FDA Offers Advice to Conserve Protective Equipment Amid COVID-19
The US Food and Drug Administration (FDA) on Wednesday offered advice to healthcare providers to conserve their supply of personal protective equipment (PPE), such as surgical masks and gowns, as fears of supply constraints mount amid the global coronavirus disease (COVID-19) pandemic.FDA’s recommendations are tiered based on the situation within individual healthcare organizations and the level of supply of PPE available to them.
FDA notes that these strategies do not apply to N95 respirators but do apply broadly to patient care beyond those being treated for COVID-19. FDA also says these recommendations are meant to augment, but not replace advice from the Centers for Disease Control and Prevention (CDC) or its Healthcare Infection Control Practices Advisory Committee (HICPAC).
While supply levels are adequate, FDA says healthcare organizations should use FDA-cleared masks and gowns “according to their labeling and local, state, and federal requirements,” and implement engineering and administrative controls to reduce surgical mask needs based on CDC/HIPAC guidelines.
Even when supplies are adequate, FDA says organizations should consider moving to reusable gowns and restricting the use of AAMSI/AAMI PB70 standard Level 3 or 4 gowns to surgeries and invasive procedures “with a medium to high risk of contamination.”
For procedures with a lower risk of contamination, FDA recommends using ANSI/AAMI PB70 standard Level 1 or 2 gowns, and “using non-surgical isolation gowns for routine care of patients that are suspected to be infected with COVID-19.”
FDA says healthcare organizations should consider contingency strategies if supplies become limited, including extended use of surgical masks and only removing used gloves and gowns. FDA also suggests using gowns that are beyond the designated shelf life for training purposes and prioritizing the use of gowns and masks based on activity.
In crisis situations where there are not enough masks and gowns to meet demand, FDA says organizations should consider extending the use of single-use gowns and prioritizing the use of unexpired FDA-cleared surgical masks for procedures with a high risk of exposure to blood or body fluids.
Other crisis measures include using expired surgical masks and reusing surgical masks when they are used to protect healthcare providers during activities with a low risk of transmission. FDA also warns organizations to watch out for counterfeit masks and gowns.
If an organization runs out of masks or gowns, FDA says it should consult CDC’s recommendations for selecting protective clothing based on fluid barrier properties.
FDA