Why the Service Manual is the Master Key to the HTM Device Lifecycle
Service manuals aren’t optional or proprietary “extras” in a hospital. They’re required for safe maintenance and compliance, and they should be non-negotiable at purchase.
Category: Standards
Standards
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Standards
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AI Chatbots Top Annual List of Health Technology Hazards
ECRI’s report also sounds the alarm on insufficient planning for systems outages, substandard medical products, missed recalls of home diabetes management devices, and more.
Standards
Latest
FDA Clears for Augmented Reality Navigation Platform for Neurosurgery
The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.
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FDA to Accept De-identified Data for Certain Medical Devices Submissions
New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.
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Survey Reveals Disconnect Between Hospital Cybersecurity Goals and IoMT Device Risk Management Practices
43% of hospital security leaders name IoMT visibility as their top cybersecurity challenge, while internal process issues create the biggest obstacle to effective risk management.
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Advocacy Group Renews Push for Medical Right to Repair
US PIRG is surveying HTM professionals to document how repair restrictions affect patient care, downtime, and costs.
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What HTM Needs to Know About The Joint Commission’s New Accreditation Model
As Accreditation 360 rolls out in January 2026, the Joint Commission explains what’s changing, what isn’t, and how HTM teams can prepare.
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GE HeathCare Recalls Carestation Anesthesia Systems Due to Shutdown Risk
GE HealthCare is updating use instructions after reports certain systems may not switch to battery mode during AC power loss, potentially disrupting ventilation and agent delivery.
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HSCC’s AI Cyber Guidance Is a Map. HTM Pros Are the Guides (Editor’s Message)
New AI cybersecurity guidance is set to roll out in early 2026, as AI becomes more embedded in healthcare technology.
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Congress Removes Military Right to Repair Provisions from Defense Bill
Bipartisan provisions that would have expanded military access to repair data and technical information were removed from the final FY26 defense authorization bill.
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FDA Launches Digital Health Pilot for Chronic Disease Technologies
The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.
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Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue
The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.
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NOxBOXi Delivery System Correction Issued After Reports of Nitric Oxide Dose Fluctuations
The FDA issued a safety alert after users reported nitric oxide dose fluctuations, potentially leading to hypoxemia or increased pulmonary artery pressure.
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Siemens Healthineers Corrects 3 Tesla MRI Systems Over Magnet Venting Blockage Risk
The issue affects certain systems in which ice may obstruct the venting system, potentially leading to dangerous overpressure events if a magnet quench occurs.
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