Respirator
(Photo : Reuters Connect)

The U.S. Food and Drug Administration has released stricter guidelines for the decontamination of face masks manufactured in China.

PPE Shortages and Reuse of Face Masks

Due to shortages of Personal Protective Equipment (PPE), particularly facemasks, many healthcare workers who continue to combat COVID-19 as frontliners are left with no choice but to decontaminate and reuse them again.

This emerging concern has led the U.S. FDA to release more stringent guidelines in decontaminating facemasks that are made in China. 

Healthcare workers have long been clamoring for new sets of PPE's to protect them from getting infected. PPE includes medical items such as facemasks, gloves, goggles, and face shields which are very important for doctors, nurses, and other frontliners in both private and public hospitals. With the spike of COVID-19 infections in the country, these protective clothing are becoming more important. Today, the U.S. has already reached more than 2 million cases, according to worldometers.

Why U.S. FDA Reissues New Guidelines Addressing Which Types of Facemasks Can be Decontaminated for Reuse?

The U.S. FDA said that facemasks that are made and manufactured in China vary in their designs and performance and based on their testing, they found out that some of these should not be decontaminated and reused. 

To address this problem that may put the lives of healthcare workers at risk or will put them at a higher risk of infection, FDA reissued certain emergency use authorization that specifies which respirators or facemasks qualify for decontamination.

This decision was made following the result of the tests made by the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health. FDA is no longer authorizing the decontamination or reuse of respirators that have exhalation valves.

In a statement released to the press, FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah said: "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."

She added: "As part of those efforts, we are announcing that we have revised and reissued a number of EUAs to amend which respirators are authorized to be decontaminated." 

Other Revisions Made by the U.S. FDA

The National Institute for Occupational Safety and Health has listed respirators that are no longer allowed to be decontaminated and reused. FDA added that there might be additional changes in the coming days as more test results are coming. 

Part of the recommendation of the CDC and NIH is that the users are to assess the proper fit of facemasks or respirators. Those that have a poor fit, visible soiling, or damage should not be used. The agency also said that they continue to be vigilant in monitoring the imported facemasks that are coming inside the country. 

In this time of the global pandemic, it is very important that Personal Protective Equipment most especially face masks should be approved by the CDC, NIH, and other concerned agencies to ensure the safety of everyone. 

Read related articles: