App Alerts Patients and Providers of FDA Recalls on Medical Devices


Nurses, patients, and caregivers can now have crucial information regarding medical devices sent directly to their smartphone.

A new smartphone app is providing nurses, patients, and caregivers with important Food and Drug Administration (FDA) alerts right at their fingertips — literally. The SoomSafety iOS mobile app alerts users of medical device recalls, and according to a press release from Soom, the company behind the app, it is the first of its kind.

“We built SoomSafety to help patients and caregivers relying on implanted medical devices and using medical devices at home to answer one critical question, ‘Is this medical device safe to use?’ said Charlie Kim, president and CEO of Soom, 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.”

Once downloaded, users can scan the barcode of the medical devices they use (or the barcode of the medical device identification card for those that are implanted), and then the app utilized openFDA data to tell current FDA implications. The app also stores the information, and will alert users of any recalls or FDA actions in the future.

Patients and providers alike have continued to show interest in the safety of medical devices — even when the FDA decides not to recall them, as was the case earlier this year with breast implants that may be linked to cancer and other illnesses.

In 2019 alone, there have been more than 2 dozen medical device recalls, ranging from equipment used to monitor intracranial pressure to different types of syringes. It is crucial that oncology nurses have this information on hand when treating patients.

“This year alone, 26 medical device products have been recalled, affecting nearly 50 million individual devices in the United States,” said Kim, who developed the app after a medical device recall put his daughter’s health in jeopardy.

Kim mentioned that many patients are not informed of recalls because of, “incomplete information in the medical device supply chain,” according to the statement.

“I’ve experienced first-hand what it feels like to wonder if a medical device that your loved one uses — relies on – is safe,” Kim 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.”

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