FDA Warns Against Use of Certain N95 Respirators
The FDA is altering their instruction to health care facility risk managers, procurement staff, and health care personnel to stop using N95 respirators made by the Shanghai Dasheng Health Products Manufacture Co., Ltd. All respirator approvals previously issued to this company have now been revoked because the company failed to implement, maintain, and control a quality management system. “All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval,” noted the Letter to Health Care Providers that went out on Aug. 25. Read More
New Lung Model Under Development
Researchers from McMaster and SickKids in Canada have received a $1 million National Sanitarium Association research grant to work toward the development of a bioengineered lung model that’s being dubbed a “clinical trial on a plate.” The model will replicate key features of the human lung, including specialized cells, blood vessels, and immune functions. “To better prepare for future pandemics, more sophisticated human lung models are needed to study disease and treatments with more precision,” said study lead Boyang Zhang. “Our lung model platform will improve clinical trial designs for COVID-19 and beyond, with broad applications to drug development, immunology, and developmental biology of the lung.” Read More
Post-Acute COVID Study Gets Underway
CHI Health Creighton University Medical Center-Bergan Mercy in Omaha, NE, the University of Texas Southwestern Medical Center in Dallas, TX, and Mount Sinai Medical School and Health System in New York City, NY, have been selected by the CDC to carry out a study on post-acute COVID-19. The investigators will examine the epidemiology of the condition to determine what percentage of COVID patients are affected and which symptoms they have. Several hundred patients will be enrolled beginning two weeks following their bout with COVID-19 or a COVID-19 hospitalization. Read More
Smart Inhaler Device Receives New Patent
According to Vivera, the U.S. Patent and Trademark Office has issued a second patent to the company for its ZICOH technology. The technology is incorporated into the company’s smart inhaler device, which features automated dose delivery, measurement, and management of medications. The company previously received a U.S. patent recognizing the ZICOH as a dose-controlled medication delivery device. “ZICOH is going to revolutionize the way drugs are prescribed, taken, and managed, especially those with low compliance or high abuse rates,” said Vivera Chairman and CEO Paul Edalat. In addition to its use for respiratory conditions like COPD and asthma, the company foresees a role for the technology in monitoring addictive medications currently fueling the opioid crisis. Read More
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Debbie Bunch is an AARC contributor who writes feature articles, news stories, and other content for Newsroom, the AARC website, and associated emailed newsletters. In her spare time, she enjoys reading, traveling, photography, and spending time with her children and grandchildren. Connect with Debbie by email or on AARConnect or LinkedIn.
