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Category: Standards
Standards
Latest
Standards
Latest
Disconnection Hazard Prompts Recall of AirLife Infant Ventilation Circuits
AirLife and manufacturer Vyaire are recalling certain infant heated wire circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature.
Medtronic Recalls Certain Newport Ventilators and Related Service Parts
Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.
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Zyno Medical Recalls Infusion Pumps Over Software Issue
Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.
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Advocate Health, Joint Commission Partner on Systemwide Accreditation Initiative
The initiative aims to enhance patient safety, care quality, and performance consistency across 69 hospitals.
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Medtronic Removes Tracheostomy Tube Over Risk of Flange Disconnection
Medtronic advises customers to return affected adult flexible tubes due to potential airway blockage and respiratory emergencies.
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Baxter Issues Correction for Novum IQ Infusion Pump Over Underinfusion Risk
The correction follows reports that extended standby time or leaving the pump powered off with an administration set loaded may reduce flow delivery.
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New Artificial Heart Technology Earns FDA Breakthrough Device Designation
The clinical-stage company earns the regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use.
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FDA Flags Three Infusion Pump Corrections from Smiths Medical as Class I Recalls
Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.
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Small Medical Practices Face Outsized Fallout from Health Data Breaches, Report Finds
New modeling shows long-term financial consequences for practices without strong cybersecurity and HIPAA safeguards.
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Right to Repair Clears Texas Legislature with Unanimous Support
If signed into law, Texas would become the ninth state to enact Right to Repair legislation.
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Joint Commission and NQF Reveal 2024 Eisenberg Award Honorees
The Joint Commission and NQF have announced the 2024 Eisenberg Award recipients, recognizing national, local, and individual achievements in patient safety and healthcare quality.
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Medical Device Recall Volume Hits Three-Year Low, But Class I Events Rise
While total recalls and units affected declined in Q1 2025, the number of Class I events increased.
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Tariff Pressures May Be Driving Advance Buying of Elective-Use Medical Devices
New data indicate increased spending on certain medical devices, though trends vary across procedures.
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