Respiratory Protection for SARS
Information for Occupational Health, Safety, and Infection Control Practitioners
There has been much discussion in the field
recently about the appropriate respiratory
protection for to be used for protection from SARS.
The following information is provided as guidance.
VHA is adhering, as in the past, to the
respirator standard of the Occupational Safety and
Health Administration (OSHA), relying on statutory
authority of the National Institute of Occupational
Safety and Health (NIOSH) to certify respirators.
VHA follows CDC guidance on infection control
procedures, as outlined on the CDC web site.
Where devices are being used in the operating room,
to prevent transmission of disease from health care
worker to patient, devices must be certified by the
Food and Drug Administration (FDA). NIOSH, OSHA,
FDA, and CDC may have some policy disagreements on
the appropriate interpretation of statutes and on
whether specific statutes apply in some situations.
Centers for Disease Control and Prevention
Interim Domestic Guidance on the Use of
Respirators to Prevent Transmission of SARS
http://www.cdc.gov/ncidod/sars/respirators.htm
CDC currently recommends routine airborne
precautions to prevent the transmission of SARS.
According to CDC, "A NIOSH-certified, disposable N95
respirator is sufficient for routine airborne
isolation precautions. Use of a higher level of
respiratory protection, i.e., powered air-purifying
respirators, may be considered for certain
aerosol-generating procedures." CDC acknowledges
that surgical masks may be adequate to prevent
transmission. As this is uncertain, they should be
used only if N-95 respirators are not available. The
link provided above provides guidance on the use and
re-use of respiratory equipment as well as cleaning
requirements and use of alternate respiratory
equipment in the event of shortages. CDC has
recently recommended avoiding re-use of disposable
respirators wherever possible because of concerns
for potential transmission (http://www.cdc.gov/ncidod/sars/respirators.htm).
Some facilities have developed local protocols and
procedures on how to deal with such reuse.
Occupational Safety and Health Administration
29 CFR 1910.134, Respiratory Protection applies to
the use of respiratory protection from SARS. Although
many employees have been assigned the use of N95 and
powered air purifying respirators (PAPRs) for
tuberculosis, the use of respiratory protection for that
application was regulated under 29 CFR 1910.139,
Respiratory Protection for M.tuberculosis.
There are many differences between the two
respirator standards, and the facility respiratory
protection programs should be reviewed to ensure
that all appropriate program elements are addressed.
Two very significant differences between the two
programs include the following:
-
Medical clearance:
- 1910.134(e)(2) Medical evaluation
procedures must be completed although these
do not necessarily require hands-on physical
examination or lung function tests.
In fact, as no respiratory contraindications
exist to the wearing on N-95 respirators,
facilities may develop policies and
procedures to allow clearance for N-95 use
in the way supported by 1910.139. Facilities
must develop a written policy with a
justification.
- 1910.134(e)(4) Administration of the
OSHA Respirator Medical Evaluation
Questionnaire or equivalent is required.
Chest symptoms by themselves, asthma, and
chronic obstructive pulmonary disease are no
contraindication to wearing an N95.
Facilities may therefore choose to develop a
policy analogous to 139, where clearance is
relatively automatic after completion of
symptom questions. Facilities must then
obviously distinguish clearance for N-95
usage from clearance for use of fitted,
cartridge-type respirators.
-
Annual fit-testing requirements:
- 1910.134(f) - The respirator standard
requires annual fit-testing.
For N-95 respirators a major goal of such
testing is training, or reminding
individuals how tight straps to respirators
must be worn. Facilities may chose to have
such fit-testing and training undertaken on
off-duty hours, for example, by responsible,
supervising night shift staff who have
worked with the respirator program
administrator to develop such a policy. In
the long run, such "just-in-time" training
and fit-testing may be more cost-effective
and more protective than "annual" refitting
of large groups of employees who rarely don
respirators.
Food and Drug Administration
Guidance on the Content and Format of Premarket
Notification [510(k)] Submissions for Surgical Masks;
Draft.
http://www.fda.gov/cdrh/ode/guidance/094.pdf
Revisions to FDA policy are underway but have not yet
been released.
The FDA approval of respirators was first raised as
an issue with the use of N95 respirators for protection
of health care workers from TB. Although OSHA and the
FDA began working on a Memorandum of Understanding, that
document was never finalized or signed. The
interpretation that OSHA and NIOSH, and in general the
FDA, have been using was basically:
- If the procedure required the use of a surgical mask
for patient protection, then an FDA device with
pre-market approval was required to be worn by the
health care worker. (FDA authority and jurisdiction)
- If the procedure required a respirator for employee
protection a NIOSH-approved respirator could be used
under a respiratory protection program for protection of
the health-care worker (OSHA authority and
jurisdiction).
- If a procedure was being performed on a patient where
respiratory protection is required for the health care
worker for a confirmed or suspected infectious exposure,
then a NIOSH-approved respirator which is also had
pre-market approval as a surgical mask would be required
to meet both needs. (OSHA and FDA jurisdiction).
When a respirator is used in healthcare settings for
medical purposes, by the definition of FD&C Act, it
becomes a medical device subject to FDA regulation. As a
medical device, the respirator is cleared by FDA as a
surgical mask.
According to Chiu S. Lin, Ph.D , FDA Office of
Evaluation, a "Surgical mask is considered a medical
device, a Class II medical device under 21 CFR 878.4040.
In fact, the ‘healthcare N95 respirator’ or the
so-called ‘surgical N95 respirator’ is a combination of
regular (industrial) N95 respirator (particulate
filtration characteristics) with the surgical mask
(resistance to fluid penetration properties)."
According NIOSH, there are currently 8 respirators that
have N95 certifications and FDA Pre-Market approval as
surgical masks. They are:
Gerson (1)
Survivair (1)
Technol (now Kimberly Clark) (2)
3M (1)
Racal (2) 1860, 1860S, and 1870 (purchased by 3M)
Makrite (1)
VHA staff searching the FDA 510(k) website were able to
find documentation only four of these. Please contact
the manufacturers directly for information if it is
needed.
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