The FDA issued an emergency use authorization of a device used to sterilize compatible N95 respirators to help prevent exposure of health care personnel to the novel coronavirus.
The FDA authorized the emergency use of Advanced Sterilization Products, Inc. (ASP) STERRAD Sterilization Systems for the use of decontaminating compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms during the COVID-19 pandemic. The agency found reasonable belief that use of the systems may be effective in preventing exposure to pathogenic airborne particulates when there are insufficient supplies of N95 respirators during the pandemic by decontaminating N95 respirators for single-user reuse.
The FDA waived the following requirements for the systems for the duration of the emergency use authorization (EUA): (1) applicable current good manufacturing practice requirements, including the quality system requirements; and (2) labeling requirements under the Food, Drug, and Cosmetic Act, except that the systems must comply with the authorized labeling requirements stated in the EUA.
Conditions of authorization. ASP must make authorized labeling for the systems available through the ASP website and notify its distribution list of health care facilities. ASP must instruct health care facilities, including all new customers, to notify ASP if they intend to use the systems for the emergency use. ASP will send the appropriate authorized labeling to each health care facility that notifies ASP of such intent. ASP must have a process in place for reporting adverse events about the systems and the decontaminated respirators, and these must be reported to the FDA weekly. ASP must also ensure that any records associated with the EUA are maintained until otherwise notified by the FDA, and records must be made available to the FDA for inspection upon request.
Advertising and promotion. The EUA requires that all advertising and promotional descriptive printed matter relating to the use of the systems be consistent with the authorized labeling. It also requires that no advertising or promotional descriptive printed matter related to the use of the systems represent or suggest that the products are safe or effective for the prevention or treatment of patients with COVID-19. Advertising and promotional descriptive matter should clearly and conspicuously state that the systems have neither been cleared nor approved for the prevention of COVID-19, the systems have been authorized by the FDA under an EUA, and the systems are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the systems, unless authorization is terminated or revoked sooner.
Requirements for health care facilities. Health care facilities must notify ASP of their intent to use the systems for emergency use. Facilities using N95 respirators that have undergone decontamination using the systems must make available to health care personnel who are or may be using the respirators the authorized fact sheet and instructions required to be provided by ASP. Facilities using decontaminated N95 respirators must monitor health care personnel using such respirators for the signs and symptoms of potential infection with SARS-CoV-2 or other respiratory infection and promptly report such information to ASP for reporting to the FDA. Reports of adverse events should be reported up to and including 14 days after the last contact with suspected SARS-CoV-2 virus. Facilities using the decontaminated respirators must inspect the respirators following the decontamination process; any discoloration or other signs of degradation with a decontaminated respirator should promptly be reported to ASP, and the health care facility should discard the respirator. Facilities must track the number of times a respirator is decontaminated, up to a maximum of two decontamination cycles per respirator. Facilities should return each respirator to its previous user.
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