Regulations/Legal
Joint Commission’s Quick Safety Issue 65 on managing packaged sterile supplies, devices
Editor's Note On June 14, The Joint Commission issued a new Quick Safety report to provide guidance for managing and storing packaged sterile supplies. Organizations must identify the best location to store supplies so staff can readily access them, and ensure the supplies are being stocked to the most optimal…
FDA: Class I recall of Woodside Acquisitions’ Oral Rapid and Joysbio SARS-CoV-2 Antigen Rapid Test Kits
Editor's Note The Food and Drug Administration (FDA) on June 9 updated the Class I recall by Woodside Acquisitions Inc of its Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) that are not authorized, cleared, or approved by the FDA. The FDA…
HCW COVID-19 exposures linked to lapses in eye protection
Editor's Note In this study, researchers from the Mayo Clinic, Rochester, Minnesota, find that the use of eye protection by health care workers (HCWs) is important in preventing patient-to-HCW transmission of COVID-19. Of 345 HCWs who had a significant occupational exposure to patients with COVID-19, nurses accounted for 55.8%,…
CDC lifts pre-departure COVID-19 testing for international travelers
Editor's Note The Centers for Disease Control and Prevention (CDC) on June 10 announced that it will no longer require international travelers to have a negative COVID-19 test before flying to the US, effective June 12. The CDC continues to recommend that travelers flying to the US get tested as…
Analysis: Even small amounts of exercise help lower depression risk
Editor's Note A systematic review and meta-analysis published in JAMA Psychiatry on April 13 shows that even small amounts of low-intensity physical activity can decrease risk of depression among adults, JAMA Network June 7 reports. The analysis included 15 cohort studies comprising 191,130 participants. The researchers estimated that if adults…
FDA: Class I recall of Medtronic HVAD Pump Implant Kit
Editor's Note The Food and Drug Administration (FDA) on June 8 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit as Class I, the most serious. The HVAD System is used as a bridge to cardiac transplants. The Kit was recalled because of a…
Bill introduced to protect HCWs like airline staff
Editor's Note US Representatives Madeleine Dean (D-Pa) and Larry Bucshon, MD, (R-Ind) on June 7 introduced a Bill to protect healthcare workers (HCWs) from violence that is modeled after protections for airline workers, the June 8 Becker’s Hospital Review reports. The Safety from Violence for Healthcare Employees Act would criminalize…
FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators
Editor's Note The Food and Drug Administration on June 3 identified the recall by Philips Respironics of all V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because an internal power fluctuation may cause the ventilator to shut down unintentionally with or without any…
Association of COVID-19 booster and Omicron in the NBA
Editor's Note This study, led by researchers at IQVIA, Durham, North Carolina, finds that in a young, healthy, highly vaccinated cohort of players and staff in the National Basketball Association (NBA), booster vaccinations were associated with a significant reduction in COVID-19 infections during the Omicron wave. Of 2,613 players and…
FDA: Class I recall of Atrium Medical’s iCast Covered Stent
Editor's Note The Food and Drug Administration (FDA) on June 2 identified the recall by Atrium Medical Corporation of its iCast Covered Stent System as Class I, the most serious. The recall was initiated because of increased complaints about the separation of the balloon or catheter hub from the delivery…
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