Supply Chain/Technology

Latest Issue of OR Manager
December 2022
Home Supply Chain/Technology

FDA: Class I recall of Integra’s CereLink ICP Monitor

Editor's Note The Food and Drug Administration (FDA) on August 31 identified the recall by Integra of its CereLink ICP Monitor as Class I, the most serious. The recall was initiated because the device may display incorrect values for a patient’s intracranial pressure (ICP) and display out-of-range pressure readings. If…

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By: Judy Mathias
September 2, 2022
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Study: Rubber bands enhance surgical mask seal akin to N95 protection

Editor's Note In this recent study, titled “A simple surgical mask modification to pass N95 respirator-equivalent fit testing standards during the COVID-19 pandemic” and published by PLOS ONE on August 24, the use of rubber bands worn over standard 3-layer surgical masks is shown to improve the mask’s protective seal…

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By: Tarsilla Moura
September 1, 2022
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FDA: Class I recall of Hamilton-C6 Intensive Care Ventilator

Editor's Note The Food and Drug Administration (FDA) on August 29 identified the recall by Hamilton Medical AG of its Hamilton-C6 Intensive Care Ventilator as Class I, the most serious. The recall was initiated because of potential water ingress between the indicator board and the ventilator’s main board that may…

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By: Judy Mathias
September 1, 2022
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FDA: Class I recall of Intera 3000 Hepatic Artery Infusion Pump

Editor's Note The Food and Drug Administration on August 29 identified the recall by Intera Oncology of its Intera 3000 Hepatic Artery Infusion Pump as Class I, the most serious. The company is recalling the pumps after receiving reports from clinicians that the pumps were delivering medication faster than expected.…

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By: Judy Mathias
August 31, 2022
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Free at-home COVID-19 tests distribution to end this Friday

Editor's Note  On Friday, September 2, the US government will stop giving away free at-home COVID-19 tests because of insufficient congressional funds, according to a senior Biden administration official, NBC News August 28 reports. The White House official said unless there is a surprise round of funding from Congress, the…

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By: Lauren McCaffrey
August 30, 2022
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FDA: Class I recall of Medtronic’s HeartWare HVAD system batteries

Editor's Note The Food and Drug Administration on August 25 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system batteries as Class I, the most serious. Medtronic is recalling the batteries because they may experience electrical faults that cause them to unexpectedly fail. A similar recall…

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By: Judy Mathias
August 29, 2022
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ANSI/AAMI ST98 provides cleaning validation requirements for device manufacturers

Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) on August 24 announced the publication of a new standard: “ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices.” The new standard not only provides manufacturers with a formalized…

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By: Judy Mathias
August 25, 2022
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FDA: Hospira recalls another lot of Propofol

Editor's Note The Food and Drug Administration (FDA) on August 22 posted the Hospira Inc (a Pfizer company) recall of one lot of Propofol Injectable Emulsion (containing Benzyl alcohol), 100 mL single patient use glass fliptop vials, lot EA7470. The recall was initiated because of visible particulates observed in two…

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By: Judy Mathias
August 23, 2022
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FDA: Class I recall of Medtronic Cobalt/Crome ICDs, CRT-Ds

Editor's Note The Food and Drug Administration (FDA) on August 19 identified the recall by Medtronic of its Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious. The devices are being recalled because of reports of short circuit-protection…

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By: Judy Mathias
August 22, 2022
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Editorial

The 2022–2023 fiscal budget for most health facilities has now been approved. Leaders across the board are facing unprecedented challenges with retaining their staff. And those leaders who choose to invest on their teams’ professional development are seeing the best results. Most, if not all, facilities have a bucket set…

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By: Jane E. Kuhn, MSN, RN, CNOR(E), NEA-BC
August 19, 2022
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Latest Issue of OR Manager
December 2022
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