1 Summa ry of Comments and NIOSH R esponse s to Docket 272 On March 14, 2014, NIOSH published a request for inform ation (RFI) [ Docket Number CDC

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– 272] and comment in the Federal R egister [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 p owered a ir - p urifying r espirators? Summary of Comments: Numerous commenters [10, 12, 13, 15, 16, 19] confirmed that elastomeric air

- purifying respirators ( EAPRs ) and p owered a ir

- p urifying r espirators ( 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 wid espread 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 p owered a ir

- p urifying r espirators are currently used in healthcare settings
. D iscussions with stakeholders indicate that this trend will likely i ncrease. 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 option s 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 grantee s to conduct a public health practice feasibility study. The grant announcement ( NIOSH: RFA

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- 009: “Assessment of Elastomeric Respirators in Healthcare Environments (R21)) was published in May 2014 and is expected to be awarded in August. This activi ty 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 healthca re 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 aerosol2

transmitted disease such as TB or measles, in the room during a n 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 administrat ion logistics, training and fit testing issues, cartridge change out policies, cleaning, and maintenance These data will be used to inform future standar ds 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 surgi cal 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 (NI OSH - 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 add ing 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 spra ys/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 we arer, 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.3

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 flu id spray and splash exposures that may occur outside the OR. The s econd 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 non

FDA cleared filtering facepiece respirators. The complexity of the initial data suggests that a larger study is warranted. In FY15 , NIOSH will consider intramural and extra mural options to address these research gaps, including collaborations with partners such as academia, the Centers for Disease Control and Prevention ( CDC ) , Veterans Health Administration ( V H A ) , and the Food and Drug Administration ( FDA ) , as well as respir ator 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: T here 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 Nation al 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 co nformity 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 sour ce (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 al l three requirements outside the OR setting, although definitive data are lacking. NIOSH also agrees that the suitability of the test methods used by the4

FDA to make this determination require additional investigation. In 2015 , NIOSH will consider intramu ral and extramural projects to address these research gaps, including collaborations with partners such as the CDC, V H A, 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 FDA cleared as a medical device) against these alternative filter test methods and the prevalence and characteristics of airborne exposures faced by healthcare worke rs 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 biol ogical 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 c oncerns 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 express ed 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 belie ved to represent near “wors t
case” 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 “wors t
- case” type test c onditions.5

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 affe ct the reported filtration results. T o 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., biolo gical 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 (“worst

case”) 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 jou rnal. After receiving the peer

- reviewed comments from the study, NIOSH will determine if addition al 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

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- 0010 11. Heimbuch, Brian, Applied Research Assoc iates, Inc. CDC

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- 0012 13. Young , Melanie, SHEA/IDSA CDC

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- 0015 16. Groah, Linda, Association of periOperative Regist ered Nurses CDC

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- 0016 18. H ailpern, Nancy, Association for Professionals in Infection Control and Epidemio logy (APIC) CDC

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