The FDA guidance provides recommendations for the use of bioburden reduction systems that use dry heat to support reuse of respirators
The US Food and Drug Administration (FDA) has issued guidance for the use of dry heat to support the reuse of certain particulate filtering facepiece respirators (FFRs) by a single user, to address the short-supply of respirators during the Covid-19 pandemic.
The guidance comes into effect immediately, and provides recommendations regarding the use of the devices that leverages dry heat for the reduction of bioburden or amount of micro-organisms present on certain respirators for reuse.
Bioburden reduction systems, which are not decontamination systems, help in achieving microbial reduction to a certain extent on a device.
In addition, the usage of the systems is allowed only with existing Centers for Disease Control and Prevention (CDC) recommendations for FFR reuse.
FDA Center for Devices and Radiological Health Surgical Sevices Division director Binita Ashar said: “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.
“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.”
FDA said that its new policy would not prevent the use of certain bioburden reducing systems using dry heat to support the reuse of otherwise disposable FFRs compatible with dry heat bioburden reduction systems without marketing authorisation.
FDA urges manufacturers to follow recommended system settings for bioburden reduction
The regulatory agency urges manufacturers to follow the recommended system settings for bioburden reduction, including temperature and time, and labelling, along with existing CDC recommendations for reuse.
The CDC recommendations for reuse include storing the respirator in breathable paper bag for at least five days before the reuse, and a limit of not more than five wears per respirator.
FDA said that the current guidance is the first policy on bioburden reduction systems for FFRs, and has not granted any EUAs for bioburden reduction systems that dry heat, till date.
The policy is applicable to bioburden reduction of FFRs that do not have exhalation valves, do not have a duck-bill design, and not contain antimicrobial or antiviral agents
Also, the policy is applicable to systems that has been FDA approved, or authorised under the FDA EUA for CDC’s NIOSH-approved FFRs, or authorised under FDA EUA for imported, non-NIOSH-approved FFRs, not manufactured in China.