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Summary of Comments and NIOSH Responses to Docket 272

On March 14, 2014, NIOSH published a request for information (RFI) [Docket Number CDC–

2014–0005, NIOSH–272] and comment in the Federal Register [79 FR 14514] titled 

“Respiratory Protective Devices Used in Healthcare.” In the RFI, NIOSH requested comments 

on four topics. Outlined below are the four questions, a summary of the comments received, and

NIOSH responses to the comments.

1. Do healthcare stakeholders anticipate expanding the use of respiratory protective 

devices to include elastomeric air-purifying respirators and/or powered air-purifying 

respirators?

Summary of Comments:

Numerous commenters [10, 12, 13, 15, 16, 19] confirmed that elastomeric air-purifying 

respirators (EAPRs) and powered air- purifying respirators (PAPRs) are being used in healthcare 

settings during patient care. Several commenters observed that this trend will likely continue [6, 

13, 16, 19], especially as PAPRs become lighter in weight and less expensive [18]. Despite 

concerns about initial costs and communication issues, two commenters viewed PAPRs as an 

attractive option for some healthcare settings [7, 10] as the primary respiratory protective device 

(RPD) or backup for users that cannot pass a fit test in an N95 filtering facepiece respirator 

(FFR). One commenter [19] noted that EAPRs are not used routinely in their experience, but 

instead stockpiled to be used in the event of a widespread shortage of FFRs (e.g., during a severe 

influenza pandemic). No comments were received indicating that the trend toward increased use 

of EAPRs and/or PAPRs in healthcare would not continue.

NIOSH Response:

NIOSH agrees with the commenters. Our survey data indicates that elastomeric air-purifying 

respirators and powered air-purifying respirators are currently used in healthcare settings. 

Discussions with stakeholders indicate that this trend will likely increase. NIOSH recognizes 

that the current certification standards for PAPRs have not been updated in over 20 years and 

that new technologies are available that could result in quieter, lighter devices better suited to 

meet healthcare worker needs. NIOSH is contributing to an Institute of Medicine meeting in 

August 2014 to discuss options for revisions to the existing PAPR standard. 

To better understand the cost issues and ease of implementing EAPRs in healthcare, NIOSH 

plans to fund one or more grantees to conduct a public health practice feasibility study. The 

grant announcement (NIOSH: RFA-OH-14-009: “Assessment of Elastomeric Respirators in 

Healthcare Environments (R21)) was published in May 2014 and is expected to be awarded in 

August. This activity will help determine the cost effectiveness of using the devices, as well as 

improving worker knowledge, experience, and comfort with them. The grantee will evaluate the 

operational aspects of using two different types of RPDs in a wide range of healthcare settings 

(emergency departments, intensive care units, long-term care, etc.) for situations in which 

respiratory protection is recommended (e.g., close contact with patients with an aerosol 
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transmitted disease such as TB or measles, in the room during an aerosol generating procedure 

on a patient with seasonal influenza, etc.). 

In addition, NIOSH has initiated a contract to assess the present use of reusable respirators in 

healthcare environments to include an assessment of present practices. Nine healthcare 

organizations will be surveyed to seek information about respirator program administration 

logistics, training and fit testing issues, cartridge change out policies, cleaning, and maintenance 

These data will be used to inform future standards development. The contract award is expected 

in August 2014, with a one-year period of performance.

2. For protections appropriate for respiratory protective devices to be used in surgical 

and/or nonsurgical healthcare environments, should NIOSH consider adding tests and 

requirements to the 42 CFR Part 84 conformity assessment process for splash/spray 

protection (fluid resistance) per ASTM F1862:2000a, or other appropriate standards? 

NIOSH seeks evidence related to the performance of existing products (NIOSH-approved, 

but not FDA-cleared as a medical device) against this standard and the prevalence and 

characteristics of actual sprays/splashes faced by healthcare workers during nonsurgical 

patient care.

Summary of Comments:

There were eight responses to this question. Two commenters [13, 16] provided a strong “Yes”, 

four commenters [10, 14, 15, and 19] provided a qualified “Yes” two commenters [(6, 7] 

indicated “No”, because there is no need for the tests to be conducted. 

In support of adding tests/requirements to the 42 CFR Part 84 conformity assessment process, 

one commenter [13] indicated that “impermeability is very important as there are relatively 

frequent instances of splashes in the non-operating room (OR) setting....”

