FDA Issues New Recommendations For Conserving Surgical Masks and Gowns During COVID-19 Crisis

In response to continuing shortages of personal protective equipment for healthcare providers, federal regulators have approved new strategies for reusing and conserving the critical equipment amid the COVID-19 epidemic.

In a letter to healthcare providers sent on April 27, the FDA outlined several recommendations for extending the use of surgical gowns and non-N95 face masks, which provides more flexible guidance depending on how big the need for personal protective equipment (PPE) is in an individual setting.

The COVID-19 pandemic has resulted in widespread shortages of personal protective equipment (PPE) in various parts of the country, including surgical masks, isolation gowns, and surgical scrubs.

This equipment is crucial in protecting health care providers as they care for patients who have tested positive for the COVID-19 virus to avoid transmission and infection.

“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,” wrote the FDA.

The new strategies outline how healthcare facilities should use PPE under various circumstances, including when there is no shortage and when there is a crisis shortage. The conservation strategies do not cover N95 respirators.

Conventional capacity strategies apply when the supply level is adequate to provide patient care without any change in routine practice.

During that time healthcare providers should use masks and gowns according to federal and state requirements but should consider implementing reusable gowns instead of disposable gowns.

ANSI/AAMI PB70 Level 3 and 4 gowns can be used for invasive surgery with a medium to high risk of contamination. Isolation gowns should be used for routine care of patients with suspected or confirmed to be infected with COVID-19.

When there is a limited supply of PPE, contingency capacity strategies should be followed. This may change patient care but will not have a significant impact on patient or healthcare provider safety, according to the FDA.

During times of limited access to surgical masks, health care facilities should consider having health care providers continue to wear the same surgical mask and only remove gloves and gowns and perform hand hygiene between treating patients with the same infectious diseases diagnosis. If a mask becomes contaminated it should be replaced.

If there is a shortage of gowns, healthcare facilities should prioritize the use for high-contact patient care which may include the opportunity for transfer of pathogens. These situations include aerosol generating procedures, like suctioning or respiratory treatments, or care activities where splashes and sprays are expected.

When the need for masks or gowns exceeds the supply crisis strategies should be employed.

During crisis strategies, level 1 and 2 gowns should be used for surgery or invasive procedures with a low risk of contamination. Facilities can extend the use of gowns without changing them between patients if the patients have the same diagnosis.

Facilities should also prioritize the use of surgical masks for healthcare providers to protect them from the risk of patient blood or fluids. They can also use surgical masks beyond the designated shelf life in low risk settings.

Healthcare providers can also reuse surgical masks while caring for multiple patients during low transmission risk situations.

If no surgical masks or gowns are available, the FDA recommends healthcare personnel refer to the CDC’s Considerations for Selecting Protective Clothing guidance.