The FDA issued revised emergency use authorizations (EUAs) to limit the number of times compatible N95 respirators for use by healthcare workers can be decontaminated by authorized systems.
The following decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times: (exact number varies, see FDA website for specific authorizations)
- Michigan State University Decontamination System
- Technical Safety Services VHP Decontamination System
- Stryker Sustainability Solutions VHP Decontamination Systems
- Steris Steam Decon Cycle in AMSCO Medium Steam Sterilizers
- Duke Decontamination System
- Sterilucent Inc Sterilization System
- Stryker Sterizone VP4 N95 Respirator Decontamination Cycle
- Advanced Sterilization Products Sterrad Sterilization System
- Steris Sterilization Systems for Decontamination of N95 Respirators
- Battelle Decontamination System
“Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simulated and real-world use, the FDA has determined that it is appropriate to protect the public health or safety to revise certain decontamination system EUAs to limit the number of decontamination cycles and respirator reuses permitted under each authorization,” the agency said in a statement.