FDA Regulation of Surgical

Masks and Respirators

Chiu S. Lin, Ph.D.

Director
Division of Anesthesiology, General Hospital, Infection Control,
and Dental Devices
Center for Devices and Radiological Health, FDA
(IOM Meeting, January 23, 2006)

1
 Presentation Topics

● Background
● 510(k) submission of surgical mask
● FDA recommendation on device
reuse
● Conclusions

2
 IOM ISSUES

● Measures that would allow cost-

effective reuse of N95 respirators in
healthcare settings.
● Developing cost-effective reusable
face masks for the public to reduce
person-person spread of influenza.

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 REUSE
● Reuse between patients with adequate
reprocessing
• Ex: Endoscopes
● Reuse by the same person with adequate
reprocessing/decontamination
• Ex: Contact lenses
● Repeat use by the same person over extended
use time (with or without reprocessing)
• Ex: “Reusable” Surgical masks??
• One wearer vs. multiple wearers
• One HCW to one pt. vs. multiple pts.
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 Center
Center for
for Devices
Devices and
and Radiological
Radiological
Health,
Health, FDA
FDA (CDRH)
(CDRH)
● CDRH/FDA regulates devices – including
articles that are intended for use in
preventing diseases.
● Most N-95 respirators are not labeled or
promoted for any such use.
● If any article, including an N95
respirator, is marketed with claims for
use in preventing transmission of avian
flu, it falls under FDA purview.

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 CDRH RESPONSIBILITIES
● Evaluate and approve/clear medical
devices for marketing to ensure they are
safe and effective
● Inspect manufacturing facilities to
ensure the quality of devices
● Take corrective actions to remove
devices from commercial distribution
when they are unsafe, misbranded, or
adulterated
● Educate consumers

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 Three Regulatory Classes
of Medical Devices

Class
Class II :: Low
Low risk
risk -- General
General Control
Control ––
510(k)
510(k) exempt
exempt (mostly)
(mostly)

Class
Class IIII :: Intermediate
Intermediate risk
risk -- Special
Special &
&
General
General Control
Control –– 510(k)
510(k)

Class
Class III
III :: High
High risk
risk -- Premarket
Premarket
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Approval
Approval (PMA)
(PMA)
 GENERAL CONTROLS
● ESTABLISHMENT REGISTRATION
● UNITED STATES AGENT (new requirement)
● LIST DEVICE
● GOOD MANUFACTURING PRACTICES (QSR)
● PREMARKET NOTIFICATION [510(k)]
● LABELING
● MEDICAL DEVICE REPORTING

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 SPECIAL CONTROLS
● Regulatory performance standards
● Special labeling requirements
● Special user education and training
● Patient registries
● Postmarket surveillance
● FDA guidance documents
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 Benefits of FDA Regulations

● Premarket review – Ensure the

device is SAFE and EFFECTIVE.
● GMP – Assure the quality of device
that actually reaches users
● Good labeling, including adequate
directions for use (Important aspect
for mass distribution of masks to
the public during pandemic)
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 Personal Protective Equipment
(PPE)
● Eye Protection
• goggles, face shields
● Masks
• Surgical masks, N-95 respirators
• Surgical N-95 respirators
● Gowns
• surgical & isolation
● Gloves
11 • examination & surgical
 FDA PPE WEB SITES

● PPE and Avian Flu

• www.fda.gov/cdrh/ppe/fluoutbreaks.html

● General discussion of PPE

• www.fda.gov/cdrh/ppe/index.html

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 Surgical Masks
● Classified under 21 CFR 878.4040 – A general
classification for apparel intended to protect both
patients and persons in contact with patients from
transfer of microorganisms, body fluids, and
particulate materials.

● Class II devices – Subject to Premarket Notification

[510(k)]

• General Control & Special Control

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 Surgical Masks

● FDA 2004 Guidance document on 510(k)

submissions for surgical masks, including N95
respirators, lays out recommendations for how
to establish substantial equivalence (as safe
and as effective) to existing devices (predicate
devices)
http://www.fda.gov/cdrh/ode/guidance/094.html

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 PREMARKET
NOTIFICATION 510(K)

A marketing application
submitted to FDA to demonstrate
that the subject device is as safe
and as effective (substantially
equivalent) to an existing legally
marketed (predicate) device
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 Surgical Masks

● Also known as:

• Laser masks
• Isolation masks
• Dental masks
• Medical procedure masks

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 Performance Characteristics of
Surgical Masks

● Fluid resistance
• ASTM F 1862-00a: Standard test method for resistance of surgical
mask to penetration by synthetic blood

● Filtration efficiency
• (1) Particulate filtration efficiency (PFE) – 0.1 µ polystyrene latex
sphere

• (2) Bacterial filtration efficiency (BFE) - ASTM F 2101-01: Standard

test method for evaluating the bacterial filtration efficiency (BFE)
of surgical mask using a biological aerosol of Staphylococcus
aureus

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 Performance Characteristics of
Surgical Masks (Cont’d)
(Cont’d)

● Air exchange (differential pressure, Delta -P)

• Measure breathability and comfort of surgical masks

● Flammability
• Class 1 and Class 2 flammability rating material for use in the
operating room (O.R.)

• Class 4 flammability rating is not appropriate for use in O.R.

(Would be labeled as NOT FOR OR USE)

● Biocompatibility
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 Surgical N -95 Respirators
N-95
● In some healthcare settings, healthcare workers
(HCWs) may be at risk to inhalation of droplets of TB
(M. tuberculosis) and exposure to body fluids that
may contain blood-borne pathogens.

● Surgical N-95 respirator, which combines both

NIOSH certified N-95 respirator and surgical mask in
one single product, is designed for this purpose.

● Require NIOSH certification as N-95 respirator and

cleared through 510(k) by FDA as surgical mask

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 N -95 Respirators
N-95 Respirators Certified
Certified by
by NIOSH
NIOSH

● For industrial uses

• Not considered as medical devices

● For medical uses

• Considered as medical devices subject to
FDA oversight

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 FDA Reprocessing Guidance

● FDA Guidance on Reusable Device

Labeling - Labeling Reusable Medical
Devices for Reprocessing in Health Care
Facilities: FDA Reviewer Guidance
(1996)
● Labeling instructions for users on how
to prepare the reusable device for reuse
● http://www.fda.gov/cdrh/ode/198.pdf

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 Reusable Device Labeling
● Labeling for a reusable device that contacts the
patient must include reprocessing instructions.
● The instructions must indicate the appropriate
microbicidal endpoint for the recommended
reprocessing method.
• Critical Device ---Sterilization
• Semicritical Device ---High level disinfection
• Noncritical Device ---Intermediate or low level
disinfection
● Surgical mask and N-95 respirator may be
considered “Non-Critical Device” (intact skin
contact and non-sterile) for the purpose of
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reprocessing, especially if used by the same
person.
 Reusable Device Labeling
(Cont’d)
● The reprocessing method must be
feasible considering the intended
location of reprocessing (e.g., hospital
vs home use).
● Reprocessing instructions must be
validated.
● After reprocessing, the device must still
meet the established performance
specifications of the original device,
after X number of times of repeated
reprocessing.

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 Validation
● Reusable devices requiring cleaning,
disinfection, or sterilization between use
must be designed in a manner that
enables the necessary steps to be
performed adequately.
● Manufacturers must establish that
devices can be reprocessed effectively
after repeated use and must establish
and validate procedures for
reprocessing.

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 Reusable
Reusable Surgical
Surgical Masks
Masks or
or N -95
N-95
Respirators
Respirators
● Instructions for preparing for reuse?
• Home vs. hospital?
• Need autoclaving or other disinfection
method to remove contaminating
microorganism, including virus?
• Would material withstand reprocessing?
● How long or how many times the mask or
respirator can be “reused”?
● After reprocessing, does the mask or respirator
still perform?

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 CONCLUSIONS
● FDA thus far has not cleared any
surgical mask or respirator as
“reusable” device.
● FDA is committed in working with
manufacturers to develop this type of
device.
● If such device is available, FDA will
perform an expedited review of
premarket submission to meet the public
health need.
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