trust. Although academic
institutions are ready to take on this role and NIOSH has been working toward
establishing centers of excellence for PPE for more than a decade, funding is notavailable.
Throughout the meeting, several participants highlighted the need to protect additional
workforce groups beyond those typically considered. This includes groups other than

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HCWs within the healthcare ecosystem, such as janitors and aides, but also the broader
essential workforce. Participants mentioned workers outside healthcare should haveaccess to respiratory protection, including those in vital industries that could consider
their own stockpiling measures. Notably, however, cultural change is required inwhich additional groups have a stake in the issue and receive related education. One
participant suggested government has a role to play in advancing this goal throughopen and honest communication about why respiratory protection is needed for thebroader essential workforce to gain public trust.

Generate consistent industry demand signal from the government
and private sector
One participant with industry experience noted that manufacturers must take many
steps to respond to increased demand, including obtaining manufacturing equipment,
raw materials, and other supplies; hiring labor; conducting quality management;
seeking necessary approvals; and distributing products. Participants explained that thedemand signal, whether from the government or the private sector, needs to be specific,
consistent, and standards-based. A specific demand signal should include details
such as the number of facepieces and filter cartridges, sizes, and required approvals.
Consistent orders with a multiyear commitment are essential for industry to sustain thiscapability, given the time needed to establish increased manufacturing. The demandalso should be standards-based, pre-specifying the appropriate and necessary NIOSH
and/or FDA approvals and other applicable standards. This approach would ensure that
all manufacturers, distributors, users, and regulators have a shared understanding of
the requirements, and market competition occurs on factors other than performancelevels. Participants also discussed the success of previous user community involvementin generating demand and developing standards, citing the example of chemical,
biological, radiological, and nuclear (CBRN) respirators following the terrorist attacks of
9/11.
While most demand comes from the private sector, participants emphasized
government’s important role, especially in safeguarding continuity of demand. They
noted that the SNS could help establish and maintain this demand signal by spreadingpurchases over the timeframe of a product’s shelf life, preventing the need for industry
to surge and then shut down. The stockpile can also relieve pressure on industry during
an emergency by providing RR supply while production ramps up.

Provide support to US-based RR manufacturers
Several participants highlighted the importance of a reliable PPE supply chain. One
participant emphasized the need for greater reliance on domestic PPE manufacturing
to ensure a resilient supply, protect the public’s health, and gain economic benefits
such as job creation. Another participant cited the need for the federal government to
uphold the spirit and statutory requirements of the Make PPE in America Act. They
called for greater clarity regarding the Buy America and Made in USA provisions,

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including whether all components need domestic sourcing and if assembly must occur
within the US. Multiple participants noted that COVID-19 highlighted the fragilityof the international PPE supply chain for the US, prompting support for US-based
manufacturing. Notably, data presented showed some backsliding in this trend, leading
to increased reliance on imports. The government has attempted incentives, such as aCenters for Medicare and Medicaid Services (CMS) payment adjustment to hospitals
purchasing US-made surgical N95s, although participation rates remain unclear. Other
incentives were mentioned as potentially valuable.
Participants also discussed roadblocks associated with group purchasing organizations(GPOs). These entities generate savings and improve efficiency for healthcare providers
by aggregating purchases across multiple providers. One participant explained that
GPOs are restrictive, often importing products from overseas to buy at the lowest prices,which ultimately hinders US products from reaching the market. Another participant
noted that while hospitals can sometimes make purchases outside of their GPO, they
may face penalties and/or higher prices.

