DRAFT NIOSH HEALTHCARE PERSONAL PROTECTIVE 

TECHNOLOGY (PPT) TARGETS

FOR 2020 TO 2030

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

DISCLAIMER

This information is distributed solely for the purpose of pre-dissemination public review and 

comment under applicable information quality guidelines. It has not been formally disseminated 

by CDC/NIOSH. It does not represent and should not be construed to represent any agency 

determination or policy.
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INTRODUCTION

The health and welfare of 18 million U.S. healthcare personnel (HCP) remains an important 

priority for the Centers for Disease Control and Prevention (CDC) and the CDC’s National 

Institute for Occupational Safety and Health (NIOSH). NIOSH accomplishes its mission to 

protect the U.S. workforce from injury and illness through scientific research, practice 

interventions, and collaborative partnerships. Industrial hygienists, infection control practitioners 

and other HCP, social scientists, engineers, and others work closely with professional societies 

and government agencies to develop and promote ways to reduce harmful workplace exposures 

to physical and chemical agents and infectious diseases. Reports issued by the Healthcare and 

Social Assistance Sector Council of the National Occupational Research Agenda (NORA) and 

the NIOSH Strategic Plan [1] demonstrate the success of these efforts.

While infection prevention and control efforts favor engineering and administrative measures

over personal protective technology (PPT), PPT nevertheless plays an important role in 

preventing transmission of infectious diseases. In this document, we distinguish between PPT 

and personal protective equipment (PPE). PPT includes PPE worn by individuals (e.g., 

respirators) and the technical methods (e.g., fit testing methods), processes, techniques, 

tools, and materials that support the development and use of PPE worn by individuals. 

This document intentionally and prominently incorporates this distinction throughout.

PPE frequently worn by HCP include gowns, gloves, goggles, face shields, head covers, 

respirators, shoe covers, and surgical masks. While some PPE, such as surgical masks and 

gloves, have been worn in healthcare settings for over 100 years, the emergence of new 

pathogens (e.g., human immunodeficiency virus) and increased medical knowledge (e.g., mode 

of transmission of Mycobacterium tuberculosis) have further evolved PPE use. In addition to 

infectious hazards, non-infectious hazards such as chemicals and exposure to drugs continue to 

pose a threat to HCP. 

In 2006, the NIOSH Personal Protective Technology Laboratory (NPPTL) began an initiative to 

develop and execute a comprehensive strategic approach to HCP protection. The resulting 

NIOSH Healthcare PPT Action Plan focused resources on and raised awareness about the PPT 

needs of HCP during a potential influenza pandemic. NIOSH undertook a research agenda to 

advance clinical practices, drive performance standards development, and inform regulation. 

NIOSH also implemented an information dissemination program to apprise healthcare 

organizations and HCP about the roles and importance of PPE in protecting themselves. After 

several updates since the Action Plan’s inception, the most recent plan (2013-18) focused on 

PPE used to reduce exposures to viral respiratory pathogens, including the influenza virus. 

Reflecting on the nation’s past decade of experiences with infectious diseases (e.g., influenza, 

Ebola, and coronavirus) and non-infectious hazards (e.g., antineoplastic and other hazardous 

drugs), NIOSH recognizes a need for additional types of PPT and an opportunity to address 

existing gaps by leveraging NIOSH’s unique capabilities related to PPT research, development, 

performance standards and test methods, and conformity assessment. To respond to this growing 

need, NIOSH developed the DRAFT NIOSH Healthcare PPT Targets for 2020 to 2030 (Draft 

PPT Targets), which inform NIOSH’s PPT efforts during this decade. The public health response 
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to the COVID-19 pandemic has delayed NIOSH’s efforts to obtain public input on the Draft PPT 

Targets; NIOSH will finalize the Draft PPT Targets after receipt of the requested public input.

NIOSH’s Draft PPT Targets define six broad objectives:

1. Conduct workplace exposure assessments and subsequent hazard evaluations to inform 

PPT policy, standards, and conformity assessment needs.

2. Develop, evaluate, and continually innovate PPE performance requirements and test 

methods through the integration of advanced PPT and design guidance.

3. Develop and disseminate strategies and tactics to extend PPT supplies during 

emergencies, disasters, or PPT shortages.

4. Develop and disseminate guidance and best practices to inform PPT implementation and 

enhance user adherence.

5. Provide national leadership to inform the design and execution of NIOSH’s Respirator 

Approval Program (RAP) and other PPT conformity assessment schemes.

6. Expand U.S. capacity for PPT research and innovation.

NIOSH engages in the following process to meet these objectives, further discussed in detail in 

this document:

• Analyzing knowledge gaps by summarizing input from stakeholders, selective literature 

review, and assessment of current relevant trends and legislation where applicable.

• Identifying priorities and detailing supporting targets that will help to close critical gaps 

in the protection of HCP, acknowledging that the achievement of the stated targets 

depends upon the resources available.

NIOSH’s overarching goal (to reduce worker illness and injury and to advance worker wellbeing) informs or directs the design, evaluation, standards development, conformity assessment 

(i.e., the demonstration that a product meets specified requirements), selection, care, 

maintenance, and use of PPT to ensure HCPs are protected from known and emerging hazards in 

all healthcare settings.

THE BURDEN OF HCP MORBIDITY AND MORTALITY

Currently, the healthcare industry in the United States employs almost 17 million people [2]. 

