FDA says to limit mask decontamination to 4 cycles

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.


Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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