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Fact Sheet for Healthcare Personnel FACT SHEET FOR HEALTHCARE PERSONNEL Coronavirus Disease 2019 Battelle Decontamination System for Decontaminating Compatible N95 Respirators January 21, 2021 (COVID-19) You have been given a decontaminated N95 What do I need to know about the emergency use of respirator that has been decontaminated using a the Battelle Decontamination System and decontamination system that is authorized to decontaminated N95 respirators? decontaminate compatible N95 respirators for multiple- user reuse by healthcare personnel (HCP) in a • The Battelle Decontamination System has been healthcare setting (i.e., HCP may receive a different authorized for emergency use to decontaminate respirator following decontamination than the one they compatible N95 respirators for multiple-user reuse had previously used) to help prevent HCP exposure to by HCP during the COVID-19 pandemic to prevent pathogenic biologic airborne particulates during the wearer exposure to pathogenic biological airborne COVID-19 pandemic. particulates, including SARS-CoV-2. o Compatible N95 respirators are either This Fact Sheet informs you of the significant known and authorized NIOSH-approved filtering facepiece potential risks and benefits of the emergency use of respirators (FFRs) or respirators that are decontaminated, compatible N95 respirators. These authorized and listed in Exhibit 1 to FDA’s compatible N95 respirators have been decontaminated emergency use authorization (EUA) for non- using the Battelle CCDS Critical Care Decontamination NIOSH-approved imported FFRs that are not System™ (hereafter referred to as “decontaminated manufactured in China, and that do not have N95 respirators” and “Battelle Decontamination exhalation valves or a duck-billed design, and do System" throughout this Fact Sheet). not contain cellulose-based materials or antimicrobial agents. The Battelle Decontamination System is not authorized for Whether or not you use a surgical mask, use with the following: • Respirators containing cellulose-based respirator, or face shield, always follow materials or antimicrobial agents; infection control measures: wash hands, • Respirators containing an exhalation cover coughs and sneezes, stay home if valve or a duck-billed design; and you may be sick. • Respirators that are authorized by the Non-NIOSH Approved Disposable Filtering Facepiece Respirators What are the symptoms of COVID-19? manufactured in China EUA. Many patients with confirmed COVID-19 have developed • Your healthcare facility is participating in a “Closed fever and/or symptoms of acute respiratory illness (e.g., System” or “Open System” arrangement with cough, difficulty breathing). However, limited information Battelle for decontamination of compatible N95 is currently available to characterize the full spectrum of respirators: clinical illness associated with COVID-19. Based on o Closed System – your healthcare facility collects what is known about the virus that causes COVID-19, compatible N95 respirators for decontamination signs and symptoms may appear any time from 2 to 14 by Battelle, and Battelle returns the days after exposure to the virus. decontaminated N95 respirators to your healthcare facility. Public health officials have identified cases of COVID-19 o Open System – a healthcare facility collects infection throughout the world, including the United compatible N95 respirators for decontamination States, which may pose risks for public health. Please by Battelle, and Battelle returns the check the CDC webpageREVOKED for the most up to date decontaminated N95 respirators to a different information. healthcare facility. o The two systems do not present different risks because the decontaminated N95 respirators Report Adverse events to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088 1 | Page FACT SHEET FOR HEALTHCARE PERSONNEL Coronavirus Disease 2019 Battelle Decontamination System for Decontaminating Compatible N95 Respirators January 21, 2021 (COVID-19) are for multiple-user reuse. See the section on breaks in or other damage to or degradation of the “What are the known and potential benefits and decontaminated N95 respirators to your healthcare risks of using decontaminated N95 respirators” facility. in this Fact Sheet for details. • Respirators that are NIOSH-approved before • Successful testing on decontaminated N95 decontamination (https://wwwn.cdc.gov/niosh-cel/) respirators demonstrated acceptable performance only retain their NIOSH approval status post- through 4 decontamination cycles for sporicidal decontamination if the respirator manufacturer activity, viricidal activity, filtration efficiency, permits the use of the