Bureau of Labor Statistics data show that employment growth in the healthcare industry will 

account for nearly one-third of the projected job growth for all industries from 2016 to 2026, 

adding 4.0 million jobs during this period. Several factors continue to increase healthcare 

demands, such as the aging “baby boomer” population, longer life expectancies, and growing 

rates of chronic conditions [3]. Healthcare settings include ambulatory healthcare services, 

hospitals, nursing and residential care facilities, dental offices, clinics, and private home care—

all of which provide services that involve complex care once only considered appropriate for 

hospital facilities. The Bureau of Labor Statistics projects that one of the fastest-growing 

occupational groups, home healthcare aides, will grow 33.7% by 2029 [4].
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In 2020, the Healthcare and Social Assistance Sector reported 5.5 injury and illness cases per 

100 full-time workers (about 806,200 total cases), a number higher than any other private 

industry sector, including industries traditionally considered dangerous such as manufacturing 

and construction [5]. Injuries and illnesses in healthcare accounted for 19.9% of the total for all 

industries. During 2019, in hospitals alone, non-fatal injury or illnesses resulting in days away 

from work reached 129.7 per 10,000 full-time equivalent (FTE) workers. In 2020, the rate 

increased to 371.7 per 10,000 FTE workers. [6]. Data on workers’ compensation claims 

estimated the average loss per claim settled for hospital workers’ injuries in 2011 was $15,860. 

During 2011, injuries and illnesses cost the healthcare industry $13.1 billion and more than 2 

million lost workdays [7]. Nursing and residential care facilities had the highest injury or illness 

incidence in 2020, with 791.7 cases per 10,000 FTE workers being injured on the job [6]. In 

addition, high financial and societal costs exist when replacing HCP who leave the profession 

because of workplace injury or illness. 

Priorities for the NIOSH Healthcare and Social Assistance Program include the prevention of 

illnesses caused by hazardous drugs and other agents through respiratory and dermal exposure 

and infectious agents. Dermal and respiratory exposure can be mitigated using PPE. Welldocumented adverse health effects associated with exposure to antineoplastic drugs (drugs that 

inhibit or prevent the growth and spread of tumors or malignant cells) include acute effects such 

as nausea, headache, skin and eye irritation, and hair loss, as well as long-term effects such as 

DNA damage, miscarriage, leukemia, and other cancers [8] [9] [10] [11] [12] [13]. The current 

NIOSH list of antineoplastic and other hazardous drugs in healthcare settings comprises nearly 

220 drugs and continues to grow [14]. NIOSH reports 8 million U.S. HCP being potentially 

exposed to hazardous drugs, including pharmacy and nursing personnel, physicians, operating 

room personnel, environmental services workers, workers in research laboratories, veterinary 

care workers, and shipping and receiving personnel [15]. A recent NIOSH study found that some 

nurses, including those expecting children, did not wear protective gloves and gowns while 

handling or administering such drugs [16]. Twelve percent of nonpregnant nurses and 9% of 

pregnant nurses indicated that they never wore gloves, and 42% of nonpregnant nurses and 38% 

of pregnant nurses reported never using a gown. PPE such as gloves, gowns, and goggles remain 

critical components, often considered the minimum required protective equipment, for handling 

and administering hazardous drugs [17]. 

NIOSH found that over 400 HCP reported acute illnesses or injuries related to disinfectant 

exposure from 2002 to 2007 in four states [18]. A 2021 systematic review using meta-analysis 

estimated that nurses, compared to those in other occupations, face an increased risk of newonset asthma and bronchial hyperresponsiveness-related symptoms [19]. In this same category of 

risk, environmental services workers represent the most common occupation (24%), followed by 

nursing and medical assistants (16%), technicians (15%), and nurses (11%). HCP account for 

about 16% of all occupational asthma cases, with up to 24% of these cases caused by exposure to 

cleaning agents [20]. HCP face one of the highest rates of occupational asthma at 8.8%, 

compared to 7.2% among all workers [20] [21].
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Other respiratory hazards for healthcare workers include surgical smoke and waste anesthetic 

gases. Several studies report toxic, mutagenic, and potentially infectious effects from smoke 

generated from lasers or electrosurgical devices during surgery [22] [23] [24]. The Occupational 

Safety and Health Administration (OSHA) estimates exposure of 500,000 workers to surgical 

smoke each year [25]. Studies show associations between anesthetic or analgesic gases and 

vapors that escape during dental and medical procedures and impaired cognition and manual 

dexterity as well as adverse reproductive outcomes [26] [27]. An estimated 250,000 U.S. HCP 

may be exposed to these waste anesthetic gases, putting them at risk of developing adverse 

health effects [28]. 

Infectious diseases pose an ongoing concern among HCP. Some such as tuberculosis have been 

around for many decades while others have emerged in recent years, including the 2009 H1N1 

pandemic influenza during which at least four nurses died, Ebola virus disease, Middle Eastern 

Respiratory Syndrome, and the SARS-CoV-2 virus that causes COVID-19. Recent infectious 

disease outbreaks disproportionally infected HCP as compared to the general public [29] [30]

[31] [32]. Even pathogens for which effective vaccines exist (e.g., rubeola virus) may cause 

epidemics among the general population when population-level immunity wanes [33]. 

Multidrug-resistant organisms present a growing challenge for HCP, with 88 cases of multidrugresistant tuberculosis and one case of extensively drug-resistant tuberculosis identified in the 

United States in 2015 [34]. 

In data across U.S. industries, healthcare occupations have one of the highest rates of 

musculoskeletal injuries attributable to overexertion. BLS data from 2014 show a rate of 33 per 

10,000 full-time workers for overexertion injuries averaged across all industries. By comparison, 

BLS data show an overexertion injury rate twice that average for hospital workers (68 per 

10,000), over three times that average for nursing home workers (107 per 10,000), and over five 

times that average for ambulance workers (174 per 10,000) [35]. Manual lifting, moving, and 

repositioning of patients, residents, or clients (i.e., manual patient handling) represents the single 

greatest risk factor for overexertion injuries in healthcare workers. Nursing aides, orderlies, and 

attendants had the highest rates of musculoskeletal disorders among all occupations in 2010. 

PPT are critical to preventing these risks among HCP. HCP rely on traditional PPE such as 

gloves, gowns, respirators, surgical masks, aprons, footwear covers, head covers, goggles, and 

face shields, as well as new innovative PPE such as exosuits, to reduce their exposure to hazards 

faced in healthcare settings. Improving the effectiveness of these PPE and advancing the 

development and use of PPT can achieve enhanced protection of HCP. 

