Regulations/Legal
FDA recommends updating boosters to target Omicron
Editor's Note The Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee on June 28 recommended updating the composition of COVID-19 booster vaccines to target the Omicron variant. The Committee noted that booster doses consisting of an Omicron monovalent or bivalent vaccine could improve neutralizing antibody responses…
The Joint Commission issues new Quick Safety on managing packaged sterile supplies, devices
Editor's Note The Joint Commission, on June 28, announced a new Quick Safety advisory on “Managing packaged sterile supplies and devices.” The advisory provides guidance to keep patients safe from infection and harm from expired or compromised supplies and devices and urges healthcare workers (HCWs) to pay close attention to…
FDA: Class I recall of GE Healthcare’s CARESCAPE R860 Ventilator
Editor's Note The Food and Drug Administration (FDA) on June 28 identified the recall by GE Healthcare of its CARESCAPE R860 Ventilator as Class I, the most serious. The recall was initiated because the ventilator backup batteries, including replacement backup batteries, may run out before they are expected to do…
FDA: Class I recall of Baxter’s Volara system with in-line ventilator adaptor
Editor's Note The Food and Drug Administration (FDA) on June 23 identified the recall by Baxter Healthcare Corporation of its Volara system with in-line ventilator adaptor as Class I, the most serious. The Volara system is used to clear mucus out of airways, expand lungs, and treat or prevent pulmonary…
Contrast media shortage reveals cracks in supply chain
May 2022 saw a critical shortage of the iodinated contrast medium (ICM) iohexol that extended well into June because of a COVID-19-related shutdown of a GE Healthcare plant in Shanghai, China, that interrupted the manufacture of ICM. According to the American College of Radiology, contrast media were added to the…
Most hospitals not providing price information for TJAs as required by CMS
Editor's Note This study from the Cleveland Clinic finds that less than one-third of US hospitals were fully compliant in 2021 with the transparency in pricing for total joint arthroplasty (TJA) rule mandated by the Centers for Medicare and Medicaid Services (CMS). Of 400 hospitals analyzed between December 1 and…
CDC: US COVID-19 cases, deaths declining
Editor's Note According to the June 24 Becker’s Hospital Review, the Centers for Disease Control and Prevention’s (CDC’s) latest US COVID-19 statistics include the following: As of June 23, the 7-day average for newly reported COVID-19 cases dropped 5.6% to 97,430. The weekly average for COVID-19 related deaths dropped by…
FDA: Class I recall of Medtronic’s HVAD batteries
Editor's Note The Food and Drug Administration (FDA), on June 23, identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) batteries as Class I, the most serious. The recall for a single lot (Model Number:1650DE) of HVAD batteries was initiated because of welding defects that allow separation…
The Joint Commission: New R3 Report on reducing healthcare disparities
Editor's Note The Joint Commission on June 22 announced a new “R3 Report—Issue 36: New Requirements to Reduce Health Care Disparities,” which examines the rationale and references behind new and revised requirements to reduce healthcare disparities in accredited organizations, effective January 1, 2023. Among the new and revised requirements: A…
The Joint Commission: New R3 Report on requirements for antibiotic stewardship
Editor's Note The Joint Commission on June 22 announced a new “R3 Report—Issue 35: New and Revised Requirements for Antibiotic Stewardship,” which details the rationale and references behind new and revised requirements to optimize the use of antibiotics, effective January 1, 2023. The requirements include 12 new and revised elements…
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