[Federal Register Volume 79, Number 50 (Friday, March 14, 2014)]
[Notices]
[Pages 14515-14517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2014-0005, Docket Number NIOSH-272]


Respiratory Protective Devices Used in Healthcare

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of request for information and comment.

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SUMMARY: Respiratory protective devices (RPDs) that are approved by the 
National Institute for Occupational Safety and Health (NIOSH) and also 
cleared by the Food and Drug Administration (FDA) \a\ as medical 
devices are widely used in surgical and non-surgical healthcare 
environments. There are reports \b\ that other NIOSH-approved RPDs that 
are not FDA-cleared medical devices are also being used to protect 
healthcare workers from inhalation hazards. The desirability of NIOSH 
incorporating additional requirements and tests in its 42 CFR Part 84 
respirator approval process to parallel the protections in the FDA 
clearance process for Surgical N95 Respirators in surgical and non-
surgical healthcare environments has been mentioned during broad-based 
and cross-agency discussions for future pandemic events as well as day-
to-day use in healthcare settings.
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    \a\ 21 CFR 878.4040 (FDA 510(K)Clearance)
    \b\ Stradtman, L, Prevalence of Respiratory Protective Devices 
in U.S. Healthcare Systems, Internal NIOSH Survey Report, Jan. 7, 
2014. (available in docket)
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    NIOSH could augment the existing requirements and tests of the 42 
CFR Part 84 conformity assessment process to incorporate requirements 
included in the FDA clearance process, such as fluid resistance and 
flammability. Both FDA and NIOSH require demonstration of filtration 
performance. The current NIOSH filtration testing requirements use non-
biological aerosol based on the assumption that all particles, 
biological or non-biological, behave according to the same principles 
of aerosol physics for filtration: That is, by impaction, interception, 
diffusion, and electrostatic attraction. NIOSH is seeking public 
comment with available supporting data that either validates or 
disproves this assumption.
    NIOSH is requesting information and comments on the following:
    1. Do healthcare stakeholders anticipate expanding the use of RPDs 
to include elastomeric air purifying respirators and/or Powered Air 
Purifying Respirators (PAPRs)?
    2. For protections appropriate for RPDs to be used in surgical and/
or non-surgical 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

[[Page 14516]]

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 non-surgical patient care.
    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).
    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 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.

DATES: All comments must be received by April 14, 2014.

FOR FURTHER INFORMATION CONTACT: Roland Berry Ann, NIOSH NPPTL, P.O. 
Box 18070, Pittsburgh, PA 15236; (412) 386-6111 (this is not a toll-
free number). Information requests can also be submitted by email to 
[email protected].

ADDRESSES: You may submit comments identified by CDC-2014-0005 and 
Docket Number NIOSH-272 by either of the two following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    Instructions: All information received in response to this notice 
must include the agency name and docket number [CDC-2014-0005; NIOSH-
272]. All relevant comments received will be posted without change to 
www.regulations.gov, including any personal information provided. All 
electronic comments should be formatted as Microsoft Word. For access 
to the docket to read background documents or comments received, go to 
www.regulations.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 42 CFR Part 84, NIOSH approves RPDs for protection against 
inhalation hazards in all occupational settings. The FDA regulates 
medical devices that are intended to prevent the transmission of 
disease in humans. FDA defines a medical device under Section 201(h) of 
the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)).
    The Occupational Safety and Health Administration's (OSHA's) 
Bloodborne Pathogens regulation specifies masks in combination with eye 
protection devices, such as goggles or glasses with solid side shields, 
or chin-length face shields, are to be worn whenever splashes, sprays, 
spatters, or droplets of blood or other potentially infectious 
materials may be generated and eye, nose, or mouth contamination can be 
reasonably anticipated. (29 CFR 1910.1030(d)(3)(x)).
    The FDA clears surgical masks (e.g., laser masks or procedure 
masks) as medical devices,\c\ in that they are intended to prevent 
disease. They protect healthcare workers from splashes, sprays, 
spatters, and droplets of respiratory secretions, blood and other body 
fluids. The FDA may issue a premarket clearance as a medical device 
only for certain NIOSH-approved N95 filtering facepiece respirators 
(FFRs) assessed for clearance characteristics equivalent to FDA-cleared 
masks that are used in the healthcare setting. Currently, the only 
medical device classification that can be applied to a NIOSH-approved 
respirator is that of a Surgical N95 Respirator.
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    \c\ According to the Food, Drug and Cosmetic Act, the FDA 
reviews for clearance medical devices that are intended to cure, 
mitigate, treat, or prevent disease in man.
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    FDA regulates NIOSH-approved Surgical N95 Respirators as medical 
devices intended for use in healthcare settings under the regulation 21 
CFR 878.4040. OSHA has the primary responsibility for enforcing proper 
use of RPDs in the workplace, including healthcare settings, as 
described in the Respiratory Protection standard (29 CFR 1910.134). 
According to section 1910.134, where respirators are required, they 
must be NIOSH-approved and used as part of a respiratory protection 
program which includes medical evaluation, training, and fit testing 
(when applicable). OSHA does not require RPDs used in a healthcare 
setting to be cleared by the FDA. Many RPDs used in healthcare settings 
have not been submitted by industry for FDA premarket clearance, and 
therefore have not been FDA-cleared as medical devices.
    There are two general categories of RPDs found in healthcare 
settings: (1) Those approved by NIOSH and (2) those approved by NIOSH 
and receiving FDA Premarket Notification [510(k)] clearance as a 
Surgical N95 Respirator by the FDA. RPDs approved by NIOSH which are 
not cleared by FDA include NIOSH-approved N95, P95, and P100 FFRs; 
Powered, Air-Purifying Respirators (PAPR); and elastomeric half 
facepiece air-purifying respirators. The most common of these is the 
N95 FFR. Surgical N95 Respirators cleared by FDA and approved by NIOSH 
are N95 FFRs that also meet certain requirements for fluid resistance 
per ASTM F1862:2000a and sometimes flammability requirements per 16 CFR 
1610 and UL 2154.

