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FDA Sets New Restrictions For Authorized N95 Decontamination Systems

After reviewing real-world data, the US agency says the decontamination systems should only be used for compatible facemasks and should not be used to clean a mask more than four times.

UV light sterilization of face mask to disinfect and allow reuse.

The US Food and Drug Administration reissued emergency use authorizations (EUAs) for N95 respirator decontamination systems used by health care workers during the coronavirus pandemic. Under the new regulations, the agency is only allowing respirators to be decontaminated up to four times and restricting the use of decontamination systems to masks proven to fit in the specific devices.

In March 2020 when there were concerns about a shortage of filtering facepiece respirators – also known as N95 respirator facemasks – for health care workers, the FDA issued an...

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