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.
Category: Standards
Standards
Latest
Standards
Latest
ECRI Names 2025 Safety Excellence Award Winner
The healthcare organization earned the honor for improving safety culture through leadership engagement, open communication, and data-driven risk reduction.
FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller
The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
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FDA Approves Implantable Device for Urge Urinary Incontinence
The tibial neuromodulation therapy is designed with a 15-year battery life and is MRI-compatible.
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2026 Healthcare Cybersecurity Benchmarking Study Opens for Enrollment
The study aims to provide benchmarks to help organizations prioritize investments and strengthen resilience against cyberattacks.
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House Committee Advances Medicare Coverage Bill for Breakthrough Medical Devices
AdvaMed urges inclusion of diagnostic tests in legislation that would provide four years of coverage for FDA-designated breakthrough technologies.
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Joint Commission, CHAI Release Initial Guidance for AI in Healthcare
The framework is the first step in a plan to develop governance playbooks and a voluntary AI certification program for US health systems.
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Understanding and Preventing Piggybacking Attacks in Your NetworkÂ
Piggybacking attacks exploit trust to slip past defenses, often going unnoticed until damage is done. Understanding how they work—and strengthening both digital and physical safeguards—can help reduce risk.
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Class I Recall Expanded for Alaris Pump Infusion Sets
The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.
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ECRI Convenes C-Suite Roundtables on Patient Safety and Quality Care
A new white paper shares insights from 17 healthcare executives on strengthening organizational resilience and continuous improvement.
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​​HIPAA Rule Update Needs Collaboration, Not Mandates (Editor’s Message)
Federal officials are eyeing a 2026 update to the HIPAA Security Rule, but healthcare needs a collaborative framework—not rigid mandates—to strengthen cybersecurity.
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Tandem Issues Correction for t:slim X2 Insulin Pumps
A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.
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Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error
Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier.
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SBOM Adoption Low as EU Mandate Looms, Report Finds
A new cybersecurity report finds few companies are prepared for the EU’s Cyber Resilience Act, which will require software component lists for connected devices.
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