The U.S. Department of Health and Human Services said in an interim final rule that battery-powered air purifying particulate respirators (PPAR100), along with gas and vapor respirators, may be used by health care workers in the absence of respirator masks. PPAR100 devices are regulated by the National Institute for Occupational Health and Safety.
The U.S. FDA said that it has granted emergency use authorization (EUA) status to several sterilization systems from Steris Corp., of Mentor, Ohio, for decontamination of N95 masks and equivalent respirator masks for the COVID-19 pandemic. The Steris systems covered under the EUA, which includes several models under the V-Pro brand, use vaporized hydrogen peroxide and must be used in the non-lumen cycle only. A maximum of 10 masks in pouches can be sterilized in a given run, the FDA said.
The FDA said it has granted EUA authorization to Terumo BCT Inc., of Lakewood, Colo., and Marker Therapeutics AG, of Zug, Switzerland, for use of the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge devices as a blood purification system to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit with confirmed or imminent respiratory failure. The product works by reducing the amount of cytokines and other inflammatory mediators by filtering the blood and returning the filtered blood to the patient.