Objective 1: Conduct workplace exposure assessments and subsequent hazard 

evaluations to inform PPT policy, standards, and conformity assessment needs

Knowledge Gaps 

Because of the variety of hazardous chemicals and biological pathogens present in various 

healthcare settings, characterizing HCP occupational exposures involves intensive use of 
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resources. Subsequent hazard evaluations also pose different sets of challenges as the exposure 

time and concentrations vary widely throughout job classifications and facilities.

The healthcare industry has recognized these challenges as endemic for decades, and they remain 

a concern to this day in many healthcare settings, including acute care, long-term care, and 

outpatient oral care facilities. Differences in these healthcare settings influence the design, 

execution, and findings of hazard evaluations. However, recent assessments of widespread 

infectious disease show higher infection rates for HCP compared to individuals from their 

surrounding communities [29] [30] [31] [32], with some infections leading to HCP death [36].

Assessing the biological hazards of the workplace exposure portfolio also poses challenges. Most 

sampling methods, by design, evaluate biological concentrations in a room or area rather than 

specific personal exposures, which makes joining specific exposure levels to adverse health 

outcomes challenging [37]. Together, the diversity of pathogens, inconsistencies in workers’ 

exposures, difficulties in evaluating those exposures, and the challenges of hazard evaluations 

create challenges for the development of effective PPT policies and standards.

These ongoing challenges demonstrate the need to identify and quantify the personal exposures 

throughout the industry, as well as investigate possible links between those exposures and 

negative health outcomes. Addressing this knowledge gap will provide the information necessary 

to mitigate these exposures more effectively through engineering and administrative controls 

while aiding in the development of effective PPT policy and standards for those remaining 

exposures.

Priorities and Targets

1. Expand the evidence base used to inform the level of protection necessary to protect HCP in 

various hazard exposure scenarios for infectious diseases.

Target 1: Conduct case studies to inform the mean airborne and surface concentrations and 

duration of exposure that may be expected for “small- ” (e.g., influenza virus) and “largesized” (e.g., tuberculosis droplet nuclei) infectious pathogens in acute, long-term, and dental 

care settings.

Target 2: Conduct a systematic literature review to identify potential adverse health effects 

resulting from exposure scenarios identified in Target 1 and address remaining knowledge 

gaps with in vitro and in vivo studies.

Target 3: Conduct a systematic literature review to recommend minimum protections 

necessary (e.g., assigned protection factor, filtration efficiency, and fit testing requirements) 

for various healthcare exposure scenarios.
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Objective 2: Develop, evaluate, and continually innovate PPE performance 

requirements and test methods through the integration of advanced PPT and 

design guidance

Knowledge Gaps

When using PPE to protect the health and safety of HCP, they must have confidence in product 

effectiveness. Conformity assessment leverages established test methods to verify that PPE 

conform to published performance requirements so that safety professionals who select them, 

and the workers who rely on them, can do so with assurance of consistent, necessary protective 

capabilities [38]. A conformity assessment (CA) program can instill this confidence in PPE 

users. CA programs range from first-party testing or inspection with a supplier’s declaration (the 

type of CA program suited for healthcare PPE) to testing by a third-party laboratory (with 

preference for accreditation). These requirements and standards provide context to establish the 

specific requirements used to evaluate a product’s performance. However, the current healthcare 

PPE CA programs do not contain all the performance tests necessary to ensure that PPE will 

adequately protect healthcare workers.

The outbreaks of the 2003 severe acute respiratory syndrome (SARS), the 2009 H1N1 influenza, 

and the 2014 Ebola virus created a heightened awareness for protecting today’s HCP. As a result, 

NIOSH sponsored studies by the National Academies of Sciences, Engineering, and Medicine 

(NASEM) on the use and effectiveness of powered air-purifying respirators (PAPRs) and the use 

of elastomeric half-mask respirators (EHMRs) in healthcare [39] [40]. The development of test 

methods must be completed before these respirators may be routinely used in healthcare settings.

These settings also have needs for improving the fit of, and fit testing for, respirators [41]. Fit 

testing represents a major barrier to the effective implementation of respirators. Employers 

identify the cost and logistics associated with fit testing as a primary challenge. Besides fit 

testing and costs, recruiting human subjects for testing when the possibility exists for infectious 

disease transmission such as during a pandemic stands as another significant challenge. The 

ability of NIOSH to rely upon humanlike robotic technologies for testing associated with its 

approval and research efforts would notably increase the rate of output and reduce the potential 

risk to human subjects by eliminating the reliance on human subjects. Finally, healthcare settings 

have a need for innovation in fit testing to include rapid fit testing methods for use in mediumand large-sized facilities (e.g., acute care facilities) and table-top methods that can be deployed 

to small community healthcare settings (e.g., pharmacies and nursing homes).

Workplaces also increasingly employ direct-reading sensors as health and safety tools that may 

detect and monitor face seal leakage continuously in real time, reducing the burden of fit testing. 

Sensors may also be useful in improving the overall effectiveness of other types of healthcare 

PPE. Development of new test methods and protocols would support feasibility assessments 

related to the use of these technologies.

Source control (i.e., to filter respiratory secretions to prevent disease transmission to others) 

remains an infection control strategy with the additional potential benefit of ultimately reducing 
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the overall exposures to HCP. However, until 2020, no standard existed to which these products 

could be tested and evaluated to demonstrate performance, and some entities claimed that 

products with the primary purpose of providing source control may also provide some level of 

personal respiratory protection. As a result, ASTM International (formerly American Society for 

Testing and Materials) developed and published a voluntary consensus standard for face 

coverings in an unprecedented timeline of only a few months. As a member of the technical 

committee overseeing this standard, NIOSH became one of many stakeholders with an interest in 

ensuring that new, sound scientific evidence be incorporated into revisions of this standard. 

Developing guidance for appropriate use of resulting products remains a critical goal. 

