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National Institute for Occupational Safety and Health

FDA allows dry heat treatment for single-user mask reuse

November 30, 2020 By Nancy Crotti

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, […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Lab Instruments & Supplies, Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, National Institute for Occupational Safety and Health, U.S. Centers for Disease Control and Prevention

Patient safety group: Most KN95 masks inferior

September 22, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Respiratory Tagged With: coronavirus, COVID-19, ECRI Institute, FDA, National Institute for Occupational Safety and Health

GM receives N95 certification for Michigan-made respirators

July 14, 2020 By Chris Newmarker

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 […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance, Respiratory Tagged With: coronavirus, COVID-19, General Motors, National Institute for Occupational Safety and Health

FDA yanks 60 Chinese companies’ respirators from emergency use list

May 7, 2020 By Nancy Crotti

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: 3m, coronavirus, COVID-19, Defense Production Act, FDA, National Institute for Occupational Safety and Health, U.S. Department of Defense

FDA eases mask regulations, seeks to boost decontamination of used masks

April 3, 2020 By Nancy Crotti

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 […]

Filed Under: 510(k), Business/Financial News, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: 3m, Battelle, Centers for Disease Control & Prevention (CDC), coronavirus, COVID-19, Donald Trump, FDA, National Institute for Occupational Safety and Health

FDA authorizes industrial respirators for use during coronavirus

March 3, 2020 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Respiratory Tagged With: Centers for Disease Control & Prevention (CDC), coronavirus, FDA, National Institute for Occupational Safety and Health

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