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…
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…
Newer COVID-19 subvariants show substantial escape from vaccination, previous infection immunity
Editor's Note In a letter published in the New England Journal of Medicine, researchers at Beth Israel Deaconess Medical Center, Boston, report that the three Omicron subvariants (BA.2.12.1, BA.4, and BA.5) currently dominant in the US substantially escape neutralizing antibodies induced by both vaccination and previous COVID-19 infection. The researchers…
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…
Machine learning model uses data from wearable devices to detect COVID-19 in HCWs
Editor's Note Researchers at the Icahn School of Medicine, Mount Sinai, New York City, have developed a machine learning model that uses physiological metrics collected from wearable devices that can detect and predict COVID-19 in healthcare workers (HCWs). A total of 407 HCWs from 7 hospitals were enrolled in the…
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…
HHS publishes guidance for health systems to strengthen cybersecurity
Editor's Note On June 16, the US Department of Health and Human Services (HSS) Health Sector Cybersecurity Coordination Center published a guidance, titled “Strengthening Cyber Posture in the Health Sector, to help health systems and other healthcare organizations “improve their overall strength, protocols, and prevention abilities for cyberattacks,” Becker’s Health…
FDA monitoring pulse oximeter accuracy and limitations
Editor's Note The US Food and Drug Administration (FDA) released a safety communication update on June 21 alerting providers that the agency “continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance.” A May 2022 study published by JAMA Internal Medicine showed that…
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- FDA launches effort to identify, slash outdated healthcare regulations under 10-to-1 rule
- The Joint Commission, NFQ announce 2024 Eisenberg Award recipients
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