Some situations require HCP to wear multiple types of PPE simultaneously. For example, 

treatment of Ebola patients required HCP to wear up to seven different types of PPE from head 

to toe (e.g., boot coverings, coveralls, respirator, gloves, and eye protection). Additional research 

is needed in test methods, selection guidance, and the interoperability of individual components 

of ensembles for healthcare. Contemporary issues include those related to heat stress [42], 

component interfaces (e.g., glove-gown or respirator and eye protection) [43], and the need to 

integrate more efficient measurement technologies [44]. 

Finally, as noted earlier, manual lifting and handling patients continues to be a major source of 

injuries for HCP. Exosuits represent a rapidly advancing form of PPT that may reduce 

musculoskeletal disorder or injury risk to HCP [45]. Advancing exosuit technologies and 

understanding the safety and efficacy of these devices can prevent injuries in numerous 

healthcare settings, such as acute care, rehabilitation, and long-term care facilities, where other 

controls may not be feasible. 

Priorities and Targets 

1. Conduct research on NIOSH-approved respirators not traditionally used in healthcare to 

inform policy solutions that may be adopted by NIOSH’s RAP. 

Target 1: Assess the adequacy of existing test methods to validate their utility in healthcare 

or identify and develop additional performance requirements and test methods for PAPR, 

EHMR, and the mostly commonly utilized filtering facepiece respirators (FFR) for use in 

healthcare settings.

2. Demonstrate the utility of novel or innovative respirator design components and features that 

may be leveraged by manufacturers to enhance PPE protections or user adherence and 

comfort.

Target 1: Develop a Sensor Integration Roadmap and initiate identified activities.

Target 2: Demonstrate the feasibility of using sensor technologies to provide real-time, fieldbased respirator fit and/or filter penetration data.

Target 3: Explore novel or innovative head suspension and facepiece designs or features that 

may provide improved fit characteristics, communication, comfort, or other desirable 

performance enhancements.

3. Advance the use of innovative technologies to optimize respirator fit assessments.
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Target 1: Evaluate an advanced humanlike articulated headform as a means for replacing the 

human subject when realistic respirator seal characteristics are a necessary component of a 

laboratory assessment.

Target 2: Facilitate the development and evaluation of a digital, smart-device-deployed 

application that scans user faces to identify an individual’s facial sizing—as described by the 

NIOSH Bivariate Panel and NIOSH Principal Component Analysis Panel—to predict the fit 

of respirators for users.

Target 3: Evaluate the utility of sensors for FFRs to be used within field-based test methods 

to provide real-time data that inform user seal checks, respirator fit during use, outward 

leakage during use, and how fit testing requirements may evolve as this technology 

penetrates the market.

4. Provide evidence-based guidance for PPE intended to provide source control and some level 

of respiratory protection for infectious diseases spread through respiratory secretions. 

Target 1: Develop and evaluate a test method to assess sneeze and cough hazards.

Target 2: Evaluate face coverings, masks intended for medical purposes, and respirators to 

determine the level of source control to be expected and to inform test method development. 

Target 3: Provide research, technical support, and guidance to establish and continually 

improve the ASTM F3502-21 Barrier Face Covering voluntary consensus standard that 

assesses outward filtration efficiency, user comfort, and fit for face coverings. 

Target 4: Conduct proof-of-concept studies towards the goal of designing next-generation 

face coverings that effectively reduce person-to-person transmission. 

5. Provide evidence-based guidance to improve performance requirements, test methods, and 

design guidance for the use of two or more PPT components at once (includes respirators, 

eye and face protection, gowns, gloves, head covers, aprons, and footwear covers). 

Target 1: Develop requirements and test methods to assess the performance at the interface of 

ensemble components and to inform design guidance for PPT interface regions. 

Target 2: Improve the efficiency of existing laboratory-based test methods for the penetration 

of blood, bodily fluids, and bloodborne pathogens. 

Target 3: Develop test methods that are then used to evaluate the efficacy of using respirators 

in combination with eye and face protection.

Target 4: Provide research, technical support, and guidance to establish a voluntary 

consensus standard that assesses comfort and wearability and integrate the developed 

standard within NIOSH guidance. 

6. Inform the test methods used to assess individual components of the HCP ensemble. 

Target 1: Provide a leadership role including research, technical support, and guidance to 

advance the ANSI/ISEA Z87.1 (draft, refer to page 3) eye and face protection standard for 

biological hazards. 
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Target 2: Ensure that test methods are adequate to assess PPE components against 

novel/emerging infectious and non-infectious hazards. 

Target 3: Provide a leadership role including research, technical support, and guidance to 

advance ASTM’s Respirator Fit Capability voluntary consensus standard for FFRs to also 

include all other air-purifying respirators (i.e., elastomeric with cartridges and canisters). 

7. Support the exploration, development, and integration of innovative technologies to advance 

HCP ensembles and identify the need for new performance requirements or test methods. 

Target 1: Demonstrate the efficacy of various eyewear coatings to reduce fogging when eye 

and face protection is worn in combination with respirators, surgical masks, or face 

coverings. 

Target 2: Advance the development of mechanized clothing to be used in a healthcare setting 

by nurses to reduce lower-back loading during patient body manipulations or location 

transfers.

Objective 3: Develop and disseminate strategies and tactics to extend PPT supplies 

during emergencies, disasters, or PPT shortages

Knowledge Gaps 

HCP use N95 FFRs more than any other respirator type. Modeling previously suggested that the 

demand for respirators used by HCP during an influenza pandemic would far exceed domestic 

supplies [46]. Some U.S. locales—despite stockpiling programs at local, regional, and national 

levels—experienced shortages of respirators during the H1N1 influenza pandemic in 2009-2010 

and the outbreak of SARS in 2003-2004. PPE orders increased up to 200-fold in October 2014 

after the first U.S. Ebola fatality and issuance of updated CDC PPE guidance [47].

In 2020, during the COVID-19 pandemic, the U.S. respirator supply chain demonstrated an 

inelasticity in relation to a limited surge production capacity for respirators and other PPE types, 

such as gowns [48]. Further, international manufacturers often serve as primary suppliers of PPE 

for the U.S. market. Obtaining needed PPE in 2020, especially respirators, proved to be difficult 

due to limited exports of raw materials and NIOSH-approved respirators produced outside of the 

United States.

