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…
ECRI announces 2023 Alerts Impact Award winners
Editor's Note ECRI, on May 18, announced the winners of its annual 2023 Alerts Impact Award. The Award is given to members of ECRI’s Alerts Workflow system for excellence in recall management. The system’s software is used by supply chain, clinical engineering, IT, pharmacy, lab, clinical departments, and ancillary-care points…
Motor vehicle crash risk after general surgery
Editor's Note Because there is limited data to guide return to driving recommendations for patients after surgery, researchers at the Massachusetts General Hospital, Boston, performed this nested case-crossover study to find if the risk of a motor vehicle crash increases after surgery, compared to before. The analysis included 70,722 licensed…
Five plead guilty in fraudulent nursing diploma scheme
Editor's Note Five of dozens of defendants charged in the Southern District of Florida for their alleged participation in an illegal licensing scheme for aspiring nurses have plead guilty to wire fraud conspiracy, according to a May 15 news release from the US Attorney’s Office, Southern District of Florida. All…
USPSTF recommends mammograms for women starting at 40
Editor's Note The US Preventive Services Task Force (USPSTF) on May 9, issued a new draft recommendation on screening for breast cancer, recommending that all women get screened for breast cancer every other year starting at age 40. In a statement, the American College of Radiology (ACR) and Society of…
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