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

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.