The Importance of Barcode Quality

The Importance of Barcode Quality

Barcodes that fail to scan, or scan incorrectly are a nuisance and an expense. But the damage they do goes much deeper. Consider two recent FDA recalls.

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Case #1 Novum IQ Syringe Pump

The manufacturer, Baxter Healthcare Corporation, is recalling this device which FDA identified as a Class 1 recall, a risk of serious injury or death. The problem is a software glitch that causes the pump to incorrectly calculate dosage. The recall includes all serial numbers produced in 2023.

Case #2 Single-Use Syringes

Leakage and an unknown black material inside syringes made by Fresenius Medical Care have led to an FDA Class 1 recall. Almost 12.5 million Sanxin Single User Sterile Syringes were involved.

Here is another situation where the barcode can make a difference.

During the manufacturing process at Medtronic, a quantity of McGrath Mac laryngoscopes failed to pass inspection and were isolated. Unfortunately, they were subsequently stolen. The manufacturer issued a public safety notification, and the FDA issued a Class 1 recall.  Nearly 6,000 devices were affected.

Why is barcode quality important? The barcode on a medical device identifies not just the product, but the date and place of manufacture, the serial and lot or batch number, the production date and expiration, and a host of other important attributes. If the barcode does not work right, a recall would be much less targeted, and far more disruptive and expensive.

Dangerous, defective products often look identical to products that work perfectly. Only the barcode can identify a recalled product and distinguish it from a valid one, and only if that barcode works right.

While it is true that a barcode verifier seems to be expensive, the larger truth is that they pay for themselves. Barcode verifiers prevent the expense of a broken supply chain and disappointed trading partners. They prevent the potential harm a defective medical device can inflict, and they can even prevent incorrect bedside dosing and the liability of wrongful death. Compared to that, the cost of a barcode verifier is negligible.

Barcode-Test LLC

Questions or comments? Contact us here. Or download our free Step by Step Guide to Barcode Quality.