Tracking down 48,000 malfunctioning pacemakers

Joan Melendez, founder and president of Xcelrate UDI, which uses barcode scanning and UDI tracking to communicate information about recalled medical products and devices, explains how it can help going about tracking devices down that have been recalled. 

A decades’ worth of pacemakers were recalled this August. The safety mode that was supposed to provide a helpful backup, became a life-threatening fault.

There are now 48,000 harmful pacemakers out there. 65 incidents have been reported, and there are no deaths -- that we know of. The truth may be very different, considering only 1-10% of adverse events are usually reported.

Are all 48,000 pacemakers implanted? Where are these patients? How many have malfunctioned and gone unreported? Without effective tracking tools, it’s hard to know.

And this is just the tip of the iceberg when it comes to medical device recalls.

The 70-year-old problem of medical recalls

The medical device recall database covers just one out of ten FDA databases/APIs that are known to have inconsistent and/or incomplete information on medical device recalls. 

The FDA estimates that 83,000 people have died because of recalled medical devices from 2008 - 2018. But the evidence points to a higher number.

In 1985, the recalled Dalkon Shield birth control device caused infections, sterility, spontaneous abortions, and multiple deaths. After thousands of women suffered, the company shortly went out of business. 34 years later in 2019, 38.8 million fluid transfer system bags were recalled. In 2020, thousands of recalled insulin pumps caused injuries and one death.

Just from these cases (that both sit outside of that timeline) we can safely assume the total number far exceeds that.

Now let’s go back to the pacemaker recall. This isn’t the first recall Boston Scientific has put out -- and it’s not the first time a pacemaker has been recalled either. The manufacturer has issued over 500 medical recall notices, and 239 pacemakers have been recalled. Again, these are just the numbers from the FDAs medical device recall database, with data which can be out of date or completely inaccurate. Recalls can be missing entire lot numbers or other trackable UDI values.

Before we get into how to stop recalls from harming patients, we have to ask -- what is a more accurate estimate of the harm recalled medical devices and products have done? And why is this information so hard to track down?

More recalls + inefficient data management = chaos

The number of recalls posted for the first half of 2021 surpasses that of the same time period for the previous five years. Amid the pandemic and a fourth wave, healthcare staff relying on manual processes and incomplete datasets are struggling to manage the effects. It’s an old problem exacerbated by new circumstances. Let’s look at how this has played out in the past.

In 2018, the pharmaceutical company Bayer stopped selling Essure, its permanent birth control device. The next year, it issued a recall.

The latest data indicates that over 5,000 women had adverse events related to this, counting over 2,000 hysterectomies. There were 101 reported deaths. But the numbers are much higher than we think and unfortunately, underreported.

Adverse events are often not reported due to cumbersome and outdated reporting methods. And in most cases the medical device unique device identification (UDI) or descriptions aren’t even known by the person reporting the adverse event.

For example, in the ‘Type of event’ column, one individual typed ‘serious injury’. But in another column wrote “She has passed away [PT: Death] she was a sufferer of essure. Had it removed last year [PT: Adverse event]”.

The correct way to do this would be to input ‘death’ under the ‘Type of event’ column.

A small mistake like this leads to inaccurate reporting and can potentially lead to more patient harm. A manufacturer may assume that only a small percentage of adverse events are happening because of misinterpretation or incorrect manual data entry.

The impact of manual processes and bad data management goes far beyond this. Manufacturers send recall notices by mail that can then take months before the recalled items are removed from inventory.

Humans trying to locate the exact recalled products or devices by looking over thousands of numbers inevitably leads to some being missed.

And tracking and communicating with patients that had an implant sometimes more than a decade ago becomes virtually impossible. Let’s look at the solutions -- and why they aren’t being adopted on a large scale.

Automate workflows with healthtech system to save time, money and lives

In 2018 the FDA’s Unique Device Identification system (UDI) went into effect for Class II and Class III medical devices. But many manufacturers are still unaware of this regulation or need; even worse, many healthcare professionals are unaware of their requirements for documentation of the UDI.

Thankfully there are ways healthcare facilities, manufacturers and government agencies can start using tech-based systems to protect patients and save time and money.

Scanning the UDI provides the device identifier (UDI-DI) and the product identifiers (UDI-PI) (ex: lot, and/or serial number, expiration date). Instead of manually typing in each UDI data element, scanning the UDI provides life-saving information in seconds.

Is this device recalled? Is this device expired? Scan the UDI and find out. The current alternative is manually searching through numerous FDA databases (that are not always up to date) to find that products’ UDI.

Trying to manually track down all 48,000 Boston Scientific pacemakers is a daunting and impossible task. UDI information such as the serial number is often hard to find in clinical documentation. Was it even documented?

If the UDI has been used correctly, healthtech systems can easily locate the affected pacemakers. Adverse events can be easier to report and analyse.

The FDA has numerous databases, as does every manufacturer. By using the UDI system, healthcare professionals and manufacturers would be able to access real-time data. And recalled and expired devices can be prevented from use.