Determine the contributions of federal, state, local, and healthcare
stockpiles
Participants stressed the necessity of a sustainable and continuously improving federal
stockpile throughout the meeting. However, they also discussed the need for states,
hospitals, and other vital industries to maintain their own stockpiles. They highlighted
several current barriers to achieving this tiered system, especially determining anappropriate balance between different stockpiles.
The potential for state-level stockpiles to supplement the SNS was mentioned.
However, ASPR lacks visibility regarding state stockpiles, and states vary widely in theirdegrees of preparedness. Conversely, one participant noted that the federal stockpile’s
tendency not to disclose its contents creates challenges for private healthcare systems’
preparedness. In terms of hospital stockpiles, a participant expressed the need forclarity regarding the expectations and role of the healthcare system within the broader
ecosystem of stockpiles. Areas for greater clarity include the number of items hospitals
are expected to hold, the extent of the government’s responsibility, delivery protocols,
and who will make these decisions. There are obvious benefits to hospitals and healthsystems having RRs readily available in their own stockpiles, one of which could be an
opportunity for healthcare workers to become familiar with the equipment. However,small and rural healthcare organizations may lack the space or funding necessary forsufficient stockpiles.
As mentioned previously, participants discussed the need to rotate items out ofstockpiles and through health systems to reduce waste due to expiration,1 which would
require improved logistics for tracking that movement. One participant describedchallenges during the COVID-19 pandemic when stockpiled ventilators arrived but were
missing parts and suggested that clear plans for distribution are required in the future.

The Major Role of Reusable Respirators in Increasing Respiratory Protection for Future Infectious Disease Emergencies: A Stakeholder Discussion | 9Key Recommendations
The Center for Health Security recommends the following concrete steps to addresseach of the 8 identified needs and opportunities identified during this meeting.
Immediately add RRs to PPE stockpiles, requiring new funding commitments for the SNS
1.

CDC/ASPR should commission the creation of a new national pandemicplanning scenario based on the transmissibility of the Omicron variant of SARS
CoV-2 and the case fatality rate of the 1918 influenza pandemic. This scenario
can guide pandemic preparedness by both the public and private sectors.

2.

The US government should create a substantial stockpile of RRs sufficient toprotect essential workers in the event of a new respiratory pandemic, with initialemphasis on the healthcare sector.
a.

ASPR and the SNS, in coordination with the Public Health Emergency
Medical Countermeasures Enterprise (PHEMCE), should establish arequirement for stockpiling RRs and request funding for procurement,
maintenance, and replenishment of RRs in the stockpile.

b.

Congress should authorize and then appropriate sufficient steady statefunding for the SNS to purchase and maintain an RR stockpile.

c.

The Office of Management and Budget (OMB) should prioritize the federal
stockpiling of RRs.

d.

The SNS should make an initial purchase of 200,000 RRs, at a cost of
approximately $10 million, to cover a large portion of the frontline hospital
workers who would be most at risk in the first months of a new respiratory
disease emergency.

e.

ASPR should conduct or commission scenario-based modeling todetermine the appropriate number of RRs to purchase in addition to theinitial 200,000.

f.

ASPR should determine target product profiles for RRs it will purchase
based on needed innovation in several factors, including protection, fit,communication, and wearability.

g.

The SNS should implement a multiyear program to gradually replace
expiring disposable respirators with newly purchased RRs.

h. FDA should approve existing EHMRs for use in healthcare (not only
through EUAs) and develop a straightforward process for approval ofinnovations.
i.

CDC should develop pre-pandemic surveillance triggers for increased RR
production and purchase in anticipation of need. Unused production canbe bought by the SNS to offset future year’s purchases.

j.

DOD should procure a substantial supply of RRs to protect its military andcivilian personnel.

The Major Role of Reusable Respirators in Increasing Respiratory Protection for Future Infectious Disease Emergencies: A Stakeholder Discussion | 10

Innovate and design more comfortable RR models to accommodate the preferences andneeds of the healthcare worker community and other potential users
3.

Manufacturers and other research organizations should develop and test
innovations in RRs to meet the needs of the diverse healthcare and essential
worker community, including addressing communication and otheraccessibility challenges and methods to assess and monitor fit.

4.

The federal government and/or Congress should make funding available
for research to identify solutions for ongoing challenges in RR fit, cleaning/
disinfection, and storage/accessibility.

5.

FDA and NIOSH should establish a unified and streamlined approval processthat negates the need for 2 separate applications.

Address institutional challenges with managing and cleaning RRs through informed
implementation practices
6.

