Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers | FDA Page 1 of 5
Surgical Mask and Gown Conservation Strategies -
Letter to Health Care Providers
Coronavirus Disease (COVID-19) (/emergency-
preparedness-and-response/counterterrorism-and-
emerging-threats/coronavirus-disease-2019-covid-
19)
• FAQs on Shortages of Surgical Masks and Gowns (https://www.fda.gov/medical-
devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-
masks-and-gowns)
• Emergency Use Authorizations for Personal Protective Equipment
(https://www.fda.gov/medical-devices/emergency-situations-medical-
devices/emergency-use-authorizations)
The U.S. Food and Drug Administration (FDA) recognizes that the need for personal
protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and
surgical suits (scrubs), may outpace the supply available to health care organizations
during the Coronavirus Disease 2019 (COVID-19) outbreak.
The following conservation strategies for use by health care organizations and
personnel are categorized for a range of needs and supply levels and are intended to
assist health care organizations as they determine operating procedures during the
COVID-19 outbreak. These strategies do not cover N95 respirators
(https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html)
and are not limited to use in the care of patients infected with COVID-19. The FDA’s
conservation strategies are intended to augment, and not intended to replace, specific
controls and procedures developed by health care organizations, the Centers for
Disease Control and Prevention (CDC (https://www.cdc.gov/coronavirus/2019-
ncov/infection-control/control-recommendations.html)), or CDC’s Healthcare
Infection Control Practices Advisory Committee (HICPAC
(https://www.cdc.gov/hicpac/index.html)) to aid in infection prevention and control.
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Conservation Strategies
For surgical masks and gowns, health care providers follow these strategies based
on the supply levels of their health care organization.
Gowns that provide lower level barrier protection, ANSI/AAMI PB70 Level 1 and 2,
are considered non-surgical isolation gowns. Gowns that provide higher level barrier
protection, ANSI/AAMI PB70 Level 3 and 4, are considered surgical gowns or surgical
isolation gowns.
Conventional Capacity Strategies (supply levels are adequate to provide patient
care without any change in routine practice)
• Use FDA-cleared surgical masks and gowns according to labeling and federal,
state, and local requirements.
• Employ engineering and administrative controls
(https://www.cdc.gov/niosh/topics/hierarchy/default.html) following CDC and
HICPAC guidelines to reduce the need for surgical masks while minimizing risks
to health care providers and patients.
• Specifically, for gowns, consider:
◦ Implementing the use of reusable gowns
(https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-
recommendations.html) instead of disposable single use gowns.
◦ Using ANSI/AAMI PB70 standard Level 3 or 4 gown (that is, sterile
surgical isolation gowns) for surgery/invasive procedures with a medium to
high risk of contamination.
◦ Using non-sterile
◦ Isolation gowns for routine care of patients that are suspected or confirmed
to be infected with COVID-19.
Contingency Capacity Strategies (limited supply levels may change patient care,
but may not have a significant impact on patient care and health care provider safety)
• During times of limited access to surgical masks, facilities could consider having
health care providers continue to wear the same surgical mask (i.e., extended
use), remove only used gloves and gowns , and perform hand hygiene between
treating patients with the same infectious disease diagnosis or exposure who are
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maintained in a confined area. If the mask, gloves, or gowns become
contaminated, replace them.
• For training, use gowns that are beyond the manufacturer-designated shelf life, if
available.
• Prioritize the use of gowns and surgical masks by the type of activities required
for patients. If there are shortages of gowns, they should be prioritized for
aerosol-generating procedures (such as suctioning, nebulizer treatments, and
other respiratory treatments or procedures), care activities where splashes and
sprays are anticipated, and high-contact patient care activities that provide
opportunities for transfer of pathogens to the hands and clothing of health care
providers. Examples of high-contact patient care activities requiring gown use
include: dressing, bathing/showering, transferring, providing hygiene, changing
linens, changing briefs or assisting with toileting, device care or use, or wound
care.
