The stakes are high when it comes to medical device safety, but recall notifications aren’t always easy to find.
With this in mind, a new Boston-based startup called Soom is aiming to target this issue with its new app, called SoomSafety. The app lets users scan the bar code of a medical device to bring up all safety and recall information about the product.
Soom pulls from the FDA’s open-source database to identify recalled products. Once a user has entered a device on their system, the app will keep this information stored and can alert a user if one of their devices has been recalled.
If a user’s product has been recalled the system is able to give them resources on what to do next. The Boston-based startup is pitching this as a technology that can be used by patients, caregivers and clinical teams alike.
WHY IT MATTERS
Medical device recalls are not so uncommon, and the consequences can be severe. In 2019, there have been more than 25 medical device recalls so far, according to the FDA.
For example, just a few weeks ago the FDA issued an alert warning that some insulin pumps from Medtronic are vulnerable to hackers, potentially allowing these hackers to remotely gain access and control them. This prompted Medtronic to issue a recall of its MiniMed 508 and MiniMed Paradigm series of insulin pumps.
With a focus on transparency and safety, the FDA has been making a push to release more reports of product safety. For example, in June the agency released 6 million reports of adverse medical device events, according to Modern Healthcare.
But this isn’t the first time that the FDA made efforts to provide more information to the public. In 2015, the agency launched a database to allow patients, providers and product manufacturers to access information tracked on medical devices.
ON THE RECORD
"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."