N95 Respirator Reuse Guidance Issued

The U.S. Food and Drug Administration (FDA) issued new guidance on November 25, 2020, regarding the use of dry heat to support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, when there is a limited supply of respirators during the COVID-19 public health emergency.

This announcement stated 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 of microbial reduction on a device; these are not decontamination systems.'

“There exists sufficient evidence demonstrating that there is a reduction of microbial load on certain respirators when exposed to certain dry heat parameters. Bioburden reduction systems can play an important role in the ongoing efforts to help address shortages of FFRs,” said Dr. Binita Ashar, Director of the Division of Surgical Devices in FDA’s Center for Devices and Radiological Health, in a press release.