AHA recommends FDA leverage existing safety efforts to improve medical device safety

The Food and Drug Administration should see how much it can leverage existing safety efforts to gather evidence and information about medical device safety, rather than relying on a separate and potentially duplicative event reporting structure, AHA told the agency today, responding to a public request for comment on the role of hospitals in modernizing evidence generation for device evaluation. Hospitals participate in a plethora of reporting and improvement activities, ranging from patient safety organizations to Hospital Improvement Innovation Networks, The Joint Commission and other federal and state initiatives, the letter notes. “Rather than creating new reporting streams, the FDA may be able to leverage existing safety reporting efforts,” wrote Ashley Thompson, AHA senior vice president for public policy analysis and development. She added, “We look forward to continuing to work with the agency to improve its own reporting process so that problems can be quickly addressed and information shared with device makers, the FDA, clinicians, and patients and their families to improve safety.”