In an effort to “close the gap” between the FDA, medical device manufacturers and consumers and/or caregivers, Soom has developed the first app that uses FDA’s open-source database (open FDA) to deliver device instructions for use, safety and recall information right to the user. With the SoomSafety app, users scan the barcode on a medical device, and the app then identifies the device and stores it. Any devices stored in the app are checked for recall information (in addition, when a recall is initiated, the app sends a push notification to the user and informs of next steps). For implantables such as pacemakers or artificial joints, the user scans the barcode on the patient medical device identification card.
“We built SoomSafety to help patients and caregivers relying on implanted medical devices and using medical devices at home answer one critical question, ‘Is this medical device safe to use?'” said Charlie Kim, president and CEO of Soom, in a press release. “Our technology makes it possible to connect previously siloed medical device data, giving patients—and their caregivers—more proactive control over their health and safety.”
The SoomSafety app is available for iOS devices only and can be downloaded from the Apple App store