New RTLS Upgrade Brings Staff Duress Coverage Beyond Hospital Walls
The RTLS platform now enables panic-button protection outdoors—extending support to parking lots, garages, and walking paths.
Category: Standards
Standards
Latest
Standards
Latest
FDA Issues Early Alert on Infusion Pump Issue from Baxter
The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.
Standards
Latest
Joint Commission Unveils Major Accreditation Overhaul
In its most significant overhaul since 1965, the Joint Commission has eliminated more than 700 requirements in a new model designed to reduce burden, align with how care is delivered today, and drive better patient outcomes.
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FDA Finalizes Medical Device Cybersecurity Premarket Guidance
The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.
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Prisma Health Wins 2025 ECRI Award for Health Technology Excellence
The health system’s multi-year effort to strengthen network design, improve workflows, and prepare for outages earned recognition following its performance during Hurricane Helene.
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FDA Releases White Paper on Cybersecurity in Medical Manufacturing
New white paper highlights the need to secure operational technologies used in medical product production.
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FDA Blocks Entry of Certain Olympus Devices Over Quality Concerns
Certain import devices from Olympus’ Aizu facility in Japan will be refused entry due to outstanding quality system violations, the FDA says.
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ECRI Launches Free AI Resource Hub to Support Safe Implementation in Healthcare
ECRI has published a collection of resources that can help healthcare leaders safely integrate artificial intelligence (AI) solutions into care delivery.
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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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