Regulations/Legal
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…
FDA: Class I recall of one lot of Draeger SafeStar 55 Breathing System Filters
Editor's Note The Food and Drug Administration (FDA) on June 21 identified the recall by Draeger, Inc, of one lot (LT2103) of its SafeStar 55 Breathing System Filters as Class I, the most serious. The Breathing System Filter is used as part of a ventilator when a patient is under…
FDA, CDC recommend COVID-19 vaccines for children under 5 years old
Editor's Note The Food and Drug Administration (FDA) authorized COVID-19 vaccines for children as young as 6 months old, which expands eligibility to some 20 million babies, toddlers, and preschoolers, CBS News June 17 reports. After convening on Saturday, June 18, the Centers for Disease Control and Prevention (CDC) also…
AHA urges ‘swift’ passing of Senate package to reduce gun violence
Editor's Note The American Hospital Association (AHA) this week voiced support for the Senate’s bipartisan framework to help reduce gun violence in communities, AHA June 14 reports. The proposal includes provisions to help the country to combat violence and make “critical investments” in behavioral healthcare, school safety resources, and support…
Free Daily News
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