Two commenters [14, 19] agreed that it would be reasonable to include this requirement, but felt 

that other issues (training comfort, usability) are more important priorities. 

Commenter #19 indicated that the operating room (OR) poses the great risk for body fluid 

sprays/splashes, but risks can also occur in the “dynamic settings of emergency and urgent care.” 

Comments from two respirator manufacturers [10, 15] agreed that there are instances where fluid 

resistance properties are needed to provide protection to the wearer, but expressed concerns 

about the current test method (ASTM F1862). Furthermore, both commenters [10, 15] expressed 

concern that testing EAPRs and PAPRs would be unnecessary and irrelevant as these devices are 

generally impervious to liquid sprays. 

Another commenter [6] indicated that they felt there was no need to add tests/requirements for 

N95 filtering facepiece respirators used in a non-surgical setting.
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NIOSH Response:

NIOSH agrees that inside the OR (e.g., surgical settings) fluid-resistance is a desirable property. 

However, outside of the OR there is a lack of consensus. This appears to be driven by two 

primary concerns. One is the uncertainty that the current test method (ASTM F1862) is an 

appropriate challenge for all body fluid spray and splash exposures that may occur outside the 

OR. The second concern is the lack of data available on the prevalence of splash and spray 

exposures outside the OR. NIOSH feels that additional research on both of these topics is 

needed. In FY14, NIOSH started a pilot study to understand the fluid-resistant properties of nonFDA cleared filtering facepiece respirators. The complexity of the initial data suggests that a 

larger study is warranted. In FY15, NIOSH will consider intramural and extramural options to 

address these research gaps, including collaborations with partners such as academia, the Centers 

for Disease Control and Prevention (CDC), Veterans Health Administration (VHA), and the 

Food and Drug Administration (FDA), as well as respirator manufacturers.

3. For RPDs to be used in surgical and/or non-surgical healthcare environments, should

NIOSH consider adding requirements and tests beyond those provided in 42 CFR Part 84 

for protection against flammability hazards per 16 CFR 1610, UL 2154, or other 

appropriate standards? NIOSH seeks evidence related to the performance of existing 

products (NIOSH-approved, but not FDA-cleared as a medical device) against this 

standard and the prevalence and characteristics of actual flammability hazards faced by 

healthcare workers during patient care (i.e., non-surgical activities). 

Summary of Comments:

There were eight responses to this question. The majority of these responses [6, 7, 13, 14, 15, 

19] indicated that additional flammability requirements would not be needed for situations 

outside the OR. 

One commenter [18] stated that data from the National Fire Protection Association indicate that 

healthcare workers are not at risk, given that most fires in healthcare are the result of cooking. 

Furthermore commenter #15 felt that “the flammability risk experienced in industry would be 

similar if not more severe than that encountered in non-surgical activities.” This commenter 

also suggested that other standards (EN 149) would be more suitable for RPD. Only commenter 

#16 indicated that “Yes” additional requirements should be added to the 42 CFR Part 84 

conformity assessment process, but no justification was provided.

NIOSH Response:

According to the FDA, an “estimated 550 to 650 surgical fires occur in the United States per 

year.” Surgical fires require (1) an ignition source (e.g., electrosurgical units, lasers, and fiber 

optic light sources), (2) a fuel source (e.g., surgical drapes, alcohol-based skin preparation 

agents, the patient), and (3) an oxidizer (e.g., oxygen, nitrous oxide, room air). NIOSH agrees 

with commenters that it is unlikely to find all three requirements outside the OR setting, although 

definitive data are lacking. NIOSH also agrees that the suitability of the test methods used by the 
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FDA to make this determination require additional investigation. In 2015, NIOSH will consider 

intramural and extramural projects to address these research gaps, including collaborations with 

partners such as the CDC, VHA, and FDA, as well as RPD manufacturers.

4. For RPDs to be used in surgical and/or non-surgical healthcare environments, should

NIOSH consider adding optional, supplemental filtration testing (e.g., ASTM F2101–01 

(Bacterial Filtration Efficiency) and ASTM F1215:1989 (Particulate Filtration Efficiency)) 

in addition to the existing NIOSH filter requirements in 42 CFR Part 84? NIOSH requests 

evidence related to the performance of existing products (NIOSH-approved, but not FDAcleared as a medical device) against these alternative filter test methods and the prevalence 

and characteristics of airborne exposures faced by healthcare workers during patient care 

(i.e., non-surgical activities). NIOSH seeks comparative results for testing against such 

candidate supplemental standards versus test results achieved in the existing filter 

efficiency tests of 42 CFR Part 84.