Healthcare and research institutions should continue to evaluate existing
strategies for implementing RRs in healthcare settings, including protocols
for disinfection and ensuring availability. Successful strategies should be
implemented more broadly.

Routinely use RRs in healthcare and beyond
7.

Hospitals should integrate RRs into their pandemic response plans.

8.

ASPR and/or the Hospital Preparedness Program (HPP) should require the13 Regional Emerging Special Pathogen Treatment Centers and 55 Special
Pathogen Treatment Centers hospitals in the National Special Pathogen System
to have RRs (EHMRs and PAPRs) in sufficient quantity for a new national
pandemic planning scenario.

9.

Professional organizations should encourage the healthcare sector to use more
RRs during interpandemic times.
a.

Healthcare settings should pilot RRs and use them more widely.

b.

CDC should fund research to determine the optimal balance of reusable vs.
disposable respirator use in interpandemic times.

c.

The Society for Healthcare Epidemiology of America (SHEA) and the
Association of Professionals in Infection Control and Epidemiology (APIC)
should promote the use of RRs in healthcare settings.

d.

CDC should promote RR use and encourage the use of its existing
implementation guide for EHMRs in healthcare.12e.

The Joint Commission should promote the use of RRs.

f.

HICPAC should examine the critical role of RRs, consider their role inprotecting HCWs, and develop accompanying recommendations.

The Major Role of Reusable Respirators in Increasing Respiratory Protection for Future Infectious Disease Emergencies: A Stakeholder Discussion | 11

Foster cultural change, education, and training at the user level
10. Congress should provide funding to advance research on PPE, including RRs,
through NIOSH’s Personal Protective Technology Program and new centers of
excellence.
11. OSHA, trade associations, and private sector and nonprofit leaders should
encourage businesses and organizations that employ critical workers tostockpile RRs, accompanied by efforts to train, educate, and communicate how
to use them and their importance.
Generate consistent industry demand signal from the government and private sector
12. RR purchases for the SNS should be spread over the products’ shelf life tomaintain a consistent and multiyear demand signal.
13. This demand signal should include specific details, such as the number of
facepieces, filter cartridges, and sizes, and specify the appropriate and necessary
NIOSH and/or FDA approvals and other applicable standards.
Provide support to US-based RR manufacturers
14. The government should uphold the requirements of the Make PPE in America
Act and provide clarity regarding the requirements of the Buy America and Madein America provisions.
15. The government should evaluate the effectiveness of incentives for purchasing
US-made healthcare supplies and consider additional incentives.
Determine the contributions of federal, state, local, and healthcare stockpiles
16. HHS should develop an overall respiratory protection plan for infectious disease
emergencies that includes recommendations on RRs.
17. As part of that plan, ASPR should provide guidance to states and healthcare
systems regarding PPE expectations for and responsibilities of the federal
government and healthcare systems during infectious disease emergencies.

Conclusion
The Johns Hopkins Center for Health Security held this stakeholder meeting to informa national strategy regarding RRs for the next pandemic. Despite identified challenges,
participants overwhelmingly recognized the need to move toward routine RR use andexpand stockpiles. They discussed current needs and opportunities, identifying 8
key areas for action: 1) adding RRs to the SNS; 2) innovating RR design; 3) adopting
informed implementation practices; 4) increasing routine use of RRs; 5) fostering user
education, training, and cultural change; 6) generating specific and consistent industry
demand signal; 7) supporting US-based manufacturing; and 8) determining stockpile
contributions at different levels. Many concrete actions were suggested to move toward
these goals, summarized in a list of recommendations from the Center for Health
Security. Implementing these recommendations would meaningfully increase pandemic
preparedness in the United States.
The Major Role of Reusable Respirators in Increasing Respiratory Protection for Future Infectious Disease Emergencies: A Stakeholder Discussion | 12

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Hines SE, Brown C, Oliver M, et al. User acceptance of reusable respirators in healthcare. Am J Infect Control. 2019;47(6):648-655. doi:10.1016/j.ajic.2018.11.021

