FAQs for Filtering Facepiece Respirator (FFR) Decontamination Systems
Decontamination systems are devices intended to decontaminate certain medical devices, such as filtering facepiece respirators (FFRs), so that they can be reused by healthcare personnel. The FDA has issued emergency use authorizations (EUAs) for some decontamination systems to decontaminate certain types of FFRs, recognizing that new FFRs are not sufficiently available during the Coronavirus Disease 2019 (COVID-19) pandemic.
The FDA has issued EUAs for decontamination systems for decontaminating FFRs for reuse by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of FFRs resulting from the COVID-19 pandemic. In addition to authorizing some decontamination systems for emergency use, the FDA has also issued guidance to help sponsors requesting EUAs for decontamination and bioburden reduction systems for surgical masks and respirators.
This page does not cover:
- Reprocessing, decontamination, or reuse of:
- Face masks, surgical masks, or face shields
- Respirators for non-medical use intended to limit industrial or general exposure to non-infectious particles, such as during construction or other industrial use
- Powered respirators such as powered air purifying respirators (PAPRs)
- Elastomeric respirators
The information provided may be useful to manufacturers of decontamination systems and healthcare facilities (HCFs) providing personal protective equipment (PPE) to HCP.
On this page:
- The Basics on Decontamination Systems for FFRs
- Developing FFR Decontamination Systems
- Using FFR Decontamination Systems
- Using Decontaminated FFRs
- The Emergency Use Authorizations for FFR Decontamination Systems
The Basics on Decontamination Systems for FFRs
A: Decontamination systems are devices intended to decontaminate certain medical devices, such as compatible FFRs, so that they can be reused by healthcare personnel.
A: The term “compatible FFRs” is defined in each EUA. Some decontamination systems are only compatible with certain models of FFRs, whereas other systems define compatible FFRs as any non-cellulose respirators that do not have an exhalation valve, antimicrobial agents, or a duck-billed design, and that are either: (1) authorized in the NIOSH-Approved Air Purifying Respirators EUA; or (2) authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. Of note, none of the existing authorized decontamination systems are authorized to decontaminate non-NIOSH-Approved disposable FFRs manufactured in China that are authorized and listed in Appendix A of the EUA.
Developing Respirator Decontamination Systems
A: To date, the FDA has authorized the emergency use of decontamination systems using vaporized hydrogen peroxide (VHP), VHP and ozone, steam, and supercritical carbon dioxide combined with a chemical additive. Several systems are authorized for decontamination of FFRs for single-user reuse, while others are authorized for multiple-user reuse.
For details on EUAs for decontamination systems, see Decontamination Systems for Personal Protective Equipment EUAs.
A: When reviewing EUA requests for decontamination systems for FFRs, the FDA considers all available scientific evidence, which generally includes information such as the intended use of the decontamination system, and evidence supporting such use, including information concerning user safety with respect to exposure to decontamination process residuals and evidence about whether the compatible FFRs may be effective for their intended use following decontamination. FDA’s recommendations on what sponsors should include in an EUA request for a decontamination or bioburden reduction system, can be found here: “Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Surgical Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”.
A: The guidance document titled “Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Surgical Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” contains recommendations for sponsors of decontamination systems about what information should be included in a pre-Emergency Use Authorization (pre-EUA) and/or EUA request to help facilitate FDA’s efficient review of such request.
Using FFR Decontamination Systems
A: Authorized Decontamination Systems for FFRs are authorized for the emergency use specified in each EUA, such as to decontaminate compatible FFRs for use by HCPs in healthcare settings. A product is only authorized for emergency use as long as the respective EUA is in effect. FDA’s EUAs are in effect for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices during the COVID-19 outbreak, unless the authorization is terminated or revoked sooner.
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.
A: Facilities should carefully review the conditions of authorization and authorized labeling for their specific decontamination systems to determine who is authorized to operate the system. Operation may be limited to the manufacturer, to a third party, or the healthcare facility.
A: FDA determines how many times authorized decontamination systems can decontaminate compatible FFRs based on the available information. At this time, FDA has authorized the decontamination systems to decontaminate each compatible FFR four or fewer times. Subsequent revisions or new EUAs may authorize a different number of decontamination cycles, based on the available scientific evidence.
A: FDA only issues an EUA when it is reasonable to conclude based on the available scientific evidence that certain criteria are met, including that the known and potential benefits of the product outweigh the known and potential risks. As new information becomes available, FDA may revise or revoke its EUAs to protect the public health or safety. In the case of decontamination systems, FDA has revised and reissued the EUAs in response to new information, such as information indicating that FFRs with exhalation valves should not be decontaminated. A summary of these revisions can be found in each EUA.
Healthcare facilities and applicable parties should refer to the authorized labeling for:
- HCP instructions for performing an OSHA self-seal check upon donning a decontaminated FFR; and
- Instructions that the HCP must either receive the same model of decontaminated FFR for which they were fit tested, or that healthcare facilities and applicable parties must provide fit testing if the HCP receives an alternate model of decontaminated FFR for decontamination systems authorized for multiple-user reuse.
