[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
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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