Regulations/Legal
FDA: Class I recall of Arrow International’s Arrow-Trerotola PTD
Editor's Note The Food and Drug Administration (FDA) on February 23 identified the recall by Arrow International (Reading, Pennsylvania), a subsidiary of Teleflex Inc, of its Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) as Class I, the most serious. The recall was initiated because of the risk of tip damage during use…
Study: COVID-19 linked with increased risk of diabetes in youths
Editor's Note According to a study in the Morbidity and Mortality Weekly Report, COVID-19 increases the risk of and may contribute to new-onset diabetes among children and adolescents, JAMA reports. JAMA’s February 22 article notes that data from previous studies showed an average of 14% of adults hospitalized with COVID-19…
FDA: Class I recall of Vyaire Medical’s Bellavista Ventilators
Editor's Note The Food and Drug Administration (FDA) on February 17 identified the recall by Vyaire Medical (Mettawa, Illinois) of its Bellavista 1000 and 1000e Series Ventilators as Class I, the most serious. The recall was initiated because of issues with the software version 6.0.1600.0 or higher, after reports of…
CDC report: US maternal mortality rate higher in 2020
Editor's Note The Centers for Disease Control and Prevention (CDC) on February 23 released the “Maternal Mortality Rates in the United States” report for 2020, after analyzing data from the National Vital Statistics System and calculating mortality rates as the number of maternal deaths per 100,000 live births. The report…
The Joint Commission releases 10 most common sentinel events of 2021
Editor's Note The Joint Commission recently released a Sentinel Event Data summary that includes a 2021 update and the 10 most common sentinel events reported to the accreditation body last year, the February 22 Becker’s Hospital Review reports. Only a small portion of all sentinel events are reported to The…
FDA: Class I recall of BASE10 Genetics RNAstill MTM specimen collection kits
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by BASE10 Genetics of its RNAstill MTM specimen collection kits as Class I, the most serious. The specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples…
FDA: Class I recall of E25Bio COVID-19 Direct Antigen Rapid Tests
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by E25Bio (Cambridge, Massachusetts) of its COVID-19 Direct Antigen Rapid Tests as Class I, the most serious. The tests are being recalled for several reasons, particularly because they were marketed and distributed in the US without…
The Joint Commission FAQ on educational expectations for privileged practitioners
Editor's Note In addition to education required to maintain licensure and certifications, each practitioner privileged through the medical staff process is expected to participate in hospital-sponsored continuing education, The Joint Commission says in a February 16 answer to a frequently asked question (FAQ) on accreditation requirements. The education is based…
Telehealth accounted for 8% of outpatient visits a year into pandemic
Editor's Note A new report published by KFF-Epic Research found that telehealth still represents a substantial share of healthcare delivery despite its use having decreased somewhat from the high seen at the start of the pandemic, the February 16 Healthcare Purchasing News reports. The research presents data from more than…
HHS says more funding is needed to combat COVID-19
Editor's Note According to the February 16 Becker’s Hospital Review, Health and Human Services (HHS) Secretary Xiaver Becerra said the Biden administration is estimating it will need some $30 billion to continue to fight against COVID-19. Another HHS representative told Politico the funding is needed "for additional resources to support…
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