In response to the shortages, NIOSH assisted CDC’s pandemic response in developing measures 

to optimize PPE supplies along the continuum of care using crisis and contingency strategies 

[49]. These measures included (1) reuse, extended use, and decontamination of FFRs; (2) using 

respirators (including N95 FFRs and other types) beyond the manufacturer-designated shelf life 

for healthcare delivery; and (3) using respirators claiming to meet international standards with 

requirements similar to NIOSH’s filtration efficiency and inhalation and exhalation breathing 

resistance requirements.

In occupational settings where respiratory hazards can be identified in advance of exposure, 

OSHA requires that employers establish a respiratory protection program (RPP). As a robust 
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program, the RPP requires significant time and attention from the employer. It includes proper 

respirator selection, donning and doffing of respirators, fitting respirators, and identifying 

potential risks to those with pre-existing cardiopulmonary disease. However, HCP who are not 

typically exposed to respiratory hazards—and therefore not covered under an RPP—may be 

unexpectedly exposed to a respiratory hazard (e.g., at-home care support during a wildfire, or 

hospital services staff during an infectious disease outbreak/pandemic). Unfortunately, these 

workers urgently require respiratory protection, and the employer must sometimes establish an 

RPP with these workers being continually exposed to a respiratory hazard. A similar situation 

exists for the general public, which does not have the support that an RPP provides or an 

established government framework to oversee the comprehensive respiratory protection needs. 

Thus, a need exists for NIOSH to coordinate with other federal entities to develop and implement 

strategies to address urgent respiratory protection gaps for HCP not covered by an RPP and for 

members of the general public, which would reduce transmission rates of infectious diseases and 

thereby reduce the risk level to HCP.

Priorities and Targets

1. Expand national capacity to provide PPT during demand surges.

Target 1: Establish the standards and a testing and evaluation framework that empower 

stockpile managers to verify manufacturer performance claims of PPE initially and 

continually within their facilities.

Target 2: Facilitate coordinated PPT inventory data sharing between software platforms by 

developing a voluntary consensus standard for PPT nomenclature and data format.

Target 3: Using Target 2 above, develop an interoperable platform to allow stockpiles that 

implement Target 1 above to share test results with the product manufacturer and further 

enable product purchasing and rotation coordination between stockpile and health systems.

Target 4: Develop and enhance best practice guidelines on elastomeric half-mask respirators 

for HCP, including strategies for fit testing, staff training, decontamination, and other 

logistics.

Target 5: Sponsor studies to evaluate use and distribution of elastomeric half-mask 

respirators and powered air-purifying respirators and their accessories to address future 

respirator shortages.

Target 6: Support initiatives to establish a national strategy to rapidly produce and supply 

PPE conforming to appropriate standards, with readily accessible technical support.

2. Improve the protections provided to HCP when contingency and crisis PPT strategies are 

implemented.

Target 1: Conduct post-market evaluations of respirators approved to international standards 

but that are not NIOSH-approved.

Target 2: Develop and evaluate laboratory-based test methods for single- and multi-use PPE 

decontamination techniques and treatments (e.g., cycles and doses).
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Target 3: Develop practical field-based test methods for filter penetration that empower 

employers to increase confidence in FFRs deployed to the workforce that are of unverified 

quality (e.g., shipments with unknown origin and after decontamination). 

Target 4: Evaluate the effectiveness of past extended use and reuse practices with 

consideration of PPE performance and the impact these practices have on user performance, 

acceptance, and adherence.

Target 5: Test novel materials and construction of PPE to optimize performance and HCP 

use, acceptance, and adherence.

Target 6: Develop evidence-based implementation guidance for extended use and reuse of 

PPE during PPE shortages. 

3. Coordinate with other federal partners to advance respiratory protection for HCP and 

members of the general public who are not part of a respiratory protection program when 

sudden respiratory hazards are present.

Target 1: Jointly sponsor a NASEM consensus study with other federal partners to provide 

recommendations for how the United States can best identify the need for, and support the 

use of, respiratory protective devices by the public and HCP who are not part of a respiratory 

protection program.

Target 2: Provide national leadership to integrate NASEM’s recommendations into the U.S. 

strategy for respiratory protection of these populations. 

Target 3: Determine the assigned protection factor that may be expected when fit testing is 

not feasible or is delayed with and without the use of a standardized sizing guide that 

matches adult individuals to a respirator size designation. 

Target 4: Determine what level of protection may be expected for various FFR filtration 

efficiencies (e.g., N95) when fit testing is not feasible or is delayed and only a user seal 

check is performed. 

Objective 4: Develop and disseminate guidance and best practices to inform PPT 

implementation and enhance user adherence

Knowledge Gaps 

Numerous studies show that HCP have limited understanding of the purpose, selection, 

maintenance, and proper use of PPE [50] [51] [52] [53] [54] [55]. Like other safety measures 

dependent on behavior, such as washing hands or wearing seat belts, PPE is most effective when 

properly used. For example, respirators or surgical gowns should be worn in the presence of 

hazards and donned and doffed correctly to prevent exposure and provide protection. 

Individual behaviors and organizational practices contribute to the safety culture in healthcare 

settings; on occasion, these cultural practices may run counter to the best interest of HCP selfprotection [50]. HCP non-adherence to guidelines, recommendations, policies, and regulations 

may be affected by time constraints, incomplete knowledge of guidelines and recommendations, 
13

concerns about interference with patient care or occupational duties, perceived discomfort, 

perceived risk of exposure or consequences of exposure, and lack of emphasis on self-protection 

[50]. As with other complex organizational problems, no single solution or remedy suffices; 

however, organizations that seek and adopt ways to achieve incremental improvements in 

workplace safety can offer enhanced protection for HCP.

Numerous opportunities exist for the development and validation of methods, tools, and 

interventions to increase HCP knowledge about PPE use. These opportunities can better position 

health systems to protect their workers in prudent and cost-saving ways during healthcare 

delivery. Healthcare organizations and HCP with a more comprehensive understanding of 

current health and safety management practices are well-positioned to support a systems-based 

approach as it enables them to identify the most prevalent individual and organizational factors 

that contribute to low adoption and execution of desired safety practices around PPE use. 

NIOSH seeks to reduce the occupational risks HCP face by conducting and supporting a systems 

approach for PPT. Such an approach considers the inter-relationships between PPE design, use, 

user guidance, user adherence and the technical methods, processes, techniques, tools, and 

materials that support the development and use of PPE. Leveraging this knowledge to develop 

targeted risk management interventions can improve the effective use of PPE in healthcare 

settings.

Providing HCP and their employers with PPT guidance and information that is up to date and 

readily and easily accessible fosters the most effective targeted health and safety practices. One 

consideration when developing guidance is content that addresses the needs of all workers and 

work circumstances. This may include traditional (e.g., N95 FFR) and non-traditional (e.g., 

EHMR) healthcare PPE, a variety of healthcare settings (e.g., long-term care facilities), and 

various types of employment arrangements (e.g., traveling nurses or contracted physicians) [56]. 

Additionally, as the U.S. healthcare industry continues to embrace non-standard work 

arrangements (e.g., contract workers), meeting the challenge of training and fitting new 

employees due to turnover can ensure HCP safely and effectively use PPE. This is particularly 

evident for PPE such as respirators, where safe and effective use depends upon factors specific to 

a single individual, such as fit and health status. Finally, as new types of PPE products (e.g., 

PAPRs, EHMRs, FFRs, and barrier face coverings) enter healthcare settings, identifying best 

practices for PPE implementation, use, and effectiveness can further protect HCP.

Priorities and Targets 

1. Provide mechanisms that improve accessibility to critical PPT guidance. 

Target 1: Conduct formative evaluations (pilots or exploratory research) to identify and 

assess information sources that organizations and HCP use to obtain PPE best practices 

guidance and establish relationships with the entities that manage the content for these 

sources.

Target 2: Continue to leverage NIOSH PPT communication channels (e.g., Respiratory 

Protection Week, PPE CASE Notes, MMWR, and social media) to disseminate best practices 

and conduct a systematic evaluation of these channels to assess and improve their impact.
14

Target 3: Facilitate discussions with continuing education, recertification, and licensure 

bodies to integrate PPE best practices into required, formal education curriculum or modules. 

Target 4: Expand NIOSH’s web-based tool, PPE-Info, to provide selection logic support and 

direct links to manufacturer products that claim to meet relevant standards to include face 

coverings. 

2. Develop and improve implementation guidance for PPT best practices.

Target 1: Conduct workforce or workplace studies to evaluate current on-the-job training 

techniques and processes and develop interventions to enhance the effectiveness of this 

training for various levels of nursing support, to include non-traditional employment 

arrangements (e.g., traveling nurses or contracted physicians). 

Target 2: Conduct a review of PPT best practices for routine and crisis operations to identify 

strategies and opportunities where the two may align, thereby reducing the need to 

implement a change in practice during future crises. 

Target 3: Document the knowledge, attitudes, and behavioral practices of HCP around PPE 

perceptions, adoption, and sustained use to inform interventions and practices in long-term 

care, at-home care, and dentistry settings. 

Target 4: Update NIOSH’s Respiratory Protection Toolkit to include contemporary content 

related to reusable respirators, crisis strategies and non-traditional employment arrangements 

(e.g., traveling nurses or contracted physicians).

3. Provide evidence-based guidance regarding the use of respiratory protective and source 

control devices not traditionally used in the U.S. healthcare settings. 

Target 1: Adapt the implementation guidance developed to enable the use of elastomeric 

half-mask respirators in healthcare during PPE shortages to support routine use of these 

respirators.

Target 2: Develop implementation guidance for routine use of powered air-purifying 

respirators in healthcare settings.

Target 3: Conduct face covering effectiveness studies at hospital facilities where source 

control is needed to inform use guidance and the ASTM consensus standard for face 

coverings. 

Objective 5: Provide national leadership to inform the design and execution of 

NIOSH’s RAP and other PPT conformity assessment schemes

Knowledge Gaps 

Conformity assessment leverages established test methods to verify that PPE conform to 

published performance requirements so that safety professionals who select them, and the 

workers who rely on them, can do so knowing that needed protective capabilities are consistently 

present [38]. As stated by NASEM: “for the consumer or worker, conformity assessment 
15

provides confidence in the claims made about the product by the manufacturer and may assist the 

consumer with purchasing decisions in determining the fitness of a product for its intended use” 

[57]. A comprehensive and tailor-made conformity assessment program is the most effective 

way to manage risks associated with potentially non-conforming PPE and instill user confidence 

in the PPE. 

No single regulatory body, official guidance, or mandating authority is charged with assessing 

conformity of all types of PPT. Historically, NIOSH has served as a national leader in PPE 

conformity assessment by overseeing the agency’s RAP (codified at 42 Code of Federal 

Regulations (CFR) Part 84) and supporting or conducting research to inform worker safety 

regulations, PPE performance standards, and infection prevention guidance. In 2017, NIOSH 

published its National Framework for Personal Protective Equipment Conformity Assessment - 

Infrastructure [38], which guides conformity assessment program owners to optimize conformity 

assessment practices using a risk-based approach. 

In 2017, NIOSH’s RAP convened an Action Planning Team to assess the RAP and identify 

specific action items that would optimize its performance. NIOSH presented these action items 

to the International Safety Equipment Association—the largest industry association for respirator 

manufacturers—and further revised them before finalizing its RAP Action Plan in 2018 and 

presenting it at a meeting with respirator manufacturers. 

In 2020 and 2021, NIOSH’s RAP experienced an unprecedented number of applications that 

outpaced human capital resources. NIOSH received a high number of applications from those 

inexperienced with the process who required much more support than applicants already familiar 

with the process. The additional support needed by the new applicants, in combination with the 

unprecedented number of applications received, posed a substantial (and unsustainable) resource 

challenge to NIOSH. Additionally, global travel limitations impacted the Program’s ability to 

perform manufacturing site audits or initial manufacturing site qualifications. 

