The FDA Announces Stricter Guidance on Respirator Reuse

Posted by Meditab Software, Inc. on Jun 9, 2020 12:42:27 PM

In a recent decision, the US Food and Drug Administration (FDA) has put forward new guidelines on what types of respirators are safe for medical professionals to decontaminate and reuse while interacting with COVID-19 patients. 

During the coronavirus pandemic, experts continue to learn more about the disease and our global situation every day. As a result, agencies and groups from the FDA to the WHO have worked to routinely update their guidance for safety procedures. 

“While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected,” Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs said in a statement. “As part of those efforts, we are announcing that we have revised and reissued a number of EUAs [emergency use authorizations] to amend which respirators are authorized to be decontaminated.”

Under normal circumstances, the National Institute for Occupational Safety and Health (NIOSH) tests and authorizes certain respirators for decontamination. As the pandemic took hold, however, the FDA provided guidance on which non-NIOSH-approved respirators could be reused. Now, among the many changes, the FDA is notably limiting the scope of non-NIOSH-approved decontamination authorizations for specifically Chinese manufactured equipment.

Overall, the FDA emphasizes, “decontaminated respirators should only be used when new FDA-cleared N95 respirators, NIOSH-approved N95 respirators, or other FDA authorized respirators are not available.” 

For each of the FDA’s in-depth changes, read the agency’s official statement

In a similar vein, the World Health Organization (WHO) has released updated guidance of its own for the use of standard masks both in medical situations and in public. As cities and countries around the world push to reopen their economies, the WHO is hoping to provide mask advice for “decision makers” as more people make their way back into community settings

You can view the updated WHO guidelines on the organization’s website

Topics/Tags/Categories: COVID-19, Guidelines

Latest Posts