Regulation, safety alerts, standards and technology from the world of anesthesia, infusion and respiratory equipment, including how artificial intelligence is changing medical devices. Each story is summarised in plain language with a link to the original source.
Photo: FritzchensFritz (CC0)A JAMA Network Open research letter reviewed 163 AI devices cleared between 2015 and 2021 and found that most updates reported no clinical or organizational benefit.
Photo: The U.S. Food and Drug Administration (Public domain)More than 500 comments reached the FDA on its August discussion paper. Manufacturers want to build on current rules; patient and physician groups want stronger postmarket monitoring.
Photo: Senior Airman Andrea Posey/U.S. Air Force (Public domain)Certain sets used with the Alaris Pump Module 8100 may deviate from programmed flow below 1 mL/h and at small bolus volumes, with delayed occlusion alarms.
A new review in npj Digital Medicine finds that closed-loop control is rare, interoperability is weak and data security is inconsistent in AI-enabled infusion systems.
Photo: Stefan Bellini (CC0)A Research and Markets report projects the market to reach USD 25.39 billion by 2035, with AI, IoT connectivity and EHR integration cited as growth drivers.
Photo: almathias (CC0)Under the Digital Omnibus agreement, AI built into regulated products such as medical devices gets an extra year, while the risk tiers and obligations stay the same.
A manufacturing error may cause the piston ventilator in Atlan A350 and A350 XL machines to fail before or during a procedure. Dräger is replacing the ventilator motor assembly.
Certain Carestation 620, 650 and 750 series machines may not ventilate effectively in Volume Control Ventilation mode, which could lead to hypoxia.
A single lot of Ivenix large volume pump administration sets was assembled with the drip chamber and Luer lock reversed, which can cause reverse flow.
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