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Hospitals Prefer Existing Mechanisms To Report Device Safety Issues, Says AHA

 
• By Sue Darcey

The American Hospital Association says US FDA should build on existing safety efforts to gather evidence about medical device adverse events "rather than relying on a potentially duplicative event reporting structure," and the Medical Imaging Technology Alliance blamed device equipment servicing companies for failing to pass on information to the agency and manufacturers about equipment failures, in comments and testimony on the agency's plan to modernize evidence generation for device evaluation.

Both hospitals and manufacturers seem reluctant to change the status quo on reporting adverse events involving devices at user facilities such as hospitals, according to comments and testimony provided in response to a Dec. 5 US FDA workshop on the role of hospitals in modernizing evidence generation for device evaluation.

"The AHA recommends that FDA examine existing safety efforts, and particularly the role of patient safety organizations, to determine the...

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More from United States

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• By Ashley Yeo

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

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• By Elizabeth Orr

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

More from North America

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

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• By Elizabeth Orr

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