Brigham & Women’s Hospital says it is developing a new, sustainable alternative to N95 respirator masks that are in demand during the COVID-19 pandemic. A team of bioengineers and clinical experts at the Boston-based hospital and the Massachusetts Institute of Technology (MIT) are working on the “injection molded autoclavable, scalable, conformable” iMASC system for providing […]
FDA restricts re-use of certain respirators for COVID-19
Certain respirators made in China and respirators with exhalation valves should not be decontaminated for re-use by healthcare workers, the FDA announced today. The agency revised these respirators’ emergency use authorizations (EUAs) to reflect the changes. The particular respirators from China “may vary in their design and performance,” the FDA said, basing its decision on […]
FDA warns of cyanide gas danger with improper use of Hologic COVID-19 tests
The FDA warned laboratories today that using certain transport media for COVID-19 samples with Hologic (NSDQ:HOLX) Panther and Panther Fusion diagnostic systems can produce deadly cyanide gas. Transport media is the liquid that maintains a specimen sample while it is transported to a laboratory. The Hologic Panther systems and others that have been sterilized using bleach […]
Battelle under fire for decontamination system performance
Major media outlets are questioning the ability of the Battelle Critical Care Decontamination System (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed. The FDA granted the nonprofit tech development company an emergency use authorization in March for its vaporized hydrogen peroxide system to decontaminate N95 respirators used […]
Steris wins second EUA to decontaminate up to 30m respirators per day
Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA […]
Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple deaths, cancer, […]
Cleanbox launches UV-C mask decontamination device
Cleanbox Technology announced that it is launching its CleanDefense ultraviolet point-of-use mask decontamination product in response to the COVID-19 pandemic. The Carlsbad, Calif.-based company’s technology uses UV-C light in an LED to decontaminate products worn on the face or the head with a focus on high-risk contagion transfer points. According to a news release, Cleanbox […]
AtomicBlue launches ultraviolet light device to decontaminate N95 masks
Atomic Blue announced today that it launched a UV-C germicidal light to eradicate the COVID-19 virus during equipment decontamination processes. Earlier this month, the National Institutes of Health validated four methods for mask decontamination, one of which was ultraviolet light. Atomic Blue said in a news release that the NIH tested its UV-C germicidal light, […]
FDA issues EUA for Sterilucent N95 hydrogen peroxide sterilization
The FDA has granted Sterilucent emergency use authorization (EUA) for its hydrogen peroxide sterilizer for use with N95 and N95-equivalent respirators — the latest in a string of mask sterilizers receiving EUAs amid the coronavirus pandemic. Minneapolis-based Sterilucent’s HC 80TT vaporized hydrogen peroxide sterilizer may now be used to decontaminate the single-use compatible respirators that […]
Could respirator decontamination solve shortage problems?
The FDA has issued an emergency use authorization for the Battelle Critical Care Decontamination System, which can decontaminate tens of thousands of respirator masks per day so that health personnel can reuse them. The Columbus, Ohio-based nonprofit tech development company announced on March 28 that it began rapid manufacturing of its system to decontaminate N95 […]
Medline reopens Illinois medtech sterilization plant
Medline Industries resumed sterilization operations at its Waukegan, Ill., plant on Friday, following state certification of the company’s $10 million in emission-control upgrades, the company announced. The Waukegan plant reopening follows the decision this week by officials in Cobb County, Ga., to allow an Atlanta Sterigenics EtO plant to reopen for 21 days to sterilize devices and products […]
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