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March 4, 2022

Around the nation: FDA issues warnings for 3 unauthorized at-home Covid-19 tests

Daily Briefing

    FDA on Tuesday issued warnings for three unauthorized at-home Covid-19 tests over the risk of false results, in today's bite-sized hospital and health industry news from Maryland, Missouri, and New Jersey.

    • Maryland: FDA on Tuesday issued warnings for three at-home Covid-19 tests over the risk of false test results. The three tests were ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), SD Biosensor Standard Q Covid-19 Ag Home Test, and Celltrion USA DiaTrust Covid-19 Ag Rapid Test—none of which are authorized by FDA. Currently, the agency has not received any reports of injuries, adverse health reactions, or deaths tied to the use of the unauthorized tests. (Gleeson, Becker's Hospital Review, 3/2)
    • Missouri: Missouri lawmakers on Wednesday advanced a bill that would allow visitors in hospitals and nursing homes statewide, even during a pandemic. Under the bill, a patient's spouse, parent, or guardian, and just one other person would be able to visit at any time. The measure was given initial approval in Wednesday's voice vote, which means it will need an additional vote to move to the GOP-led Senate. The bill came in response to strict visitor limits in hospitals and nursing homes during the start of the Covid-19 pandemic. Republican House members said that some patients died alone, without friends or family by their side because of the visitor restrictions. According to state Rep. Ed Lewis (R), patients need an "advocate" when they're at their most vulnerable. "That person should be able to have someone that can speak for them and make sure that they get the quality health care that they ought to have," Lewis added. (AP/Modern Healthcare, 3/3)
    • New Jersey: RWJBarnabas Health on Tuesday announced that chief strategy and business development officer, Mark Manigan, had been appointed as president of the health system, effective immediately. In addition, Manigan will take over as CEO following previous RWJBarnabas president, Barry Ostrowsky's retirement at the end of 2022. Ostrowsky will retain the title of CEO until that time, and Manigan will officially step into the CEO role on Jan. 1, 2023. "Mark Manigan is a formidable strategist who has driven remarkable growth and expansion for the health system since joining in 2019," Ostrowsky said. "In defining those attributes for success needed in our next leader, the Board sought an individual with a broad portfolio of experiences, plus a bold vision for the future. I am confident that Mark brings all these skills and much more to this position." (Ray, HealthLeaders Media, 3/2)

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