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.
Category: Standards
Standards
Latest
Standards
Latest
How Gaps in Requirements Traceability Fuel Recalls and Injuries
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
Standards
Latest
Playbook for Managing Connected Medical Devices
A seven-step guide to managing and securing connected medical devices across healthcare delivery organizations.
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Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks
A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.Â
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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.
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BD Recalls Alaris Pump Modules Serviced With Previously Recalled Parts
The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.
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SunMed Holdings Removes Adult Manual Resuscitator Devices
The Class I recall involves devices with incorrectly assembled B/V filters.
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BD Recalls Certain Alaris Pump Infusion Sets Over Accuracy Issues
Use with select infusion sets may lead to over- or under-infusion, bolus inaccuracies, and alarm delays, BD warns in recall notice.
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Senate NDAA Includes Right-to-Repair Provision for Military Equipment
Advocacy groups urge the House to adopt similar language in its version of the bill.
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Lake Havasu City Physical Therapist Dies in Hyperbaric Chamber Fire
Walter Foxcroft III was killed in a flash fire inside a hyperbaric chamber, according to the Lake Havasu City Fire Department. Foxcroft was the founder of Havasu Health and Hyperbarics, where the incident occurred.
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Disconnection Hazard Prompts Recall of AirLife Infant Ventilation Circuits
AirLife and manufacturer Vyaire are recalling certain infant heated wire circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature.
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Bipartisan Bill Would Expand Military’s Right to Repair Equipment
The newly introduced legislation would require all military branches to include right to repair provisions in contracts, aiming to cut costs and improve readiness.
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HL7 Launches AI Office to Develop Standards for Artificial Intelligence in Healthcare
New initiative aims to create global standards for transparent, interoperable, and safe AI in clinical and operational settings.
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AMMA, AdvaMed Back Key Measures in ‘One Big Beautiful Bill’
The bill, signed into law on July 4, includes tax, trade, and investment provisions that industry groups say will support domestic manufacturing and medtech innovation.
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