Supply Chain/Technology

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February 2025
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FDA: Class I recall of Baxter Clearlink Basic Solution Set with Duovent

Editor's Note The Food and Drug Administration (FDA) on September 15 identified Baxter Healthcare Corporation’s recall of its ClearLink Basic Solution Set with Duovent as Class I, the most serious. The recall was initiated because of the risk for leaks that may expose providers and patients to hazardous toxic substances…

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By: Judy Mathias
September 19, 2022
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FDA: Class I recall of Medtronic Xomed NIM Contact, NIM Standard Reinforced EMG Endotracheal Tubes

Editor's Note The Food and Drug Administration on September 12 identified the recall by Medtronic Xomed of its NIM Contact Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube as Class I, the most serious. The recall was initiated after Medtronic Xomed received customer complaints about obstruction of…

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By: Judy Mathias
September 14, 2022
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AHA releases part 3, final workforce guide series

Editor's Note The American Hospital Association (AHA) on September 7 released part three of a three-part series of its workforce guide focused on strategies, resources, and case studies from hospitals and other health systems. The AHA Board of Trustees’ Task Force on Workforce provided guidance for the series with input…

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By: Tarsilla Moura
September 9, 2022
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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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