ECRI Announces Winners of 2025 Alerts Impact Award
The annual award recognizes excellence in recall management among healthcare institutions worldwide.
Category: Standards
Standards
Latest
Standards
Latest
FDA Expands Early Alert Program for High-Risk Device Issues
The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.
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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US and Global Agencies Release ‘Shared Vision’ of Software Bill of Materials for Cybersecurity
The guidance promotes the use of a Software Bill of Materials to increase transparency in the software supply chain, impacting medical device security and vulnerability management.
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The Cybersecurity Threat Lurking in Legacy Medical Devices
Why HTM teams must treat “old but working” as a high-stakes cyber risk—and how to protect patients and operations now.
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Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
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CISA Issues Draft Guide for Software Bill of Materials
The updated voluntary guidance reflects the evolution of SBOM practices and aims to help organizations better manage software supply chain risks.
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Federal Wheelchair Right to Repair Act Introduced in Congress
The proposed legislation would require manufacturers to provide parts, documentation, and tools, following similar laws passed in four states.
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Hamilton Medical Removes Breathing Circuits Over Serious Ventilation Risk
The devices may have cracks that could lead to patient rebreathing of exhaled gases.
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FDA Issues Class I Recall for Ambu Manual Resuscitators
The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.
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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.
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Hamilton Medical Corrects C6 Ventilators Over Circuit Board Defect
The FDA has issued a Class I recall designation for the correction, which addresses a fault that can cause ventilation to stop unexpectedly.
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AdvaMed Urges CMS to Revise Proposed DME Competitive Bidding Rule
The medtech association cites risks to patient safety, reduced competition, and potential cost increases if the rule is implemented as is.
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