New app aims to make it easier to assess device safety

Software vendor SoomSafety has built a free mobile app that enables healthcare providers and patients to ensure the safe use of a medical device.

The app enables users to receive instructions for directions on how to use, as well as safety and recall information directly from the device manufacturer and the Food and Drug Administration.

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

The app is intended to prove it can access safety and use information from scanning a medical device barcode, thanks to a FDA decision in the early 2000s to enable the use of application programming interfaces to make it easier for healthcare stakeholders to find industry information.

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This year, 26 medical devices have been recalled, affecting nearly 50 million individual devices, Kim notes, and many patients never learn of recalls because of incomplete information in the medical device supply chain. “It should be fundamental that devices are considered safe, and when they are not, that patients and providers are alerted.”

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In particular, SoomSafety is targeted at helping home care patients and caregivers ensure a product is safe. “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.”

Patients with medical devices can scan device information off the bar code of the devices, with that information stored in a database and made available if necessary to ensure the device remains safe. The app itself combs devices to assess if any safety issues arise, and SoomSafety picks up the information as well as it helps the company see how use of the app is working.

Kim got the idea for SoomSafety when his daughter became seriously ill via a medical device that threatened her life, and Kim learned the device was still being used across the industry even though it had been recalled. With launch of the app, Kim wants to develop open communication with manufacturers and consumers to accelerate use of the app and have the app work with electronic health records and enterprise resource planning applications, with manufacturers selling it to hospitals.

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