Healthcare technology company Soom has launched a mobile app that provides patients, nurses, and caregivers medical device recall information directly from the device manufacturer and U.S. Food and Drug Administration.
The company says it is the first mobile app to close the information gap between the U.S. FDA, manufacturers and medical device users.
"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?'" Charlie Kim, president and CEO of Soom, said in a statement. "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."
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Soom is a Boston-based company that provides a cloud-based enterprise software-as-a-service platform.
The app uses openFDA, an open-source database that enables developers to use FDA data in applications.
Companies have issued 26 medical device recalls in 2019, affecting nearly 50 million individual devices in the United States.
Many patients are never informed of these recalls due to incomplete information in the medical device supply chain, Kim said.
Users of the app can scan the barcode on a medical device, such as an insulin pump, nebulizer or apnea monitor, to automatically identify the device and store it in the app. The app also identifies and stores implanted medical devices like artificial joints, pacemakers and heart valves by scanning the barcode on a patient's medical device identification card.
Once a device is stored, the app checks for FDA recall information, provides next steps in the event of a recall and pushes notifications if the device is ever recalled. In addition, the app displays safety and use information for each stored device, according to the company.
Kim said the idea for the moble app was prompted by his own personal experience with a medical device recall that impacted one of his family members.
"I've experienced first-hand what it feels like to wonder if a medical device that your loved one uses—relies on—is safe," he said. "It's a feeling that no patient, parent or caregiver should have to endure. That's why at Soom we're dedicated to finding new ways to use technology to ensure clarity and confidence in the medical devices we use."