The FDA has announced that it will allow the use of dry heat to lower the bioburden on masks used by healthcare workers treating COVID-19 patients. While not authorizing equipment made by a particular company, guidance released last week said healthcare providers may use dry heat to reprocess NIOSH-approved filtering facepiece respirators, such as N95s, […]
National Institute for Occupational Safety and Health
Patient safety group: Most KN95 masks inferior
Up to 70% of KN95 masks tested by patient-safety organization ECRI do not meet U.S. standards for effectiveness, the group announced today. The findings indicate increased risks of contracting COVID-19 for care providers and patients at hospitals and other healthcare organizations that imported the masks from China, according to the Plymouth, Pa.-based, not-for-profit group. Get the […]
GM receives N95 certification for Michigan-made respirators
General Motors (NYSE:GM) announced today that the National Institute for Occupational Safety and Health has provided an N95-level certification for the respirators the automaker is churning out of its Warren, Mich. plant. NIOSH, which is part of the CDC, created the new certification process in order to increase the supply of filtering facepiece respirators needed […]
FDA yanks 60 Chinese companies’ respirators from emergency use list
The FDA has removed respirators made by 60 companies in China from its emergency use authorization (EUA) list for COVID-19 over concerns that they may be “sub-standard.” The list, which had totaled 74 manufacturers when issued April 24, still includes 15 models of N95 respirators made in China by 3M (NYSE:MMM), plus a number of models […]
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 […]
FDA authorizes industrial respirators for use during coronavirus
The FDA has authorized the use of certain industrial respirator masks for healthcare workers during the coronavirus outbreak. The N95 disposable filtering facepiece respirators have been approved by the National Institute for Occupational Safety and Health (NIOSH) as non-powered air-purifying particulate respirators. Healthcare workers will be allowed to use these, including those that have passed […]
