Healthcare staff need access to real time data, says Joan Melendez

The FDA has estimated that around 83,000 people died due to recalled medical devices between 2008 and 2018. But this problem has been around for decades, so we know the number is much higher. The question is, does everyone else know?

We’re improving patient safety in two main ways: providing helpful healthtech tools, and education. Whether it’s promoting patient advocacy or providing tips for healthcare staff, we believe individuals should be fully informed in order to make the best and safest decisions.

Our Founder and President Joan Melendez, published an article in HIT Consultant filling in some of the information gaps around medical recalls for healthcare staff:

After a hospital purchases medical devices and supplies, the supply chain manager, quality manager and/or hospital leadership are notified of the recall.

It can take months to find its way to the individuals that can remove the recalled medical device from inventory. To make matters worse, recall notices are mailed, and this in itself could take weeks — or never arrive. And so the recalled medical device could still be endangering lives.

Establishing new lines of communication internally, as well as with the FDA and manufacturers, is something all healthcare facilities should be able to do, and could potentially save lives. 

Don’t be afraid to ask — who are the recall notices being delivered to, how are they being delivered, and can the process be improved?

But one of the biggest and most critical issues? Access to real time data. Without this, healthcare staff are forced to make decisions based on potentially inaccurate or out of date data. 

Joan comments on this issue, and how it has played out in real time:

On January 13, 2021, Silk Road initiated a recall of 5 lot numbers of a medical device. They later sent out 3 additional recall notifications, 4 separate notices, that totaled 104 lot numbers. 

The FDA took 41 days and on February 23, 2021, posted the recall incorrectly, with only the initial 5 lot numbers. 5 months later, and several emails from myself to the FDA, and still only 5 lot numbers are displayed in the FDA’s APIs and databases. 

The other 101 lots will now remain undetected by hospitals unless they understand that four notifications had been sent. This recalled product continues to be used with patients, potentially resulting in injury. 

Hospitals should be able to rely on the FDA recall website or third-party recall systems for up-to-date and accurate medical recall data. But as we can see, data isn’t always reliable or timely. 

Along with incomplete and missing data, the Silk Road case demonstrates the dangerously long amount of time it takes for data to be shared. How many of Silk Road’s recalled products have been used (or are still in a hospital’s inventory) since January? It’s impossible to know. 

If your healthcare facility is struggling with these problems, we can help.

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