3Radonovich LJ, Roberge R, Balg A, Levinson A, Doerr DE, Shaffer RE, Davey V. Better
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The Major Role of Reusable Respirators in Increasing Respiratory Protection for Future Infectious Disease Emergencies: A Stakeholder Discussion | 13

Appendix A: Participant List
Amesh Adalja, MD
Senior Scholar
Johns Hopkins Center for Health Security
Steve Adams, MPH
Deputy Assistant Secretary and Director
Strategic National Stockpile,
Administration for Strategic Preparedness
and Response
US Department of Health and Human
Services
Chris Bakerlee, PhD
Senior Program Associate, Biosecurity &Pandemic Preparedness
Open Philanthropy
Bill Beaver, MA
Biodefense Policy Advisor
US Department of Defense
Rocco Casagrande, PhD
Executive Chair
Gryphon Scientific
Emily Champlin, JD
Senior Policy Advisor
American Nurses Association
Jim Chang, MS
Director of Safety and Environmental
HealthUniversity of Maryland Medical Center
Anita Cicero, JD
Deputy Director
Johns Hopkins Center for Health Security
Maryann D’Alessandro, PhD
Director
CDC National Institute for Occupational
Safety and Health (NIOSH) National
Personal Protective Technology Laboratory

Claudio Dente
President / CEO
American Medical Manufacturers
Association (AMMA)
Zane Frund, PhD
Executive Director, Research & Engineering
Department
MSA Safety
Atul Grover, MD, PhD
Executive Director, Research & Action
Institute
Association of American Medical Colleges(AAMC)Dan Hanfling, MD
Director, Private Sector StrategicPartnerships
White House Office of Pandemic
Preparedness and Response Policy
Stella Hines, MD
Branch Chief, Field Studies Branch,
Respiratory Health Division
NIOSH
Melissa Hopkins, JD
Health Security Policy Advisor
Johns Hopkins Center for Health Security
Tom Inglesby. MD
Director
Johns Hopkins Center for Health Security
Julia Limage, MSc, PhD
Director
Office of Strategy, Policy, andRequirements, Administration for
Strategic Preparedness and Response(ASPR)US Department of Health and Human
Services

The Major Role of Reusable Respirators in Increasing Respiratory Protection for Future Infectious Disease Emergencies: A Stakeholder Discussion | 14

Lisa Maragakis, MD, MPH
Professor of Medicine, Infectious Diseases
Johns Hopkins University School of
Medicine
Aman Patel
Executive Director
Technologies for Pandemic Defense
Cheryl Peterson, MSN
Director, Nursing Practice and Policy
American Nursing Association
Lew Radonovich, MD
Deputy Director
Respiratory Health Division, CDC/NIOSH
Lewis Rubinson, MD, PhD
VP, Technical Staff
In-Q-Tel
Mike Schiller
Executive Director, Supply Chain
American Hospital Association
Dan Shipp
Past PresidentInternational Safety Equipment
Association
Eileen SimmonsBusiness Development Director, Personal
Safety Division
3M

Mali Smith
Government Relations andCommunications Manager
Goldstein Policy Solutions (representing
American Medical Manufacturers
Association)
Elizabeth Stower
Global Regulatory Affairs and Public Policy
Advisor
3M
Joel Straus
Policy Research Associate
Johns Hopkins Center for Health Security
Jacob Swett, PhD
Executive Director
Blueprint Biosecurity
Eric Toner, MD
Senior Scholar
Johns Hopkins Center for Health Security
Sharon Vanairsdale Carrasco, DNP, APRN,ACNS-BC, NP-C, CEN, FAEN, FAAN, FNAP
Associate Clinical Professor
Emory University
Caitlin Walker
PhD Candidate
Johns Hopkins Center for Health Security

The Major Role of Reusable Respirators in Increasing Respiratory Protection for Future Infectious Disease Emergencies: A Stakeholder Discussion | 15

Johns Hopkins
Center for Health Security
700 E. Pratt Street, Suite 900
Baltimore, MD 21202
Tel: 443-573-3304
Fax: 443-573-3305
centerhealthsecurity@jhu.edu
centerforhealthsecurity.org