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New Mobile App Notifies Patients, Caregivers and Nurses of Medical Device Recalls

Using barcode and knowledge graph technologies, the app sits on top of all other databases to provide complete and current information to users.

In a consumer-driven world where recalls for food and cars are immediately blared in emails, letters, TV commercials, and other sources, it is surprising (and yet no secret) that a similarly effective system is not put in place for medical device recalls, despite that these recalls affect the lives of many U.S. citizens.

As of July 23 of this year, there have been 30 recalled devices, all identified as Class I recalls—the most critical kind as the use of these devices can result in serious injuries or death—by the U.S. Food and Drug Administration (FDA). To put things in perspective, 32 Class I recalls total were sent out in 2018. The FDA reports that recalls affect more than 750 devices, which is nearly 50 million individual devices in the U.S.

However, the number of recalls featured in these kinds of lists often differs due to:

  • Some Class I recalls are not being included in the FDA’s annual lists.
  • Some of the entries on the list account for more than one database entry when the recall affects multiple models made by a company.

These discrepancies concerning information in the medical device supply chain add to the difficulties patients already have in learning about these recalls and result in many patients never being informed.

A recent blog post by Stericycle Services’ ExpertSolutions titled “Medical Device Trends and Why They Make for Tough Tracking” explains that one of the biggest challenges of industry is being able to quickly and effectively track recalled product. “It lags behind in its capacity to alert patients about safety issues,” says ExpertSolutions. “For the tens of millions of patients with implantable devices, they must keep their own records and then check manufacturing codes and dates of recalled products against theirs.”

Attempts have been made to fix this issue. The FDA started digitizing its records a decade ago and released its openFDA, a collection of databases that house information. However, only some of the databases cross-reference. Final Rule was also issued by the FDA requiring medical devices to have a unique device identifier (UDI) which would provide information such as the manufacturer, the specific device model, and its lot and serial numbers so that companies can more easily determine the scope of the recall.

Now Soom, a mission-based organization set on connecting medical device manufacturers, healthcare providers, home care providers, and patients, has launched an iOS mobile app called SoomSafety to bridge the gaps between sources of important healthcare information.

How it works