To address these challenges, NIOSH implemented a variety of policy and human capital 

solutions to (1) accelerate application turnaround times for high-priority respirator types, (2) 

evaluate manufacturing sites virtually, and (3) provide information to fill knowledge gaps for 

new applicants. Importantly, as NIOSH plans for transitioning back to conventional operations, it 

plans to assess the root causes (policy and standards gaps or resource limitations) for the 

challenges experienced. Further, NIOSH also plans to review the near-term solutions 

implemented to address these challenges to determine the potential value if they were continued 

in the current (or an adapted) form. 

Conformity assessment challenges also exist for non-respiratory PPE. For example, the language 

in current standards continues to preclude third parties such as stockpiles from performing postmarket quality assurance evaluations on critical PPE items such as surgical and isolation gowns 

[58]. This poses a particular concern as US. Strategic National Stockpile, state, and private 

stockpiles depleted their inventory in early 2020 and subsequently needed to purchase millions 

of gowns with no ability to verify the initial or ongoing quality of these products. Additionally, 

challenges related to product labeling and packaging for surgical and isolation gowns and face 
16

coverings continue to be noted by stakeholders—e.g., group purchasing organizations and 

stockpiles. Challenges include labeling insufficiently durable to environmental conditions during 

shipment nor accessible to those managing and distributing large shipments and pallets. Further, 

individual product labels are sometimes misleading—e.g., claiming conformity for the material 

when the fully assembled and constructed product did not conform.

Finally, questions remain about the quality and performance of gloves and other PPE types (e.g., 

gowns) used when handling hazardous drugs (e.g., antineoplastic or chemotherapy drugs) or 

drugs with the potential for dermal absorption such as fentanyl and its analogs. Several studies 

indicate that antineoplastic drugs may permeate gloves, including nitrile gloves [59] [60] [61]. 

Further, researchers know little about the protective ability of gloves against continually 

changing formulations of drugs as well as their precursors and analogs. NIOSH’s review of 

available products found five glove models where the manufacturer claimed protection against 

one drug (i.e., fentanyl), but test methods to assess product performance and validate these 

claims are lacking [62]. Characterizing the performance of gowns and other PPE used to prevent 

exposure to hazardous drugs with the potential for dermal absorption can be used to inform the 

conformity assessment.

Priorities and Targets

1. Optimize NIOSH RAP operations by integrating modern and innovative technologies and 

artificial intelligence approaches.

Target 1: Develop and implement an “information enterprise system” with input from 

stakeholders to enhance records management, efficient internal operations, manufacturer 

tracking of approvals and applications, user access to respirator approval information, and 

communication between NIOSH and applicants through the incorporation of artificial 

intelligence.

Target 2: Integrate the use of remote, digital technologies to enhance reviews and 

assessments of proposed or active manufacturing sites.

2. Implement policy solutions within NIOSH’s RAP that advance the state of respiratory 

protection in the United States.

Target 1: Continue coordination efforts with the Food and Drug Administration to expand the 

respiratory protection available to HCPs and to streamline approvals/decisions for respirators 

used in healthcare.

Target 2: Continue to update requirements and test methods (federal and consensus) for 

powered air-purifying respirators to establish evidence-based standards that enable the safe 

and effective use of these respiratory protective devices in healthcare settings (e.g., where 

there is a need for a sterile field and communication).

Target 3: Integrate ASTM’s Respirator Fit Capability Standard into the regulatory framework 

of NIOSH’s RAP.
17

Target 4: Assess the outcome of Objective 1 from these NIOSH Healthcare PPT Targets to 

determine the need for additions or revisions to U.S.-based conformity assessment 

frameworks.

3. Identify the need for additional standards solutions to enhance respirator protections in the 

United States.

Target 1: Conduct surveillance to assess exposure hazards and PPE usage characteristics for 

HCP working in facility types where limited PPE usage research has been conducted (e.g., 

outpatient settings) and healthcare occupational groups where limited PPE usage research has 

been conducted (e.g., home healthcare support in remote work locations). 

Target 2: Evaluate the impact of current regulations on respirator innovation. 

Target 3: Develop a Roadmap to address any issues identified from Targets 1 and 2 above. 

4. Implement changes to practices, procedures, and informational products used by the NIOSH 

RAP to optimize performance.

Target 1: Enhance existing post-market respirator testing and evaluation to include 

evaluating respiratory protective devices at the point-of-use (e.g., evaluate the effect of 

storage conditions), leveraging the PPT nomenclature and data format standard and resulting 

software platforms mentioned previously (refer to Objective 3, Priority 1, Targets 2 and 3). 

Target 2: Leverage the PPT nomenclature and data format consensus standard to provide 

greater connectivity between the NIOSH RAP’s Certified Equipment List and third-party 

vendor platforms for PPE inventory management. 

Target 3: Develop NIOSH-accredited third-party facility knowledge, skills, and abilities for 

NIOSH respirator testing and quality assurance capabilities to enhance NIOSH agility during 

surge events and improve efficiencies and support technology innovators during routine 

demands, to provide trusted testing support, and develop a strategy for leveraging and 

maintaining trust with these laboratories (per federal guidance).

Target 4: Establish a sustainable approach to routinely review and update the NIOSH 

Standard Testing Procedures with consideration for the latest technological advancements. 

Target 5: Develop and formalize crisis strategy practices, procedures, and informational 

products that the Program will implement when an emergency is declared. 

5. Inform the design of conformity assessment programs where NIOSH is not the scheme 

owner or where no current scheme owner exists. 

Target 1: Provide leadership through research, technical support, and guidance to optimize 

the conformity assessment schemes for HCP ensembles and components (e.g., surgical and 

isolation gowns). 

