FDA: Class I recall of Arrow Endurance Extended Dwell Peripheral Catheter System
Editor's Note The Food and Drug Administration (FDA), on June 26, identified the recall by Teleflex, and their subsidiary Arrow International, of the Arrow Endurance Extended Dwell Peripheral Catheter System as Class I, the most serious. The recall was initiated because of the risk of catheter separation and leakage. If…
Pfizer warns FDA of penicillin shortage
Editor's Note Pfizer alerted the Food and Drug Administration (FDA) on June 12 that its supply of two forms of injectable penicillin—Bicillin L-A and Bicillin C-R—may run out by the end of this month, the June 13 The Hill reports. Pfizer cited a combination of factors for the shortage, including…
FDA: Class I recall of Walnut Wearable Smart Thermometers
Editor's Note The Food and Drug Administration, on June 12, identified the recall of the rechargeable Walnut Wearable Smart Thermometer as Class I, the most serious. BearCare, Inc, is recalling the thermometers after receiving reports of skin burns and irritation resulting from use of the device. The company reports five…
The Joint Commission, NQF accepting applications for 2023 Eisenberg Awards
Editor's Note The Joint Commission and National Quality Forum (NQF) announced, on June 12, that they are now accepting applications for the 2023 John M. Eisenberg Patient Safety and Quality Awards, through August 7. The annual Awards, which recognize major achievements by individuals and organizations that use innovative approaches to…
FDA: Class I recall of specific Abiomed Impella 5.5 with SmartAssist heart pumps
Editor's Note The Food and Drug Administration (FDA), on June 5, identified the recall by Abiomed of specific Impella 5.5 with SmartAssist heart pumps as Class I, the most serious. The recall was initiated because of fluid leaking from the purge sidearm of the pump. If the leak issue is…
The Joint Commission revises CAH requirements to align with CMS
Editor's Note The Joint Commission, on May 31, announced that it has added several new and revised elements of performance (EPs) for critical access hospitals (CAHs) that address restraint and seclusion, the complaint process, and unified and integrated structures for CAHs that are part of a multihospital system, effective June…
Mobilization associated with fewer postoperative complications, shorter hospital stays
Editor's Note In a recent study led by researchers at Cleveland Clinic in Cleveland, OH, mobilization after elective surgery was found to be associated with fewer postoperative complications and shorter lengths of stay (LOS), and is an important component of Enhanced Recovery After Surgery (ERAS) protocols. This retrospective observational study…
FDA: Class I recall of certain SD BioSensor Pilot COVID-19 At-Home Tests
Editor's Note The Food and Drug Administration (FDA), on May 25, identified the recall by SD BioSensor, Inc, of certain Pilot COVID-19 At-Home Tests as Class I, the most serious. The recall was initiated because the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus,…
FDA: Class I recall of Draeger Medical’s Seattle PAP Plus, breathing circuit/anesthesia kits
Editor's Note The Food and Drug Administration (FDA), on May 24, identified the recall by Draeger Medical of the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits as Class I, the most serious. The recall was initiated after finding that glued connections may loosen before or…
FDA: Class I recall of certain ICU Medical infusion system batteries
Editor's Note The Food and Drug Administration (FDA), on May 22, identified the recall by ICU Medical of replacement batteries for its Plum 360, Plum A+, and Plum A+3 infusions systems as Class I, the most serious. The recall was initiated because a manufacturing defect substantially diminished how long the…
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