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Tracking 48,000 Malfunctioning Pacemakers-Med-Tech Innovation

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Joan Melendez, Founder and President of Xcelrate UDI, uses barcode scanning and UDI tracking to convey information about recalled medical products and devices, and explains how they can help track recalled devices.

Decades of pacemakers were recalled in August of this year. The safe mode, which was supposed to provide a useful backup, has become a life-threatening obstacle.

Currently, there are 48,000 harmful pacemakers. 65 cases have been reported and no one we know of. The truth can be very different, given that usually only 1-10% of adverse events are reported.

Are all 48,000 pacemakers embedded? Where are these patients? How many people have been reported malfunctioning? Without an effective tracking tool, it’s hard to know.

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

70-year-old problem with medical recall

The medical device recall database covers one-tenth of the FDA databases / APIs where information about medical device recalls is known to be inconsistent or incomplete.

The FDA estimates that 83,000 people died from medical device recalls between 2008 and 2018. But the evidence shows more numbers.

In 1985, the recalled Dalcon Shield contraceptive device caused infections, infertility, spontaneous abortion, and multiple deaths. The company went out of business shortly after thousands of women suffered. In 2019, 34 years later, 38.8 million liquid transfer system bags were recalled. In 2020, thousands of recalled insulin pumps were injured and one died.

From these cases (both outside that timeline), you can safely infer that the total number is well above that.

Now let’s return to the pacemaker recall. It’s not the first recall from Boston Scientific. This is not the first time a pacemaker has been recalled. Manufacturers have issued over 500 medical recall notices and 239 pacemakers have been recalled. Again, these are numbers from the FDA’s Medical Device Recall Database, and the data may be out of date or completely inaccurate. The recall may be missing the entire lot number or other traceable UDI values.

Before we get into ways to prevent recalls from harming patients, we need to ask what is a more accurate estimate of the harm done by the recalled medical device or product. And why is it so difficult to track this information?

More recalls + inefficient data management = mess

The number of recalls posted in the first half of 2021 has exceeded that of the same period in the last five years. In the pandemic and the fourth wave, medical staff relying on manual processes and incomplete datasets are struggling to manage their impact. The old problem was exacerbated by the new situation. Let’s see how this has been done in the past.

In 2018, pharmaceutical company Bayer stopped selling Essure, a permanent contraceptive. The following year, we issued a recall.

The latest data show that more than 5,000 women had associated adverse events, counting more than 2,000 hysterectomy. 101 deaths were reported. But that number is far higher than we think, and unfortunately it is underreported.

Adverse events are often not reported due to the cumbersome and outdated reporting method. And, in most cases, the unique device identification (UDI) or description of a medical device is not even known to the person reporting the adverse event.

for example,[イベントの種類]In the column, one individual entered a serious injury.But another column wrote she died[PT: Death] She was suffering from a grudge.Did you delete it last year? [PT: Adverse event]..

The correct way to do this is[イベントのタイプ]Entering death in the column.

Such small mistakes can lead to inaccurate reporting and harm to more patients. The manufacturer may assume that only a small portion of the adverse event has occurred due to misinterpretation or incorrect manual data entry.

The impact of manual processes and improper data management goes far beyond this. The manufacturer will send you a recall notification by email, but it may take several months for the recalled item to be removed from inventory.

People who look through thousands of numbers to find exactly the recalled product or device will inevitably miss some.

It also makes tracking and communication of patients who received implants more than 10 years ago virtually impossible. Let’s take a look at the solutions-and why they haven’t been adopted on a large scale.

Save time, money and lives by automating workflows with Healthtech systems

In 2018, the FDAsUnique Device Identification System (UDI) came into effect for Class II and Class III medical devices. However, many manufacturers are not yet aware of this regulation or need. To make matters worse, many healthcare professionals are unaware of the UDI documentation requirements.

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

Scanning the UDI will provide you with a device identifier (UDI-DI) and product identifier (UDI-PI) (eg lot, serial number, expiration date). Instead of manually entering each UDI data element, scanning the UDI provides life-saving information in seconds.

Will this device be recalled? Is this device expired? Scan the UDI to find out. The current alternative is to manually search a large number of FDA databases (not always up to date) to find the UDI for that product.

Manually tracking the 48,000 Boston Scientific pacemakers can be a daunting and impossible task. UDI information, such as serial numbers, is often difficult to find in clinical documentation. Was it also documented?

If the UDI is used correctly, the health tech system can easily find the affected pacemaker. Adverse events can be easier to report and analyze.

As with all manufacturers, the FDA has a large number of databases. The UDI system gives healthcare professionals and manufacturers access to real-time data. You can also prevent the use of recalled and expired devices.

Sources

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2/ https://www.med-technews.com/medtech-insights/medtech-regulatory-insights/tracking-down-48-000-malfunctioning-pacemakers/

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