FDA Issues New Policy on Dry Heat for Reuse of Certain Respi
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U.S. Food and Drug Administration (FDA) issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply of respirators during the COVID-19 public health emergency.

The immediately-in-effect guidance provides the FDA’s thinking and recommendations regarding the use of bioburden reduction systems that use dry heat to reduce the bioburden, or amount of microorganisms present, on certain respirators for reuse by a single user.

Bioburden reduction systems are intended to achieve a certain level in microbial reduction on a device; these are not decontamination systems. Additionally, these systems should only be used in conjunction with existing Centers for Disease Control and Prevention (CDC) recommendations for FFR reuse.

Under this policy, the FDA does not intend to object to the use of certain dry heat systems for the purpose of reducing bioburden and supporting single-user reuse of otherwise disposable FFRs that are compatible with dry heat bioburden reduction systems without marketing authorization.

Currently, there are no FDA-cleared or approved devices for decontamination or bioburden reduction of respirators.

Source: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-dry-heat-reuse-certain-respirators