More than 4 million recalled medical devices may harm patients in 2021. And that’s just what we can see has been “posted” on the FDA site through June 25, 2021. The number of medical device recalls issued halfway through 2021 is far higher than in the previous five years. Healthcare facilities are now facing both a higher number of recalls and a shortage of essential medical devices and products.
The FDA has noted that recalled medical devices caused almost 100,000 deaths between 2008 and 2021 — but before and after this time period? When it comes to the UDI, the FDA’s activities don’t automatically translate into protection for patients unless health providers and manufacturers are proactive.
Recalls are voluntarily done by a manufacturer. The FDA has only mandated 4 medical recalls in the entire time of their existence, which means that the safety of patients largely lies in the hands of private, commercial companies. This is the tip of the iceberg when it comes to medical device recalls and safety.
Today, manufacturers and healthcare providers don’t need to wait on the government to improve patient safety. But I still find that healthcare workers are unaware of how rampant this problem is.
Here are four things I believe healthcare workers need to know about medical device recalls to improve patient safety.
1. Recall notices don’t go to the right person
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?
2. Hospitals aren’t always told the lot number
Let’s say a healthcare facility purchases a new batch of pacemakers from a distributor. Because they’re not going through the manufacturer, the hospital is not always provided with the specific lot numbers.
A year later, the manufacturer issues recall notice for specific lot numbers.
Because the distributors don’t record the lots they’ve sold, they resend the manufacturer’s notice to all hospitals they have sold those devices too, duplicating work and causing confusion. The fate of patients is now dependent on the manual deciphering of what can often be thousands of lot numbers consisting of numbers and letters.
The manufacturer sends an additional notice to the healthcare facilities that have sold those medical devices. And for healthcare facilities that didn’t purchase from the manufacturer? They may not get that notice? There’s no way of knowing the correct medical devices to remove since most recalls do not affect the entire model.
Relying on manual tracking and documentation processes is dangerous. Hospitals either remain unaware of a recall notice and continue using dangerous medical devices or rely on individuals to sort through hundreds of lot numbers to find theirs. A mistake as simple as identifying an ‘O’ instead of a ‘0’ could cost lives.
3. Recall databases are updated by hospitals
I was once in a hospital operating room, scanning cement that was about to be used in surgery. The hospital in question relied on its subscription to the Emergency Care Research Institute (ECRI) database to receive any recalls notices.
But ECRI didn’t have all the relevant lot numbers in their database. We ended up pulling recalled cement in several hospitals.
Recall databases such as ECRI are used by healthcare facilities to find and remove recalled devices. Unfortunately, these recall companies aren’t updated by manufacturers directly in most cases, but in fact, by their own network of hospitals.
Without a fully regulated and systemized approach, this leads to incorrect or incomplete information, a lack of real-time (potentially life-saving) data, and an unreliable system.
Finding other third-party recall systems that use more than 1 of the FDA’s APIs or databases, or reaching out to a manufacturer directly, may be the safest option.
4. Most hospitals don’t have access to real-time recall data
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.
So how can healthcare workers and professionals start reducing the impact medical recall notices have on their patients?
Real-time access to medical device recall data where it matters most, at the point of care. Replace manual recall checks with workflow automation through vendors who specialize in recall identification and prevention.
Look for solutions that integrate seamlessly into clinical workflows to eliminate human error and are designed to reduce patient risk with recalled medical devices and supplies.
About Joan Melendez
Joan Melendez is the Founder and President of Xcelrate UDI. Joan has over 25 years of experience with healthcare applications, specializing in perioperative, anesthesia and trauma workflows. Melendez created Xcelrate UDI to help significantly improve patient safety with medical devices, implants and vaccines at the point of care.