The U.S. Food and Drug Administration issued an emergency use authorization (EUA) that has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by health care workers in hospital settings, the administration announced on Monday.
“Our nation’s health care workers are among the many heroes of this pandemic and we need to do everything we can to increase the availability of the critical medical devices they need, like N95 respirators,” said FDA Commissioner Stephen M. Hahn, M.D.
The FDA granted the EUA to Advanced Sterilization Products (ASP) for the STERRAD Sterilization Cycles (STERRAD 100S Cycle, STERRAD NX Standard Cycle, or STERRAD 100NX Express Cycle), which uses vaporized hydrogen peroxide gas plasma sterilization.
There are approximately 9,930 STERRAD Sterilization systems in approximately 6,300 hospitals across the U.S. STERRAD 100S Cycle, STERRAD NX Standard Cycle and STERRAD 100NX Express Cycle vary in reprocessing times from 55 minutes, to 28 minutes, and 24 minutes. Each can reprocess approximately 480 respirators per day.
Battelle was awarded a EUA to support front-line healthcare workers as they face critical shortages of personal protective equipment (PPE) in March 2020.
“I want to thank the FDA team for their professionalism and help in authorizing the use of our technology at this critical moment for our nation,” said Lou Von Thaer, President and CEO of Battelle and five-time Wash100 Award recipient. “Everybody who has worked on this project shares the same goal of protecting first responders and healthcare workers who are at the front lines of the pandemic.”
The Battelle CCDS Critical Care Decontamination System will operate at Battelle’s West Jefferson, Ohio facility under the EUA and is capable of decontaminating up to 80,000 respirator masks per system each day using concentrated, vapor phase hydrogen peroxide (VPHP).
The respirator masks are exposed to the validated concentration level for 2.5 hours to decontaminate biological contaminants, including SARS-CoV-2. Battelle CCDS can decontaminate the same respirator mask up to 20 times without degrading the mask’s performance.
In addition, the FDA awarded PerkinElmer an EUA for the Company’s New Coronavirus RT-PCR test.
“Despite the challenging environment, our employees have demonstrated unwavering commitment over the past two months to combat this global pandemic,” said Prahlad Singh, president and chief executive officer, PerkinElmer. “The breadth of PerkinElmer’s total workflow solution puts us in a unique position to rapidly address the needs of our clinical diagnostics customers.”
PerkinElmer’s RT-PCR test is marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is available in over 30 countries worldwide. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this kit to detect SARS-CoV-2, the virus that causes COVID-19.
“FDA staff continue to work around the clock, across government and with the private sector to find solutions. This authorization will help provide access to millions of respirators so our health care workers on the front lines can be better protected and provide the best care to patients with COVID-19,” Hahn added.
The FDA EUAs have continued the administration’s effort to combat the COVID-19 pandemic. The administration has additionally developed a new program across public, academic and private sectors to fight COVID-19 in April 2020.
“The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible,” said HHS Secretary Alex Azar. “As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies.”
The program is designed to expedite the development of potentially safe and effective life-saving treatments. The Coronavirus Treatment Acceleration Program (CTAP) will utilize new tools to develop and deliver therapies to sick patients as quickly as possible, as well as support research to further evaluate whether the treatments are safe and effective for treating patients with COVID-19.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.