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Updated Information on Respirator 

Decontamination Systems

Office of Health Technology 4: Surgical and Infection Control Devices

Office of Product Evaluation and Quality (OPEQ)

Center for Devices and Radiological Health (CDRH)
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• Definition of Decontamination Systems

• Authorized Decontamination Systems

• Scope of Authorizations

• Resources

• Questions

Agenda
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• Decontamination systems are devices intended to decontaminate 

certain medical devices, such as compatible N95 respirators, so 

they can be reused by healthcare personnel.

• The FDA issued Emergency Use Authorizations (EUAs) 

authorizing the emergency use of some decontamination systems 

to decontaminate certain respirators recognizing that availability of 

filtering facepiece respirators (FFRs) is an integral part of routine 

patient care during the COVID-19 pandemic.

Decontamination Systems for 

Filtering Facepiece Respirators (FFRs)
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Q: When should decontamination systems for FFRs be used?

A: The CDC recommends as soon as new supplies can meet the projected 

demand, all reuse and decontamination of respirators should be discontinued. 

FFRs should only be reused when operating at crisis capacity due to the inability 

of FFR supplies to meet the demand.

CDC provides information on Implementing Filtering Facepiece Respirator (FFR) 

Reuse, Including Reuse after Decontamination, When There Are Known 

Shortages of N95 Respirators.

Crisis Capacity Strategies and Decontaminated 

Filtering Facepiece Respirators (FFRs)
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Decontamination systems that have been reissued EUAs are 

authorized to decontaminate compatible N95 respirators using the 

following technologies:

– Vaporized Hydrogen Peroxide (VHP)

– Steam

– VHP/ozone

Types of Authorized Decontamination Systems
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On January 21, 2021, the FDA reissued certain decontamination system 

EUAs by making the following changes, as applicable:

– Limit the maximum number of decontamination cycles to ≤ 4

• Evidence demonstrates that significant respirator fit failure 

occurs after 5 donnings and doffings.

– Require post-authorization studies (PAS) to confirm the maximum 

number of decontamination cycles

• Real world data on fit testing and filtration efficiency testing to 

demonstrate that respirator functional integrity is maintained.

• Timely communication of PAS results in authorized labeling.

Updates to Decontamination System EUAs
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– Revised authorized labeling for decontamination systems intended for 

multiple-user reuse to ensure respirator fit

• Evidence demonstrates that most contaminants that enter an N95 

respirators are the result of face seal leakage; therefore, fit is 

important in respirator functional assessment.

• End users must receive the same model of decontaminated, 

compatible N95 respirator for which they have been fit tested. And, if 

that model is unavailable, then healthcare facilities must provide fit 

testing prior to the use of an alternative model.

–Revised authorized labeling for all decontamination systems instructing 

users to perform OSHA self-seal check

.

–Authorization excludes respirators with antimicrobials and duckbill 

respirators from decontamination

.

Updates to Decontamination System EUAs, 

continued
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• Previous Webinars from this Series, including recordings of a previous webinar on Decontaminating 

Respirators for Health Care Personnel Use, held on July 7, 2020: 

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-series-respirators-andother-personal-protective-equipment-ppe-health-care-personnel-use#previous

• FDA Decontamination Systems for Personal Protective Equipment EUAs: 

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizationsmedical-devices/decontamination-systems-personal-protective-equipment-euas

• CDC Implementing FFR Reuse, Including Reuse after Decontamination, When There Are Known Shortages of 

N95 Respirators: 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html

• CDC Strategies for Optimizing the Supply of N95 Respirators: 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html

• CDC Personal Protective Equipment (PPE) Burn Rate Calculator: 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/burn-calculator.html

• OSHA Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace: 

https://www.osha.gov/coronavirus/safework

• OSHA enforcement memoranda that include time-limited discretions:

https://www.osha.gov/coronavirus/standards#temp_enforcement_guidance

Resources
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Questions?

Email: CDRH-COVID19-SurgicalMasks@fda.hhs.gov

Slide Presentation, Transcript, and Webinar Recording 

will be available at:

www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics and 

Sub-heading Personal Protective Equipment (PPE)

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