January 22, 2021 By Nancy Crotti
Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times.
The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major media organizations and nurses began to question the claims about the number of times an FFR could be safely decontaminated and reused. Companies, universities and other organizations gained EUAs for sterilizing masks up to 10 times (Sterilucent and Steris), and Stryker (up to two times), with a total of 13 organizations now holding 15 such EUAs.
Today, the FDA announced that it has reissued EUAs for nine of those decontamination systems to reprocess each compatible N95 respirator up to four times only. Renewed EUAs went to Advanced Sterilization Products, Battelle, Duke University, Michigan State University, Sterilucent, Steris (two EUAs), Stryker (two EUAs), and Technical Safety Services.
