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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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