Target 2: Provide leadership through research, technical support, and guidance to establish a 

conformity assessment scheme for face coverings that provide source control to reduce the 

spread of infectious disease. 
18

Target 3: Assess the effectiveness of existing product and package labeling requirements for 

PPE used by HCP to document the ability of PPE selectors, purchasers, distributors, and 

users to accurately discern the appropriate use conditions for a given product. 

Objective 6: Expand U.S. capacity for PPT research and innovation

Knowledge Gaps 

In 2008, the NASEM recommended that NIOSH “establish and sustain extramural PPT Centers 

of Excellence (COEs). These PPT COEs could be developed to “work closely with the NIOSH 

intramural research program to improve PPT, increase field research, and explore and implement 

research to practice interventions.” Realization of this recommendation would establish a strong 

extramural community and provide the opportunity to extend scientific inquiry into the 

behavioral sciences and other types of expertise not yet well developed within NIOSH’s Personal 

Protective Technology Program, including its NPPTL. 

Several recent efforts also recognize the need for greater PPT research and innovation capacity 

where recommendations align with NIOSH’s unique capabilities, as detailed below. 

• In December 2020, the Federal Emergency Management Agency announced a Plan of 

Action to establish a national strategy for the manufacture, allocation, and distribution of 

medical devices to respond to COVID-19 as part of a Voluntary Agreement for the 

Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to 

a Pandemic. 

• In January 2021, President Biden signed Executive Order 14001, resulting in the July 

2021 National Strategy for a Resilient Public Health Supply Chain, where Resiliency 

Recommendation 4 is to “launch a new public health supplies innovation center and 

product standardization task force.” 

• Also in January 2021, the National Strategy for the COVID-19 Response and Pandemic 

Preparedness was published, with Goal 4 being, “immediately expand emergency relief 

and exercise of the Defense Production Act,” with subsequent text discussing both[?] 

PPE as a critical supply and specific needs to address shortages. 

• In September 2021, the White House released American Pandemic Preparedness: 

Transforming our Capabilities, where the first goal under Building Core Capabilities was 

to have effective, comfortable, and affordable PPE and where a sub-goal focused on PPE 

innovation. 

• Additionally, the White House Implementation Plan for Countering Biological Threats 

and Pandemic Preparedness (forthcoming publication) identifies the need to promote a 

science and technology base to support biodefense. PPE serve a crucial role in meeting 

this objective.

Meeting the objectives outlined in these various strategy documents requires not only greater 

national capacity for PPT research and innovation, but also equitable PPE protections for HCP 

who rely on PPE for protection. Addressing gaps in PPE use, availability, accessibility, 

acceptability, and knowledge that exist for only a subset of PPE users with shared characteristics 

may reduce inequities related to PPE. These worker populations may include, but are not limited 

to, workers who are of an atypical size; who are members of a gender, racial, ethnic, or linguistic 
19

minority group; who conduct non-traditional healthcare worker activities; or who are members of 

sub-disciplines that are not the primary focus of the current PPT activities within their larger 

field. For example, a recent study found that housekeeping staff employed in healthcare settings 

had the highest rate of SARS-CoV-2 seroprevalence (34.5%)—a rate higher than that observed 

for HCP working in intensive care settings (14.8%) [63]. Examples of challenges faced by some 

members of these populations include difficulty finding a single-use FFR that fits their facial 

dimensions, PPE limitations when religious practices require growing facial hair or wearing a 

head wrap, language difficulties and cultural differences when reading guidance documents, and 

limited scientific studies or training modules that address hazard scenarios experienced by a 

small sub-population of workers.

Priorities and Targets

1. Expand private sector engagement in PPT research and technology development.

Target 1: Establish PPT COEs within the academic community to support a pipeline of PPT 

researchers by establishing laboratory capabilities, administering academic training, and 

fostering outreach and continuing education specific to PPT.

Target 2: Establish a new NPPTL Program that leverages both Broad Agency Announcement 

and Request for Proposal contract types to engage technology developers, engineering firms, 

suppliers, and manufacturers to advance the development and production of next-generation 

PPT for HCP.

Target 3: Once established, leverage the NPPTL RAP and PPT COEs to drive innovative 

PPT design to include novel materials, construction, use of sensors, and usability issues.

Target 4: Guide PPT COEs to develop the national capacity for: (1) research and 

development of new technologies and approaches to PPT, including sensor technology to 

increase efficacy; (2) human factors or ergonomics approaches to evaluating the factors that 

influence the adoption and usage of PPE such as performance, comfort, fit, and usability; (3) 

sociotechnical systems analyses of the influences of factors such as health and safety 

management systems, safety culture, and regulatory requirements; and (4) innovative 

approaches to the design, manufacture, and maintenance of PPE that enhance factors such as 

the effectiveness and acceptance of PPE in varied user populations, availability, and the 

ability to rapidly customize and produce PPT during crises.

Target 5: Leverage the research conducted by the newly established PPT COEs to establish 

evidence-based PPT guidance.

2. Towards the goal of providing equitable PPE protections for all U.S. workers, address 

existing gaps in PPE use, availability, accessibility, acceptability, and knowledge.

Target 1: Establish relationships with the research community that address PPE equity 

challenges and challenges for workers whose jobs place them at higher levels of risk.

Target 2: Conduct literature reviews and engage with members of the PPE community to 

identify PPE availability, accessibility, knowledge, and use challenges that allow PPE equity 

challenges to persist or allow challenges for high-risk workers to persist.
20

Target 3: Integrate test procedures and tasks into existing and newly developed projects to 

address the unique needs of both PPE users experiencing inequitable PPE protections, and 

workers whose jobs place them at high risk, where appropriate.

Target 4: Leverage ASTM’s Respirator Fit Capability Standard to identify populations of 

workers who may not have adequate options for respiratory protection and recommend 

possible strategies to close this gap.

Target 5: Publish a national strategy to provide equitable PPE protections for all U.S. 

workers by (a) identifying and prioritizing goals into near- , mid- , and long-term efforts and 

(b) providing a roadmap and timelines for how members of the PPE community can work in 

coordination to systematically address all gaps and challenges.
21

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