Applicability to Pandemic Preparedness

    During the early stages of a pandemic, before vaccines are widely 
available and the mode(s) of disease transmission are fully understood, 
personal protective equipment will be an important component of a non-
pharmaceutical intervention strategy to reduce disease transmission. 
Some of the RPDs used as part of the intervention could be RPDs in 
frequent or daily use for non-outbreak hazards.
    Due to the expected importance of RPD use during a pandemic, the 
HHS recommends that healthcare facilities stockpile a 6-8 week supply 
of disposable N95 FFRs. However, it has been documented \d\ that the 
stockpiling recommendation has been a challenge for healthcare 
facilities. Noted barriers to stockpiling N95 FFRs include: lack of 
storage space, limited use within normal working parameters, shelf-life 
limitations, and working against the typical ``just-in-time'' supply 
chains, which only allow for a limited number of on-hand supplies. This 
is challenging due to the sheer number of RPDs that will be needed 
during a pandemic. According to the CDC, an estimated 90

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million N95 FFRs would be needed to protect healthcare workers during a 
42-day pandemic. The rapid increase in RPD usage was apparent during 
the 2009 H1N1 pandemic.e f RPD usage may also increase 
beyond pandemic recommendations due to concerns about disease 
transmission.
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    \d\ According to the Food, Drug and Cosmetic Act, the FDA 
reviews for clearance medical devices that are intended to cure, 
mitigate, treat, or prevent disease in man.
    \e\ Bunyan D, Ritchie L, Jenkins D, Coia JE. Respiratory and 
facial protection: a critical review of recent literature. J Hosp. 
Infect. 2013 Nov; 85(3):165-9.
    \f\ Association of State and Territorial Health Officials. 
Assessing Policy Barriers to Effective Public Health Response in the 
H1N1 Influenza Pandemic. Arlington: Association of State and 
Territorial Health Officials; 2010.Generally, N95 FFRs are the 
primary choice of respiratory protection over PAPRs or elastomeric 
respirators for numerous reasons. They are disposable and therefore 
do not require cleaning or reprocessing. They are lighter in weight 
and less cumbersome to don and doff as straps are generally not 
adjustable; nor are there any filter cartridges to be manipulated. 
Also, they are familiar to HCWs because of their resemblance to 
surgical masks commonly used in healthcare environments.
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    Because of the potential for splashes and sprays (e.g., from a 
severed artery, cough, or sneeze), some facilities have selected NIOSH 
approved and FDA-cleared Surgical N95 respirators as the primary option 
for protecting healthcare workers during a pandemic. However, other 
NIOSH-approved RPDs might need to be considered because there may not 
be enough of the FDA-cleared devices to protect healthcare workers and 
other essential personnel during a pandemic or outbreak.
    NIOSH-approved respiratory protective devices that are also FDA-
cleared medical devices are widely used in surgical and non-surgical 
healthcare environments. There are reports b c that other 
types of NIOSH-approved RPDs that are not FDA-cleared medical devices 
are being used as well to protect workers in both surgical and non-
surgical healthcare environments from inhalation hazards. The 
desirability of NIOSH incorporating additional requirements and tests 
in its 42 CFR Part 84 respirator approval process to parallel the 
protections in the FDA clearance process for Surgical N95 Respirators 
in surgical and non-surgical healthcare environments has been mentioned 
during broad-based and cross-agency planning discussions for dealing 
with future pandemics.
    NIOSH intends to use this information to consider augmenting the 
existing protections of 42 CFR Part 84 to incorporate requirements 
included in the FDA clearance process, such as fluid resistance and 
flammability. b c NIOSH is seeking public comment on the 
desirability of adding requirements and tests in its 42 CFR Part 84 
respirator approval process to parallel the protections in the FDA 
clearance process.
    Both FDA and NIOSH require demonstration of filtration performance. 
The current NIOSH filtration testing requirements use non-biological 
aerosol based on the assumption that all particles, biological or non-
biological, behave according to the same principles of aerosol physics 
for filtration: that is, by impaction, interception, diffusion, and 
electrostatic attraction. NIOSH is seeking public comment with 
available supporting data that either validates or disproves this 
assumption.
    Next Steps: NIOSH will determine next steps after all comments are 
reviewed and assessed. NIOSH intends to provide an entry to the docket 
regarding next steps no later than June 30, 2014.

    Dated: March 10, 2014.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2014-05611 Filed 3-13-14; 8:45 a.m.]
BILLING CODE 4163-19-P