Summary of Comments:

Most commenters (7, 10, 11, 13, 14, 15, 19) indicated that NIOSH should not add supplemental 

filtration testing such as ASTM F2101 as the FDA requires. Concerns were expressed about 

costs of the additional tests (10, 19) and complexity of tests using biological particles (10). One 

commenter (15) indicated that “the NIOSH tests are better predictors, reproducible, and more 

stringent than the filter efficiency tests required by FDA.” These comments were based upon 

several peer-reviewed articles. Similar concerns were raised by commenter #10 regarding 

ASTM F1215 and commenter #11 on the lack of statistical difference in filtration results 

between similarly sized inert and viable particles. 

Although no commenters indicated that NIOSH should add these tests to the 42 CFR Part 84 

conformity assessment process, several expressed opinions that the decision should be made by 

the scientific community (12), that they did not have direct data to support or oppose additional 

testing (18), and that it would be “nice to have” but not a requirement (9).

NIOSH Response:

NIOSH agrees with the commenters. Particle capture by a respirator filter depends on a number 

of factors including the charge, shape, size, and density of the particle. Particle capture is not 

dependent upon whether the particle is infectious or not. Scientific understanding of filtration 

theory is well characterized and there is a strong understanding of how different test conditions 

affect respirator filtration efficiency. This information can be exploited to create most rigorous 

or “worst-case” type conditions. The test conditions used by NIOSH in 42 CFR Part 84 for 

respirator certification testing of air-purifying respirators are believed to represent near “worstcase” conditions for all types of workplaces, including those in healthcare. Thus, NIOSH 

believes that it is not necessary to test a respirator filter with a biological aerosol, but rather, to 

focus on “worst-case” type test conditions. 
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While the science of aerosol filtration is well understood, there is still some confusion caused by 

having multiple test methods used by multiple federal agencies. As noted by the commenters,

the choice of key test parameters can greatly affect the reported filtration results. 

To better understand the different test methods, NIOSH initiated a FY14 pilot study to compare 

filtration results obtained from using the NIOSH sodium chloride test conditions with those 

found in ASTM 2101 (e.g., biological filtration efficiency (BFE), virus filtration efficiency 

(VFE), and ASTM F2299 particle filtration efficiency (PFE) tests). 

Preliminary findings are that the NIOSH sodium chloride test is more conservative (“worstcase”) than BFE, VFE, and PFE. The preliminary findings imply that the NIOSH test should be 

retained. NIOSH plans to publish findings from this study in 2015 in a peer-reviewed scientific 

journal. After receiving the peer-reviewed comments from the study, NIOSH will determine if 

additional research is needed or if the current NIOSH test procedure will continue to be used.

Docket Responses:

To view the comments, copy and paste the links below into your browser address bar.

6. Lagace, Sandra CDC-2014-0005-0006

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0006

7. McMullen, John, Immediate Response Technologies CDC-2014-0005-0007 

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0007

8. Anonymous CDC-2014-0005-0008

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0008

9. Peterson, Greg CDC-2014-0005-0009 

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0009

10. Green,Larry, Syntech, Intl. CDC-2014-0005-0010 

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0010

11. Heimbuch, Brian, Applied Research Associates, Inc. CDC-2014-0005-0011

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0011

12. Gruden, MaryAnn, AOHP - Association of Occupational Health Professionals in 

Healthcare CDC-2014-0005-0012

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0012

13. Young , Melanie, SHEA/IDSA CDC-2014-0005-0013 

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0013
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14. Fuller, Thomas CDC-2014-0005-0014

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0014

15. Colton Craig, 3M Personal Safety Division CDC-2014-0005-0015 

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0015

16. Groah, Linda, Association of periOperative Registered Nurses CDC-2014-0005-0016

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0016

18. Hailpern, Nancy, Association for Professionals in Infection Control and Epidemiology 

(APIC) CDC-2014-0005-0018

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0018

19. Radonovich, Lewis, VHA CDC-2014-0005-0019

http://www.regulations.gov/#!documentDetail;D=CDC-2014-0005-0019