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 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), or CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) to aid in infection prevention and control.
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 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 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 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.
- 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
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. 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 firstname.lastname@example.org.
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.
- Device manufacturers and user organizations must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by organizations that are subject to the FDA's user facility reporting requirements 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.
If you have questions about this letter, please see FAQs on Shortages of Surgical Masks and Gowns, contact email@example.com or, for general questions, the Division of Industry and Consumer Education (DICE).