FDA: Surgical Mask and Gown Conservation Strategies
By GSN Staff
The FDA issued a letter for health care workers (HCWs) that discussed conservation strategies for personal protective equipment (PPE) during the COVID-19 pandemic.
The strategies cover PPE, such as surgical masks, surgical and isolation gowns, and surgical suits, but not N95 respirators.
For surgical masks and gowns, the FDA recommended that HCWs follow these strategies based on the supply needs of their health care organization. Gowns that have ANSI/AAMI PB70 Level 1 and 2 barrier protection are considered nonsurgical isolation gowns. Gowns that have ANSI/AAMI PB70 Level 3 and 4 barrier protection and/or can be used for a sterile procedure 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 local, state and federal requirements. Employ engineering and administrative controls following the CDC and its Healthcare Infection Control Practices Advisory Committee guidelines to reduce the need for surgical masks while minimizing risks to HCWs and patients.
Specifically, for gowns, consider:
- implementing the use of reusable gowns instead of disposable single-use gowns;
- using an ANSI/AAMI PB70 standard Level 3 or 4 gown (i.e., sterile surgical isolation gowns) for surgery/invasive procedures with a medium to high risk for contamination;
- using sterile nonsurgical isolation gowns for surgery/invasive procedures with a low risk for contamination; and
- using nonsurgical isolation gowns for routine care of patients who are suspected 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 HCWs 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 (e.g., 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.
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:
- Extend the use of single-use gowns for HCWs 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 the CDC recommendations and/or ANSI (American National Standards Institute) standards for fluid resistance and bacterial filtration efficiency.
- Prioritize the use of unexpired FDA-cleared surgical masks for HCWs in procedures where it is important to protect the health care provider and/or the patient from risk for exposure to blood and body fluids.
- Use surgical masks beyond the manufacturer-designated shelf life in a setting where there is a lower risk for transmission(e.g., nonsurgical). The user should visibly inspect the product before use and, if there are concerns (e.g., degraded materials or visible tears), discard the product.
- Reuse surgical masks during care for multiple patients where they are used to protect the health care provider from an activity with low transmission risk (e.g., dispensing medications), and thus do not create a risk to the health care provider or patient. If the mask becomes contaminated, replace it.
The FDA warned that counterfeit masks and gowns may be on the market, especially during this time of reduced supply.
PPE includes protective clothing, gowns, gloves, face shields, goggles, face masks and respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
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