December 3, 2020

FDA Issues Policy for Bioburden Reduction Systems Using Dry Heat to Support Reuse of FFRs

A new policy from the Food and Drug Administration provides recommendations for bioburden reduction systems that use dry heat to support single-person reuse of certain filtering facepiece respirators, or FFRs. According to FDA, such systems can help address shortages of FFRs in healthcare settings during the COVID-19 public health emergency.

An FDA press release clarifies that bioburden reduction, which achieves a certain level of microbial reduction on a device, is not the same as decontamination, which results in a higher level of microbial reduction.

“There exists sufficient evidence demonstrating that there is a reduction of microbial load on certain respirators when exposed to certain dry heat parameters,” said Dr. Binita Ashar, director of the Division of Surgical Devices in FDA’s Center for Devices and Radiological Health.

The parameters specified in the policy include subjecting respirators to consistent temperatures of 70 C for 60 minutes or 75 C for 30 minutes. The policy defines sufficient bioburden reduction as at least a 3-log reduction in non-enveloped viruses or vegetative bacteria while maintaining respirator integrity. The system would need to provide highly controlled convective heat transfer and allow close monitoring and recording of temperature throughout the heating cycle to confirm accurate and even distribution of heat.

The policy also requires labeling to clarify the difference between decontamination and bioburden reduction, and to specify which FFRs may be subjected to the dry heat system. FDA states that the policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19.

To date, FDA has issued no emergency use authorizations (EUAs) for bioburden reduction systems that use dry heat. EUAs have been issued for certain decontamination systems for compatible FFRs.

For more information, download the policy from the FDA website.