Battelle announced today that it entered into a collaborative agreement with Spark Biomedical to jointly run a pilot clinical study. Through the joint study, the two companies aim to advance the remote detection and treatment of opioid use disorder (OUD) using wearable biosensors. According to a news release, the study’s primary objective is to collect […]
Battelle
FDA revokes Battelle mask decontamination EUA
The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers. In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. […]
FDA says to limit mask decontamination to 4 cycles
Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times. The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major media […]
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 […]
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 […]
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 […]
Stryker gains emergency nod for respirator decontamination
The FDA has granted Stryker (NYSE:SYK) an emergency use authorization to decontaminate used N95 respirators using the company’s Sterizone VP4 sterilizer during the coronavirus outbreak. The Sterizone VP4 uses vaporized hydrogen peroxide to sterilize up to 20 of the masks in one cycle, according to the FDA. Stryker’s sterilizer is the fourth that uses vaporized hydrogen […]
U.S. Defense Department using Defense Production Act to boost N95 masks supply
The U.S. Defense Department is using the Korean War-era Defense Production Act to boost the nation’s supply of N95 respirator masks by 39 million over the next 90 days. Defense Secretary Mark T. Esper made the announcement yesterday, saying the $133 million contract would “ensure our government has the industrial capacity to meet the nation’s […]
Steris wins FDA nod to sterilize used respirators in hospitals
The FDA has granted Steris (NYSE:STE) emergency use authorization (EUA) for a vaporized hydrogen peroxide system to decontaminate up to 750,000 N95 respirators and equivalent masks per day in hospitals treating COVID-19 patients. The Steris V-PRO 1 Plus, maX and maX2 low-temperature sterilization systems use the Steris N95 non-lumen decontamination cycle. Hydrogen peroxide vapor fills the […]
Aptar applies for EUA for N95 decontamination process
Aptar announced that it is seeking FDA emergency use authorization (EUA) for its N95 mask decontamination process with ActivShield. The N95 masks (produced by Honeywell (NYSE:HON) and 3M (NYSE:MMM)) are in short supply and high demand during the COVID-19 pandemic. To disinfect the masks, a small strip of Aptar’s ActivShield is placed alongside an N95 mask inside a […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency […]