The U.S. Food and Drug Administration (FDA) reversed its position on the use of N95 masks that have been decontaminated, noting that the practice is and potentially dangerous, the administration reported on Sunday.
"The agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination. Based on the FDA's increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by health care personnel," the FDA stated.
Of the EUAs, the FDA issued an authorization in April 2020 to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by health care workers in hospital settings.
The administration granted an EUA to Advanced Sterilization Products (ASP) for the STERRAD Sterilization Cycles (STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle), which uses vaporized hydrogen peroxide gas plasma sterilization.
There are approximately 9,930 STERRAD Sterilization systems in approximately 6,300 hospitals across the U.S. STERRAD 100S Cycle, STERRAD NX Standard Cycle and STERRAD 100NX Express Cycle vary in reprocessing times from 55 minutes, to 28 minutes, and 24 minutes. Each can reprocess approximately 480 respirators per day.
"Government officials and healthcare executives wasted time and resources and put frontline workers at risk chasing the unproven and dangerous dream of mask decontamination. Nurses and healthcare professionals caring for patients during this pandemic knew all along that these processes lacked rigorous evidence, could damage N95 masks and may create lasting health problems,” said RN and Massachusetts Nurses Association (MNA) president Donna Kelly-Williams said in response to the FDA reversal.
Battelle was also awarded an EUA from the FDA to support front-line healthcare workers as they face critical shortages of personal protective equipment (PPE) in March 2020. The Battelle CCDS Critical Care Decontamination System will operate at Battelle’s West Jefferson, Ohio facility under the EUA and is capable of decontaminating up to 80,000 respirator masks per system each day using concentrated, vapor phase hydrogen peroxide (VPHP).
The respirator masks are exposed to the validated concentration level for 2.5 hours to decontaminate biological contaminants, including SARS-CoV-2. Battelle CCDS can decontaminate the same respirator mask up to 20 times without degrading the mask’s performance.
The MNA has taken a leadership position in opposing the use of these products due to the risks to the health and safety of nurses and other healthcare workers who are caring for patients. The MNA called for the halt of decontamination of masks, and that nurses and healthcare professionals have the right to consent or refuse to use decontaminated masks.
"The lack of reliable information on these practices, as well as the potential safety risks of these decontamination procedures pose risks to the health and safety of health care workers, as well as the general public at large require that these practices be halted," the MNA statement noted.
The changes prohibit the decontamination of N95 respirators that were manufactured in China, which accounts for the majority of available products utilized across the globe. The MNA is calling on healthcare organizations to act immediately to procure an adequate supply of new personal protective products (PPE) that meet the standard that had been in place pre-pandemic.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.