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.

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: Authorized decontamination and bioburden reduction 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 declaration is terminated or authorization is revoked sooner.

A: The FDA and CDC recommend that 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.

A: The FDA and CDC recommend that 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.

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).

A. The process of bioburden reduction involves two concepts. The first is the bioburden, which is the whole population of viable microorganisms that inhabit a non-sterile surface or device. A dry heat bioburden reduction treatment, such as application of temperatures of 70° C for 60 minutes or 75° C for 30 minutes, will kill many of the moderately-resistant microbes present, resulting in a reduction in microbial numbers – the second concept. As described in the FDA guidance, 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, bioburden reduction treatment should result in ≥ 3-log (1,000-fold) reduction in microbial numbers and is consistent with a Tier 3 bioburden reduction system, as explained in the guidance.

A. Healthcare personnel should continue to use a new, properly fitting FDA-cleared or authorized respirator if one is available. However, in shortage situations, when there is an insufficient supply of new respirators that have been FDA-cleared or authorized, FDA recognizes that healthcare personnel may need to reuse their own respirator.

In the event that healthcare personnel need to reuse their respirators, bioburden reduction systems in general can be used to reduce the number of viable microorganisms on the respirator. A bioburden reduction system is intended to support single-user reuse of certain respirators to supplement the Centers for Disease Control and Prevention (CDC) existing recommendations for the limited reuse of filtering facepiece respirators (FFRs) – including N95 respirators – under Crisis Capacity Strategies. According to CDC, "reuse" refers to the practice of healthcare personnel wearing an otherwise single-use, disposable FFR for multiple encounters with different patients and removing it after each encounter.

The CDC recommends, in part:

• Storing the FFR in a breathable container such as a paper bag for 5 days before the next use
• Limiting reuse to no more than five donnings per FFR

Healthcare personnel should note that any compatible respirator that has undergone bioburden reduction is only to be reused by a single user, in addition to, not instead of, following the CDC recommendations.

A. Bioburden Reduction Systems and Decontamination Systems both are intended to kill and reduce microorganisms on a non-sterile device surface. They are intended to kill different numbers of microorganisms and in some cases, different types of microorganisms.  

However, Bioburden Reduction Systems are only for use in addition to existing CDC reuse recommendations for single-user reuse of certain FFRs, whereas for Decontamination Systems, reuse of certain FFRs is not generally limited to the CDC reuse recommendations.

The FDA guidance, 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, describes three tiers (categories) of Decontamination Systems and Bioburden Reduction Systems. The tiers are based on the reduction in microbial numbers that the system can achieve and the types of microorganisms that the system is intended to kill. Tier 1 and Tier 2 describe the considerations for "Decontamination Systems." Tier 3 describes the considerations for "Bioburden Reduction Systems."  

Tier 1 Decontamination Systems kill microorganisms considered to be the most resistant organisms and achieve ≥ 6-log (1,000,000-fold) reduction in microbial numbers. Tier 2 Decontamination Systems kill moderately-resistant organisms and achieve ≥; 6-log (1,000,000-fold) reduction in microbial numbers. Tier 3 Bioburden Reduction Systems kill moderately-resistant organisms and achieve ≥ 3-log (1,000-fold) reduction in microbial numbers Bioburden Reduction Systems are not Tier 1 or Tier 2 systems. Respirators that undergo bioburden reduction in Bioburden Reduction Systems should be processed in a manner that prevents inadvertent personnel exposure to contaminated FFRs and eliminate potential cross-contamination between FFRs (for example, individual packaging and labeling for respirators).

A. Single-user reuse means that the same person should use the respirator following bioburden reduction.

A. Bioburden Reduction Systems that use dry heat are compatible with FFRs that do not have exhalation valves, do not incorporate a duck-bill design, do not contain antimicrobial/antiviral agents, and are one of three types of FFRs. They are:

1. Authorized under the Emergency Use Authorization (EUA) for NIOSH-approved FFRs, or
2. Authorized under the EUA for non-NIOSH-approved FFRs not manufactured in China, or
3. FDA-cleared as intended for use by healthcare personnel.

FFRs that have exhalation valves, incorporate a duck-bill design, or contain antimicrobial/antiviral agents are excluded from the scope of the guidance because available information and data suggest that such FFRs may not perform as intended after bioburden reduction. Likewise, FFRs manufactured in China are excluded from the scope of the guidance  because the FDA's review of available information and data suggests that these types of FFRs may not perform as intended after exposure to the dry heat parameters outlined in the guidance. FDA is considering revising the FFR EUAs mentioned above to include within their scope of authorization bioburden reduction under certain circumstances. At this time, respirators that have been bioburden reduced are not authorized under an existing EUA.

Unless otherwise confirmed by the NIOSH approval holder for the respirator that the post-bioburden reduction-treated respirator meets the NIOSH approval criteria (for example, in the FFR labeling), the bioburden reduced respirator is no longer considered NIOSH-approved. This means the fit, filtration, and breathability of the bioburden-reduced respirator may not meet NIOSH approval requirements.

A. Generally, if you are an owner or operator of an establishment engaged in the manufacture of a dry heat bioburden reduction system that meets the device definition under Section 201(h) of the Federal Food, Drug, and Cosmetic Act, you must register your establishment and list your device with FDA (See 21 CFR 807.20(a)).

A. Please visit the webpage, Registration and Listing of Medical Devices during the COVID-19 Pandemic for answers to frequently asked questions about procedures and requirements concerning the registration of facilities and the listing of devices during the COVID-19 pandemic.

A. As a medical device manufacturer or device user facility, you must track and report certain device-related adverse events and product problems to the FDA (21 CFR Part 803). Manufacturers and device user facilities of bioburden reduction systems can use the product code QKY to report adverse events.

Review the information on the webpage Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents, for information about adverse event reporting for medical devices distributed under EUAs or that are the subject of COVID-19-related guidance documents and related resources.

Voluntary reports from health care personnel can be submitted through MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Healthcare personnel should follow the reporting procedures established by their organizations.

A. You may find contacts for additional questions about medical devices at this webpage: Contacts for Medical Devices During the COVID-19 Pandemic. For all general questions, you may contact the Division of Industry and Consumer Education (DICE). Users should contact manufacturers to obtain additional information about their bioburden reduction systems and follow their labeling.