The FDA is reissuing the individual emergency use authorizations (EUAs) to define which private security respirators are fit for mask decontamination guidance due to public health and safety concerns about original masks.
The company has stated that some respirators should not be selected for reuse by health care staff, a decision reached by the FDA based on an increased perception of the production and design of these respirators. The EUAs are in place for the term of the coronavirus disease 2019 (COVID-19) pandemic.
The FDA Case
In the first case, the FDA received from the CDC’s National Institute for Occupational Safety and Health (NIOSH) trial that allowed respirators made in China might vary in their design and product.
As such, the FDA decided that the available data do not confirm the decontamination of these respirators, and the company has subsequently changed the material EUAs.
Additionally, the FDA is examining related EUAs to authorize no longer decontamination or reuse of respirators that have exhalation valves.
- The FDA’s reissued EUAs invade the first Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China by changing the scope of maintenance such that allowed respirators listed in Appendix A will no longer be qualified if sanitized.
- Various decontamination methods so that they are no longer allowed to clean vents made in China, where relevant, and only allow decontamination of non-cellulose respirators that do not have an exhalation valve that is either enabled in the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA or that are accredited and recognized in an exhibit of the EUA for imported, non-NIOSH-approved disposable filtering facepiece respirators to be disinfected.
Users of any respirator (whether or not purified) should always assess for proper fit after employment. Respirators with a poor fit, visible soiling, or loss should not be used.
Scope of Authorization
For the EUAs covering introduced respirators, the FDA also tightens measures to include new language related to decontamination and to revise the Scope of Authorization concerning which jurisdictions are included in the requirements for qualification in both EUAs, among other revisions.
The FDA’s reversal on decontamination direction for unique masks used for personal security was cited as an instance of the importance of input from front-line health care professionals by the Massachusetts Nurses Association (MNA).
The MNA had called for the halt of decontamination of masks in April 2020 due to a lack of safety and efficacy evidence, according to the organization.
MNA President Donna Kelly-Williams, RN, said mask decontamination guidance processes had put front-line health care experts at risk.
Anand Shah, MD, FDA Deputy Commissioner for Medical and Scientific Affairs, told the agency is continuing to adapt to the evolving demands of Americans, based on science and data, during the pandemic.
In a public comment, the MNA advanced health care plans to quickly procure enough uncontaminated, unique strength material that meets pre-pandemic standards. It also supported the federal administration to fully activate the Defense Production Act to prepare the immediate production of safe and proper N95 masks.
New cases would allow for the safe reopening of health care settings and help prepare the country for a possible second wave of COVID-19 illness in the fall, according to the plan.