Crisis or Alternate Strategies (may need to be considered if surgical mask or gown
demand exceeds the supply)
• If Surgical Masks and/or Gowns Are Running Low
◦ Using ANSI/AAMI PB70 standard Level 1 or 2 gown (that is, sterile non-
surgical isolation gowns) for surgery/invasive procedures with a low risk of
contamination.
◦ Extend the use of single use gowns for health care providers without
changing the gown between patients with the same infectious disease
diagnosis or exposure who are maintained in a confined area. If the gown
becomes contaminated, replace it.
◦ Use surgical masks and/or gowns that meet CDC recommendations and/or
ANSI standards for fluid resistance and bacterial filtration efficiency.
◦ Prioritize the use of unexpired FDA-cleared surgical masks for health care
providers in procedures where it is important to protect the health care
provider and/or the patient from risk of exposure to blood and body fluids.
◦ Use surgical masks beyond the manufacturer-designated shelf life in a
setting where there is a lower risk of transmission(e.g., non-surgical). The
user should visibly inspect the product prior to use and, if there are
concerns (such as degraded materials or visible tears), discard the product.
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◦ Re-use surgical masks during care for multiple patients where they are
used to protect the health care provider from an activity with low
transmission risk (such as dispensing medications) and thus do not create
a risk to the health care provider or patient. If the mask becomes
contaminated, replace it.
◦ Be aware that counterfeit masks and gowns may be on the market,
especially during this time of increased demand.
• If No Surgical Masks and/or Gowns Are Available, see CDC’s
Considerations for Selecting Protective Clothing used in Healthcare
for Protection against Microorganisms in Blood and Body Fluids
(https://www.cdc.gov/niosh/npptl/topics/protectiveclothing/)
◦ NIOSH (https://www.cdc.gov/niosh/emres/2019_ncov.html) and OSHA
(https://www.osha.gov/SLTC/covid-19/) have issued standards and
recommendations for protective clothing based on fluid barrier properties.
FDA Actions
The FDA is collaborating with manufacturers of surgical masks and gowns to better
understand the current supply chain issues related to the COVID-19 outbreak, and to
avoid any widespread shortages of these products.
On March 25, 2020, the FDA issued the guidance, Enforcement Policy for Gowns,
Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health
Emergency (/regulatory-information/search-fda-guidance-documents/enforcement-
policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-
health). This guidance provides a policy to help expand the availability of surgical
apparel for health care professionals during the COVID-19 public health emergency.
The FDA will continue to keep health care providers, manufacturers, and the public
informed if new or additional information becomes available.
Reporting Problems to the FDA
The FDA encourages users and facilities who are concerned about distribution of a
medical product, or anticipates a potential or actual shortage, to notify the FDA. For
potential or actual supply issues, email information to the FDA at
deviceshortages@fda.hhs.gov (mailto:deviceshortages@fda.hhs.gov).
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The FDA also encourages health care providers to report any adverse events or
suspected adverse events experienced with gowns or surgical masks.
• Voluntary reports can be submitted through MedWatch, the FDA Safety
Information and Adverse Event Reporting program (/safety/medwatch-fda-
safety-information-and-adverse-event-reporting-program/reporting-serious-
problems-fda).
• Device manufacturers and user organizations must comply with the applicable
Medical Device Reporting (MDR) regulations (/medical-devices/postmarket-
requirements-devices/mandatory-reporting-requirements-manufacturers-
importers-and-device-user-facilities).
• Health care personnel employed by organizations that are subject to the FDA's
user facility reporting requirements (/medical-devices/postmarket-
requirements-devices/mandatory-reporting-requirements-manufacturers-
importers-and-device-user-facilities) should follow the reporting procedures
established by their organizations.
Prompt reporting of adverse events can help the FDA identify and better understand
the risks associated with medical devices.
Contact Information
If you have questions about this letter, please see FAQs on Shortages of Surgical Masks
and Gowns (/medical-devices/personal-protective-equipment-infection-control/faqs-
shortages-surgical-masks-and-gowns-during-covid-19-pandemic), contact
deviceshortages@fda.hhs.gov (mailto:deviceshortages@fda.hhs.gov) or, for general
questions, the Division of Industry and Consumer Education (DICE) (/medical-
devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-
industry-and-consumer-education-dice).
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