Tag: safety

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FDA Issues Early Alert on React Health VOCSN Ventilators Over Cable Issue

Unseated internal flow transducer connectors can trigger device reboots and therapy interruptions, prompting updated checkout and handling protocols.

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FDA Issues Warning Letter to Zoll Medical Over Quality System Violations

The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.

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Barcode Medication Scanners Identified as Key Safeguard in ICU Near-Miss Events

A study of 288 critical care incidents found barcode scanning technology and nurse intervention frequently stopped potential patient harm before it occurred.

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FDA Issues Early Alert on React Health VOCSN Ventilators Over Cable Issue

Unseated internal flow transducer connectors can trigger device reboots and therapy interruptions, prompting updated checkout and handling protocols.

FDA Issues Recall Alert for B Braun Medical Hemodialysis Blood Tubing Set

Nov 20, 2025

The alert follows reports of damaged patient connectors that could introduce micro-air bubbles, trigger air-in-line alarms, and lead to treatment delays or blood loss during hemodialysis.

ECRI Names 2025 Safety Excellence Award Winner

Nov 12, 2025

The healthcare organization earned the honor for improving safety culture through leadership engagement, open communication, and data-driven risk reduction.

ECRI Announces Winners of 2025 Alerts Impact Award

Nov 4, 2025

The annual award recognizes excellence in recall management among healthcare institutions worldwide.

Building an AI Roadmap That Balances Vision with Value

Oct 28, 2025

A deliberate approach to AI adoption helps health systems achieve real impact while upholding safety and trust.

Why Post-Market Surveillance Is the Real Test of Medical Device Safety

Oct 8, 2025

Effective post-market surveillance depends on HTM teams to bridge the gap between regulatory oversight and real-world performance.

Joint Commission Names Inaugural Recipient of the 2025 Healthcare Innovation Award

Sep 24, 2025

Tampa General Hospital is honored for integrating new strategies and technologies to improve patient safety and care quality.

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FDA Announces Class I Recall for ICU Medical Infusion Pump

A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.