A: This was not included in any decontamination system EUAs, since FDA has not evaluated whether decontaminated FFRs can be stored. Please refer to CDC’s reuse recommendations, including on storing FFRs between uses, available at Implementing Filtering Facepiece Respirator (FFR) Reuse, Including Reuse after Decontamination, When There Are Known Shortages of N95 Respirators.
A: Facilities should carefully review the EUA for their specific decontamination system and whether it is authorized for single-user or multiple-user reuse. Some of these systems are authorized to decontaminate FFRs for single-user reuse, while others are authorized for multiple-user reuse. Each EUA identifies how user reuse works. For example, in the case of multiple-user reuse, the EUA may specify that the HCP must either receive the same model of decontaminated FFR for which they were fit tested or healthcare facilities and other applicable parties must provide fit testing if the HCP receives an alternative decontaminated FFR model.
Using Decontaminated FFRs
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.
A: The CDC has identified factors to consider (fit, filtration performance, contamination and soiling, and damage) to help users determine how many uses or donnings of a decontaminated FFR may be appropriate for a particular circumstance. For complete information, please refer to Implementing Filtering Facepiece Respirator (FFR) Reuse, Including Reuse after Decontamination, When There Are Known Shortages of N95 Respirators. The EUA and instructions for use, labeling, and Fact Sheet for HCP for their specific decontamination systems should be carefully reviewed to determine the number of decontamination cycles authorized by the FDA.
A: The EUA and instructions for use, labeling, and Fact Sheet for HCP for their specific decontamination systems should be carefully reviewed to determine whether the system is authorized to decontaminate FFRs for a single user or multiple users.
A: As required by each EUA, decontaminated respirators that are visibly soiled or damaged must be discarded and not reused or further decontaminated. Discard the FFR in the event of headaches or dizziness and inform the decontamination system manufacturer. Consider submitting a MedWatch Report for observed or suspected adverse events to FDA.
The FDA reviews the safety information available, including the data on the continued effectiveness for filtering, fit, and breathability following decontamination or bioburden reduction and exposure to decontamination or bioburden reduction process residuals. FDA only issues an EUA when it is reasonable to conclude based on the available scientific evidence that certain criteria are met, including that the known and potential benefits of the product outweigh the known and potential risks.
A: Yes; CDC recommends, and updates to the authorized labeling of certain decontamination systems reflect, that HCP should perform the OSHA self-seal test of the decontaminated FFR to confirm that the FFR fits appropriately. If the user seal check does not pass, discard the FFR.
A: Based on the totality of scientific evidence available from simulated use studies and real-world use, the FDA believes that decontamination systems may be effective at decontamination of FFRs for either single user reuse or multiple user reuse, as specified in each EUA. Please note that based on the available information at this time, FDA has only authorized decontamination systems to decontaminate FFRs four or fewer times. More information can be found in the authorized labeling of each system, including in the Fact Sheet for HCP.
The Emergency Use Authorizations for FFR Decontamination Systems
A: In March 2020, the FDA, in response to the evolving public health emergency and continued concerns about FFR availability, issued its first EUA for a decontamination system. Since that time, the FDA has authorized additional decontamination systems, engaged with stakeholders regarding the real-world use of these systems, and reviewed evidence from adverse events and scientific literature, including studies regarding FFR failures from simulated and real-world use. Prior to reissuance of the EUAs, a majority of the decontamination systems were authorized for a maximum number of cycles based upon bench testing without simulated or real-world use. The maximum number of cycles that had been authorized ranged from 1 to 20. Since that time, simulated and real-world use have demonstrated that the limiting factor for safe decontamination and reuse depends more on extended use and repeated donning and doffing than on the number of times it has been decontaminated. Specifically, fit is negatively impacted as indicated by failed fit testing as reported in the literature.
On January 21, 2021, based on the totality of scientific evidence available, the FDA determined that it was appropriate in order to protect the public health or safety to reissue certain decontamination system EUAs by making the following changes, as applicable:
- Revising the scope of authorization and the conditions of authorization to limit the maximum number of decontamination cycles to four (4) or fewer and to require a post-authorization study to confirm that the identified number of maximum cycles is the appropriate maximum number of decontamination cycles
- Revising the authorized labeling to instruct healthcare personnel (HCP) to perform an OSHA self-seal check upon donning a decontaminated FFR
- For decontamination systems authorized for multiple-user reuse, requiring instructions that the HCP must either receive the same model of decontaminated FFR for which they were fit tested or healthcare facilities and other applicable parties must provide HCP with fit testing prior to HCP using an alternative model of decontaminated FFR
- FFRs with antimicrobials, duck-bill design, or that have an exhalation valve are excluded from the definition of what are considered compatible N95 respirators in which the authorized decontamination systems are authorized to decontaminate
A: Manufacturers may submit additional data to the FDA to request to expand the scope of authorization (for example, to increase the maximum number of decontamination cycles, or to support the inclusion of additional types/models of compatible FFRs, including duckbills and FFRs with antimicrobials).