decontamination method with breathability, form fit testing, and strap integrity the specific system and cycle parameters. To testing. determine the NIOSH approval status of a specific decontaminated NIOSH-approved respirator, please • Use of decontaminated N95 respirators: check with the respirator manufacturer and/or check Decontaminated N95 respirators are not sterile the respirator labeling. If a respirator is no longer HCP must perform a user seal check of the NIOSH-approved after use of the particular decontaminated N95 respirator according to decontamination method, its performance (i.e., fit, OSHA standards prior to beginning a shift. If the filtration, and breathability) might not consistently user seal check does not pass, the respirator meet NIOSH approved N95 standards. must be discarded HCP must receive the same model of Use appropriate personal protective equipment (PPE) decontaminated, compatible N95 respirator for when caring for individuals suspected of having COVID- which they have been fit tested. If such 19 as outlined in the CDC webpages, including Interim respirator model is unavailable, then healthcare Infection Prevention and Control Recommendations for facilities must provide HCP with fit testing prior Healthcare Personnel During the COVID-19 Pandemic, to using an alternative model of decontaminated, Infection Control, and FAQ on PPE. compatible N95 respirator Inspect respirators after each use prior to Current information on COVID-19 for healthcare submission for decontamination personnel is available at CDC’s webpage, Information Discard respirators with visible soiling (e.g., for Healthcare Professionals (see links provided in blood) or damage – do not use and do not send “Where can I go for updates and more information” for decontamination section). The number of times a respirator has been decontaminated is written on the respirator What are the known and potential benefits and risks (maximum 4 times) of using decontaminated compatible N95 respirators Report problems with decontaminated N95 that were decontaminated using the Battelle respirators to your healthcare facility Decontamination System? Potential benefits include: • Monitor yourself for signs and symptoms of • potential infection with SARS-CoV-2 or other May help prevent exposure to airborne pathogens, respiratory infection for up to and including 14 days and therefore reduce the risk of infection or illness after last contact with the SARS-CoV-2 virus and • Extends the usability of compatible N95 respirators related material, and promptly report such by allowing for decontamination and reuse information to your healthcare facility. REVOKEDPotential risks include: • Report damage or discoloration observed upon • Failure of filtration efficiency receipt of the decontaminated N95 respirators, and • Reduced breathability potential exposure of healthcare personnel from • Strap failure and ineffective face-fit Report Adverse events to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088 2 | Page FACT SHEET FOR HEALTHCARE PERSONNEL Coronavirus Disease 2019 Battelle Decontamination System for Decontaminating Compatible N95 Respirators January 21, 2021 (COVID-19) • Reused respirators may not have been effectively totality of scientific evidence available, it is reasonable to decontaminated of SARS-CoV-2 or other pathogens believe that the Battelle Decontamination System may • Cross-contamination from ineffective be effective at preventing HCP exposure to pathogenic decontamination biological airborne particulates during periods of insufficient respirator supply during the COVID-19 Overview of the Battelle Decontamination System pandemic by decontaminating, for a maximum of 4 decontamination cycles per respirator, compatible N95 The Battelle Decontamination System is a self-contained respirators that are contaminated or potentially decontamination device that uses vapor phase hydrogen contaminated with SARS-CoV-2 or other pathogenic peroxide (VPHP) for decontamination of compatible N95 microorganisms. respirators that are contaminated or potentially contaminated with SARS-CoV-2 and other pathogenic The EUA for the Battelle Decontamination System is in microorganisms. effect for the duration of the COVID-19 declaration justifying emergency use of medical devices, unless Each decontamination cycle in the Battelle terminated or revoked (after which the products may no Decontamination System consists of injecting VPHP into longer be used). the decontamination chamber until achieving a saturated atmosphere indicated by micro condensation; maintaining the VPHP exposure for a 150-minute dwell Where can I go for updates and more time; and allowing the VPHP
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