COVID-19 update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators
The 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.
"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. "Today's guidance is another example of how FDA is working to address critical shortages in personal protective equipment and help protect health care personnel during the COVID-19 public health emergency."
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